Ankylosing spondylitis

MILAN – High-intensity interval training (HIIT) has been shown to enhance cardiorespiratory fitness (CRF) and mitigate cardiovascular disease (CVD) risk factors in patients with inflammatory joint diseases (IJD) in a randomized trial. Notably, the positive response in CRF did not coincide with changes in pain or fatigue.

Kristine Norden, of the Center for Treatment of Rheumatic and Musculoskeletal Diseases, Norwegian National Advisory Unit on Rehabilitation in Rheumatology, Diakonhjemmet Hospital, Oslo, presented the late-breaking results of the ExeHeart trial at the annual European Congress of Rheumatology. The trial aimed to evaluate the short- and long-term effects of 12 weeks of supervised HIIT in patients with IJD.

Viktor Cap/Thinkstock

Ms. Norden said in an interview that “HIIT is a feasible physiotherapeutic intervention with sustainable effects in patients with IJD. It does not exacerbate symptoms of IJD and can be implemented in primary care settings.”
 

The trial

The ExeHeart trial is a randomized controlled trial designed to assess the effects of HIIT on CRF, CVD risk, and disease activity in patients with IJD. The trial is a collaborative effort with patient research partners and aligns with patients’ requests for effective nonpharmacologic treatments. The outcomes being evaluated include CRF (primary outcome), CVD risk factors, anthropometric measures, disease activity, and patient-reported outcomes related to pain, fatigue, disease, physical activity, and exercise.

A total of 60 patients with IJD were recruited from the Preventive Cardio-Rheuma clinic at Diakonhjemmet. They were randomly assigned to receive either standard care (including relevant lifestyle advice and cardiopreventive medication) or standard care along with a 12-week HIIT intervention supervised by physiotherapists. Assessments were conducted at baseline, at 3 months (primary endpoint), and at 6 months post baseline. There was no supervised intervention between the 3- and 6-month time points.

The median age of the participants was 59 years, with 34 participants (57%) being women. The types of IJD among the participants included rheumatoid arthritis in 45%, spondyloarthritis in 32%, and psoriatic arthritis in 23%. Furthermore, 49 patients (82%) had a high risk for CVD.

The participants were divided into two groups: a control group (n = 30) and a HIIT group (n = 30). The HIIT group underwent a 12-week intervention consisting of twice-a-week supervised 4x4-minute HIIT sessions at 90%-95% of peak heart rate, alternated with moderate activity at 70%. The control group engaged in unsupervised moderate-intensity exercise sessions. The primary outcome measured was the change in CRF, assessed through peak oxygen uptake (VO_{2 max}) using a cardiopulmonary exercise test. Secondary outcomes – pain and fatigue – were evaluated using a questionnaire (Numeric Rating Scale 0-10, where 0 represents no pain or fatigue).

Following HIIT, a statistically significant difference was observed in VO_{2 max} (2.5 mL/kg per min; P < .01) in favor of the exercise group at 3 months, while no significant differences were found in pain and fatigue. This discrepancy in VO_{2 max} between the groups was maintained at 6 months (2.6 mL/kg per min; P < .01), with no notable disparities in pain and fatigue. A per-protocol analysis at 3 months demonstrated a difference in VO_{2 max} between the groups (3.2 mL/kg per min; P < .01).

Ms. Norden concluded that the clinical implications of these findings are significant, as increased CRF achieved through HIIT reflects an improvement in the body’s ability to deliver oxygen to working muscles. Consequently, this enhancement in CRF can lead to overall health improvements and a reduced risk for CVD.
 

Long-lasting effects

Christopher Edwards, MBBS, MD, honorary consultant rheumatologist at University Hospital Southampton (England) NHS Foundation Trust Medicine, University of Southampton, was concerned about future maintenance of increased CRF. “I really wish we had data on these patients at 12 months as well, so we could see if the effects last even longer. Regarding intensity, there are clear indications that engaging in moderate and high-intensity workouts is more beneficial,” Dr. Norden said. “So, I would certainly recommend at least one high-intensity exercise session per week for those patients, while also incorporating lower and moderate-intensity exercises if desired. However, for individuals aiming to maximize their oxygen uptake, high-intensity exercise is considered the most effective approach.”

There is compelling evidence supporting the benefits of physical activity in improving disease activity among patients with IJD, making it a critical component of nonpharmacologic treatment. However, individuals with rheumatic and musculoskeletal conditions generally exhibit lower levels of physical activity, compared with their healthy counterparts. Recognizing the importance of CVD prevention in patients with IJD, EULAR recommends routine CVD screening for individuals diagnosed with IJD.

Ms. Norden and coauthors report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

MILAN – High-intensity interval training (HIIT) has been shown to enhance cardiorespiratory fitness (CRF) and mitigate cardiovascular disease (CVD) risk factors in patients with inflammatory joint diseases (IJD) in a randomized trial. Notably, the positive response in CRF did not coincide with changes in pain or fatigue.

Kristine Norden, of the Center for Treatment of Rheumatic and Musculoskeletal Diseases, Norwegian National Advisory Unit on Rehabilitation in Rheumatology, Diakonhjemmet Hospital, Oslo, presented the late-breaking results of the ExeHeart trial at the annual European Congress of Rheumatology. The trial aimed to evaluate the short- and long-term effects of 12 weeks of supervised HIIT in patients with IJD.

Viktor Cap/Thinkstock

Ms. Norden said in an interview that “HIIT is a feasible physiotherapeutic intervention with sustainable effects in patients with IJD. It does not exacerbate symptoms of IJD and can be implemented in primary care settings.”
 

The trial

The ExeHeart trial is a randomized controlled trial designed to assess the effects of HIIT on CRF, CVD risk, and disease activity in patients with IJD. The trial is a collaborative effort with patient research partners and aligns with patients’ requests for effective nonpharmacologic treatments. The outcomes being evaluated include CRF (primary outcome), CVD risk factors, anthropometric measures, disease activity, and patient-reported outcomes related to pain, fatigue, disease, physical activity, and exercise.

A total of 60 patients with IJD were recruited from the Preventive Cardio-Rheuma clinic at Diakonhjemmet. They were randomly assigned to receive either standard care (including relevant lifestyle advice and cardiopreventive medication) or standard care along with a 12-week HIIT intervention supervised by physiotherapists. Assessments were conducted at baseline, at 3 months (primary endpoint), and at 6 months post baseline. There was no supervised intervention between the 3- and 6-month time points.

The median age of the participants was 59 years, with 34 participants (57%) being women. The types of IJD among the participants included rheumatoid arthritis in 45%, spondyloarthritis in 32%, and psoriatic arthritis in 23%. Furthermore, 49 patients (82%) had a high risk for CVD.

The participants were divided into two groups: a control group (n = 30) and a HIIT group (n = 30). The HIIT group underwent a 12-week intervention consisting of twice-a-week supervised 4x4-minute HIIT sessions at 90%-95% of peak heart rate, alternated with moderate activity at 70%. The control group engaged in unsupervised moderate-intensity exercise sessions. The primary outcome measured was the change in CRF, assessed through peak oxygen uptake (VO_{2 max}) using a cardiopulmonary exercise test. Secondary outcomes – pain and fatigue – were evaluated using a questionnaire (Numeric Rating Scale 0-10, where 0 represents no pain or fatigue).

Following HIIT, a statistically significant difference was observed in VO_{2 max} (2.5 mL/kg per min; P < .01) in favor of the exercise group at 3 months, while no significant differences were found in pain and fatigue. This discrepancy in VO_{2 max} between the groups was maintained at 6 months (2.6 mL/kg per min; P < .01), with no notable disparities in pain and fatigue. A per-protocol analysis at 3 months demonstrated a difference in VO_{2 max} between the groups (3.2 mL/kg per min; P < .01).

Ms. Norden concluded that the clinical implications of these findings are significant, as increased CRF achieved through HIIT reflects an improvement in the body’s ability to deliver oxygen to working muscles. Consequently, this enhancement in CRF can lead to overall health improvements and a reduced risk for CVD.
 

Long-lasting effects

Christopher Edwards, MBBS, MD, honorary consultant rheumatologist at University Hospital Southampton (England) NHS Foundation Trust Medicine, University of Southampton, was concerned about future maintenance of increased CRF. “I really wish we had data on these patients at 12 months as well, so we could see if the effects last even longer. Regarding intensity, there are clear indications that engaging in moderate and high-intensity workouts is more beneficial,” Dr. Norden said. “So, I would certainly recommend at least one high-intensity exercise session per week for those patients, while also incorporating lower and moderate-intensity exercises if desired. However, for individuals aiming to maximize their oxygen uptake, high-intensity exercise is considered the most effective approach.”

There is compelling evidence supporting the benefits of physical activity in improving disease activity among patients with IJD, making it a critical component of nonpharmacologic treatment. However, individuals with rheumatic and musculoskeletal conditions generally exhibit lower levels of physical activity, compared with their healthy counterparts. Recognizing the importance of CVD prevention in patients with IJD, EULAR recommends routine CVD screening for individuals diagnosed with IJD.

Ms. Norden and coauthors report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

MILAN – High-intensity interval training (HIIT) has been shown to enhance cardiorespiratory fitness (CRF) and mitigate cardiovascular disease (CVD) risk factors in patients with inflammatory joint diseases (IJD) in a randomized trial. Notably, the positive response in CRF did not coincide with changes in pain or fatigue.

Kristine Norden, of the Center for Treatment of Rheumatic and Musculoskeletal Diseases, Norwegian National Advisory Unit on Rehabilitation in Rheumatology, Diakonhjemmet Hospital, Oslo, presented the late-breaking results of the ExeHeart trial at the annual European Congress of Rheumatology. The trial aimed to evaluate the short- and long-term effects of 12 weeks of supervised HIIT in patients with IJD.

Viktor Cap/Thinkstock

Ms. Norden said in an interview that “HIIT is a feasible physiotherapeutic intervention with sustainable effects in patients with IJD. It does not exacerbate symptoms of IJD and can be implemented in primary care settings.”
 

The trial

The ExeHeart trial is a randomized controlled trial designed to assess the effects of HIIT on CRF, CVD risk, and disease activity in patients with IJD. The trial is a collaborative effort with patient research partners and aligns with patients’ requests for effective nonpharmacologic treatments. The outcomes being evaluated include CRF (primary outcome), CVD risk factors, anthropometric measures, disease activity, and patient-reported outcomes related to pain, fatigue, disease, physical activity, and exercise.

A total of 60 patients with IJD were recruited from the Preventive Cardio-Rheuma clinic at Diakonhjemmet. They were randomly assigned to receive either standard care (including relevant lifestyle advice and cardiopreventive medication) or standard care along with a 12-week HIIT intervention supervised by physiotherapists. Assessments were conducted at baseline, at 3 months (primary endpoint), and at 6 months post baseline. There was no supervised intervention between the 3- and 6-month time points.

The median age of the participants was 59 years, with 34 participants (57%) being women. The types of IJD among the participants included rheumatoid arthritis in 45%, spondyloarthritis in 32%, and psoriatic arthritis in 23%. Furthermore, 49 patients (82%) had a high risk for CVD.

The participants were divided into two groups: a control group (n = 30) and a HIIT group (n = 30). The HIIT group underwent a 12-week intervention consisting of twice-a-week supervised 4x4-minute HIIT sessions at 90%-95% of peak heart rate, alternated with moderate activity at 70%. The control group engaged in unsupervised moderate-intensity exercise sessions. The primary outcome measured was the change in CRF, assessed through peak oxygen uptake (VO_{2 max}) using a cardiopulmonary exercise test. Secondary outcomes – pain and fatigue – were evaluated using a questionnaire (Numeric Rating Scale 0-10, where 0 represents no pain or fatigue).

Following HIIT, a statistically significant difference was observed in VO_{2 max} (2.5 mL/kg per min; P < .01) in favor of the exercise group at 3 months, while no significant differences were found in pain and fatigue. This discrepancy in VO_{2 max} between the groups was maintained at 6 months (2.6 mL/kg per min; P < .01), with no notable disparities in pain and fatigue. A per-protocol analysis at 3 months demonstrated a difference in VO_{2 max} between the groups (3.2 mL/kg per min; P < .01).

Ms. Norden concluded that the clinical implications of these findings are significant, as increased CRF achieved through HIIT reflects an improvement in the body’s ability to deliver oxygen to working muscles. Consequently, this enhancement in CRF can lead to overall health improvements and a reduced risk for CVD.
 

Long-lasting effects

Christopher Edwards, MBBS, MD, honorary consultant rheumatologist at University Hospital Southampton (England) NHS Foundation Trust Medicine, University of Southampton, was concerned about future maintenance of increased CRF. “I really wish we had data on these patients at 12 months as well, so we could see if the effects last even longer. Regarding intensity, there are clear indications that engaging in moderate and high-intensity workouts is more beneficial,” Dr. Norden said. “So, I would certainly recommend at least one high-intensity exercise session per week for those patients, while also incorporating lower and moderate-intensity exercises if desired. However, for individuals aiming to maximize their oxygen uptake, high-intensity exercise is considered the most effective approach.”

There is compelling evidence supporting the benefits of physical activity in improving disease activity among patients with IJD, making it a critical component of nonpharmacologic treatment. However, individuals with rheumatic and musculoskeletal conditions generally exhibit lower levels of physical activity, compared with their healthy counterparts. Recognizing the importance of CVD prevention in patients with IJD, EULAR recommends routine CVD screening for individuals diagnosed with IJD.

Ms. Norden and coauthors report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

MILAN – Most people with recent-onset chronic back pain who are referred to a rheumatologist and then diagnosed with definite axial spondyloarthritis (axSpA) maintain that diagnosis over the next 2 years, but for those with residual diagnostic uncertainty for axSpA, particular characteristics may help to identify those who will or will not go on to receive a definite diagnosis, according to presentations given at the annual European Congress of Rheumatology.

Although a rheumatologist’s early axSpA diagnosis is reliable, new research also presented at the meeting reveals that the axSpA clinical phenotype presentation has great heterogeneity around the world, adding to the challenge.

These findings also dovetail with the consensus of an expert panel from the Assessment of SpondyloArthritis international Society (ASAS) that determined early axSpA should be defined by a duration of axial symptoms of less than 2 years, a move that should make research studies of early disease more consistent.
 

Diagnosis at first sight

To help in overcoming the long diagnostic delay typically encountered by patients with axSpA, researchers involved in the longitudinal Spondyloarthritis Caught Early (SPACE) cohort have sought to measure the prevalence of axSpA and the reliability of an early diagnosis in patients with chronic back pain (CBP). SPACE researcher Mary Lucy Marques, MD, a rheumatologist at Coimbra (Portugal) Hospital and University Center, and PhD student at Leiden (the Netherlands) University Medical Center, presented the main results of the study, which included patients younger than 45 years with CBP of unknown origin lasting 3 months to 2 years.

Patients referred to rheumatologists were judged at each visit for the presence or absence of axSpA, and the baseline judgment was reviewed after 2 years to assess its reliability. Baseline diagnostic judgments remained rather stable, and definite axSpA was present in one-third of the patients referred to the rheumatologist (175 out of 555 patients; 32%). After 2 years, the number of patients with definite axSpA diagnosis changed to 165, due to 5% of the definite diagnoses being refuted and 8% gaining a definite axSpA diagnosis. Among the features related to axSpA, the presence (or absence) of imaging-detected sacroiliitis at baseline was the best discriminator for a definite diagnosis at 2 years.

In commenting on these findings, Alexandre Sepriano, MD, PhD, assistant professor of rheumatology, NOVA Medical School, Lisbon, Portugal, who was not involved in the study, said: “These data show that the key is likely the referral of the ‘right patients’ to tertiary care centers. The [ASAS] has developed referral criteria that can be used for this purpose. According to these, patients with chronic low back pain starting before 45 years of age should be referred to a rheumatologist if at least one additional SpA feature is present.

“It should be acknowledged that axSpA is not a disease of males only. In fact, there is a 1:1 ratio between males and females in the full spectrum of the disease. Also, although imaging findings are important, not all patients will have these. Similarly, not all patients with imaging abnormalities will have the disease, and their sole presence without other SpA features does not suffice for diagnosis.”
 

Repeated assessment: Is it worth it?

Despite the positive findings described above, residual diagnostic uncertainty remained for 15% of patients, representing an obstacle to initiating an appropriate treatment. Therefore, it is important to understand whether and how the repeated assessment of axSpA features is of value for a definite diagnosis.

This last question was addressed in a second abstract also presented by Dr. Marques that focused on the yield of repeated assessment in CBP patients with suspected axSpA from the SPACE cohort. The main outcome of the study was the clinical diagnosis of definite axSpA at 2 years. Compared with baseline, at the 2-year evaluation 32 patients changed their diagnosis and were classified as definite axSpA: Sixteen were previously described as uncertain axSpA at baseline, 11 as uncertain no axSpA, and 5 as definite no axSpA.

On average, three axSpA features were present at baseline with one or two adjunctive features found throughout the study that led to the final diagnosis of definite axSpA. These adjunctive features were most commonly response to NSAIDs and sacroiliitis on MRI. Dr. Marques and colleagues concluded that the yield of repeated assessment in this setting was modest for a new diagnosis of definite axSpA. “Usefulness of repeating MRI in terms of diagnostic yield is low but can be considered in HLA-B27+ patients, especially if male,” Dr. Marques said, commenting on the analysis of SpA features in patients who changed their diagnosis to definite axSpA at 2 years.

“The early diagnosis of axial spondyloarthritis remains a challenge,” Dr. Sepriano said in commenting on the second SPACE study. “Probably one of the main reasons is the yet suboptimal awareness of the [full spectrum] of the disease in a primary care setting, in which most patients will first show up to get medical care. It is now well-known that patients do not always have changes in pelvic radiographs and that waiting for these to make a diagnosis of [radiographic] axSpA results in further delay and in missing many patients who will never develop these changes.

“Still, recognizing the clinical picture of early axSpA and differentiating it from other more common causes of chronic back pain (e.g., degenerative spinal disease) can sometimes be difficult. Continuous efforts in raising awareness and in education will likely result in further reducing the diagnostic delay gap and, as such, improve the prognosis of this often-debilitating rheumatic inflammatory disease.”

One epidemiologic size does not fit all

According to data from the International Map of Axial Spondyloarthritis (IMAS), axSpA clinical phenotype presentation shows great heterogeneity around the world. Marco Garrido-Cumbrera, PhD, of the University of Seville in Spain, presented the results of an analysis of an IMAS online survey (2017-2022).

The study, supported by Novartis, aimed at exploring differences in axSpA clinical phenotype presentation in a large sample of unselected patients: a total of 5,557 individuals from 27 countries across five regions. The results showed statistically significant differences among countries in almost all the analyzed characteristics, from age at onset of symptoms (the highest in Latin America) to HLA-B27 positivity frequency (lowest in Latin America and highest in Asia).

Differences also emerged in the presence of a positive family history of the disease (most common in Europe) and of physical and mental comorbidities (common in Africa). The authors also reported treatment data showing that most of the patients had used NSAIDs, and almost half of the patients had ever taken biologic disease-modifying antirheumatic drugs. Data also showed a mean delay in diagnosis of 7 years, with the longest values observed in South Africa and the lowest in Asia.
 

A consensus definition of early AxSpA

Early axSpA for the first time has been defined based on ASAS expert consensus, and the definition was presented at the meeting by Victoria Navarro-Compán, MD, PhD, of La Paz University Hospital, Madrid. An international working group came to a definition based on the symptom duration and taking solely axial symptoms into account. At the end of a five-step process, the group successfully developed the first consensus definition of early axSpA: “patients with diagnosis of axSpA with axial symptoms duration of ≤ 2 years.” Also to be noted are axial symptoms as assessed by a rheumatologist, which should include spinal/buttock pain or morning stiffness.

As reported by the authors, this ASAS definition is based on expert consensus, with the limitation of a lack of scientific evidence to support it, especially with regard to the specific duration of symptoms from the time of disease onset. Nonetheless, ASAS recommends the use of this definition in studies referring to early axSpA.

Dr. Marques reports no relevant financial relationships. Dr. Navarro-Compán reports serving on the speakers bureau for AbbVie, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Pfizer, and UCB; consulting for AbbVie, Eli Lilly, Galapagos, MoonLake, Merck Sharp & Dohme, Novartis, Pfizer, and UCB; and receiving grant/research support from AbbVie and Novartis. Dr. Garrido-Cumbrera reports receiving grant or research support from Novartis.
 

A version of this article originally appeared on Medscape.com.

MILAN – Most people with recent-onset chronic back pain who are referred to a rheumatologist and then diagnosed with definite axial spondyloarthritis (axSpA) maintain that diagnosis over the next 2 years, but for those with residual diagnostic uncertainty for axSpA, particular characteristics may help to identify those who will or will not go on to receive a definite diagnosis, according to presentations given at the annual European Congress of Rheumatology.

Although a rheumatologist’s early axSpA diagnosis is reliable, new research also presented at the meeting reveals that the axSpA clinical phenotype presentation has great heterogeneity around the world, adding to the challenge.

These findings also dovetail with the consensus of an expert panel from the Assessment of SpondyloArthritis international Society (ASAS) that determined early axSpA should be defined by a duration of axial symptoms of less than 2 years, a move that should make research studies of early disease more consistent.
 

Diagnosis at first sight

To help in overcoming the long diagnostic delay typically encountered by patients with axSpA, researchers involved in the longitudinal Spondyloarthritis Caught Early (SPACE) cohort have sought to measure the prevalence of axSpA and the reliability of an early diagnosis in patients with chronic back pain (CBP). SPACE researcher Mary Lucy Marques, MD, a rheumatologist at Coimbra (Portugal) Hospital and University Center, and PhD student at Leiden (the Netherlands) University Medical Center, presented the main results of the study, which included patients younger than 45 years with CBP of unknown origin lasting 3 months to 2 years.

Patients referred to rheumatologists were judged at each visit for the presence or absence of axSpA, and the baseline judgment was reviewed after 2 years to assess its reliability. Baseline diagnostic judgments remained rather stable, and definite axSpA was present in one-third of the patients referred to the rheumatologist (175 out of 555 patients; 32%). After 2 years, the number of patients with definite axSpA diagnosis changed to 165, due to 5% of the definite diagnoses being refuted and 8% gaining a definite axSpA diagnosis. Among the features related to axSpA, the presence (or absence) of imaging-detected sacroiliitis at baseline was the best discriminator for a definite diagnosis at 2 years.

In commenting on these findings, Alexandre Sepriano, MD, PhD, assistant professor of rheumatology, NOVA Medical School, Lisbon, Portugal, who was not involved in the study, said: “These data show that the key is likely the referral of the ‘right patients’ to tertiary care centers. The [ASAS] has developed referral criteria that can be used for this purpose. According to these, patients with chronic low back pain starting before 45 years of age should be referred to a rheumatologist if at least one additional SpA feature is present.

“It should be acknowledged that axSpA is not a disease of males only. In fact, there is a 1:1 ratio between males and females in the full spectrum of the disease. Also, although imaging findings are important, not all patients will have these. Similarly, not all patients with imaging abnormalities will have the disease, and their sole presence without other SpA features does not suffice for diagnosis.”
 

Repeated assessment: Is it worth it?

Despite the positive findings described above, residual diagnostic uncertainty remained for 15% of patients, representing an obstacle to initiating an appropriate treatment. Therefore, it is important to understand whether and how the repeated assessment of axSpA features is of value for a definite diagnosis.

This last question was addressed in a second abstract also presented by Dr. Marques that focused on the yield of repeated assessment in CBP patients with suspected axSpA from the SPACE cohort. The main outcome of the study was the clinical diagnosis of definite axSpA at 2 years. Compared with baseline, at the 2-year evaluation 32 patients changed their diagnosis and were classified as definite axSpA: Sixteen were previously described as uncertain axSpA at baseline, 11 as uncertain no axSpA, and 5 as definite no axSpA.

On average, three axSpA features were present at baseline with one or two adjunctive features found throughout the study that led to the final diagnosis of definite axSpA. These adjunctive features were most commonly response to NSAIDs and sacroiliitis on MRI. Dr. Marques and colleagues concluded that the yield of repeated assessment in this setting was modest for a new diagnosis of definite axSpA. “Usefulness of repeating MRI in terms of diagnostic yield is low but can be considered in HLA-B27+ patients, especially if male,” Dr. Marques said, commenting on the analysis of SpA features in patients who changed their diagnosis to definite axSpA at 2 years.

“The early diagnosis of axial spondyloarthritis remains a challenge,” Dr. Sepriano said in commenting on the second SPACE study. “Probably one of the main reasons is the yet suboptimal awareness of the [full spectrum] of the disease in a primary care setting, in which most patients will first show up to get medical care. It is now well-known that patients do not always have changes in pelvic radiographs and that waiting for these to make a diagnosis of [radiographic] axSpA results in further delay and in missing many patients who will never develop these changes.

“Still, recognizing the clinical picture of early axSpA and differentiating it from other more common causes of chronic back pain (e.g., degenerative spinal disease) can sometimes be difficult. Continuous efforts in raising awareness and in education will likely result in further reducing the diagnostic delay gap and, as such, improve the prognosis of this often-debilitating rheumatic inflammatory disease.”

One epidemiologic size does not fit all

According to data from the International Map of Axial Spondyloarthritis (IMAS), axSpA clinical phenotype presentation shows great heterogeneity around the world. Marco Garrido-Cumbrera, PhD, of the University of Seville in Spain, presented the results of an analysis of an IMAS online survey (2017-2022).

The study, supported by Novartis, aimed at exploring differences in axSpA clinical phenotype presentation in a large sample of unselected patients: a total of 5,557 individuals from 27 countries across five regions. The results showed statistically significant differences among countries in almost all the analyzed characteristics, from age at onset of symptoms (the highest in Latin America) to HLA-B27 positivity frequency (lowest in Latin America and highest in Asia).

Differences also emerged in the presence of a positive family history of the disease (most common in Europe) and of physical and mental comorbidities (common in Africa). The authors also reported treatment data showing that most of the patients had used NSAIDs, and almost half of the patients had ever taken biologic disease-modifying antirheumatic drugs. Data also showed a mean delay in diagnosis of 7 years, with the longest values observed in South Africa and the lowest in Asia.
 

A consensus definition of early AxSpA

Early axSpA for the first time has been defined based on ASAS expert consensus, and the definition was presented at the meeting by Victoria Navarro-Compán, MD, PhD, of La Paz University Hospital, Madrid. An international working group came to a definition based on the symptom duration and taking solely axial symptoms into account. At the end of a five-step process, the group successfully developed the first consensus definition of early axSpA: “patients with diagnosis of axSpA with axial symptoms duration of ≤ 2 years.” Also to be noted are axial symptoms as assessed by a rheumatologist, which should include spinal/buttock pain or morning stiffness.

As reported by the authors, this ASAS definition is based on expert consensus, with the limitation of a lack of scientific evidence to support it, especially with regard to the specific duration of symptoms from the time of disease onset. Nonetheless, ASAS recommends the use of this definition in studies referring to early axSpA.

Dr. Marques reports no relevant financial relationships. Dr. Navarro-Compán reports serving on the speakers bureau for AbbVie, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Pfizer, and UCB; consulting for AbbVie, Eli Lilly, Galapagos, MoonLake, Merck Sharp & Dohme, Novartis, Pfizer, and UCB; and receiving grant/research support from AbbVie and Novartis. Dr. Garrido-Cumbrera reports receiving grant or research support from Novartis.
 

A version of this article originally appeared on Medscape.com.

MILAN – Most people with recent-onset chronic back pain who are referred to a rheumatologist and then diagnosed with definite axial spondyloarthritis (axSpA) maintain that diagnosis over the next 2 years, but for those with residual diagnostic uncertainty for axSpA, particular characteristics may help to identify those who will or will not go on to receive a definite diagnosis, according to presentations given at the annual European Congress of Rheumatology.

Although a rheumatologist’s early axSpA diagnosis is reliable, new research also presented at the meeting reveals that the axSpA clinical phenotype presentation has great heterogeneity around the world, adding to the challenge.

These findings also dovetail with the consensus of an expert panel from the Assessment of SpondyloArthritis international Society (ASAS) that determined early axSpA should be defined by a duration of axial symptoms of less than 2 years, a move that should make research studies of early disease more consistent.
 

Diagnosis at first sight

To help in overcoming the long diagnostic delay typically encountered by patients with axSpA, researchers involved in the longitudinal Spondyloarthritis Caught Early (SPACE) cohort have sought to measure the prevalence of axSpA and the reliability of an early diagnosis in patients with chronic back pain (CBP). SPACE researcher Mary Lucy Marques, MD, a rheumatologist at Coimbra (Portugal) Hospital and University Center, and PhD student at Leiden (the Netherlands) University Medical Center, presented the main results of the study, which included patients younger than 45 years with CBP of unknown origin lasting 3 months to 2 years.

Patients referred to rheumatologists were judged at each visit for the presence or absence of axSpA, and the baseline judgment was reviewed after 2 years to assess its reliability. Baseline diagnostic judgments remained rather stable, and definite axSpA was present in one-third of the patients referred to the rheumatologist (175 out of 555 patients; 32%). After 2 years, the number of patients with definite axSpA diagnosis changed to 165, due to 5% of the definite diagnoses being refuted and 8% gaining a definite axSpA diagnosis. Among the features related to axSpA, the presence (or absence) of imaging-detected sacroiliitis at baseline was the best discriminator for a definite diagnosis at 2 years.

In commenting on these findings, Alexandre Sepriano, MD, PhD, assistant professor of rheumatology, NOVA Medical School, Lisbon, Portugal, who was not involved in the study, said: “These data show that the key is likely the referral of the ‘right patients’ to tertiary care centers. The [ASAS] has developed referral criteria that can be used for this purpose. According to these, patients with chronic low back pain starting before 45 years of age should be referred to a rheumatologist if at least one additional SpA feature is present.

“It should be acknowledged that axSpA is not a disease of males only. In fact, there is a 1:1 ratio between males and females in the full spectrum of the disease. Also, although imaging findings are important, not all patients will have these. Similarly, not all patients with imaging abnormalities will have the disease, and their sole presence without other SpA features does not suffice for diagnosis.”
 

Repeated assessment: Is it worth it?

Despite the positive findings described above, residual diagnostic uncertainty remained for 15% of patients, representing an obstacle to initiating an appropriate treatment. Therefore, it is important to understand whether and how the repeated assessment of axSpA features is of value for a definite diagnosis.

This last question was addressed in a second abstract also presented by Dr. Marques that focused on the yield of repeated assessment in CBP patients with suspected axSpA from the SPACE cohort. The main outcome of the study was the clinical diagnosis of definite axSpA at 2 years. Compared with baseline, at the 2-year evaluation 32 patients changed their diagnosis and were classified as definite axSpA: Sixteen were previously described as uncertain axSpA at baseline, 11 as uncertain no axSpA, and 5 as definite no axSpA.

On average, three axSpA features were present at baseline with one or two adjunctive features found throughout the study that led to the final diagnosis of definite axSpA. These adjunctive features were most commonly response to NSAIDs and sacroiliitis on MRI. Dr. Marques and colleagues concluded that the yield of repeated assessment in this setting was modest for a new diagnosis of definite axSpA. “Usefulness of repeating MRI in terms of diagnostic yield is low but can be considered in HLA-B27+ patients, especially if male,” Dr. Marques said, commenting on the analysis of SpA features in patients who changed their diagnosis to definite axSpA at 2 years.

“The early diagnosis of axial spondyloarthritis remains a challenge,” Dr. Sepriano said in commenting on the second SPACE study. “Probably one of the main reasons is the yet suboptimal awareness of the [full spectrum] of the disease in a primary care setting, in which most patients will first show up to get medical care. It is now well-known that patients do not always have changes in pelvic radiographs and that waiting for these to make a diagnosis of [radiographic] axSpA results in further delay and in missing many patients who will never develop these changes.

“Still, recognizing the clinical picture of early axSpA and differentiating it from other more common causes of chronic back pain (e.g., degenerative spinal disease) can sometimes be difficult. Continuous efforts in raising awareness and in education will likely result in further reducing the diagnostic delay gap and, as such, improve the prognosis of this often-debilitating rheumatic inflammatory disease.”

One epidemiologic size does not fit all

According to data from the International Map of Axial Spondyloarthritis (IMAS), axSpA clinical phenotype presentation shows great heterogeneity around the world. Marco Garrido-Cumbrera, PhD, of the University of Seville in Spain, presented the results of an analysis of an IMAS online survey (2017-2022).

The study, supported by Novartis, aimed at exploring differences in axSpA clinical phenotype presentation in a large sample of unselected patients: a total of 5,557 individuals from 27 countries across five regions. The results showed statistically significant differences among countries in almost all the analyzed characteristics, from age at onset of symptoms (the highest in Latin America) to HLA-B27 positivity frequency (lowest in Latin America and highest in Asia).

Differences also emerged in the presence of a positive family history of the disease (most common in Europe) and of physical and mental comorbidities (common in Africa). The authors also reported treatment data showing that most of the patients had used NSAIDs, and almost half of the patients had ever taken biologic disease-modifying antirheumatic drugs. Data also showed a mean delay in diagnosis of 7 years, with the longest values observed in South Africa and the lowest in Asia.
 

A consensus definition of early AxSpA

Early axSpA for the first time has been defined based on ASAS expert consensus, and the definition was presented at the meeting by Victoria Navarro-Compán, MD, PhD, of La Paz University Hospital, Madrid. An international working group came to a definition based on the symptom duration and taking solely axial symptoms into account. At the end of a five-step process, the group successfully developed the first consensus definition of early axSpA: “patients with diagnosis of axSpA with axial symptoms duration of ≤ 2 years.” Also to be noted are axial symptoms as assessed by a rheumatologist, which should include spinal/buttock pain or morning stiffness.

As reported by the authors, this ASAS definition is based on expert consensus, with the limitation of a lack of scientific evidence to support it, especially with regard to the specific duration of symptoms from the time of disease onset. Nonetheless, ASAS recommends the use of this definition in studies referring to early axSpA.

Dr. Marques reports no relevant financial relationships. Dr. Navarro-Compán reports serving on the speakers bureau for AbbVie, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Pfizer, and UCB; consulting for AbbVie, Eli Lilly, Galapagos, MoonLake, Merck Sharp & Dohme, Novartis, Pfizer, and UCB; and receiving grant/research support from AbbVie and Novartis. Dr. Garrido-Cumbrera reports receiving grant or research support from Novartis.
 

A version of this article originally appeared on Medscape.com.

MILAN – Secukinumab (Cosentyx) and biosimilar adalimumab-adaz (Hyrimoz) injection proved to have similar efficacy for limiting spinal radiographic progression over a 2-year period in patients with radiographic axial spondyloarthritis (r-axSpA) in the SURPASS study, a phase 3b, randomized controlled trial.

The study, presented at the annual European Congress of Rheumatology, represents the first head-to-head trial comparing the effects of two biologic disease-modifying antirheumatic drugs (bDMARDs) in axSpA. Notably, secukinumab and adalimumab-adaz target different pathways as an interleukin-17A inhibitor and a tumor necrosis factor (TNF) inhibitor, respectively.

Both TNF and IL-17A have been implicated in the pathogenesis of axSpA. Anti-TNF agents and the IL-17A inhibitor secukinumab have demonstrated effectiveness in improving symptoms, signs, and physical function in patients with axSpA and are approved therapies for the disease. However, limited data exist regarding the effect of bDMARDs in slowing radiographic progression, which is a key therapeutic goal in axSpA to prevent irreversible structural damage.

The SURPASS trial, funded by Novartis, enrolled 859 biologic-naive adult patients with moderate to severe r-axSpA. Participants were randomly assigned (1:1:1) to receive secukinumab 150 mg (n = 287), secukinumab 300 mg (n = 286), or adalimumab-adaz 40 mg (n = 286). The primary endpoint was the proportion of patients with no radiographic progression at the 2-year mark (week 104). Radiographic progression was defined as a change from baseline in modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS; range, 0-72) of 0.5 or less. The radiographic assessments were conducted by three independent evaluators who were blinded to treatment and the chronology of images.

Baseline characteristics indicated that the study population (78.5% male; mean age, 42.1 years) had a high risk of radiographic progression. The proportion of patients with no radiographic progression at week 104 was 66.1% in the secukinumab 150-mg arm, 66.9% in the secukinumab 300-mg arm, and 65.6% in the adalimumab-adaz arm. The mean change from baseline in mSASSS was 0.54, 0.55, and 0.72, respectively.

Notably, more than half of the patients (56.9%, 53.8%, and 53.3%, respectively) with at least one syndesmophyte at baseline did not develop new syndesmophytes over the 2-year period. The observed reductions in sacroiliac joint and spinal edema were comparable across all treatment groups. The safety profile of secukinumab and adalimumab-adaz was consistent with their well-established profiles.

No significant differences were observed between the treatment groups in terms of the primary and secondary endpoints. Study presenter and lead author Xenofon Baraliakos, MD, PhD, medical director of the Rheumatism Centre and professor of internal medicine and rheumatology at Ruhr University Bochum (Germany), stated: “Anti-TNF therapy has been considered the gold-standard treatment for axial spondyloarthritis in terms of slowing or halting radiographic progression. Our aim was to investigate whether other modes of action, such as IL-17 inhibition, achieve the same results. The primary hypothesis was that IL-17 inhibition could be even more effective than TNF blockade. However, our data indicate that secukinumab is at least as good as TNF blockers.

“Several risk factors, including high C-reactive protein [CRP] levels, male gender, high disease activity, and baseline radiographic damage (e.g., presence of syndesmophytes), are associated with structural progression,” Dr. Baraliakos explained. “We performed subgroup analyses and found no differences. This is a positive outcome as it suggests that there is no need to select patients based on either secukinumab or anti-TNF agents.”

When making treatment decisions, other factors must be taken into consideration. “Our study specifically examined radiographic progression. The clinical outcomes, indications, and contraindications for anti-TNF agents and secukinumab differ,” Dr. Baraliakos explained. “For instance, secukinumab may be preferred for patients with psoriasis, while adalimumab is more suitable for those with inflammatory bowel disease. Although these bDMARDs are not interchangeable, they have the same positive effect on radiographic progression.”
 

Not a definitive answer about structural progression

An open question remains. Alexandre Sepriano, MD, PhD, a rheumatologist at Hospital Egas Moniz and researcher at NOVA Medical School, both in Lisbon, commented: “The study was designed to maximize the chances of detecting a difference, if any, in spinal radiographic progression between secukinumab 150 mg and 300 mg and adalimumab. The included patients had a high risk of progression at baseline; in addition to back pain, they either had elevated CRP or at least one syndesmophyte on spine radiographs. Consequently, baseline structural damage was high [mean mSASSS, 17].”

“After 2 years, no difference was observed in the percentage of patients with no progression across the study arms. This finding does not definitively answer whether bDMARDs can modify structural progression or if secukinumab and adalimumab are equally effective in this regard,” explained Dr. Sepriano, who was not involved in the study. “However, there is good news for patients. Both secukinumab and adalimumab are potent anti-inflammatory drugs that effectively alleviate axial inflammation caused by the disease. This was demonstrated by the reduction in inflammatory scores on MRI in the SURPASS study. It aligns with robust evidence that both IL-17 inhibitors and TNF inhibitors are effective in improving symptoms in individuals with axSpA.

“Researchers continue to make significant efforts to understand how axial inflammation contributes to pathological new bone formation in axSpA,” Dr. Sepriano continued. “Understanding these mechanisms can guide future research aimed at interfering with disease progression. Furthermore, the use of new methods to quantify structural progression in axSpA, such as low-dose CT, which has shown greater sensitivity to change than traditional methods, can pave the way for new studies with fewer patients and shorter follow-up periods, thereby increasing the likelihood of detecting treatment effects.”

Dr. Baraliakos has received speaking and consulting fees and grant/research support from AbbVie, Bristol-Myers Squibb, Celgene, Chugai, Merck Sharp & Dohme, Novartis, Pfizer, and UCB. Dr. Sepriano has received speaking and/or consulting fees from AbbVie, Novartis, UCB, and Lilly. The trial was sponsored by Novartis.

A version of this article first appeared on Medscape.com.

MILAN – Secukinumab (Cosentyx) and biosimilar adalimumab-adaz (Hyrimoz) injection proved to have similar efficacy for limiting spinal radiographic progression over a 2-year period in patients with radiographic axial spondyloarthritis (r-axSpA) in the SURPASS study, a phase 3b, randomized controlled trial.

The study, presented at the annual European Congress of Rheumatology, represents the first head-to-head trial comparing the effects of two biologic disease-modifying antirheumatic drugs (bDMARDs) in axSpA. Notably, secukinumab and adalimumab-adaz target different pathways as an interleukin-17A inhibitor and a tumor necrosis factor (TNF) inhibitor, respectively.

Both TNF and IL-17A have been implicated in the pathogenesis of axSpA. Anti-TNF agents and the IL-17A inhibitor secukinumab have demonstrated effectiveness in improving symptoms, signs, and physical function in patients with axSpA and are approved therapies for the disease. However, limited data exist regarding the effect of bDMARDs in slowing radiographic progression, which is a key therapeutic goal in axSpA to prevent irreversible structural damage.

The SURPASS trial, funded by Novartis, enrolled 859 biologic-naive adult patients with moderate to severe r-axSpA. Participants were randomly assigned (1:1:1) to receive secukinumab 150 mg (n = 287), secukinumab 300 mg (n = 286), or adalimumab-adaz 40 mg (n = 286). The primary endpoint was the proportion of patients with no radiographic progression at the 2-year mark (week 104). Radiographic progression was defined as a change from baseline in modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS; range, 0-72) of 0.5 or less. The radiographic assessments were conducted by three independent evaluators who were blinded to treatment and the chronology of images.

Baseline characteristics indicated that the study population (78.5% male; mean age, 42.1 years) had a high risk of radiographic progression. The proportion of patients with no radiographic progression at week 104 was 66.1% in the secukinumab 150-mg arm, 66.9% in the secukinumab 300-mg arm, and 65.6% in the adalimumab-adaz arm. The mean change from baseline in mSASSS was 0.54, 0.55, and 0.72, respectively.

Notably, more than half of the patients (56.9%, 53.8%, and 53.3%, respectively) with at least one syndesmophyte at baseline did not develop new syndesmophytes over the 2-year period. The observed reductions in sacroiliac joint and spinal edema were comparable across all treatment groups. The safety profile of secukinumab and adalimumab-adaz was consistent with their well-established profiles.

No significant differences were observed between the treatment groups in terms of the primary and secondary endpoints. Study presenter and lead author Xenofon Baraliakos, MD, PhD, medical director of the Rheumatism Centre and professor of internal medicine and rheumatology at Ruhr University Bochum (Germany), stated: “Anti-TNF therapy has been considered the gold-standard treatment for axial spondyloarthritis in terms of slowing or halting radiographic progression. Our aim was to investigate whether other modes of action, such as IL-17 inhibition, achieve the same results. The primary hypothesis was that IL-17 inhibition could be even more effective than TNF blockade. However, our data indicate that secukinumab is at least as good as TNF blockers.

“Several risk factors, including high C-reactive protein [CRP] levels, male gender, high disease activity, and baseline radiographic damage (e.g., presence of syndesmophytes), are associated with structural progression,” Dr. Baraliakos explained. “We performed subgroup analyses and found no differences. This is a positive outcome as it suggests that there is no need to select patients based on either secukinumab or anti-TNF agents.”

When making treatment decisions, other factors must be taken into consideration. “Our study specifically examined radiographic progression. The clinical outcomes, indications, and contraindications for anti-TNF agents and secukinumab differ,” Dr. Baraliakos explained. “For instance, secukinumab may be preferred for patients with psoriasis, while adalimumab is more suitable for those with inflammatory bowel disease. Although these bDMARDs are not interchangeable, they have the same positive effect on radiographic progression.”
 

Not a definitive answer about structural progression

An open question remains. Alexandre Sepriano, MD, PhD, a rheumatologist at Hospital Egas Moniz and researcher at NOVA Medical School, both in Lisbon, commented: “The study was designed to maximize the chances of detecting a difference, if any, in spinal radiographic progression between secukinumab 150 mg and 300 mg and adalimumab. The included patients had a high risk of progression at baseline; in addition to back pain, they either had elevated CRP or at least one syndesmophyte on spine radiographs. Consequently, baseline structural damage was high [mean mSASSS, 17].”

“After 2 years, no difference was observed in the percentage of patients with no progression across the study arms. This finding does not definitively answer whether bDMARDs can modify structural progression or if secukinumab and adalimumab are equally effective in this regard,” explained Dr. Sepriano, who was not involved in the study. “However, there is good news for patients. Both secukinumab and adalimumab are potent anti-inflammatory drugs that effectively alleviate axial inflammation caused by the disease. This was demonstrated by the reduction in inflammatory scores on MRI in the SURPASS study. It aligns with robust evidence that both IL-17 inhibitors and TNF inhibitors are effective in improving symptoms in individuals with axSpA.

“Researchers continue to make significant efforts to understand how axial inflammation contributes to pathological new bone formation in axSpA,” Dr. Sepriano continued. “Understanding these mechanisms can guide future research aimed at interfering with disease progression. Furthermore, the use of new methods to quantify structural progression in axSpA, such as low-dose CT, which has shown greater sensitivity to change than traditional methods, can pave the way for new studies with fewer patients and shorter follow-up periods, thereby increasing the likelihood of detecting treatment effects.”

Dr. Baraliakos has received speaking and consulting fees and grant/research support from AbbVie, Bristol-Myers Squibb, Celgene, Chugai, Merck Sharp & Dohme, Novartis, Pfizer, and UCB. Dr. Sepriano has received speaking and/or consulting fees from AbbVie, Novartis, UCB, and Lilly. The trial was sponsored by Novartis.

A version of this article first appeared on Medscape.com.

MILAN – Secukinumab (Cosentyx) and biosimilar adalimumab-adaz (Hyrimoz) injection proved to have similar efficacy for limiting spinal radiographic progression over a 2-year period in patients with radiographic axial spondyloarthritis (r-axSpA) in the SURPASS study, a phase 3b, randomized controlled trial.

The study, presented at the annual European Congress of Rheumatology, represents the first head-to-head trial comparing the effects of two biologic disease-modifying antirheumatic drugs (bDMARDs) in axSpA. Notably, secukinumab and adalimumab-adaz target different pathways as an interleukin-17A inhibitor and a tumor necrosis factor (TNF) inhibitor, respectively.

Both TNF and IL-17A have been implicated in the pathogenesis of axSpA. Anti-TNF agents and the IL-17A inhibitor secukinumab have demonstrated effectiveness in improving symptoms, signs, and physical function in patients with axSpA and are approved therapies for the disease. However, limited data exist regarding the effect of bDMARDs in slowing radiographic progression, which is a key therapeutic goal in axSpA to prevent irreversible structural damage.

The SURPASS trial, funded by Novartis, enrolled 859 biologic-naive adult patients with moderate to severe r-axSpA. Participants were randomly assigned (1:1:1) to receive secukinumab 150 mg (n = 287), secukinumab 300 mg (n = 286), or adalimumab-adaz 40 mg (n = 286). The primary endpoint was the proportion of patients with no radiographic progression at the 2-year mark (week 104). Radiographic progression was defined as a change from baseline in modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS; range, 0-72) of 0.5 or less. The radiographic assessments were conducted by three independent evaluators who were blinded to treatment and the chronology of images.

Baseline characteristics indicated that the study population (78.5% male; mean age, 42.1 years) had a high risk of radiographic progression. The proportion of patients with no radiographic progression at week 104 was 66.1% in the secukinumab 150-mg arm, 66.9% in the secukinumab 300-mg arm, and 65.6% in the adalimumab-adaz arm. The mean change from baseline in mSASSS was 0.54, 0.55, and 0.72, respectively.

Notably, more than half of the patients (56.9%, 53.8%, and 53.3%, respectively) with at least one syndesmophyte at baseline did not develop new syndesmophytes over the 2-year period. The observed reductions in sacroiliac joint and spinal edema were comparable across all treatment groups. The safety profile of secukinumab and adalimumab-adaz was consistent with their well-established profiles.

No significant differences were observed between the treatment groups in terms of the primary and secondary endpoints. Study presenter and lead author Xenofon Baraliakos, MD, PhD, medical director of the Rheumatism Centre and professor of internal medicine and rheumatology at Ruhr University Bochum (Germany), stated: “Anti-TNF therapy has been considered the gold-standard treatment for axial spondyloarthritis in terms of slowing or halting radiographic progression. Our aim was to investigate whether other modes of action, such as IL-17 inhibition, achieve the same results. The primary hypothesis was that IL-17 inhibition could be even more effective than TNF blockade. However, our data indicate that secukinumab is at least as good as TNF blockers.

“Several risk factors, including high C-reactive protein [CRP] levels, male gender, high disease activity, and baseline radiographic damage (e.g., presence of syndesmophytes), are associated with structural progression,” Dr. Baraliakos explained. “We performed subgroup analyses and found no differences. This is a positive outcome as it suggests that there is no need to select patients based on either secukinumab or anti-TNF agents.”

When making treatment decisions, other factors must be taken into consideration. “Our study specifically examined radiographic progression. The clinical outcomes, indications, and contraindications for anti-TNF agents and secukinumab differ,” Dr. Baraliakos explained. “For instance, secukinumab may be preferred for patients with psoriasis, while adalimumab is more suitable for those with inflammatory bowel disease. Although these bDMARDs are not interchangeable, they have the same positive effect on radiographic progression.”
 

Not a definitive answer about structural progression

An open question remains. Alexandre Sepriano, MD, PhD, a rheumatologist at Hospital Egas Moniz and researcher at NOVA Medical School, both in Lisbon, commented: “The study was designed to maximize the chances of detecting a difference, if any, in spinal radiographic progression between secukinumab 150 mg and 300 mg and adalimumab. The included patients had a high risk of progression at baseline; in addition to back pain, they either had elevated CRP or at least one syndesmophyte on spine radiographs. Consequently, baseline structural damage was high [mean mSASSS, 17].”

“After 2 years, no difference was observed in the percentage of patients with no progression across the study arms. This finding does not definitively answer whether bDMARDs can modify structural progression or if secukinumab and adalimumab are equally effective in this regard,” explained Dr. Sepriano, who was not involved in the study. “However, there is good news for patients. Both secukinumab and adalimumab are potent anti-inflammatory drugs that effectively alleviate axial inflammation caused by the disease. This was demonstrated by the reduction in inflammatory scores on MRI in the SURPASS study. It aligns with robust evidence that both IL-17 inhibitors and TNF inhibitors are effective in improving symptoms in individuals with axSpA.

“Researchers continue to make significant efforts to understand how axial inflammation contributes to pathological new bone formation in axSpA,” Dr. Sepriano continued. “Understanding these mechanisms can guide future research aimed at interfering with disease progression. Furthermore, the use of new methods to quantify structural progression in axSpA, such as low-dose CT, which has shown greater sensitivity to change than traditional methods, can pave the way for new studies with fewer patients and shorter follow-up periods, thereby increasing the likelihood of detecting treatment effects.”

Dr. Baraliakos has received speaking and consulting fees and grant/research support from AbbVie, Bristol-Myers Squibb, Celgene, Chugai, Merck Sharp & Dohme, Novartis, Pfizer, and UCB. Dr. Sepriano has received speaking and/or consulting fees from AbbVie, Novartis, UCB, and Lilly. The trial was sponsored by Novartis.

A version of this article first appeared on Medscape.com.

CLEVELAND – About half (52%) of patients living with both axial spondyloarthritis and inflammatory bowel disease (IBD) reached clinical remission of axSpA at 12 months after starting a tumor necrosis factor inhibitor (TNFi), researchers have found.

The disease course for axSpA among patients with IBD who start anti-TNF agents is not well understood.

Rahul S. Dalal, MD, an advanced fellow in IBD with the division of gastroenterology, hepatology, and endoscopy at Brigham and Women’s Hospital, Boston, and colleagues studied whether certain clinical factors were associated with remission of axSpA after patients with axSpA, who also had Crohn’s disease (CD) or ulcerative colitis (UC), started anti-TNF therapy.
 

Short IBD duration, adalimumab linked with higher remission odds

They found that those who had IBD for less than 5 years and those taking the TNFi adalimumab (Humira and biosimilars), as opposed to another TNFi, had a higher likelihood of reaching axSpA remission at 1 year. The odds ratios calculated for those factors were statistically significant.

Dr. Dalal said that most of the patients in the study (70%) were prescribed adalimumab, and because the study didn’t compare TNFis head to head, it’s hard to say whether adalimumab should be the preferred treatment for these patients.

“But it’s an interesting question that should be addressed in a bigger study,” he said.

Other TNFis included infliximab (Remicade and biosimilars) in 27%, golimumab (Simponi) in 2%, and certolizumab pegol (Cimzia) in 1%.

He presented the results at the annual meeting of the Spondyloarthritis Research and Treatment Network (SPARTAN).

Study details

Included in the retrospective cohort study were 82 adults with IBD and either ankylosing spondylitis or sacroiliitis who started anti-TNF agents approved for IBD between January 2012 and October 2021 at a large academic center.

Clinical remission of axSpA was the primary outcome, defined as the absence or adequate control of pain and/or stiffness related to axSpA as documented in the rheumatology note 1 year (+/– 2 months) after starting anti-TNF agents.

The secondary outcome was clinical remission of IBD, defined as 2 or less on the simple clinical colitis activity index, a score of less than 5 on the Harvey-Bradshaw Index, or provider assessment with no use of oral or intravenous glucocorticoids for 30 days. Dr. Dalal said 74% in the study reached that endpoint in the study period.

“Some patients had good response to anti-TNF treatments for their IBD but not necessarily for their spondyloarthritis,” he explained.

There were insufficient observations to calculate odds ratios for the variables, including Hispanic ethnicity, endoscopic inflammation, and prior history of using vedolizumab (Entyvio), secukinumab (Cosentyx), and ustekinumab (Stelara), the authors noted.

Dr. Dalal said it’s important to study this population because patients with IBD and axSpA take some of the same medications, but it’s not known how each medication acts in patients.

“We don’t have much data to tell us who’s going to respond to treatments from both diseases simultaneously,” he said.
 

Conclusions called ‘reassuring’

Jean Liew, MD, a spondyloarthritis specialist at Boston University, who was not part of the study, noted that the team reported univariate associations of clinical factors with achievement of clinical axSpA remission, but no multivariable analyses with adjustment for potential confounders.

She said the finding of half the patients achieving clinical remission is “reassuring, as anecdotally we may find that patients with IBD-associated spondyloarthritis tend to have more difficult-to-treat symptoms as well as more limited treatment options. For example, they cannot use [interleukin]-17 inhibitors.”

She noted the study is small and descriptive and further analyses are limited by the small number of patients.

“I think if a study of the same type could be performed at a larger scale with larger numbers, it could generate more data on which type of patient with IBD-associated spondyloarthritis is more likely to have a good response after starting a TNF inhibitor,” she said. “Of course, the other question is how long those patients would have good disease control while on the TNF inhibitor. What is the persistence of the medication? This study doesn’t ask or answer that question.”

Dr. Dalal added that in future research it will be important to look at response to medications beyond TNFis, especially Janus kinase inhibitors.

That will help show “whether there is a treatment algorithm that can be tailored to this population in terms of what agents to choose first,” he said. “I think we need multicenter studies to do this.”

Dr. Dalal has received grant funding from Pfizer and Janssen and has served as a consultant for Centaur Labs and Janssen. Dr. Liew has no relevant financial relationships.

CLEVELAND – About half (52%) of patients living with both axial spondyloarthritis and inflammatory bowel disease (IBD) reached clinical remission of axSpA at 12 months after starting a tumor necrosis factor inhibitor (TNFi), researchers have found.

The disease course for axSpA among patients with IBD who start anti-TNF agents is not well understood.

Rahul S. Dalal, MD, an advanced fellow in IBD with the division of gastroenterology, hepatology, and endoscopy at Brigham and Women’s Hospital, Boston, and colleagues studied whether certain clinical factors were associated with remission of axSpA after patients with axSpA, who also had Crohn’s disease (CD) or ulcerative colitis (UC), started anti-TNF therapy.
 

Short IBD duration, adalimumab linked with higher remission odds

They found that those who had IBD for less than 5 years and those taking the TNFi adalimumab (Humira and biosimilars), as opposed to another TNFi, had a higher likelihood of reaching axSpA remission at 1 year. The odds ratios calculated for those factors were statistically significant.

Dr. Dalal said that most of the patients in the study (70%) were prescribed adalimumab, and because the study didn’t compare TNFis head to head, it’s hard to say whether adalimumab should be the preferred treatment for these patients.

“But it’s an interesting question that should be addressed in a bigger study,” he said.

Other TNFis included infliximab (Remicade and biosimilars) in 27%, golimumab (Simponi) in 2%, and certolizumab pegol (Cimzia) in 1%.

He presented the results at the annual meeting of the Spondyloarthritis Research and Treatment Network (SPARTAN).

Study details

Included in the retrospective cohort study were 82 adults with IBD and either ankylosing spondylitis or sacroiliitis who started anti-TNF agents approved for IBD between January 2012 and October 2021 at a large academic center.

Clinical remission of axSpA was the primary outcome, defined as the absence or adequate control of pain and/or stiffness related to axSpA as documented in the rheumatology note 1 year (+/– 2 months) after starting anti-TNF agents.

The secondary outcome was clinical remission of IBD, defined as 2 or less on the simple clinical colitis activity index, a score of less than 5 on the Harvey-Bradshaw Index, or provider assessment with no use of oral or intravenous glucocorticoids for 30 days. Dr. Dalal said 74% in the study reached that endpoint in the study period.

“Some patients had good response to anti-TNF treatments for their IBD but not necessarily for their spondyloarthritis,” he explained.

There were insufficient observations to calculate odds ratios for the variables, including Hispanic ethnicity, endoscopic inflammation, and prior history of using vedolizumab (Entyvio), secukinumab (Cosentyx), and ustekinumab (Stelara), the authors noted.

Dr. Dalal said it’s important to study this population because patients with IBD and axSpA take some of the same medications, but it’s not known how each medication acts in patients.

“We don’t have much data to tell us who’s going to respond to treatments from both diseases simultaneously,” he said.
 

Conclusions called ‘reassuring’

Jean Liew, MD, a spondyloarthritis specialist at Boston University, who was not part of the study, noted that the team reported univariate associations of clinical factors with achievement of clinical axSpA remission, but no multivariable analyses with adjustment for potential confounders.

She said the finding of half the patients achieving clinical remission is “reassuring, as anecdotally we may find that patients with IBD-associated spondyloarthritis tend to have more difficult-to-treat symptoms as well as more limited treatment options. For example, they cannot use [interleukin]-17 inhibitors.”

She noted the study is small and descriptive and further analyses are limited by the small number of patients.

“I think if a study of the same type could be performed at a larger scale with larger numbers, it could generate more data on which type of patient with IBD-associated spondyloarthritis is more likely to have a good response after starting a TNF inhibitor,” she said. “Of course, the other question is how long those patients would have good disease control while on the TNF inhibitor. What is the persistence of the medication? This study doesn’t ask or answer that question.”

Dr. Dalal added that in future research it will be important to look at response to medications beyond TNFis, especially Janus kinase inhibitors.

That will help show “whether there is a treatment algorithm that can be tailored to this population in terms of what agents to choose first,” he said. “I think we need multicenter studies to do this.”

Dr. Dalal has received grant funding from Pfizer and Janssen and has served as a consultant for Centaur Labs and Janssen. Dr. Liew has no relevant financial relationships.

CLEVELAND – About half (52%) of patients living with both axial spondyloarthritis and inflammatory bowel disease (IBD) reached clinical remission of axSpA at 12 months after starting a tumor necrosis factor inhibitor (TNFi), researchers have found.

The disease course for axSpA among patients with IBD who start anti-TNF agents is not well understood.

Rahul S. Dalal, MD, an advanced fellow in IBD with the division of gastroenterology, hepatology, and endoscopy at Brigham and Women’s Hospital, Boston, and colleagues studied whether certain clinical factors were associated with remission of axSpA after patients with axSpA, who also had Crohn’s disease (CD) or ulcerative colitis (UC), started anti-TNF therapy.
 

Short IBD duration, adalimumab linked with higher remission odds

They found that those who had IBD for less than 5 years and those taking the TNFi adalimumab (Humira and biosimilars), as opposed to another TNFi, had a higher likelihood of reaching axSpA remission at 1 year. The odds ratios calculated for those factors were statistically significant.

Dr. Dalal said that most of the patients in the study (70%) were prescribed adalimumab, and because the study didn’t compare TNFis head to head, it’s hard to say whether adalimumab should be the preferred treatment for these patients.

“But it’s an interesting question that should be addressed in a bigger study,” he said.

Other TNFis included infliximab (Remicade and biosimilars) in 27%, golimumab (Simponi) in 2%, and certolizumab pegol (Cimzia) in 1%.

He presented the results at the annual meeting of the Spondyloarthritis Research and Treatment Network (SPARTAN).

Study details

Included in the retrospective cohort study were 82 adults with IBD and either ankylosing spondylitis or sacroiliitis who started anti-TNF agents approved for IBD between January 2012 and October 2021 at a large academic center.

Clinical remission of axSpA was the primary outcome, defined as the absence or adequate control of pain and/or stiffness related to axSpA as documented in the rheumatology note 1 year (+/– 2 months) after starting anti-TNF agents.

The secondary outcome was clinical remission of IBD, defined as 2 or less on the simple clinical colitis activity index, a score of less than 5 on the Harvey-Bradshaw Index, or provider assessment with no use of oral or intravenous glucocorticoids for 30 days. Dr. Dalal said 74% in the study reached that endpoint in the study period.

“Some patients had good response to anti-TNF treatments for their IBD but not necessarily for their spondyloarthritis,” he explained.

There were insufficient observations to calculate odds ratios for the variables, including Hispanic ethnicity, endoscopic inflammation, and prior history of using vedolizumab (Entyvio), secukinumab (Cosentyx), and ustekinumab (Stelara), the authors noted.

Dr. Dalal said it’s important to study this population because patients with IBD and axSpA take some of the same medications, but it’s not known how each medication acts in patients.

“We don’t have much data to tell us who’s going to respond to treatments from both diseases simultaneously,” he said.
 

Conclusions called ‘reassuring’

Jean Liew, MD, a spondyloarthritis specialist at Boston University, who was not part of the study, noted that the team reported univariate associations of clinical factors with achievement of clinical axSpA remission, but no multivariable analyses with adjustment for potential confounders.

She said the finding of half the patients achieving clinical remission is “reassuring, as anecdotally we may find that patients with IBD-associated spondyloarthritis tend to have more difficult-to-treat symptoms as well as more limited treatment options. For example, they cannot use [interleukin]-17 inhibitors.”

She noted the study is small and descriptive and further analyses are limited by the small number of patients.

“I think if a study of the same type could be performed at a larger scale with larger numbers, it could generate more data on which type of patient with IBD-associated spondyloarthritis is more likely to have a good response after starting a TNF inhibitor,” she said. “Of course, the other question is how long those patients would have good disease control while on the TNF inhibitor. What is the persistence of the medication? This study doesn’t ask or answer that question.”

Dr. Dalal added that in future research it will be important to look at response to medications beyond TNFis, especially Janus kinase inhibitors.

That will help show “whether there is a treatment algorithm that can be tailored to this population in terms of what agents to choose first,” he said. “I think we need multicenter studies to do this.”

Dr. Dalal has received grant funding from Pfizer and Janssen and has served as a consultant for Centaur Labs and Janssen. Dr. Liew has no relevant financial relationships.

The U.S. Food and Drug Administration has approved the biosimilar adalimumab-aaty (Yuflyma) in a citrate-free, high-concentration formulation, the manufacturer, Celltrion USA, announced today. It is the ninth biosimilar of adalimumab (Humira) to be approved in the United States.
 

Yuflyma is approved for the treatment of adult patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa. It is also approved for polyarticular juvenile idiopathic arthritis for patients aged 2 years or older, as well as for Crohn’s disease in adults and in pediatric patients aged 6 years or older.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The formulation was approved on the basis of a comprehensive data package of analytic, preclinical, and clinical studies, according to Celltrion USA, “demonstrating that Yuflyma is comparable to the reference product Humira in terms of efficacy, safety, pharmacokinetics, and immunogenicity up to 24 weeks and 1 year following treatment.”

The company conducted a double-blind, randomized phase 3 trial that compared switching from reference adalimumab to Yuflyma with continuing either reference adalimumab or Yuflyma for patients with active rheumatoid arthritis. In that trial, the efficacy, pharmacokinetics, safety, and immunogenicity of Yuflyma and reference adalimumab were comparable after 1 year of treatment, including after switching from reference adalimumab to Yuflyma.

“Currently, more than 80% of patients treated with Humira in the United States rely on a high-concentration and citrate-free formulation of this medication. The availability of a high-concentration and citrate-free formulation adalimumab biosimilar provides an important treatment option for patients with inflammatory diseases who benefit from this effective therapy,” said Jonathan Kay, MD, of the University of Massachusetts, Worcester, in the press release.

The citrate-free formulation is thought to lead to less pain on injection.

Yuflyma will be available in prefilled syringe and autoinjector administration options.

Celltrion USA plans to market the drug in the United States in July 2023. Following the initial launch of 40 mg/0.4 mL, the company plans to launch dose forms of 80 mg/0.8 mL and 20 mg/0.2 mL.

Celltrion USA is also seeking an interchangeability designation from the FDA following the completion of an interchangeability trial of 366 patients with chronic plaque psoriasis. The interchangeability designation would mean that patients successfully switched from Humira to Yuflyma multiple times in the trial. The interchangeability designation would allow pharmacists to autosubstitute Humira with Yuflyma. In these cases, individual state laws control how and whether physicians will be notified of this switch.

If interchangeability is approved for Yuflyma, which the company tentatively expects in the fourth quarter of 2024, it would be just the third interchangeable biosimilar approved by the FDA overall and the second adalimumab biosimilar to be designated as such, after adalimumab-adbm (Cyltezo) in October 2021.

Yuflyma was approved in Canada in December 2021 for 10 indications: rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, adult ulcerative colitis, hidradenitis suppurativa, plaque psoriasis, adult uveitis, and pediatric uveitis.

In February 2022, the European Commission granted marketing authorization for Yuflyma across those 10 indications, as well as for nonradiographic axial spondyloarthritis, pediatric plaque psoriasis, and pediatric Crohn’s disease.

In April 2022, Celltrion USA signed a licensing agreement with AbbVie, the manufacturer of Humira. Under that agreement, Celltrion will pay royalties to AbbVie on sales of their individual biosimilars, and AbbVie agreed to drop all patent litigation.

The full prescribing information for Yuflyma is available here.

A version of this article first appeared on Medscape.com.

The U.S. Food and Drug Administration has approved the biosimilar adalimumab-aaty (Yuflyma) in a citrate-free, high-concentration formulation, the manufacturer, Celltrion USA, announced today. It is the ninth biosimilar of adalimumab (Humira) to be approved in the United States.
 

Yuflyma is approved for the treatment of adult patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa. It is also approved for polyarticular juvenile idiopathic arthritis for patients aged 2 years or older, as well as for Crohn’s disease in adults and in pediatric patients aged 6 years or older.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The formulation was approved on the basis of a comprehensive data package of analytic, preclinical, and clinical studies, according to Celltrion USA, “demonstrating that Yuflyma is comparable to the reference product Humira in terms of efficacy, safety, pharmacokinetics, and immunogenicity up to 24 weeks and 1 year following treatment.”

The company conducted a double-blind, randomized phase 3 trial that compared switching from reference adalimumab to Yuflyma with continuing either reference adalimumab or Yuflyma for patients with active rheumatoid arthritis. In that trial, the efficacy, pharmacokinetics, safety, and immunogenicity of Yuflyma and reference adalimumab were comparable after 1 year of treatment, including after switching from reference adalimumab to Yuflyma.

“Currently, more than 80% of patients treated with Humira in the United States rely on a high-concentration and citrate-free formulation of this medication. The availability of a high-concentration and citrate-free formulation adalimumab biosimilar provides an important treatment option for patients with inflammatory diseases who benefit from this effective therapy,” said Jonathan Kay, MD, of the University of Massachusetts, Worcester, in the press release.

The citrate-free formulation is thought to lead to less pain on injection.

Yuflyma will be available in prefilled syringe and autoinjector administration options.

Celltrion USA plans to market the drug in the United States in July 2023. Following the initial launch of 40 mg/0.4 mL, the company plans to launch dose forms of 80 mg/0.8 mL and 20 mg/0.2 mL.

Celltrion USA is also seeking an interchangeability designation from the FDA following the completion of an interchangeability trial of 366 patients with chronic plaque psoriasis. The interchangeability designation would mean that patients successfully switched from Humira to Yuflyma multiple times in the trial. The interchangeability designation would allow pharmacists to autosubstitute Humira with Yuflyma. In these cases, individual state laws control how and whether physicians will be notified of this switch.

If interchangeability is approved for Yuflyma, which the company tentatively expects in the fourth quarter of 2024, it would be just the third interchangeable biosimilar approved by the FDA overall and the second adalimumab biosimilar to be designated as such, after adalimumab-adbm (Cyltezo) in October 2021.

Yuflyma was approved in Canada in December 2021 for 10 indications: rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, adult ulcerative colitis, hidradenitis suppurativa, plaque psoriasis, adult uveitis, and pediatric uveitis.

In February 2022, the European Commission granted marketing authorization for Yuflyma across those 10 indications, as well as for nonradiographic axial spondyloarthritis, pediatric plaque psoriasis, and pediatric Crohn’s disease.

In April 2022, Celltrion USA signed a licensing agreement with AbbVie, the manufacturer of Humira. Under that agreement, Celltrion will pay royalties to AbbVie on sales of their individual biosimilars, and AbbVie agreed to drop all patent litigation.

The full prescribing information for Yuflyma is available here.

A version of this article first appeared on Medscape.com.

The U.S. Food and Drug Administration has approved the biosimilar adalimumab-aaty (Yuflyma) in a citrate-free, high-concentration formulation, the manufacturer, Celltrion USA, announced today. It is the ninth biosimilar of adalimumab (Humira) to be approved in the United States.
 

Yuflyma is approved for the treatment of adult patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa. It is also approved for polyarticular juvenile idiopathic arthritis for patients aged 2 years or older, as well as for Crohn’s disease in adults and in pediatric patients aged 6 years or older.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The formulation was approved on the basis of a comprehensive data package of analytic, preclinical, and clinical studies, according to Celltrion USA, “demonstrating that Yuflyma is comparable to the reference product Humira in terms of efficacy, safety, pharmacokinetics, and immunogenicity up to 24 weeks and 1 year following treatment.”

The company conducted a double-blind, randomized phase 3 trial that compared switching from reference adalimumab to Yuflyma with continuing either reference adalimumab or Yuflyma for patients with active rheumatoid arthritis. In that trial, the efficacy, pharmacokinetics, safety, and immunogenicity of Yuflyma and reference adalimumab were comparable after 1 year of treatment, including after switching from reference adalimumab to Yuflyma.

“Currently, more than 80% of patients treated with Humira in the United States rely on a high-concentration and citrate-free formulation of this medication. The availability of a high-concentration and citrate-free formulation adalimumab biosimilar provides an important treatment option for patients with inflammatory diseases who benefit from this effective therapy,” said Jonathan Kay, MD, of the University of Massachusetts, Worcester, in the press release.

The citrate-free formulation is thought to lead to less pain on injection.

Yuflyma will be available in prefilled syringe and autoinjector administration options.

Celltrion USA plans to market the drug in the United States in July 2023. Following the initial launch of 40 mg/0.4 mL, the company plans to launch dose forms of 80 mg/0.8 mL and 20 mg/0.2 mL.

Celltrion USA is also seeking an interchangeability designation from the FDA following the completion of an interchangeability trial of 366 patients with chronic plaque psoriasis. The interchangeability designation would mean that patients successfully switched from Humira to Yuflyma multiple times in the trial. The interchangeability designation would allow pharmacists to autosubstitute Humira with Yuflyma. In these cases, individual state laws control how and whether physicians will be notified of this switch.

If interchangeability is approved for Yuflyma, which the company tentatively expects in the fourth quarter of 2024, it would be just the third interchangeable biosimilar approved by the FDA overall and the second adalimumab biosimilar to be designated as such, after adalimumab-adbm (Cyltezo) in October 2021.

Yuflyma was approved in Canada in December 2021 for 10 indications: rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, adult ulcerative colitis, hidradenitis suppurativa, plaque psoriasis, adult uveitis, and pediatric uveitis.

In February 2022, the European Commission granted marketing authorization for Yuflyma across those 10 indications, as well as for nonradiographic axial spondyloarthritis, pediatric plaque psoriasis, and pediatric Crohn’s disease.

In April 2022, Celltrion USA signed a licensing agreement with AbbVie, the manufacturer of Humira. Under that agreement, Celltrion will pay royalties to AbbVie on sales of their individual biosimilars, and AbbVie agreed to drop all patent litigation.

The full prescribing information for Yuflyma is available here.

A version of this article first appeared on Medscape.com.

CLEVELAND – Documenting the prevalence of axial spondyloarthritis (axSpA) among Black Americans has been difficult because of little published data, but new research suggests that when Black Americans do have the disease, it seems to be more severe.

Iman Abutineh, MD, of the University of Tennessee, Memphis, discussed her team’s work at the annual meeting of the Spondyloarthritis Research and Treatment Network (SPARTAN).

A total of 244 patients with axSpA were identified, including 168 (69%) males, 78 (32%) Black patients, and 143 (59%) White patients.

Average age of onset for patients overall was 27.7 years, and age at diagnosis was 36.1 years with a 7-year delay in diagnosis. Sixty-six (27%) patients had nonradiographic axSpA, 83% were on tumor necrosis factor inhibitors, and 38% were prescribed glucocorticoids.

The researchers found several differences by race.

White patients were more likely to be HLA-B27 positive (77% vs. 59%; P = .010). White patients also had higher prevalence of psoriasis, coronary artery disease, and family history of SpA. White females had a higher prevalence of inflammatory bowel disease, fibromyalgia, depression, and lower grades of sacroiliitis.
 

Black patients had more hip involvement

A higher percentage of Black patients had elevated erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and hip involvement. In comparing hip involvement, the researchers found that 39 (39%) White males had hip involvement as did 9 (21%) White females. In comparison, 22 (45%) Black men in the study and 14 (54%) Black women showed hip involvement (P = .035).

After adjustment for age, sex, HLA-B27, and insurance status, Black patients had higher grades of sacroiliitis with an odds ratio of 2.32 (95% confidence interval, 1.23-4.44). Black patients had a numerically longer delay in diagnosis, compared with Whites (7.93 vs. 6.64 years), but this did not achieve statistical significance (P = .454), the researchers wrote.
 

Study addresses racial disparities

“Traditionally we think of axial spondyloarthritis largely in Caucasian males who are HLA-B27 positive,” Dr. Abutineh said, “and we found that there is still a significant portion of patients who don’t meet the criteria that do have disease that is very significant.”

Although actual prevalence was not clear from this study, Dr. Abutineh said their data suggest a 3-to-1 ratio of White-to-Black patients with spondyloarthritis, “but of the Black patients who are diagnosed, their disease is almost always more severe. That points to why it’s important to have a high index of suspicion for this disease in that patient population because if you miss it, it could be detrimental to the patients.”

Swetha Alexander, MD, a rheumatology fellow at the University of Utah, Salt Lake City, who was not part of the study, said in an interview, “It is an excellent and timely study addressing the racial disparities and inequities surrounding axSpA diagnosis. It highlights the delay in diagnosis and increased burden of disease among Black Americans.”

She said the study may prompt a further look into barriers to care for Black Americans and their beliefs regarding seeking health care for their pain.
 

Higher rates of nonradiographic axSpA among Black patients

The rate of nonradiographic axSpA among Black Americans was more than twice that of their White counterparts, which, Dr. Alexander noted, could make it more difficult to diagnose axSpA in that population.

The odds ratio for Black patients having nonradiographic axSpA, compared with Whites, was 2.265 (95% CI, 1.082-4.999; P = .035), after adjustment for age, sex, and HLA-B27 status.

Adult patients with axSpA were identified from rheumatology clinics at four major hospital systems and one private clinic in Shelby County, Tenn., between 2011 and 2021. Patients met modified New York (mNY) or Assessment of Spondyloarthritis International Society (ASAS) criteria as assessed by reviewers.

The authors and Dr. Alexander reported no relevant financial relationships.

CLEVELAND – Documenting the prevalence of axial spondyloarthritis (axSpA) among Black Americans has been difficult because of little published data, but new research suggests that when Black Americans do have the disease, it seems to be more severe.

Iman Abutineh, MD, of the University of Tennessee, Memphis, discussed her team’s work at the annual meeting of the Spondyloarthritis Research and Treatment Network (SPARTAN).

A total of 244 patients with axSpA were identified, including 168 (69%) males, 78 (32%) Black patients, and 143 (59%) White patients.

Average age of onset for patients overall was 27.7 years, and age at diagnosis was 36.1 years with a 7-year delay in diagnosis. Sixty-six (27%) patients had nonradiographic axSpA, 83% were on tumor necrosis factor inhibitors, and 38% were prescribed glucocorticoids.

The researchers found several differences by race.

White patients were more likely to be HLA-B27 positive (77% vs. 59%; P = .010). White patients also had higher prevalence of psoriasis, coronary artery disease, and family history of SpA. White females had a higher prevalence of inflammatory bowel disease, fibromyalgia, depression, and lower grades of sacroiliitis.
 

Black patients had more hip involvement

A higher percentage of Black patients had elevated erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and hip involvement. In comparing hip involvement, the researchers found that 39 (39%) White males had hip involvement as did 9 (21%) White females. In comparison, 22 (45%) Black men in the study and 14 (54%) Black women showed hip involvement (P = .035).

After adjustment for age, sex, HLA-B27, and insurance status, Black patients had higher grades of sacroiliitis with an odds ratio of 2.32 (95% confidence interval, 1.23-4.44). Black patients had a numerically longer delay in diagnosis, compared with Whites (7.93 vs. 6.64 years), but this did not achieve statistical significance (P = .454), the researchers wrote.
 

Study addresses racial disparities

“Traditionally we think of axial spondyloarthritis largely in Caucasian males who are HLA-B27 positive,” Dr. Abutineh said, “and we found that there is still a significant portion of patients who don’t meet the criteria that do have disease that is very significant.”

Although actual prevalence was not clear from this study, Dr. Abutineh said their data suggest a 3-to-1 ratio of White-to-Black patients with spondyloarthritis, “but of the Black patients who are diagnosed, their disease is almost always more severe. That points to why it’s important to have a high index of suspicion for this disease in that patient population because if you miss it, it could be detrimental to the patients.”

Swetha Alexander, MD, a rheumatology fellow at the University of Utah, Salt Lake City, who was not part of the study, said in an interview, “It is an excellent and timely study addressing the racial disparities and inequities surrounding axSpA diagnosis. It highlights the delay in diagnosis and increased burden of disease among Black Americans.”

She said the study may prompt a further look into barriers to care for Black Americans and their beliefs regarding seeking health care for their pain.
 

Higher rates of nonradiographic axSpA among Black patients

The rate of nonradiographic axSpA among Black Americans was more than twice that of their White counterparts, which, Dr. Alexander noted, could make it more difficult to diagnose axSpA in that population.

The odds ratio for Black patients having nonradiographic axSpA, compared with Whites, was 2.265 (95% CI, 1.082-4.999; P = .035), after adjustment for age, sex, and HLA-B27 status.

Adult patients with axSpA were identified from rheumatology clinics at four major hospital systems and one private clinic in Shelby County, Tenn., between 2011 and 2021. Patients met modified New York (mNY) or Assessment of Spondyloarthritis International Society (ASAS) criteria as assessed by reviewers.

The authors and Dr. Alexander reported no relevant financial relationships.

CLEVELAND – Documenting the prevalence of axial spondyloarthritis (axSpA) among Black Americans has been difficult because of little published data, but new research suggests that when Black Americans do have the disease, it seems to be more severe.

Iman Abutineh, MD, of the University of Tennessee, Memphis, discussed her team’s work at the annual meeting of the Spondyloarthritis Research and Treatment Network (SPARTAN).

A total of 244 patients with axSpA were identified, including 168 (69%) males, 78 (32%) Black patients, and 143 (59%) White patients.

Average age of onset for patients overall was 27.7 years, and age at diagnosis was 36.1 years with a 7-year delay in diagnosis. Sixty-six (27%) patients had nonradiographic axSpA, 83% were on tumor necrosis factor inhibitors, and 38% were prescribed glucocorticoids.

The researchers found several differences by race.

White patients were more likely to be HLA-B27 positive (77% vs. 59%; P = .010). White patients also had higher prevalence of psoriasis, coronary artery disease, and family history of SpA. White females had a higher prevalence of inflammatory bowel disease, fibromyalgia, depression, and lower grades of sacroiliitis.
 

Black patients had more hip involvement

A higher percentage of Black patients had elevated erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and hip involvement. In comparing hip involvement, the researchers found that 39 (39%) White males had hip involvement as did 9 (21%) White females. In comparison, 22 (45%) Black men in the study and 14 (54%) Black women showed hip involvement (P = .035).

After adjustment for age, sex, HLA-B27, and insurance status, Black patients had higher grades of sacroiliitis with an odds ratio of 2.32 (95% confidence interval, 1.23-4.44). Black patients had a numerically longer delay in diagnosis, compared with Whites (7.93 vs. 6.64 years), but this did not achieve statistical significance (P = .454), the researchers wrote.
 

Study addresses racial disparities

“Traditionally we think of axial spondyloarthritis largely in Caucasian males who are HLA-B27 positive,” Dr. Abutineh said, “and we found that there is still a significant portion of patients who don’t meet the criteria that do have disease that is very significant.”

Although actual prevalence was not clear from this study, Dr. Abutineh said their data suggest a 3-to-1 ratio of White-to-Black patients with spondyloarthritis, “but of the Black patients who are diagnosed, their disease is almost always more severe. That points to why it’s important to have a high index of suspicion for this disease in that patient population because if you miss it, it could be detrimental to the patients.”

Swetha Alexander, MD, a rheumatology fellow at the University of Utah, Salt Lake City, who was not part of the study, said in an interview, “It is an excellent and timely study addressing the racial disparities and inequities surrounding axSpA diagnosis. It highlights the delay in diagnosis and increased burden of disease among Black Americans.”

She said the study may prompt a further look into barriers to care for Black Americans and their beliefs regarding seeking health care for their pain.
 

Higher rates of nonradiographic axSpA among Black patients

The rate of nonradiographic axSpA among Black Americans was more than twice that of their White counterparts, which, Dr. Alexander noted, could make it more difficult to diagnose axSpA in that population.

The odds ratio for Black patients having nonradiographic axSpA, compared with Whites, was 2.265 (95% CI, 1.082-4.999; P = .035), after adjustment for age, sex, and HLA-B27 status.

Adult patients with axSpA were identified from rheumatology clinics at four major hospital systems and one private clinic in Shelby County, Tenn., between 2011 and 2021. Patients met modified New York (mNY) or Assessment of Spondyloarthritis International Society (ASAS) criteria as assessed by reviewers.

The authors and Dr. Alexander reported no relevant financial relationships.

The U.S. Food and Drug Administration on May 22 approved a new autoinjection option for adalimumab-adbm (Cyltezo), a biosimilar to AbbVie’s adalimumab (Humira), ahead of Cyltezo’s commercial launch on July 1, 2023.

Cyltezo was approved by the FDA in 2017 as a prefilled syringe and was the first biosimilar deemed to be interchangeable with Humira in 2021. It is indicated to treat multiple chronic inflammatory conditions, including rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and hidradenitis suppurativa. This new design, which features one-button, three-step activation, has been certified as an “Ease of Use” product by the Arthritis Foundation, Boehringer Ingelheim said in a press release. The 40-mg, prefilled Cyltezo Pen will be available in two-, four-, and six-pack options.

“The FDA approval of the Cyltezo Pen is great news for patients living with chronic inflammatory diseases who may prefer administering the medication needed to manage their conditions via an autoinjector,” said Stephen Pagnotta, the executive director and biosimilar commercial lead at Boehringer Ingelheim in a statement; “we’re excited to be able to offer the Cyltezo Pen as an additional option to patients at Cyltezo’s launch on July 1.”

A version of this article first appeared on Medscape.com.

The U.S. Food and Drug Administration on May 22 approved a new autoinjection option for adalimumab-adbm (Cyltezo), a biosimilar to AbbVie’s adalimumab (Humira), ahead of Cyltezo’s commercial launch on July 1, 2023.

Cyltezo was approved by the FDA in 2017 as a prefilled syringe and was the first biosimilar deemed to be interchangeable with Humira in 2021. It is indicated to treat multiple chronic inflammatory conditions, including rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and hidradenitis suppurativa. This new design, which features one-button, three-step activation, has been certified as an “Ease of Use” product by the Arthritis Foundation, Boehringer Ingelheim said in a press release. The 40-mg, prefilled Cyltezo Pen will be available in two-, four-, and six-pack options.

“The FDA approval of the Cyltezo Pen is great news for patients living with chronic inflammatory diseases who may prefer administering the medication needed to manage their conditions via an autoinjector,” said Stephen Pagnotta, the executive director and biosimilar commercial lead at Boehringer Ingelheim in a statement; “we’re excited to be able to offer the Cyltezo Pen as an additional option to patients at Cyltezo’s launch on July 1.”

A version of this article first appeared on Medscape.com.

The U.S. Food and Drug Administration on May 22 approved a new autoinjection option for adalimumab-adbm (Cyltezo), a biosimilar to AbbVie’s adalimumab (Humira), ahead of Cyltezo’s commercial launch on July 1, 2023.

Cyltezo was approved by the FDA in 2017 as a prefilled syringe and was the first biosimilar deemed to be interchangeable with Humira in 2021. It is indicated to treat multiple chronic inflammatory conditions, including rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and hidradenitis suppurativa. This new design, which features one-button, three-step activation, has been certified as an “Ease of Use” product by the Arthritis Foundation, Boehringer Ingelheim said in a press release. The 40-mg, prefilled Cyltezo Pen will be available in two-, four-, and six-pack options.

“The FDA approval of the Cyltezo Pen is great news for patients living with chronic inflammatory diseases who may prefer administering the medication needed to manage their conditions via an autoinjector,” said Stephen Pagnotta, the executive director and biosimilar commercial lead at Boehringer Ingelheim in a statement; “we’re excited to be able to offer the Cyltezo Pen as an additional option to patients at Cyltezo’s launch on July 1.”

A version of this article first appeared on Medscape.com.

CLEVELAND – With early diagnosis an ongoing complex target for axial spondyloarthritis (axSpA), new research may help to answer where the biggest delays lie.

Gregory McDermott, MD, a research fellow at Brigham and Women’s Hospital in Boston, led a pilot study with data from Mass General Brigham electronic health records. He shared top results at the annual meeting of the Spondyloarthritis Research and Treatment Network (SPARTAN) , where addressing delay in diagnosis was a major theme.

Included in the cohort were 554 patients who had three ICD-9 or ICD-10 codes and an imaging report of sacroiliitis, ankylosis, or syndesmophytes, and were screened via manual chart review for modified New York and Assessment of Spondyloarthritis International Society criteria.

The average diagnostic delay for axSpA was 6.8 years in this study (median, 3.8 years), relatively consistent with findings in previous studies globally, and the average age of onset was 29.5.

The researchers also factored in history of specialty care for back pain (orthopedics, physical medicine and rehabilitation, pain medicine) or extra-articular manifestations (ophthalmology, dermatology, gastroenterology) before axSpA diagnosis. Other factors included smoking and insurance status, along with age, sex, race, and other demographic data.

The results showed shorter delays in diagnosing axSpA were associated with older age at symptom onset and peripheral arthritis, whereas longer delays (more than 4 years) were associated with a history of uveitis, ankylosing spondylitis at diagnosis, and being among those in the 80-99th percentile on the social vulnerability index (SVI). The SVI includes U.S. census data on factors including housing type, household composition and disability status, employment status, minority status, non-English speaking, educational attainment, transportation, and mean income level.
 

Notable uveitis finding

Dr. McDermott said the team was surprised by the association between having had uveitis and delayed axSpA diagnosis.

Among patients with uveitis, 12% had a short delay from symptom onset to axSpA diagnosis of 0-1 years, but more than twice that percentage (27%) had a delay of more than 4 years (P < .001).

“We thought the finding related to uveitis was interesting and potentially clinically meaningful as 27% of axSpA patients in our cohort with more than 4 years of diagnostic delay sought ophthalmology care prior to their diagnosis, [compared with 13% of patients with a diagnosis within 1 year],” Dr. McDermott said. “This practice setting in particular may be a place where we can intervene with simple screening or increased education in order to get people appropriately referred to rheumatology care.”

Longer delays can lead to more functional impairment, radiographic progression, and work disability, as well as poorer quality of life, increased depression, and higher unemployment and health care costs, Dr. McDermott said.
 

Patients may miss key treatment window

Maureen Dubreuil, MD, MSc, assistant professor at Boston University and a rheumatologist with the VA Boston Healthcare System, who was not part of the study, said: “This study addressed a critically important problem in the field – that diagnosis of axSpA is delayed by 7 years, which is much longer than the average time to diagnosis for other forms of arthritis, such as rheumatoid arthritis, which is under 6 months.

“It is critical that diagnostic delay is reduced in axSpA because undiagnosed individuals may miss an important window of opportunity to receive treatment that prevents permanent structural damage and functional declines. This work, if confirmed in other data, would allow development of interventions to improve timely evaluation of individuals with chronic back pain who may have axSpA, particularly among those with within lower socioeconomic strata, and those who are older or have uveitis.”
 

Study tests screening tool

Among the ideas proposed for reducing the delay was a referral strategy with a screening tool.

Swetha Alexander, MD, a rheumatology fellow at the University of Utah, Salt Lake City, who presented her team’s poster, noted that, in the United States, patients with chronic back pain often come first to a primary care doctor or another specialty and not to a rheumatologist.

As an internal medicine resident at Yale University, New Haven, Conn., Dr. Alexander and colleagues there conducted the Finding Axial Spondyloarthritis (FaxSpA) study to test whether patient self-referral or referral by other physicians, guided by answers to a screening tool, could help to speed the process of getting patients more likely to have axSpA to a rheumatologist.

Dr. Alexander said they found that using the screening tool was better than having no referral strategy, explaining that screening helped diagnose about 34% of the study population with axSpA, whereas if a patient came in with chronic back pain to a primary care physician without any screening and ultimately to a rheumatologist, “you’re only capturing about 20%,” she said, citing estimates in the literature.
 

Questions may need rewording

However, the researchers found that patient interpretation of the screening questions was different depending on whether they were answering online or directly from a rheumatologist’s in-person questions. For more success, Dr. Alexander said, the questions may need to be reworded or more education may be needed for both patients and physicians to get more valid information.

For instance, she said, when the screening tool asks about inflammation, the patient may assume the physician is asking about pain and answer one way, but when a rheumatologist asks the question a slightly different way in the clinic, the patient may give a different answer.
 

First questions in portal, on social media

In the screening intervention (called A-tool) patients first answered three questions via the MyChart portal or Facebook. If they answered all three questions positively, they would move on to another round of questions and the answers would decide whether they would be eligible to come into the rheumatologist to get evaluated for axSpA.

At the study visit, rheumatologists asked the same questions as the online A-tool, which focus on SpA features with reasonable sensitivity and specificity for axSpA (no labs or imaging included). Clinicians’ judgment was considered the gold standard for diagnosis of axSpA.

The authors reported that 1,274 patients answered questions with the screening tool via Facebook (50%) and MyChart (50%) from April 2019 to February 2022. Among the responders, 507 (40%) were eligible for a rheumatologist visit.

As of May 2022, 100 patients were enrolled. Of the enrolled patients, 86 patients completed all the study procedures, including study visit, labs, and imaging (x-ray and MRI of the pelvis). Of the 86 patients, 29 (34%) were diagnosed with axSpA.

The tool appears to help narrow the chronic back pain patients who need to be seen by a rheumatologist for potential axSpA, Dr. Alexander said, which may help to speed diagnosis and also save time and resources.

Dr. McDermott, Dr. Dubreuil, and Dr. Alexander reported no relevant financial relationships. The FaxSpA study was supported with funding from Novartis and the Spondylitis Association of America.

CLEVELAND – With early diagnosis an ongoing complex target for axial spondyloarthritis (axSpA), new research may help to answer where the biggest delays lie.

Gregory McDermott, MD, a research fellow at Brigham and Women’s Hospital in Boston, led a pilot study with data from Mass General Brigham electronic health records. He shared top results at the annual meeting of the Spondyloarthritis Research and Treatment Network (SPARTAN) , where addressing delay in diagnosis was a major theme.

Included in the cohort were 554 patients who had three ICD-9 or ICD-10 codes and an imaging report of sacroiliitis, ankylosis, or syndesmophytes, and were screened via manual chart review for modified New York and Assessment of Spondyloarthritis International Society criteria.

The average diagnostic delay for axSpA was 6.8 years in this study (median, 3.8 years), relatively consistent with findings in previous studies globally, and the average age of onset was 29.5.

The researchers also factored in history of specialty care for back pain (orthopedics, physical medicine and rehabilitation, pain medicine) or extra-articular manifestations (ophthalmology, dermatology, gastroenterology) before axSpA diagnosis. Other factors included smoking and insurance status, along with age, sex, race, and other demographic data.

The results showed shorter delays in diagnosing axSpA were associated with older age at symptom onset and peripheral arthritis, whereas longer delays (more than 4 years) were associated with a history of uveitis, ankylosing spondylitis at diagnosis, and being among those in the 80-99th percentile on the social vulnerability index (SVI). The SVI includes U.S. census data on factors including housing type, household composition and disability status, employment status, minority status, non-English speaking, educational attainment, transportation, and mean income level.
 

Notable uveitis finding

Dr. McDermott said the team was surprised by the association between having had uveitis and delayed axSpA diagnosis.

Among patients with uveitis, 12% had a short delay from symptom onset to axSpA diagnosis of 0-1 years, but more than twice that percentage (27%) had a delay of more than 4 years (P < .001).

“We thought the finding related to uveitis was interesting and potentially clinically meaningful as 27% of axSpA patients in our cohort with more than 4 years of diagnostic delay sought ophthalmology care prior to their diagnosis, [compared with 13% of patients with a diagnosis within 1 year],” Dr. McDermott said. “This practice setting in particular may be a place where we can intervene with simple screening or increased education in order to get people appropriately referred to rheumatology care.”

Longer delays can lead to more functional impairment, radiographic progression, and work disability, as well as poorer quality of life, increased depression, and higher unemployment and health care costs, Dr. McDermott said.
 

Patients may miss key treatment window

Maureen Dubreuil, MD, MSc, assistant professor at Boston University and a rheumatologist with the VA Boston Healthcare System, who was not part of the study, said: “This study addressed a critically important problem in the field – that diagnosis of axSpA is delayed by 7 years, which is much longer than the average time to diagnosis for other forms of arthritis, such as rheumatoid arthritis, which is under 6 months.

“It is critical that diagnostic delay is reduced in axSpA because undiagnosed individuals may miss an important window of opportunity to receive treatment that prevents permanent structural damage and functional declines. This work, if confirmed in other data, would allow development of interventions to improve timely evaluation of individuals with chronic back pain who may have axSpA, particularly among those with within lower socioeconomic strata, and those who are older or have uveitis.”
 

Study tests screening tool

Among the ideas proposed for reducing the delay was a referral strategy with a screening tool.

Swetha Alexander, MD, a rheumatology fellow at the University of Utah, Salt Lake City, who presented her team’s poster, noted that, in the United States, patients with chronic back pain often come first to a primary care doctor or another specialty and not to a rheumatologist.

As an internal medicine resident at Yale University, New Haven, Conn., Dr. Alexander and colleagues there conducted the Finding Axial Spondyloarthritis (FaxSpA) study to test whether patient self-referral or referral by other physicians, guided by answers to a screening tool, could help to speed the process of getting patients more likely to have axSpA to a rheumatologist.

Dr. Alexander said they found that using the screening tool was better than having no referral strategy, explaining that screening helped diagnose about 34% of the study population with axSpA, whereas if a patient came in with chronic back pain to a primary care physician without any screening and ultimately to a rheumatologist, “you’re only capturing about 20%,” she said, citing estimates in the literature.
 

Questions may need rewording

However, the researchers found that patient interpretation of the screening questions was different depending on whether they were answering online or directly from a rheumatologist’s in-person questions. For more success, Dr. Alexander said, the questions may need to be reworded or more education may be needed for both patients and physicians to get more valid information.

For instance, she said, when the screening tool asks about inflammation, the patient may assume the physician is asking about pain and answer one way, but when a rheumatologist asks the question a slightly different way in the clinic, the patient may give a different answer.
 

First questions in portal, on social media

In the screening intervention (called A-tool) patients first answered three questions via the MyChart portal or Facebook. If they answered all three questions positively, they would move on to another round of questions and the answers would decide whether they would be eligible to come into the rheumatologist to get evaluated for axSpA.

At the study visit, rheumatologists asked the same questions as the online A-tool, which focus on SpA features with reasonable sensitivity and specificity for axSpA (no labs or imaging included). Clinicians’ judgment was considered the gold standard for diagnosis of axSpA.

The authors reported that 1,274 patients answered questions with the screening tool via Facebook (50%) and MyChart (50%) from April 2019 to February 2022. Among the responders, 507 (40%) were eligible for a rheumatologist visit.

As of May 2022, 100 patients were enrolled. Of the enrolled patients, 86 patients completed all the study procedures, including study visit, labs, and imaging (x-ray and MRI of the pelvis). Of the 86 patients, 29 (34%) were diagnosed with axSpA.

The tool appears to help narrow the chronic back pain patients who need to be seen by a rheumatologist for potential axSpA, Dr. Alexander said, which may help to speed diagnosis and also save time and resources.

Dr. McDermott, Dr. Dubreuil, and Dr. Alexander reported no relevant financial relationships. The FaxSpA study was supported with funding from Novartis and the Spondylitis Association of America.

CLEVELAND – With early diagnosis an ongoing complex target for axial spondyloarthritis (axSpA), new research may help to answer where the biggest delays lie.

Gregory McDermott, MD, a research fellow at Brigham and Women’s Hospital in Boston, led a pilot study with data from Mass General Brigham electronic health records. He shared top results at the annual meeting of the Spondyloarthritis Research and Treatment Network (SPARTAN) , where addressing delay in diagnosis was a major theme.

Included in the cohort were 554 patients who had three ICD-9 or ICD-10 codes and an imaging report of sacroiliitis, ankylosis, or syndesmophytes, and were screened via manual chart review for modified New York and Assessment of Spondyloarthritis International Society criteria.

The average diagnostic delay for axSpA was 6.8 years in this study (median, 3.8 years), relatively consistent with findings in previous studies globally, and the average age of onset was 29.5.

The researchers also factored in history of specialty care for back pain (orthopedics, physical medicine and rehabilitation, pain medicine) or extra-articular manifestations (ophthalmology, dermatology, gastroenterology) before axSpA diagnosis. Other factors included smoking and insurance status, along with age, sex, race, and other demographic data.

The results showed shorter delays in diagnosing axSpA were associated with older age at symptom onset and peripheral arthritis, whereas longer delays (more than 4 years) were associated with a history of uveitis, ankylosing spondylitis at diagnosis, and being among those in the 80-99th percentile on the social vulnerability index (SVI). The SVI includes U.S. census data on factors including housing type, household composition and disability status, employment status, minority status, non-English speaking, educational attainment, transportation, and mean income level.
 

Notable uveitis finding

Dr. McDermott said the team was surprised by the association between having had uveitis and delayed axSpA diagnosis.

Among patients with uveitis, 12% had a short delay from symptom onset to axSpA diagnosis of 0-1 years, but more than twice that percentage (27%) had a delay of more than 4 years (P < .001).

“We thought the finding related to uveitis was interesting and potentially clinically meaningful as 27% of axSpA patients in our cohort with more than 4 years of diagnostic delay sought ophthalmology care prior to their diagnosis, [compared with 13% of patients with a diagnosis within 1 year],” Dr. McDermott said. “This practice setting in particular may be a place where we can intervene with simple screening or increased education in order to get people appropriately referred to rheumatology care.”

Longer delays can lead to more functional impairment, radiographic progression, and work disability, as well as poorer quality of life, increased depression, and higher unemployment and health care costs, Dr. McDermott said.
 

Patients may miss key treatment window

Maureen Dubreuil, MD, MSc, assistant professor at Boston University and a rheumatologist with the VA Boston Healthcare System, who was not part of the study, said: “This study addressed a critically important problem in the field – that diagnosis of axSpA is delayed by 7 years, which is much longer than the average time to diagnosis for other forms of arthritis, such as rheumatoid arthritis, which is under 6 months.

“It is critical that diagnostic delay is reduced in axSpA because undiagnosed individuals may miss an important window of opportunity to receive treatment that prevents permanent structural damage and functional declines. This work, if confirmed in other data, would allow development of interventions to improve timely evaluation of individuals with chronic back pain who may have axSpA, particularly among those with within lower socioeconomic strata, and those who are older or have uveitis.”
 

Study tests screening tool

Among the ideas proposed for reducing the delay was a referral strategy with a screening tool.

Swetha Alexander, MD, a rheumatology fellow at the University of Utah, Salt Lake City, who presented her team’s poster, noted that, in the United States, patients with chronic back pain often come first to a primary care doctor or another specialty and not to a rheumatologist.

As an internal medicine resident at Yale University, New Haven, Conn., Dr. Alexander and colleagues there conducted the Finding Axial Spondyloarthritis (FaxSpA) study to test whether patient self-referral or referral by other physicians, guided by answers to a screening tool, could help to speed the process of getting patients more likely to have axSpA to a rheumatologist.

Dr. Alexander said they found that using the screening tool was better than having no referral strategy, explaining that screening helped diagnose about 34% of the study population with axSpA, whereas if a patient came in with chronic back pain to a primary care physician without any screening and ultimately to a rheumatologist, “you’re only capturing about 20%,” she said, citing estimates in the literature.
 

Questions may need rewording

However, the researchers found that patient interpretation of the screening questions was different depending on whether they were answering online or directly from a rheumatologist’s in-person questions. For more success, Dr. Alexander said, the questions may need to be reworded or more education may be needed for both patients and physicians to get more valid information.

For instance, she said, when the screening tool asks about inflammation, the patient may assume the physician is asking about pain and answer one way, but when a rheumatologist asks the question a slightly different way in the clinic, the patient may give a different answer.
 

First questions in portal, on social media

In the screening intervention (called A-tool) patients first answered three questions via the MyChart portal or Facebook. If they answered all three questions positively, they would move on to another round of questions and the answers would decide whether they would be eligible to come into the rheumatologist to get evaluated for axSpA.

At the study visit, rheumatologists asked the same questions as the online A-tool, which focus on SpA features with reasonable sensitivity and specificity for axSpA (no labs or imaging included). Clinicians’ judgment was considered the gold standard for diagnosis of axSpA.

The authors reported that 1,274 patients answered questions with the screening tool via Facebook (50%) and MyChart (50%) from April 2019 to February 2022. Among the responders, 507 (40%) were eligible for a rheumatologist visit.

As of May 2022, 100 patients were enrolled. Of the enrolled patients, 86 patients completed all the study procedures, including study visit, labs, and imaging (x-ray and MRI of the pelvis). Of the 86 patients, 29 (34%) were diagnosed with axSpA.

The tool appears to help narrow the chronic back pain patients who need to be seen by a rheumatologist for potential axSpA, Dr. Alexander said, which may help to speed diagnosis and also save time and resources.

Dr. McDermott, Dr. Dubreuil, and Dr. Alexander reported no relevant financial relationships. The FaxSpA study was supported with funding from Novartis and the Spondylitis Association of America.

CLEVELAND – Patients with axial spondyloarthritis or psoriatic arthritis who used Janus kinase (JAK) inhibitors did not have higher risk of myocardial infarction, stroke, or venous thromboembolism (VTE), compared with those who used tumor necrosis factor inhibitors (TNFi), according to new research.

The information was presented in a poster at the annual meeting of the Spondyloarthritis Research and Treatment Network (SPARTAN).

Patients with axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA) have increased cardiovascular risk compared with the general population. Emerging evidence has suggested that TNFi may protect the cardiovascular system and that there are cardiovascular and thrombotic concerns with JAK inhibitors.

Sali Merjanah, MD, a rheumatology fellow at Boston University, and colleagues, compared how drugs in the two treatment classes affected the likelihood of major adverse cardiovascular events (MACE) or VTE. MACE in this study were myocardial infarction and stroke.

In a search of the Marketscan Database during 2006-2021, the researchers identified 1,621 TNFi and 47 JAK inhibitor users with 273 and 8 cases of MACE, respectively. They identified 2,507 TNFi and 96 JAK users with 452 and 26 cases of VTE, respectively. Patients were aged 18-65 years and had at least one inpatient or two outpatient axSpA or PsA ICD-9 or ICD-10 diagnosis codes separated by at least 7 days.

The likelihood of MACE was 14% lower among JAK inhibitor users than TNFi users (the reference group), whereas the likelihood of VTE was 39% higher for JAK inhibitor users, but neither comparison was statistically significant. JAK/TNFi nonusers had a statistically significant 27% greater likelihood of MACE than did TNFi users. The likelihood for VTE was 12% higher for JAK/TNFi nonusers, compared with TNFi users, but this finding was not statistically significant. The researchers adjusted comparisons for age, medications, and comorbidities.
 

Small numbers complicate the research

Lianne Gensler, MD, director of the Ankylosing Spondylitis Clinic at the University of California, San Francisco, who was not part of the study, said the limitations the authors list are important to note. The researchers said that the study’s small number of JAK inhibitor users, short duration of exposure, and low event rate limit its precision, and there is potential misclassification of TNF/JAK inhibitor exposure, as well as confounding by indication.

Dr. Gensler noted that these same limitations apply to studies of patients with RA as well that try to answer the question of risk for MACE and malignancy when using these drugs,

“MACE is a rare event, malignancy is a rare event. So it’s like finding a needle in a haystack, and the haystack is really big. You either have to enrich the haystack with more needles or you have to make a smaller haystack,” Dr. Gensler said.

Nevertheless, she said, she credits the researchers for bringing the available information to light.

“I think we have to do this many different ways to try to get at the answer in a partial way,” she said.

The data were drawn from 2006 to 2021, but JAK inhibitors have only been approved for axSpA in the last one and a half years and for PsA at the end of 2017.

Additionally, the people taking JAK inhibitors would have likely already failed TNFis, she said, adding that this can make it hard to tell whether an event was linked with the JAK or the TNFi.
 

Nonusers may have other risk factors

She pointed out that in this study patients who were not using TNF or JAK inhibitors had slightly higher risk numerically for both MACE and VTE than did those using TNFis.

“There, the assumption is always that this is confounding by indication, meaning it is likely that the people who are nonusers have other risk factors for MACE, which is why we’re not giving them these drugs.”

Having heart failure, for instance, is a contraindication for using a TNF inhibitor, she noted. “So it’s not that these are protective compared to nonusers. It’s probably that the nonuser has higher risk and is not getting treated with these drugs to begin with.”

The authors properly concluded from the data that patients using JAK inhibitors did not have higher risk of MACE or VTE, compared with those who used TNFis, she said, but larger studies with more follow-up are needed.

“No evidence doesn’t mean no effect,” she said. “Part of it depends on the [statistical] power and the population you’re studying.”

Dr. Gensler is a consultant for AbbVie, Acceleron, Eli Lilly, Janssen, Novartis, Pfizer, and UCB; and has received grant support from Novartis and UCB. The authors’ financial relationships were not available.

CLEVELAND – Patients with axial spondyloarthritis or psoriatic arthritis who used Janus kinase (JAK) inhibitors did not have higher risk of myocardial infarction, stroke, or venous thromboembolism (VTE), compared with those who used tumor necrosis factor inhibitors (TNFi), according to new research.

The information was presented in a poster at the annual meeting of the Spondyloarthritis Research and Treatment Network (SPARTAN).

Patients with axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA) have increased cardiovascular risk compared with the general population. Emerging evidence has suggested that TNFi may protect the cardiovascular system and that there are cardiovascular and thrombotic concerns with JAK inhibitors.

Sali Merjanah, MD, a rheumatology fellow at Boston University, and colleagues, compared how drugs in the two treatment classes affected the likelihood of major adverse cardiovascular events (MACE) or VTE. MACE in this study were myocardial infarction and stroke.

In a search of the Marketscan Database during 2006-2021, the researchers identified 1,621 TNFi and 47 JAK inhibitor users with 273 and 8 cases of MACE, respectively. They identified 2,507 TNFi and 96 JAK users with 452 and 26 cases of VTE, respectively. Patients were aged 18-65 years and had at least one inpatient or two outpatient axSpA or PsA ICD-9 or ICD-10 diagnosis codes separated by at least 7 days.

The likelihood of MACE was 14% lower among JAK inhibitor users than TNFi users (the reference group), whereas the likelihood of VTE was 39% higher for JAK inhibitor users, but neither comparison was statistically significant. JAK/TNFi nonusers had a statistically significant 27% greater likelihood of MACE than did TNFi users. The likelihood for VTE was 12% higher for JAK/TNFi nonusers, compared with TNFi users, but this finding was not statistically significant. The researchers adjusted comparisons for age, medications, and comorbidities.
 

Small numbers complicate the research

Lianne Gensler, MD, director of the Ankylosing Spondylitis Clinic at the University of California, San Francisco, who was not part of the study, said the limitations the authors list are important to note. The researchers said that the study’s small number of JAK inhibitor users, short duration of exposure, and low event rate limit its precision, and there is potential misclassification of TNF/JAK inhibitor exposure, as well as confounding by indication.

Dr. Gensler noted that these same limitations apply to studies of patients with RA as well that try to answer the question of risk for MACE and malignancy when using these drugs,

“MACE is a rare event, malignancy is a rare event. So it’s like finding a needle in a haystack, and the haystack is really big. You either have to enrich the haystack with more needles or you have to make a smaller haystack,” Dr. Gensler said.

Nevertheless, she said, she credits the researchers for bringing the available information to light.

“I think we have to do this many different ways to try to get at the answer in a partial way,” she said.

The data were drawn from 2006 to 2021, but JAK inhibitors have only been approved for axSpA in the last one and a half years and for PsA at the end of 2017.

Additionally, the people taking JAK inhibitors would have likely already failed TNFis, she said, adding that this can make it hard to tell whether an event was linked with the JAK or the TNFi.
 

Nonusers may have other risk factors

She pointed out that in this study patients who were not using TNF or JAK inhibitors had slightly higher risk numerically for both MACE and VTE than did those using TNFis.

“There, the assumption is always that this is confounding by indication, meaning it is likely that the people who are nonusers have other risk factors for MACE, which is why we’re not giving them these drugs.”

Having heart failure, for instance, is a contraindication for using a TNF inhibitor, she noted. “So it’s not that these are protective compared to nonusers. It’s probably that the nonuser has higher risk and is not getting treated with these drugs to begin with.”

The authors properly concluded from the data that patients using JAK inhibitors did not have higher risk of MACE or VTE, compared with those who used TNFis, she said, but larger studies with more follow-up are needed.

“No evidence doesn’t mean no effect,” she said. “Part of it depends on the [statistical] power and the population you’re studying.”

Dr. Gensler is a consultant for AbbVie, Acceleron, Eli Lilly, Janssen, Novartis, Pfizer, and UCB; and has received grant support from Novartis and UCB. The authors’ financial relationships were not available.

CLEVELAND – Patients with axial spondyloarthritis or psoriatic arthritis who used Janus kinase (JAK) inhibitors did not have higher risk of myocardial infarction, stroke, or venous thromboembolism (VTE), compared with those who used tumor necrosis factor inhibitors (TNFi), according to new research.

The information was presented in a poster at the annual meeting of the Spondyloarthritis Research and Treatment Network (SPARTAN).

Patients with axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA) have increased cardiovascular risk compared with the general population. Emerging evidence has suggested that TNFi may protect the cardiovascular system and that there are cardiovascular and thrombotic concerns with JAK inhibitors.

Sali Merjanah, MD, a rheumatology fellow at Boston University, and colleagues, compared how drugs in the two treatment classes affected the likelihood of major adverse cardiovascular events (MACE) or VTE. MACE in this study were myocardial infarction and stroke.

In a search of the Marketscan Database during 2006-2021, the researchers identified 1,621 TNFi and 47 JAK inhibitor users with 273 and 8 cases of MACE, respectively. They identified 2,507 TNFi and 96 JAK users with 452 and 26 cases of VTE, respectively. Patients were aged 18-65 years and had at least one inpatient or two outpatient axSpA or PsA ICD-9 or ICD-10 diagnosis codes separated by at least 7 days.

The likelihood of MACE was 14% lower among JAK inhibitor users than TNFi users (the reference group), whereas the likelihood of VTE was 39% higher for JAK inhibitor users, but neither comparison was statistically significant. JAK/TNFi nonusers had a statistically significant 27% greater likelihood of MACE than did TNFi users. The likelihood for VTE was 12% higher for JAK/TNFi nonusers, compared with TNFi users, but this finding was not statistically significant. The researchers adjusted comparisons for age, medications, and comorbidities.
 

Small numbers complicate the research

Lianne Gensler, MD, director of the Ankylosing Spondylitis Clinic at the University of California, San Francisco, who was not part of the study, said the limitations the authors list are important to note. The researchers said that the study’s small number of JAK inhibitor users, short duration of exposure, and low event rate limit its precision, and there is potential misclassification of TNF/JAK inhibitor exposure, as well as confounding by indication.

Dr. Gensler noted that these same limitations apply to studies of patients with RA as well that try to answer the question of risk for MACE and malignancy when using these drugs,

“MACE is a rare event, malignancy is a rare event. So it’s like finding a needle in a haystack, and the haystack is really big. You either have to enrich the haystack with more needles or you have to make a smaller haystack,” Dr. Gensler said.

Nevertheless, she said, she credits the researchers for bringing the available information to light.

“I think we have to do this many different ways to try to get at the answer in a partial way,” she said.

The data were drawn from 2006 to 2021, but JAK inhibitors have only been approved for axSpA in the last one and a half years and for PsA at the end of 2017.

Additionally, the people taking JAK inhibitors would have likely already failed TNFis, she said, adding that this can make it hard to tell whether an event was linked with the JAK or the TNFi.
 

Nonusers may have other risk factors

She pointed out that in this study patients who were not using TNF or JAK inhibitors had slightly higher risk numerically for both MACE and VTE than did those using TNFis.

“There, the assumption is always that this is confounding by indication, meaning it is likely that the people who are nonusers have other risk factors for MACE, which is why we’re not giving them these drugs.”

Having heart failure, for instance, is a contraindication for using a TNF inhibitor, she noted. “So it’s not that these are protective compared to nonusers. It’s probably that the nonuser has higher risk and is not getting treated with these drugs to begin with.”

The authors properly concluded from the data that patients using JAK inhibitors did not have higher risk of MACE or VTE, compared with those who used TNFis, she said, but larger studies with more follow-up are needed.

“No evidence doesn’t mean no effect,” she said. “Part of it depends on the [statistical] power and the population you’re studying.”

Dr. Gensler is a consultant for AbbVie, Acceleron, Eli Lilly, Janssen, Novartis, Pfizer, and UCB; and has received grant support from Novartis and UCB. The authors’ financial relationships were not available.

Are there clinically significant differences between axial spondyloarthritis with psoriasis and psoriatic arthritis with axial symptoms? Does it matter?

It all depends on whom you ask, but right now the evidence seems to be tipping in favor of the “splitters” who cite evidence supporting their contention that axial spondyloarthritis (axSpA)/ankylosing spondylitis (AS) with psoriasis and psoriatic arthritis (PsA) with axial symptoms are distinct clinical entities that require more precise diagnosis and treatment.

“Lumpers,” in contrast, argue that they are different points on the same clinical spectrum.

The debate is not just of academic interest, but has real consequences for patients, say specialists on both sides of the aisle.
 

Overlapping features, different presentations

“Axial SpA and axPsA have overlapping features but also meaningful differences in genetics, clinical presentation, imaging, and immunophenotype. Efforts are underway to develop classification criteria for axPsA to aid research efforts as well as clinical diagnosis and management,” Philip J. Mease, MD, director of rheumatology research at Swedish Medical Center/Providence–St. Joseph Health in Seattle, and colleagues contend.

In an editorial published in the International Journal of Rheumatic Diseases, Dr. Mease and colleagues noted that, although HLA-B*27 is a genetic risk factor for both axPsA and axSpA, some HLA-B alleles are significantly associated with axPsA, whereas other alleles are associated with axSpA.

In addition, while genes in the interleukin-23 and IL-17 pathway are associated with increased risk for axSpA, genes in the IL-13 pathway have been identified as risk markers for axPsA, they noted.
 

Two cohorts better than one?

Dafna Gladman, MD, professor of medicine at the University of Toronto and senior scientist at the Schroeder Arthritis Institute at Toronto Western Hospital, and colleagues have a unique perspective on the similarities and differences between the disease entities.

Her group’s research uses data on cohorts of patients treated in two separate clinics at Toronto Western Hospital: one for patients with PsA, and one for patients with axial spondyloarthritis, including those with ankylosing spondylitis, nonradiographic axSpA, and spondylitis associated with inflammatory bowel disease.

“Our work has shown that there are differences, and one of the reasons that it’s now important is that the anti–IL-23 medications, both the IL-12/23 inhibitor ustekinumab [Stelara] and the IL-23 inhibitor guselkumab [Tremfya] work for psoriatic arthritis, whereas IL-23 did not work in ankylosing spondylitis, so that provided further impetus to look into the distinction between the two groups,” Dr. Gladman said in an interview.

Dr. Gladman and colleagues published a study in Rheumatology in which they compared clinical presentations and features of patients with AS with or without psoriasis with patients with axPsA.

They found that patients with AS with or without psoriasis tended to be younger, had a higher proportion of males to females, and were more likely to be positive for HLA-B*27. Patients with AS also had more back pain at presentation, worse axial disease activity scores, worse global assessments by physicians, and higher grades of sacroiliitis, and they were more likely to be taking biologic agents.

“What that showed, right off the top, that whether we’re looking at the total group or we’re looking specifically at those patients who have psoriasis or don’t have psoriasis, they are different from those with psoriatic arthritis with axial disease,” she said.

They concluded that “axPsA seems to be a distinct entity.”
 

Two clinics, same presentation

Because the aforementioned study included all patients with PsA with or without peripheral disease, the investigators decided to filter out some of the background noise and conduct a second study in which they compared patients who presented to the two clinics with the same presentation, either with spinal disease and psoriasis to the spondylitis clinic, or with psoriasis and isolated axial disease to the PsA clinic.

The results, published in Annals of the Rheumatic Diseases, showed that just 2.03% of patients with PsA had isolated axial disease, and an additional 29.38% had axial and peripheral disease.

In this study, “you can see that even in that group there are distinct differences. The patients that are labeled psoriatic spondylitis are different from those that are labeled ankylosing spondylitis with psoriasis,” Dr. Gladman said.

Isolated axial disease in patients with PsA was associated with HLA-B*27 positivity and lower Health Assessment Questionnaire scores. In addition, patients who were HLA-B*27 positive also had a nearly eightfold higher risk for developing peripheral disease over time.

Patients with isolated axial PsA were significantly more likely to be diagnosed at an older age (mean, 37.44 vs. 29.65 years), had higher Psoriasis Area Severity Index scores and a higher likelihood of having psoriatic nail lesions than patients with AS with isolated axial disease and psoriasis.

In contrast, patients with isolated axSpA with psoriasis were more likely to have inflammatory back pain, spinal pain, joint pain/swelling, and areas of localized tenderness, and they had greater severity of morning stiffness.

Dr. Gladman noted that, although AS and PsA are associated with the same gene that encodes for the IL-23 receptor, each condition is associated with a different single-nucleotide polymorphism.

Same disease, different flavors?

But as Mark Twain said, it is difference of opinion that makes horse races, and some specialists in rheumatology say that axSpA amd axPsA are just two sides of the same coin.

Pramod Rathod

“There are always different schools of thought. I believe that they are not different diseases, but a spectrum of diseases,” said Shailendra Singh, MD, a rheumatologist at Unity Health Medical Center in Searcy, Ark., and past president of the Arkansas Rheumatology Association.

In an interview, Dr. Singh said that the spectrum ranges from diseases with primarily axial involvement, such as AS, to those with primarily peripheral involvement, such as reactive arthritis.

He pointed out that these conditions have overlapping symptoms, including enthesitis, dactylitis, and uveitis, and inflammatory arthritis.

Daniel Wendling, MD, PhD, from the Centre Hospitalier Régional Universitaire de Besançon (France), Université de Franche-Comté, and colleagues agreed.

“The criteria currently available for both SpA [ASAS (Assessment of Spondyloarthritis International Society) criteria] and PsA [CASPAR (Classification for Psoriatic Arthritis) criteria] are classification criteria, not diagnostic criteria. They are not very stringent and are not exclusive. Thus, the same patient can easily be classified simultaneously in both entities, making the distinction between axSpA with psoriasis and axPsA theoretical,” they wrote in an editorial published in Joint Bone Spine.

They cited as an example of the allegedly fuzzy criteria a prospective study conducted by the investigators in Bath, England, in which modified New York criteria for AS were met by 24% of patients with AS, and CASPAR criteria for PsA were met by an equal number of patients with AS.
 

Therapeutic implications

Dr. Wendling and colleagues acknowledge the differences cited in studies by Dr. Gladman, Dr. Mease, and others between patients with axPsA and those with axSpA, but argue that the differences are not that great and not so clear.

“It should also be emphasized that, although some differences between axPsA and axSpA reach statistical significance, they are mostly at the margin, with low odd ratios,” they wrote.

“It is also important to consider the variability in the definition of axPsA, sometimes simply ‘physician reported’ and elsewhere based on the modified New York radiographic criteria; the latter are only present late in the course of the disease, and this may induce bias,” they continued.

Dr. Singh agreed that, as noted by Dr. Gladman, some patients will respond to anti–IL-17, anti–IL-23, and anti–IL-12/23 agents, whereas others will have better responses with tumor necrosis factor (TNF) inhibitors, and still others, such as those with peripheral involvement in the hands and feet may fare better with nonbiologic disease-modifying antirheumatic drugs such as methotrexate.
 

Answers to come?

Dr. Gladman noted that the information available to date about the efficacy of IL-23 inhibition in axPsA is based on a post hoc analysis of the PSUMMIT 1 and 2 controlled trials in PsA, and is not definitive.

The randomized, controlled STAR trial, currently recruiting patients, is designed to see whether guselkumab can reduce axial symptoms and inflammation in patients with active axPsA.

“What I say is, there is a rationale for [anti–IL-23] to work in psoriatic arthritis, and not work in ankylosing spondylitis,” she said.

In contrast, IL-17 inhibitors, anti-TNF agents, and Janus kinase inhibitors show efficacy against both axPsA and AS. Rituximab is ineffective against PsA, but has shown efficacy against AS, especially in patients with neurologic complications from anti-TNF agents.

“There may be other medications that would work more specifically in axial psoriatic arthritis that don’t work in ankylosing spondylitis, but at least recognizing that there may be some differences, and that therefore a correct diagnosis should be obtained, might be important,” she said.

Ideally, the picture will become clearer with results from the ongoing Axial Involvement in Psoriatic Arthritis cohort, a joint project of ASAS and the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis. The multinational, cross-sectional study is designed “to systematically evaluate clinical and imaging manifestations indicative of axial involvement in patients with PsA and to develop classification criteria and a unified nomenclature for axial involvement in PsA that would allow defining a homogeneous subgroup of patients for research.”

Stay tuned.

Dr. Gladman’s research is supported by a grant from the Krembil Foundation. Dr. Singh disclosed research support from various companies. Funding sources and conflict of interest disclosures from other works cited are contained in their respective references.

Are there clinically significant differences between axial spondyloarthritis with psoriasis and psoriatic arthritis with axial symptoms? Does it matter?

It all depends on whom you ask, but right now the evidence seems to be tipping in favor of the “splitters” who cite evidence supporting their contention that axial spondyloarthritis (axSpA)/ankylosing spondylitis (AS) with psoriasis and psoriatic arthritis (PsA) with axial symptoms are distinct clinical entities that require more precise diagnosis and treatment.

“Lumpers,” in contrast, argue that they are different points on the same clinical spectrum.

The debate is not just of academic interest, but has real consequences for patients, say specialists on both sides of the aisle.
 

Overlapping features, different presentations

“Axial SpA and axPsA have overlapping features but also meaningful differences in genetics, clinical presentation, imaging, and immunophenotype. Efforts are underway to develop classification criteria for axPsA to aid research efforts as well as clinical diagnosis and management,” Philip J. Mease, MD, director of rheumatology research at Swedish Medical Center/Providence–St. Joseph Health in Seattle, and colleagues contend.

In an editorial published in the International Journal of Rheumatic Diseases, Dr. Mease and colleagues noted that, although HLA-B*27 is a genetic risk factor for both axPsA and axSpA, some HLA-B alleles are significantly associated with axPsA, whereas other alleles are associated with axSpA.

In addition, while genes in the interleukin-23 and IL-17 pathway are associated with increased risk for axSpA, genes in the IL-13 pathway have been identified as risk markers for axPsA, they noted.
 

Two cohorts better than one?

Dafna Gladman, MD, professor of medicine at the University of Toronto and senior scientist at the Schroeder Arthritis Institute at Toronto Western Hospital, and colleagues have a unique perspective on the similarities and differences between the disease entities.

Her group’s research uses data on cohorts of patients treated in two separate clinics at Toronto Western Hospital: one for patients with PsA, and one for patients with axial spondyloarthritis, including those with ankylosing spondylitis, nonradiographic axSpA, and spondylitis associated with inflammatory bowel disease.

“Our work has shown that there are differences, and one of the reasons that it’s now important is that the anti–IL-23 medications, both the IL-12/23 inhibitor ustekinumab [Stelara] and the IL-23 inhibitor guselkumab [Tremfya] work for psoriatic arthritis, whereas IL-23 did not work in ankylosing spondylitis, so that provided further impetus to look into the distinction between the two groups,” Dr. Gladman said in an interview.

Dr. Gladman and colleagues published a study in Rheumatology in which they compared clinical presentations and features of patients with AS with or without psoriasis with patients with axPsA.

They found that patients with AS with or without psoriasis tended to be younger, had a higher proportion of males to females, and were more likely to be positive for HLA-B*27. Patients with AS also had more back pain at presentation, worse axial disease activity scores, worse global assessments by physicians, and higher grades of sacroiliitis, and they were more likely to be taking biologic agents.

“What that showed, right off the top, that whether we’re looking at the total group or we’re looking specifically at those patients who have psoriasis or don’t have psoriasis, they are different from those with psoriatic arthritis with axial disease,” she said.

They concluded that “axPsA seems to be a distinct entity.”
 

Two clinics, same presentation

Because the aforementioned study included all patients with PsA with or without peripheral disease, the investigators decided to filter out some of the background noise and conduct a second study in which they compared patients who presented to the two clinics with the same presentation, either with spinal disease and psoriasis to the spondylitis clinic, or with psoriasis and isolated axial disease to the PsA clinic.

The results, published in Annals of the Rheumatic Diseases, showed that just 2.03% of patients with PsA had isolated axial disease, and an additional 29.38% had axial and peripheral disease.

In this study, “you can see that even in that group there are distinct differences. The patients that are labeled psoriatic spondylitis are different from those that are labeled ankylosing spondylitis with psoriasis,” Dr. Gladman said.

Isolated axial disease in patients with PsA was associated with HLA-B*27 positivity and lower Health Assessment Questionnaire scores. In addition, patients who were HLA-B*27 positive also had a nearly eightfold higher risk for developing peripheral disease over time.

Patients with isolated axial PsA were significantly more likely to be diagnosed at an older age (mean, 37.44 vs. 29.65 years), had higher Psoriasis Area Severity Index scores and a higher likelihood of having psoriatic nail lesions than patients with AS with isolated axial disease and psoriasis.

In contrast, patients with isolated axSpA with psoriasis were more likely to have inflammatory back pain, spinal pain, joint pain/swelling, and areas of localized tenderness, and they had greater severity of morning stiffness.

Dr. Gladman noted that, although AS and PsA are associated with the same gene that encodes for the IL-23 receptor, each condition is associated with a different single-nucleotide polymorphism.

Same disease, different flavors?

But as Mark Twain said, it is difference of opinion that makes horse races, and some specialists in rheumatology say that axSpA amd axPsA are just two sides of the same coin.

Pramod Rathod

“There are always different schools of thought. I believe that they are not different diseases, but a spectrum of diseases,” said Shailendra Singh, MD, a rheumatologist at Unity Health Medical Center in Searcy, Ark., and past president of the Arkansas Rheumatology Association.

In an interview, Dr. Singh said that the spectrum ranges from diseases with primarily axial involvement, such as AS, to those with primarily peripheral involvement, such as reactive arthritis.

He pointed out that these conditions have overlapping symptoms, including enthesitis, dactylitis, and uveitis, and inflammatory arthritis.

Daniel Wendling, MD, PhD, from the Centre Hospitalier Régional Universitaire de Besançon (France), Université de Franche-Comté, and colleagues agreed.

“The criteria currently available for both SpA [ASAS (Assessment of Spondyloarthritis International Society) criteria] and PsA [CASPAR (Classification for Psoriatic Arthritis) criteria] are classification criteria, not diagnostic criteria. They are not very stringent and are not exclusive. Thus, the same patient can easily be classified simultaneously in both entities, making the distinction between axSpA with psoriasis and axPsA theoretical,” they wrote in an editorial published in Joint Bone Spine.

They cited as an example of the allegedly fuzzy criteria a prospective study conducted by the investigators in Bath, England, in which modified New York criteria for AS were met by 24% of patients with AS, and CASPAR criteria for PsA were met by an equal number of patients with AS.
 

Therapeutic implications

Dr. Wendling and colleagues acknowledge the differences cited in studies by Dr. Gladman, Dr. Mease, and others between patients with axPsA and those with axSpA, but argue that the differences are not that great and not so clear.

“It should also be emphasized that, although some differences between axPsA and axSpA reach statistical significance, they are mostly at the margin, with low odd ratios,” they wrote.

“It is also important to consider the variability in the definition of axPsA, sometimes simply ‘physician reported’ and elsewhere based on the modified New York radiographic criteria; the latter are only present late in the course of the disease, and this may induce bias,” they continued.

Dr. Singh agreed that, as noted by Dr. Gladman, some patients will respond to anti–IL-17, anti–IL-23, and anti–IL-12/23 agents, whereas others will have better responses with tumor necrosis factor (TNF) inhibitors, and still others, such as those with peripheral involvement in the hands and feet may fare better with nonbiologic disease-modifying antirheumatic drugs such as methotrexate.
 

Answers to come?

Dr. Gladman noted that the information available to date about the efficacy of IL-23 inhibition in axPsA is based on a post hoc analysis of the PSUMMIT 1 and 2 controlled trials in PsA, and is not definitive.

The randomized, controlled STAR trial, currently recruiting patients, is designed to see whether guselkumab can reduce axial symptoms and inflammation in patients with active axPsA.

“What I say is, there is a rationale for [anti–IL-23] to work in psoriatic arthritis, and not work in ankylosing spondylitis,” she said.

In contrast, IL-17 inhibitors, anti-TNF agents, and Janus kinase inhibitors show efficacy against both axPsA and AS. Rituximab is ineffective against PsA, but has shown efficacy against AS, especially in patients with neurologic complications from anti-TNF agents.

“There may be other medications that would work more specifically in axial psoriatic arthritis that don’t work in ankylosing spondylitis, but at least recognizing that there may be some differences, and that therefore a correct diagnosis should be obtained, might be important,” she said.

Ideally, the picture will become clearer with results from the ongoing Axial Involvement in Psoriatic Arthritis cohort, a joint project of ASAS and the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis. The multinational, cross-sectional study is designed “to systematically evaluate clinical and imaging manifestations indicative of axial involvement in patients with PsA and to develop classification criteria and a unified nomenclature for axial involvement in PsA that would allow defining a homogeneous subgroup of patients for research.”

Stay tuned.

Dr. Gladman’s research is supported by a grant from the Krembil Foundation. Dr. Singh disclosed research support from various companies. Funding sources and conflict of interest disclosures from other works cited are contained in their respective references.

Are there clinically significant differences between axial spondyloarthritis with psoriasis and psoriatic arthritis with axial symptoms? Does it matter?

It all depends on whom you ask, but right now the evidence seems to be tipping in favor of the “splitters” who cite evidence supporting their contention that axial spondyloarthritis (axSpA)/ankylosing spondylitis (AS) with psoriasis and psoriatic arthritis (PsA) with axial symptoms are distinct clinical entities that require more precise diagnosis and treatment.

“Lumpers,” in contrast, argue that they are different points on the same clinical spectrum.

The debate is not just of academic interest, but has real consequences for patients, say specialists on both sides of the aisle.
 

Overlapping features, different presentations

“Axial SpA and axPsA have overlapping features but also meaningful differences in genetics, clinical presentation, imaging, and immunophenotype. Efforts are underway to develop classification criteria for axPsA to aid research efforts as well as clinical diagnosis and management,” Philip J. Mease, MD, director of rheumatology research at Swedish Medical Center/Providence–St. Joseph Health in Seattle, and colleagues contend.

In an editorial published in the International Journal of Rheumatic Diseases, Dr. Mease and colleagues noted that, although HLA-B*27 is a genetic risk factor for both axPsA and axSpA, some HLA-B alleles are significantly associated with axPsA, whereas other alleles are associated with axSpA.

In addition, while genes in the interleukin-23 and IL-17 pathway are associated with increased risk for axSpA, genes in the IL-13 pathway have been identified as risk markers for axPsA, they noted.
 

Two cohorts better than one?

Dafna Gladman, MD, professor of medicine at the University of Toronto and senior scientist at the Schroeder Arthritis Institute at Toronto Western Hospital, and colleagues have a unique perspective on the similarities and differences between the disease entities.

Her group’s research uses data on cohorts of patients treated in two separate clinics at Toronto Western Hospital: one for patients with PsA, and one for patients with axial spondyloarthritis, including those with ankylosing spondylitis, nonradiographic axSpA, and spondylitis associated with inflammatory bowel disease.

“Our work has shown that there are differences, and one of the reasons that it’s now important is that the anti–IL-23 medications, both the IL-12/23 inhibitor ustekinumab [Stelara] and the IL-23 inhibitor guselkumab [Tremfya] work for psoriatic arthritis, whereas IL-23 did not work in ankylosing spondylitis, so that provided further impetus to look into the distinction between the two groups,” Dr. Gladman said in an interview.

Dr. Gladman and colleagues published a study in Rheumatology in which they compared clinical presentations and features of patients with AS with or without psoriasis with patients with axPsA.

They found that patients with AS with or without psoriasis tended to be younger, had a higher proportion of males to females, and were more likely to be positive for HLA-B*27. Patients with AS also had more back pain at presentation, worse axial disease activity scores, worse global assessments by physicians, and higher grades of sacroiliitis, and they were more likely to be taking biologic agents.

“What that showed, right off the top, that whether we’re looking at the total group or we’re looking specifically at those patients who have psoriasis or don’t have psoriasis, they are different from those with psoriatic arthritis with axial disease,” she said.

They concluded that “axPsA seems to be a distinct entity.”
 

Two clinics, same presentation

Because the aforementioned study included all patients with PsA with or without peripheral disease, the investigators decided to filter out some of the background noise and conduct a second study in which they compared patients who presented to the two clinics with the same presentation, either with spinal disease and psoriasis to the spondylitis clinic, or with psoriasis and isolated axial disease to the PsA clinic.

The results, published in Annals of the Rheumatic Diseases, showed that just 2.03% of patients with PsA had isolated axial disease, and an additional 29.38% had axial and peripheral disease.

In this study, “you can see that even in that group there are distinct differences. The patients that are labeled psoriatic spondylitis are different from those that are labeled ankylosing spondylitis with psoriasis,” Dr. Gladman said.

Isolated axial disease in patients with PsA was associated with HLA-B*27 positivity and lower Health Assessment Questionnaire scores. In addition, patients who were HLA-B*27 positive also had a nearly eightfold higher risk for developing peripheral disease over time.

Patients with isolated axial PsA were significantly more likely to be diagnosed at an older age (mean, 37.44 vs. 29.65 years), had higher Psoriasis Area Severity Index scores and a higher likelihood of having psoriatic nail lesions than patients with AS with isolated axial disease and psoriasis.

In contrast, patients with isolated axSpA with psoriasis were more likely to have inflammatory back pain, spinal pain, joint pain/swelling, and areas of localized tenderness, and they had greater severity of morning stiffness.

Dr. Gladman noted that, although AS and PsA are associated with the same gene that encodes for the IL-23 receptor, each condition is associated with a different single-nucleotide polymorphism.

Same disease, different flavors?

But as Mark Twain said, it is difference of opinion that makes horse races, and some specialists in rheumatology say that axSpA amd axPsA are just two sides of the same coin.

Pramod Rathod

“There are always different schools of thought. I believe that they are not different diseases, but a spectrum of diseases,” said Shailendra Singh, MD, a rheumatologist at Unity Health Medical Center in Searcy, Ark., and past president of the Arkansas Rheumatology Association.

In an interview, Dr. Singh said that the spectrum ranges from diseases with primarily axial involvement, such as AS, to those with primarily peripheral involvement, such as reactive arthritis.

He pointed out that these conditions have overlapping symptoms, including enthesitis, dactylitis, and uveitis, and inflammatory arthritis.

Daniel Wendling, MD, PhD, from the Centre Hospitalier Régional Universitaire de Besançon (France), Université de Franche-Comté, and colleagues agreed.

“The criteria currently available for both SpA [ASAS (Assessment of Spondyloarthritis International Society) criteria] and PsA [CASPAR (Classification for Psoriatic Arthritis) criteria] are classification criteria, not diagnostic criteria. They are not very stringent and are not exclusive. Thus, the same patient can easily be classified simultaneously in both entities, making the distinction between axSpA with psoriasis and axPsA theoretical,” they wrote in an editorial published in Joint Bone Spine.

They cited as an example of the allegedly fuzzy criteria a prospective study conducted by the investigators in Bath, England, in which modified New York criteria for AS were met by 24% of patients with AS, and CASPAR criteria for PsA were met by an equal number of patients with AS.
 

Therapeutic implications

Dr. Wendling and colleagues acknowledge the differences cited in studies by Dr. Gladman, Dr. Mease, and others between patients with axPsA and those with axSpA, but argue that the differences are not that great and not so clear.

“It should also be emphasized that, although some differences between axPsA and axSpA reach statistical significance, they are mostly at the margin, with low odd ratios,” they wrote.

“It is also important to consider the variability in the definition of axPsA, sometimes simply ‘physician reported’ and elsewhere based on the modified New York radiographic criteria; the latter are only present late in the course of the disease, and this may induce bias,” they continued.

Dr. Singh agreed that, as noted by Dr. Gladman, some patients will respond to anti–IL-17, anti–IL-23, and anti–IL-12/23 agents, whereas others will have better responses with tumor necrosis factor (TNF) inhibitors, and still others, such as those with peripheral involvement in the hands and feet may fare better with nonbiologic disease-modifying antirheumatic drugs such as methotrexate.
 

Answers to come?

Dr. Gladman noted that the information available to date about the efficacy of IL-23 inhibition in axPsA is based on a post hoc analysis of the PSUMMIT 1 and 2 controlled trials in PsA, and is not definitive.

The randomized, controlled STAR trial, currently recruiting patients, is designed to see whether guselkumab can reduce axial symptoms and inflammation in patients with active axPsA.

“What I say is, there is a rationale for [anti–IL-23] to work in psoriatic arthritis, and not work in ankylosing spondylitis,” she said.

In contrast, IL-17 inhibitors, anti-TNF agents, and Janus kinase inhibitors show efficacy against both axPsA and AS. Rituximab is ineffective against PsA, but has shown efficacy against AS, especially in patients with neurologic complications from anti-TNF agents.

“There may be other medications that would work more specifically in axial psoriatic arthritis that don’t work in ankylosing spondylitis, but at least recognizing that there may be some differences, and that therefore a correct diagnosis should be obtained, might be important,” she said.

Ideally, the picture will become clearer with results from the ongoing Axial Involvement in Psoriatic Arthritis cohort, a joint project of ASAS and the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis. The multinational, cross-sectional study is designed “to systematically evaluate clinical and imaging manifestations indicative of axial involvement in patients with PsA and to develop classification criteria and a unified nomenclature for axial involvement in PsA that would allow defining a homogeneous subgroup of patients for research.”

Stay tuned.

Dr. Gladman’s research is supported by a grant from the Krembil Foundation. Dr. Singh disclosed research support from various companies. Funding sources and conflict of interest disclosures from other works cited are contained in their respective references.