Psoriatic Arthritis

Being identified as someone that was advised to stay at home and shield, or keep away from face-to-face interactions with others, during the COVID-19 pandemic was indicative of an increased risk for dying from COVID-19 within 28 days of infection, a U.K. study of inflammatory arthritis patients versus the general population suggests.

In fact, shielding status was the highest ranked of all the risk factors identified for early mortality from COVID-19, with a hazard ratio of 1.52 (95% confidence interval, 1.40-1.64) comparing people with and without inflammatory arthritis (IA) who had tested positive.

The list of risk factors associated with higher mortality in the IA patients versus the general population also included diabetes (HR, 1.38), smoking (HR, 1.27), hypertension (HR, 1.19), glucocorticoid use (HR, 1.17), and cancer (HR, 1.10), as well as increasing age (HR, 1.08) and body mass index (HR, 1.01).

Also important was the person’s prior hospitalization history, with those needing in-hospital care in the year running up to their admission for COVID-19 associated with a 34% higher risk for death, and being hospitalized previously with a serious infection was associated with a 20% higher risk.

This has more to do people’s overall vulnerability than their IA, suggested the team behind the findings, who also found that the risk of catching COVID-19 was significantly lower among patients with IA than the general population (3.5% vs. 6%), presumably because of shielding.

Examining the risks for COVID-19 in real-life practice

“COVID-19 has caused over 10 million deaths,” Roxanne Cooksey, PhD, said at the annual meeting of the British Society for Rheumatology. “It’s greatly affected vulnerable individuals, which includes individuals with IA, this is due to their compromised immune system and increased risk of infection and the medications that they take to manage their conditions.

“Previous studies have had mixed results about whether people with IA have an increased risk of poor outcome,” added Dr. Cooksey, who is a postdoctoral researcher in the division of infection and immunity at Cardiff (Wales) University.

“So, our research question looks to investigate inflammatory arthritis – that’s rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis – to see whether the conditions themselves or indeed their medications predispose individuals to an increased risk of contracting COVID or even more adverse outcomes.”

Dr. Cooksey and colleagues looked specifically at COVID-19 infection rates and outcomes in adults living in Wales during the first year of the pandemic (March 2020 to May 2021). As such they used routinely collected, anonymized health data from the SAIL Databank and performed a retrospective, population-based cohort study. In total, there were 1,966 people with inflammatory arthritis identified as having COVID-19 and 166,602 people without IA but who had COVID-19 in the study population.

As might be expected, people with inflammatory arthritis who tested positive for COVID-19 were older than those testing positive in the general population, at a mean of 62 years versus 46 years. They were also more likely to have been advised to shield (49.4% versus 4.6%), which in the United Kingdom constituted of receiving a letter telling them about the importance of social distancing, wearing a mask when out in public, and quarantining themselves at home whenever possible.

The main outcomes were hospitalizations and mortality within 28 days of COVID-19 infection. Considering the overall inflammatory arthritis population, rates of both outcomes were higher versus the general population. And when the researchers analyzed the risks according to the type of inflammatory arthritis, the associations were not statistically significant in a multivariable analysis for people with any of the inflammatory arthritis diagnoses: rheumatoid arthritis (n = 1,283), psoriatic arthritis (n = 514), or ankylosing spondylitis (n = 246). Some patients had more than one inflammatory arthritis diagnosis.
 

What does this all mean?

Dr. Cooksey conceded that there were lots of limitations to the data collected – from misclassification bias to data possibly not have been recorded completely or missing because of the disruption to health care services during the early stages of the pandemic. Patients may have been told to shield but not actually shielded, she observed, and maybe because a lack of testing COVID-19 cases were missed or people could have been asymptomatic or unable to be tested.

“The study supports the role of shielding in inflammatory arthritis,” Dr. Cooksey said, particularly in those with RA and the risk factors associated with an increased risk in death. However, that may not mean the entire population, she suggested, saying that “refining the criteria for shielding will help mitigate the negative effects of the entire IA population.”

Senior team member Ernest Choy, MD, added his thoughts, saying that, rather than giving generic shielding recommendations to all IA patients, not everyone has the same risk, so maybe not everyone needs to shield to the same level.

“Psoriatic arthritis patients and ankylosing spondylitis patients are younger, so they really don’t have as high a risk like patients with rheumatoid arthritis,” he said.

Dr. Choy, who is professor of rheumatology at the Cardiff Institute of Infection & Immunity, commented that it was not surprising to find that a prior serious infection was a risk for COVID-19 mortality. This risk factor was examined because of the known association between biologic use and the risk for serious infection.

Moreover, he said that, “if you have a serious comorbidity that requires you to get admitted to hospital, that is a reflection of your vulnerability.”

Dr. Cooksey and Dr. Choy had no relevant conflicts of interest to disclose.

Being identified as someone that was advised to stay at home and shield, or keep away from face-to-face interactions with others, during the COVID-19 pandemic was indicative of an increased risk for dying from COVID-19 within 28 days of infection, a U.K. study of inflammatory arthritis patients versus the general population suggests.

In fact, shielding status was the highest ranked of all the risk factors identified for early mortality from COVID-19, with a hazard ratio of 1.52 (95% confidence interval, 1.40-1.64) comparing people with and without inflammatory arthritis (IA) who had tested positive.

The list of risk factors associated with higher mortality in the IA patients versus the general population also included diabetes (HR, 1.38), smoking (HR, 1.27), hypertension (HR, 1.19), glucocorticoid use (HR, 1.17), and cancer (HR, 1.10), as well as increasing age (HR, 1.08) and body mass index (HR, 1.01).

Also important was the person’s prior hospitalization history, with those needing in-hospital care in the year running up to their admission for COVID-19 associated with a 34% higher risk for death, and being hospitalized previously with a serious infection was associated with a 20% higher risk.

This has more to do people’s overall vulnerability than their IA, suggested the team behind the findings, who also found that the risk of catching COVID-19 was significantly lower among patients with IA than the general population (3.5% vs. 6%), presumably because of shielding.

Examining the risks for COVID-19 in real-life practice

“COVID-19 has caused over 10 million deaths,” Roxanne Cooksey, PhD, said at the annual meeting of the British Society for Rheumatology. “It’s greatly affected vulnerable individuals, which includes individuals with IA, this is due to their compromised immune system and increased risk of infection and the medications that they take to manage their conditions.

“Previous studies have had mixed results about whether people with IA have an increased risk of poor outcome,” added Dr. Cooksey, who is a postdoctoral researcher in the division of infection and immunity at Cardiff (Wales) University.

“So, our research question looks to investigate inflammatory arthritis – that’s rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis – to see whether the conditions themselves or indeed their medications predispose individuals to an increased risk of contracting COVID or even more adverse outcomes.”

Dr. Cooksey and colleagues looked specifically at COVID-19 infection rates and outcomes in adults living in Wales during the first year of the pandemic (March 2020 to May 2021). As such they used routinely collected, anonymized health data from the SAIL Databank and performed a retrospective, population-based cohort study. In total, there were 1,966 people with inflammatory arthritis identified as having COVID-19 and 166,602 people without IA but who had COVID-19 in the study population.

As might be expected, people with inflammatory arthritis who tested positive for COVID-19 were older than those testing positive in the general population, at a mean of 62 years versus 46 years. They were also more likely to have been advised to shield (49.4% versus 4.6%), which in the United Kingdom constituted of receiving a letter telling them about the importance of social distancing, wearing a mask when out in public, and quarantining themselves at home whenever possible.

The main outcomes were hospitalizations and mortality within 28 days of COVID-19 infection. Considering the overall inflammatory arthritis population, rates of both outcomes were higher versus the general population. And when the researchers analyzed the risks according to the type of inflammatory arthritis, the associations were not statistically significant in a multivariable analysis for people with any of the inflammatory arthritis diagnoses: rheumatoid arthritis (n = 1,283), psoriatic arthritis (n = 514), or ankylosing spondylitis (n = 246). Some patients had more than one inflammatory arthritis diagnosis.
 

What does this all mean?

Dr. Cooksey conceded that there were lots of limitations to the data collected – from misclassification bias to data possibly not have been recorded completely or missing because of the disruption to health care services during the early stages of the pandemic. Patients may have been told to shield but not actually shielded, she observed, and maybe because a lack of testing COVID-19 cases were missed or people could have been asymptomatic or unable to be tested.

“The study supports the role of shielding in inflammatory arthritis,” Dr. Cooksey said, particularly in those with RA and the risk factors associated with an increased risk in death. However, that may not mean the entire population, she suggested, saying that “refining the criteria for shielding will help mitigate the negative effects of the entire IA population.”

Senior team member Ernest Choy, MD, added his thoughts, saying that, rather than giving generic shielding recommendations to all IA patients, not everyone has the same risk, so maybe not everyone needs to shield to the same level.

“Psoriatic arthritis patients and ankylosing spondylitis patients are younger, so they really don’t have as high a risk like patients with rheumatoid arthritis,” he said.

Dr. Choy, who is professor of rheumatology at the Cardiff Institute of Infection & Immunity, commented that it was not surprising to find that a prior serious infection was a risk for COVID-19 mortality. This risk factor was examined because of the known association between biologic use and the risk for serious infection.

Moreover, he said that, “if you have a serious comorbidity that requires you to get admitted to hospital, that is a reflection of your vulnerability.”

Dr. Cooksey and Dr. Choy had no relevant conflicts of interest to disclose.

Being identified as someone that was advised to stay at home and shield, or keep away from face-to-face interactions with others, during the COVID-19 pandemic was indicative of an increased risk for dying from COVID-19 within 28 days of infection, a U.K. study of inflammatory arthritis patients versus the general population suggests.

In fact, shielding status was the highest ranked of all the risk factors identified for early mortality from COVID-19, with a hazard ratio of 1.52 (95% confidence interval, 1.40-1.64) comparing people with and without inflammatory arthritis (IA) who had tested positive.

The list of risk factors associated with higher mortality in the IA patients versus the general population also included diabetes (HR, 1.38), smoking (HR, 1.27), hypertension (HR, 1.19), glucocorticoid use (HR, 1.17), and cancer (HR, 1.10), as well as increasing age (HR, 1.08) and body mass index (HR, 1.01).

Also important was the person’s prior hospitalization history, with those needing in-hospital care in the year running up to their admission for COVID-19 associated with a 34% higher risk for death, and being hospitalized previously with a serious infection was associated with a 20% higher risk.

This has more to do people’s overall vulnerability than their IA, suggested the team behind the findings, who also found that the risk of catching COVID-19 was significantly lower among patients with IA than the general population (3.5% vs. 6%), presumably because of shielding.

Examining the risks for COVID-19 in real-life practice

“COVID-19 has caused over 10 million deaths,” Roxanne Cooksey, PhD, said at the annual meeting of the British Society for Rheumatology. “It’s greatly affected vulnerable individuals, which includes individuals with IA, this is due to their compromised immune system and increased risk of infection and the medications that they take to manage their conditions.

“Previous studies have had mixed results about whether people with IA have an increased risk of poor outcome,” added Dr. Cooksey, who is a postdoctoral researcher in the division of infection and immunity at Cardiff (Wales) University.

“So, our research question looks to investigate inflammatory arthritis – that’s rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis – to see whether the conditions themselves or indeed their medications predispose individuals to an increased risk of contracting COVID or even more adverse outcomes.”

Dr. Cooksey and colleagues looked specifically at COVID-19 infection rates and outcomes in adults living in Wales during the first year of the pandemic (March 2020 to May 2021). As such they used routinely collected, anonymized health data from the SAIL Databank and performed a retrospective, population-based cohort study. In total, there were 1,966 people with inflammatory arthritis identified as having COVID-19 and 166,602 people without IA but who had COVID-19 in the study population.

As might be expected, people with inflammatory arthritis who tested positive for COVID-19 were older than those testing positive in the general population, at a mean of 62 years versus 46 years. They were also more likely to have been advised to shield (49.4% versus 4.6%), which in the United Kingdom constituted of receiving a letter telling them about the importance of social distancing, wearing a mask when out in public, and quarantining themselves at home whenever possible.

The main outcomes were hospitalizations and mortality within 28 days of COVID-19 infection. Considering the overall inflammatory arthritis population, rates of both outcomes were higher versus the general population. And when the researchers analyzed the risks according to the type of inflammatory arthritis, the associations were not statistically significant in a multivariable analysis for people with any of the inflammatory arthritis diagnoses: rheumatoid arthritis (n = 1,283), psoriatic arthritis (n = 514), or ankylosing spondylitis (n = 246). Some patients had more than one inflammatory arthritis diagnosis.
 

What does this all mean?

Dr. Cooksey conceded that there were lots of limitations to the data collected – from misclassification bias to data possibly not have been recorded completely or missing because of the disruption to health care services during the early stages of the pandemic. Patients may have been told to shield but not actually shielded, she observed, and maybe because a lack of testing COVID-19 cases were missed or people could have been asymptomatic or unable to be tested.

“The study supports the role of shielding in inflammatory arthritis,” Dr. Cooksey said, particularly in those with RA and the risk factors associated with an increased risk in death. However, that may not mean the entire population, she suggested, saying that “refining the criteria for shielding will help mitigate the negative effects of the entire IA population.”

Senior team member Ernest Choy, MD, added his thoughts, saying that, rather than giving generic shielding recommendations to all IA patients, not everyone has the same risk, so maybe not everyone needs to shield to the same level.

“Psoriatic arthritis patients and ankylosing spondylitis patients are younger, so they really don’t have as high a risk like patients with rheumatoid arthritis,” he said.

Dr. Choy, who is professor of rheumatology at the Cardiff Institute of Infection & Immunity, commented that it was not surprising to find that a prior serious infection was a risk for COVID-19 mortality. This risk factor was examined because of the known association between biologic use and the risk for serious infection.

Moreover, he said that, “if you have a serious comorbidity that requires you to get admitted to hospital, that is a reflection of your vulnerability.”

Dr. Cooksey and Dr. Choy had no relevant conflicts of interest to disclose.

Reducing the frequency of routine blood monitoring for methotrexate in patients with rheumatoid arthritis during the COVID-19 pandemic was associated with no adverse outcomes for patients, British researchers have found.

Similar laboratory results were recorded in patients who were switched from testing once per month to once every 3 or 5 months, Natasha Wood, a general practice trainee at North Devon District Hospital in Barnstaple, England, reported at the annual meeting of the British Society for Rheumatology.

sshepard/iStock

“Less frequent monitoring did not result in patient harm,” she said.

“There’s an increasing evidence base; we wonder whether now’s the time to reconsider our DMARD-monitoring strategy,” Ms. Wood said.
 

Changes in monitoring because of pandemic

Methotrexate monitoring is important to minimize the risk of harm to patients, and it is recommended that standard laboratory tests, such as a complete blood count, creatinine, and liver enzymes are measured regularly. Indeed, both the BSR and the American College of Rheumatology have specific recommendations on the monitoring of methotrexate and other conventional synthetic disease-modifying antirheumatic drugs (csDMARDS).

“The BSR used to advise for monthly blood tests in patients taking methotrexate,” Ms. Wood said, but the BSR moved to recommend testing patients on a stable dose every 3 months in 2017.

“Things of course changed again rapidly with COVID, with the BSR quickly updating their guidelines advising for less frequent monitoring in this patient group,” Ms. Wood said.

As a result, the North Devon Clinical Commissioning Group, which covers the hospital where Ms. Wood works, agreed to allow testing every 6 months for patients on a stable methotrexate dose. “This was across specialties, so not just rheumatology, but dermatology and gastroenterology as well,” she said.

“This provided us with a really exciting and unique opportunity to look at this patient group and see what happened,” Ms. Wood explained.

Effect of less frequent monitoring

At the meeting, Ms. Wood presented the results of an audit of 854 patients found via a search of hospital pathology records who were stable on methotrexate monotherapy for at least 12 months.

Two subanalyses were performed: One looked at patients who had changed from blood testing once every month to once every 3 months (n = 229) and the other looking at a group of 120 patients who had gone from testing once every 3 months to approximately every 5 months.

The mean age of patients was 67 for monthly testing, 69 for testing every 3 months, and 66 for testing about every 5 months, with around two-thirds of patients being of female sex.

A comparison of the number of blood tests performed to the end of April 2020 with the number performed to the end of April 2021 showed that there had mainly been a shift from testing once per month to once every 3 months, with some patients being tested in line with the revised BSR guidelines at around 5 months.

“Interestingly, a third of this group had no changed monitoring frequency despite the change in guidelines,” Ms. Wood said.

“Prepandemic, most patients [were] having monthly bloods despite BSR advice from 2017, and despite the pandemic with the updated shared care guidelines,” patients were still having blood drawn every 3 months, Ms. Wood noted. This perhaps needs further investigation and consideration to understand why recommended changes to the frequency of testing are not being adhered to.

The overall distribution of laboratory findings was similar among those who went from testing once per month to once every 3 months and from every 3 months to every 5 months. This included the distribution of neutrophils, whole blood counts, and alanine aminotransferase. There were some changes for platelets, mean cell volume, and the estimated glomerular filtration rate, but these were not clinically significant.

“Abnormal blood results aren’t common in stable methotrexate monotherapy patients,” Ms. Wood reported. “Where abnormalities did occur, it was in the context of patients being concurrently unwell and symptomatic.”
 

Time for patient-initiated testing?

There are several advantages of less frequent methotrexate monitoring, Ms. Wood said. One is the practicalities of getting to and from appointments, particularly in remote locations, such as where she works.

In addition to reducing workloads and pressure on already busy hospitals and primary care, this could have a huge environmental impact, she suggested.

Moreover, “moderate-quality evidence” supports the current monitoring frequency recommendation.

“We know that our numbers are small – we’re a small center – but our findings are consistent with much larger studies across the U.K.,” Ms. Wood said.

“We wonder whether there’s the possibility of moving towards annual monitoring with good safety netting and patient education for additional blood tests if they are unwell,” she said, adding that “now may be the time for patient-initiated methotrexate monitoring.”

Ms. Wood disclosed Janssen sponsorship for attending the BSR 2022 annual meeting.

Reducing the frequency of routine blood monitoring for methotrexate in patients with rheumatoid arthritis during the COVID-19 pandemic was associated with no adverse outcomes for patients, British researchers have found.

Similar laboratory results were recorded in patients who were switched from testing once per month to once every 3 or 5 months, Natasha Wood, a general practice trainee at North Devon District Hospital in Barnstaple, England, reported at the annual meeting of the British Society for Rheumatology.

sshepard/iStock

“Less frequent monitoring did not result in patient harm,” she said.

“There’s an increasing evidence base; we wonder whether now’s the time to reconsider our DMARD-monitoring strategy,” Ms. Wood said.
 

Changes in monitoring because of pandemic

Methotrexate monitoring is important to minimize the risk of harm to patients, and it is recommended that standard laboratory tests, such as a complete blood count, creatinine, and liver enzymes are measured regularly. Indeed, both the BSR and the American College of Rheumatology have specific recommendations on the monitoring of methotrexate and other conventional synthetic disease-modifying antirheumatic drugs (csDMARDS).

“The BSR used to advise for monthly blood tests in patients taking methotrexate,” Ms. Wood said, but the BSR moved to recommend testing patients on a stable dose every 3 months in 2017.

“Things of course changed again rapidly with COVID, with the BSR quickly updating their guidelines advising for less frequent monitoring in this patient group,” Ms. Wood said.

As a result, the North Devon Clinical Commissioning Group, which covers the hospital where Ms. Wood works, agreed to allow testing every 6 months for patients on a stable methotrexate dose. “This was across specialties, so not just rheumatology, but dermatology and gastroenterology as well,” she said.

“This provided us with a really exciting and unique opportunity to look at this patient group and see what happened,” Ms. Wood explained.

Effect of less frequent monitoring

At the meeting, Ms. Wood presented the results of an audit of 854 patients found via a search of hospital pathology records who were stable on methotrexate monotherapy for at least 12 months.

Two subanalyses were performed: One looked at patients who had changed from blood testing once every month to once every 3 months (n = 229) and the other looking at a group of 120 patients who had gone from testing once every 3 months to approximately every 5 months.

The mean age of patients was 67 for monthly testing, 69 for testing every 3 months, and 66 for testing about every 5 months, with around two-thirds of patients being of female sex.

A comparison of the number of blood tests performed to the end of April 2020 with the number performed to the end of April 2021 showed that there had mainly been a shift from testing once per month to once every 3 months, with some patients being tested in line with the revised BSR guidelines at around 5 months.

“Interestingly, a third of this group had no changed monitoring frequency despite the change in guidelines,” Ms. Wood said.

“Prepandemic, most patients [were] having monthly bloods despite BSR advice from 2017, and despite the pandemic with the updated shared care guidelines,” patients were still having blood drawn every 3 months, Ms. Wood noted. This perhaps needs further investigation and consideration to understand why recommended changes to the frequency of testing are not being adhered to.

The overall distribution of laboratory findings was similar among those who went from testing once per month to once every 3 months and from every 3 months to every 5 months. This included the distribution of neutrophils, whole blood counts, and alanine aminotransferase. There were some changes for platelets, mean cell volume, and the estimated glomerular filtration rate, but these were not clinically significant.

“Abnormal blood results aren’t common in stable methotrexate monotherapy patients,” Ms. Wood reported. “Where abnormalities did occur, it was in the context of patients being concurrently unwell and symptomatic.”
 

Time for patient-initiated testing?

There are several advantages of less frequent methotrexate monitoring, Ms. Wood said. One is the practicalities of getting to and from appointments, particularly in remote locations, such as where she works.

In addition to reducing workloads and pressure on already busy hospitals and primary care, this could have a huge environmental impact, she suggested.

Moreover, “moderate-quality evidence” supports the current monitoring frequency recommendation.

“We know that our numbers are small – we’re a small center – but our findings are consistent with much larger studies across the U.K.,” Ms. Wood said.

“We wonder whether there’s the possibility of moving towards annual monitoring with good safety netting and patient education for additional blood tests if they are unwell,” she said, adding that “now may be the time for patient-initiated methotrexate monitoring.”

Ms. Wood disclosed Janssen sponsorship for attending the BSR 2022 annual meeting.

Reducing the frequency of routine blood monitoring for methotrexate in patients with rheumatoid arthritis during the COVID-19 pandemic was associated with no adverse outcomes for patients, British researchers have found.

Similar laboratory results were recorded in patients who were switched from testing once per month to once every 3 or 5 months, Natasha Wood, a general practice trainee at North Devon District Hospital in Barnstaple, England, reported at the annual meeting of the British Society for Rheumatology.

sshepard/iStock

“Less frequent monitoring did not result in patient harm,” she said.

“There’s an increasing evidence base; we wonder whether now’s the time to reconsider our DMARD-monitoring strategy,” Ms. Wood said.
 

Changes in monitoring because of pandemic

Methotrexate monitoring is important to minimize the risk of harm to patients, and it is recommended that standard laboratory tests, such as a complete blood count, creatinine, and liver enzymes are measured regularly. Indeed, both the BSR and the American College of Rheumatology have specific recommendations on the monitoring of methotrexate and other conventional synthetic disease-modifying antirheumatic drugs (csDMARDS).

“The BSR used to advise for monthly blood tests in patients taking methotrexate,” Ms. Wood said, but the BSR moved to recommend testing patients on a stable dose every 3 months in 2017.

“Things of course changed again rapidly with COVID, with the BSR quickly updating their guidelines advising for less frequent monitoring in this patient group,” Ms. Wood said.

As a result, the North Devon Clinical Commissioning Group, which covers the hospital where Ms. Wood works, agreed to allow testing every 6 months for patients on a stable methotrexate dose. “This was across specialties, so not just rheumatology, but dermatology and gastroenterology as well,” she said.

“This provided us with a really exciting and unique opportunity to look at this patient group and see what happened,” Ms. Wood explained.

Effect of less frequent monitoring

At the meeting, Ms. Wood presented the results of an audit of 854 patients found via a search of hospital pathology records who were stable on methotrexate monotherapy for at least 12 months.

Two subanalyses were performed: One looked at patients who had changed from blood testing once every month to once every 3 months (n = 229) and the other looking at a group of 120 patients who had gone from testing once every 3 months to approximately every 5 months.

The mean age of patients was 67 for monthly testing, 69 for testing every 3 months, and 66 for testing about every 5 months, with around two-thirds of patients being of female sex.

A comparison of the number of blood tests performed to the end of April 2020 with the number performed to the end of April 2021 showed that there had mainly been a shift from testing once per month to once every 3 months, with some patients being tested in line with the revised BSR guidelines at around 5 months.

“Interestingly, a third of this group had no changed monitoring frequency despite the change in guidelines,” Ms. Wood said.

“Prepandemic, most patients [were] having monthly bloods despite BSR advice from 2017, and despite the pandemic with the updated shared care guidelines,” patients were still having blood drawn every 3 months, Ms. Wood noted. This perhaps needs further investigation and consideration to understand why recommended changes to the frequency of testing are not being adhered to.

The overall distribution of laboratory findings was similar among those who went from testing once per month to once every 3 months and from every 3 months to every 5 months. This included the distribution of neutrophils, whole blood counts, and alanine aminotransferase. There were some changes for platelets, mean cell volume, and the estimated glomerular filtration rate, but these were not clinically significant.

“Abnormal blood results aren’t common in stable methotrexate monotherapy patients,” Ms. Wood reported. “Where abnormalities did occur, it was in the context of patients being concurrently unwell and symptomatic.”
 

Time for patient-initiated testing?

There are several advantages of less frequent methotrexate monitoring, Ms. Wood said. One is the practicalities of getting to and from appointments, particularly in remote locations, such as where she works.

In addition to reducing workloads and pressure on already busy hospitals and primary care, this could have a huge environmental impact, she suggested.

Moreover, “moderate-quality evidence” supports the current monitoring frequency recommendation.

“We know that our numbers are small – we’re a small center – but our findings are consistent with much larger studies across the U.K.,” Ms. Wood said.

“We wonder whether there’s the possibility of moving towards annual monitoring with good safety netting and patient education for additional blood tests if they are unwell,” she said, adding that “now may be the time for patient-initiated methotrexate monitoring.”

Ms. Wood disclosed Janssen sponsorship for attending the BSR 2022 annual meeting.

The Food and Drug Administration has approved upadacitinib (Rinvoq) as an oral treatment for active ankylosing spondylitis in adults, its manufacturer AbbVie announced April 29.

Upadacitinib, a selective and reversible Janus kinase inhibitor, is the second drug in its class to be FDA approved for ankylosing spondylitis, after tofacitinib (Xeljanz) in December.

Upadacitinib is now indicated for patients with active ankylosing spondylitis (AS) who have had an insufficient response or intolerance with one or more tumor necrosis factor (TNF) blockers. Upadacitinib is already approved by the FDA for adults with active psoriatic arthritis, moderately to severely active rheumatoid arthritis, and moderately to severely active ulcerative colitis who have had an insufficient response or intolerance with one or more TNF inhibitors. It also has been approved for adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis.

The European Medicines Agency gave marketing approval for upadacitinib in adults with active AS in January 2021.

Two main clinical studies form the basis for the FDA’s approval decision. The phase 3 SELECT-AXIS 2 clinical trial involved patients with an inadequate response or intolerance to one or two biologic disease-modifying antirheumatic drugs (bDMARDs). A total of 44.5% patients with AS who were randomly assigned to upadacitinib 15 mg once daily met the primary endpoint of at least 40% improvement in Assessment in Spondyloarthritis International Society response criteria (ASAS 40) at 14 weeks, compared against 18.2% with placebo.

The second study, the phase 2/3 SELECT-AXIS 1 clinical trial, tested upadacitinib in patients who had never taken bDMARDs and had an inadequate response or intolerance to at least two NSAIDs. In this study, significantly more patients randomly assigned to 15 mg upadacitinib achieved ASAS 40 at 14 weeks, compared with placebo (51% vs. 26%).

Patients randomly assigned to upadacitinib also showed significant improvements in signs and symptoms of AS, as well as improvements in physical function and disease activity, compared with placebo, after 14 weeks. The safety profile for patients with AS treated with upadacitinib was similar to that seen in studies of patients with rheumatoid arthritis or psoriatic arthritis. Potential severe side effects include increased risk for death in patients aged 50 years and older with at least one cardiovascular risk factor; increased risk of serious infections, such as tuberculosis; and increased risk of certain cancers, according to the company statement.

Read the complete prescribing information here.

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

The Food and Drug Administration has approved upadacitinib (Rinvoq) as an oral treatment for active ankylosing spondylitis in adults, its manufacturer AbbVie announced April 29.

Upadacitinib, a selective and reversible Janus kinase inhibitor, is the second drug in its class to be FDA approved for ankylosing spondylitis, after tofacitinib (Xeljanz) in December.

Upadacitinib is now indicated for patients with active ankylosing spondylitis (AS) who have had an insufficient response or intolerance with one or more tumor necrosis factor (TNF) blockers. Upadacitinib is already approved by the FDA for adults with active psoriatic arthritis, moderately to severely active rheumatoid arthritis, and moderately to severely active ulcerative colitis who have had an insufficient response or intolerance with one or more TNF inhibitors. It also has been approved for adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis.

The European Medicines Agency gave marketing approval for upadacitinib in adults with active AS in January 2021.

Two main clinical studies form the basis for the FDA’s approval decision. The phase 3 SELECT-AXIS 2 clinical trial involved patients with an inadequate response or intolerance to one or two biologic disease-modifying antirheumatic drugs (bDMARDs). A total of 44.5% patients with AS who were randomly assigned to upadacitinib 15 mg once daily met the primary endpoint of at least 40% improvement in Assessment in Spondyloarthritis International Society response criteria (ASAS 40) at 14 weeks, compared against 18.2% with placebo.

The second study, the phase 2/3 SELECT-AXIS 1 clinical trial, tested upadacitinib in patients who had never taken bDMARDs and had an inadequate response or intolerance to at least two NSAIDs. In this study, significantly more patients randomly assigned to 15 mg upadacitinib achieved ASAS 40 at 14 weeks, compared with placebo (51% vs. 26%).

Patients randomly assigned to upadacitinib also showed significant improvements in signs and symptoms of AS, as well as improvements in physical function and disease activity, compared with placebo, after 14 weeks. The safety profile for patients with AS treated with upadacitinib was similar to that seen in studies of patients with rheumatoid arthritis or psoriatic arthritis. Potential severe side effects include increased risk for death in patients aged 50 years and older with at least one cardiovascular risk factor; increased risk of serious infections, such as tuberculosis; and increased risk of certain cancers, according to the company statement.

Read the complete prescribing information here.

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

The Food and Drug Administration has approved upadacitinib (Rinvoq) as an oral treatment for active ankylosing spondylitis in adults, its manufacturer AbbVie announced April 29.

Upadacitinib, a selective and reversible Janus kinase inhibitor, is the second drug in its class to be FDA approved for ankylosing spondylitis, after tofacitinib (Xeljanz) in December.

Upadacitinib is now indicated for patients with active ankylosing spondylitis (AS) who have had an insufficient response or intolerance with one or more tumor necrosis factor (TNF) blockers. Upadacitinib is already approved by the FDA for adults with active psoriatic arthritis, moderately to severely active rheumatoid arthritis, and moderately to severely active ulcerative colitis who have had an insufficient response or intolerance with one or more TNF inhibitors. It also has been approved for adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis.

The European Medicines Agency gave marketing approval for upadacitinib in adults with active AS in January 2021.

Two main clinical studies form the basis for the FDA’s approval decision. The phase 3 SELECT-AXIS 2 clinical trial involved patients with an inadequate response or intolerance to one or two biologic disease-modifying antirheumatic drugs (bDMARDs). A total of 44.5% patients with AS who were randomly assigned to upadacitinib 15 mg once daily met the primary endpoint of at least 40% improvement in Assessment in Spondyloarthritis International Society response criteria (ASAS 40) at 14 weeks, compared against 18.2% with placebo.

The second study, the phase 2/3 SELECT-AXIS 1 clinical trial, tested upadacitinib in patients who had never taken bDMARDs and had an inadequate response or intolerance to at least two NSAIDs. In this study, significantly more patients randomly assigned to 15 mg upadacitinib achieved ASAS 40 at 14 weeks, compared with placebo (51% vs. 26%).

Patients randomly assigned to upadacitinib also showed significant improvements in signs and symptoms of AS, as well as improvements in physical function and disease activity, compared with placebo, after 14 weeks. The safety profile for patients with AS treated with upadacitinib was similar to that seen in studies of patients with rheumatoid arthritis or psoriatic arthritis. Potential severe side effects include increased risk for death in patients aged 50 years and older with at least one cardiovascular risk factor; increased risk of serious infections, such as tuberculosis; and increased risk of certain cancers, according to the company statement.

Read the complete prescribing information here.

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

Results of a meta-analysis carried out by a French team indicate that there is a link between a father’s or mother’s autoimmune disease and their children’s risk of developing certain neurodevelopmental disorders (autism spectrum disorder [ASD] and attention-deficit/hyperactivity disorder). This meta-analysis is the first to separately explore the link between a father’s or mother’s autoimmune disease and the onset of neurodevelopmental disorders in their children.

According to its authors, these associations may result from exposure to environmental factors that contribute to autoimmune disorders, such as exposure to pollutants or cigarette smoke, and/or genetic predisposition, including genes relating to cytokines or to the HLA system.

Research is needed to determine the pathophysiologic links between these associations. This study suggests that there could be a shared mechanism between both parents, even though the maternal route seems to constitute an additional excess risk.
 

Why is this important?

Neurodevelopmental disorders are said to occur because of a close interrelationship between a person’s genes and environment. Immune-mediated adverse reactions may play an important role in triggering such disorders, as has been shown in associated epidemiologic studies and in animal studies. Autoimmune and autoinflammatory disorders are effectively characterized by the activation of the immune system, the circulation of autoantibodies, and the secretion of cytokines that are harmful to certain tissues.

Some relevant studies suggest a link between autoimmune disorders in the family or in the mother and the onset of neurodevelopmental disorders in their children. However, none of the studies have distinguished the influence of each of the parents so as to provide data that can be used to assess whether this association is more likely to be direct, and thus established during pregnancy, or rather genetic or environmental.
 

Main findings

Overall, the meta-analysis involved 14 studies that included 845,411 mothers and 601,148 fathers with an autoimmune disease, 4,984,965 control mothers and 4,992,854 control fathers. There were 182,927 children with neurodevelopmental disorders and 14,168,474 with no such diagnosis.

Globally, autoimmune diseases in mothers (adjusted odds ratio, 1.27 [1.03-1.57]; P = .02; I2 = 65%) and in fathers (AOR, 1.18 [1.07-1.30]; P = .01; I2 = 15.5%) are associated with a diagnosis of ASD in children. Similarly, they are associated with an increased risk of ADHD in children (AOR, 1.31 [1.11-1.55]; P = .001; I2 = 93% and AOR, 1.14 [1.10-1.17]; P < .0001; I2 = 0%, respectively, for mothers and fathers).

In mothers, type 1 diabetes (AOR, 1.60 [1.18-2.18]; P = .002; I2 = 0%), psoriasis (AOR, 1.45 [1.14-1.85]; P = .002; I2 = 0%), and rheumatoid arthritis (AOR, 1.38 [1.14-1.68]; P = .001; I2 = 0.8%) were associated with a risk of ASD in children. These three conditions also predisposed children to the risk of ADHD (AOR, 1.36 [1.24-1.52]; 1.41 [1.29-1.54]; and 1.32 [1.25-1.40], respectively, all P < .0001).

In fathers, type 1 diabetes considered in isolation was associated with a risk of ASD and ADHD in children (AOR, 1.42 [1.10-1.83] and 1.19 [1.08-1.31], respectively), while psoriasis (AOR, 1.18 [1.12-1.24]; P < .0001) is associated with a risk of ADHD in children.

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

Results of a meta-analysis carried out by a French team indicate that there is a link between a father’s or mother’s autoimmune disease and their children’s risk of developing certain neurodevelopmental disorders (autism spectrum disorder [ASD] and attention-deficit/hyperactivity disorder). This meta-analysis is the first to separately explore the link between a father’s or mother’s autoimmune disease and the onset of neurodevelopmental disorders in their children.

According to its authors, these associations may result from exposure to environmental factors that contribute to autoimmune disorders, such as exposure to pollutants or cigarette smoke, and/or genetic predisposition, including genes relating to cytokines or to the HLA system.

Research is needed to determine the pathophysiologic links between these associations. This study suggests that there could be a shared mechanism between both parents, even though the maternal route seems to constitute an additional excess risk.
 

Why is this important?

Neurodevelopmental disorders are said to occur because of a close interrelationship between a person’s genes and environment. Immune-mediated adverse reactions may play an important role in triggering such disorders, as has been shown in associated epidemiologic studies and in animal studies. Autoimmune and autoinflammatory disorders are effectively characterized by the activation of the immune system, the circulation of autoantibodies, and the secretion of cytokines that are harmful to certain tissues.

Some relevant studies suggest a link between autoimmune disorders in the family or in the mother and the onset of neurodevelopmental disorders in their children. However, none of the studies have distinguished the influence of each of the parents so as to provide data that can be used to assess whether this association is more likely to be direct, and thus established during pregnancy, or rather genetic or environmental.
 

Main findings

Overall, the meta-analysis involved 14 studies that included 845,411 mothers and 601,148 fathers with an autoimmune disease, 4,984,965 control mothers and 4,992,854 control fathers. There were 182,927 children with neurodevelopmental disorders and 14,168,474 with no such diagnosis.

Globally, autoimmune diseases in mothers (adjusted odds ratio, 1.27 [1.03-1.57]; P = .02; I2 = 65%) and in fathers (AOR, 1.18 [1.07-1.30]; P = .01; I2 = 15.5%) are associated with a diagnosis of ASD in children. Similarly, they are associated with an increased risk of ADHD in children (AOR, 1.31 [1.11-1.55]; P = .001; I2 = 93% and AOR, 1.14 [1.10-1.17]; P < .0001; I2 = 0%, respectively, for mothers and fathers).

In mothers, type 1 diabetes (AOR, 1.60 [1.18-2.18]; P = .002; I2 = 0%), psoriasis (AOR, 1.45 [1.14-1.85]; P = .002; I2 = 0%), and rheumatoid arthritis (AOR, 1.38 [1.14-1.68]; P = .001; I2 = 0.8%) were associated with a risk of ASD in children. These three conditions also predisposed children to the risk of ADHD (AOR, 1.36 [1.24-1.52]; 1.41 [1.29-1.54]; and 1.32 [1.25-1.40], respectively, all P < .0001).

In fathers, type 1 diabetes considered in isolation was associated with a risk of ASD and ADHD in children (AOR, 1.42 [1.10-1.83] and 1.19 [1.08-1.31], respectively), while psoriasis (AOR, 1.18 [1.12-1.24]; P < .0001) is associated with a risk of ADHD in children.

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

Results of a meta-analysis carried out by a French team indicate that there is a link between a father’s or mother’s autoimmune disease and their children’s risk of developing certain neurodevelopmental disorders (autism spectrum disorder [ASD] and attention-deficit/hyperactivity disorder). This meta-analysis is the first to separately explore the link between a father’s or mother’s autoimmune disease and the onset of neurodevelopmental disorders in their children.

According to its authors, these associations may result from exposure to environmental factors that contribute to autoimmune disorders, such as exposure to pollutants or cigarette smoke, and/or genetic predisposition, including genes relating to cytokines or to the HLA system.

Research is needed to determine the pathophysiologic links between these associations. This study suggests that there could be a shared mechanism between both parents, even though the maternal route seems to constitute an additional excess risk.
 

Why is this important?

Neurodevelopmental disorders are said to occur because of a close interrelationship between a person’s genes and environment. Immune-mediated adverse reactions may play an important role in triggering such disorders, as has been shown in associated epidemiologic studies and in animal studies. Autoimmune and autoinflammatory disorders are effectively characterized by the activation of the immune system, the circulation of autoantibodies, and the secretion of cytokines that are harmful to certain tissues.

Some relevant studies suggest a link between autoimmune disorders in the family or in the mother and the onset of neurodevelopmental disorders in their children. However, none of the studies have distinguished the influence of each of the parents so as to provide data that can be used to assess whether this association is more likely to be direct, and thus established during pregnancy, or rather genetic or environmental.
 

Main findings

Overall, the meta-analysis involved 14 studies that included 845,411 mothers and 601,148 fathers with an autoimmune disease, 4,984,965 control mothers and 4,992,854 control fathers. There were 182,927 children with neurodevelopmental disorders and 14,168,474 with no such diagnosis.

Globally, autoimmune diseases in mothers (adjusted odds ratio, 1.27 [1.03-1.57]; P = .02; I2 = 65%) and in fathers (AOR, 1.18 [1.07-1.30]; P = .01; I2 = 15.5%) are associated with a diagnosis of ASD in children. Similarly, they are associated with an increased risk of ADHD in children (AOR, 1.31 [1.11-1.55]; P = .001; I2 = 93% and AOR, 1.14 [1.10-1.17]; P < .0001; I2 = 0%, respectively, for mothers and fathers).

In mothers, type 1 diabetes (AOR, 1.60 [1.18-2.18]; P = .002; I2 = 0%), psoriasis (AOR, 1.45 [1.14-1.85]; P = .002; I2 = 0%), and rheumatoid arthritis (AOR, 1.38 [1.14-1.68]; P = .001; I2 = 0.8%) were associated with a risk of ASD in children. These three conditions also predisposed children to the risk of ADHD (AOR, 1.36 [1.24-1.52]; 1.41 [1.29-1.54]; and 1.32 [1.25-1.40], respectively, all P < .0001).

In fathers, type 1 diabetes considered in isolation was associated with a risk of ASD and ADHD in children (AOR, 1.42 [1.10-1.83] and 1.19 [1.08-1.31], respectively), while psoriasis (AOR, 1.18 [1.12-1.24]; P < .0001) is associated with a risk of ADHD in children.

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

Although most patients with psoriatic arthritis (PsA) have concomitant psoriasis, many with PsA who are enrolled in clinic trials as well as in rheumatology clinic do not have severe psoriasis. Therefore, an unanswered question is how much psoriasis symptoms contribute to impaired quality of life (QOL) in PsA patients. This question was addressed in a recent study by Taylor and colleagues. This post hoc analysis of two phase 3 studies, OPAL Broaden and OPAL Beyond, included 816 patients with active PsA and an inadequate response to previous therapies who received tofacitinib, adalimumab, or placebo. The analyses demonstrated that Itch Severity Item (ISI) scores of 7-10, Physician's Global Assessment of Psoriasis (PGA-PsO) scores of 4, and Patient's Global Joint and Skin Assessment-Visual Analog Scale (PGJS-VAS) scores of 90-100 mm corresponded with Dermatology Life Quality Index (DLQI) scores categorized as having a very large effect on a patient's life. An improvement of ≥ 3 points in ISI, ≥ 2 points in PGA-PsO, and ≥ 40 mm in PGJS-VAS translated to a clinically meaningful improvement in DLQI scores; improvements from baseline of ≥4/≥3/≥40-mm in the above scores, respectively, were also associated with clinically meaningful improvements across SF-36v2 (Short-Form Health Survey) domains. Thus, dermatologic symptoms are substantially associated with QOL in patients with active PsA, and improvements in skin measures could translate to clinically meaningful improvements in their QOL.

There is also increasing scrutiny on sex differences in PsA. Eder and colleagues conducted a post hoc analysis of two phase 3 trials that included 679 patients with active PsA who were either biologic-naive (SPIRIT-P1) or showed an inadequate response to one or two tumor necrosis factor inhibitors (TNFi) (SPIRIT-P2) and were randomly assigned to receive ixekizumab, an IL-17A inhibitor (IL-17Ai), or placebo. They demonstrated that at baseline female vs male patients had significantly higher Health Assessment Questionnaire Disability Index scores (P ≤ .003), with a significantly higher proportion of male vs female patients in the ixekizumab every-4-weeks treatment arm (53.8% vs 38.3%) and ixekizumab every-2-weeks treatment arm(41.2% vs 28.1%) achieving ≥50% and ≥70% improvement in the American College of Rheumatology response criteria, respectively (both P < .05). Thus, female patients with PsA exhibited significantly higher disease activity at baseline and a poorer response to ixekizumab.

Janus kinase (JAK) inhibitors have been shown to improve inflammatory and other types of pain in rheumatoid arthritis. To further evaluate the effect of inhibition of JAK1 on pain, McInnes and colleagues aimed to evaluate the effect of upadacitinib on pain outcomes in patients with active PsA or ankylosing spondylitis across three randomized trials (SELECT-PsA-1 and -2 for PsA; SELECT-AXIS 1 for ankylosing spondylitis). A significantly higher proportion of patients receiving 15 mg upadacitinib vs placebo achieved ≥30%, ≥50%, and ≥70% reductions in pain as early as 2 weeks (P < .05), with improvements sustained up to week 56. Further research on whether improvement in pain is at least partially independent of improvement in musculoskeletal inflammation is required.

Persistence of drug treatment is an important outcome and is a surrogate measure of safety and effectiveness. Vegas and colleagues assessed the long-term persistence of different biologic classes in a nationwide cohort study that included 16,892 adults with psoriasis and 6531 adults with PsA who initiated first-line treatment with a TNFi, IL-12/23 inhibitors (IL-12/23i), or an IL-17i. Treatment persistence was higher with IL-17i than with TNFi (weighted hazard ratio [HR] 0.70; P < .001) or IL-12/23i (weighted HR 0.69; P < .001); however, IL-12/23i and TNFi showed similar persistence (P = .70). Thus, IL-17i may be associated with higher treatment persistence in PsA compared with TNFi.

Although most patients with psoriatic arthritis (PsA) have concomitant psoriasis, many with PsA who are enrolled in clinic trials as well as in rheumatology clinic do not have severe psoriasis. Therefore, an unanswered question is how much psoriasis symptoms contribute to impaired quality of life (QOL) in PsA patients. This question was addressed in a recent study by Taylor and colleagues. This post hoc analysis of two phase 3 studies, OPAL Broaden and OPAL Beyond, included 816 patients with active PsA and an inadequate response to previous therapies who received tofacitinib, adalimumab, or placebo. The analyses demonstrated that Itch Severity Item (ISI) scores of 7-10, Physician's Global Assessment of Psoriasis (PGA-PsO) scores of 4, and Patient's Global Joint and Skin Assessment-Visual Analog Scale (PGJS-VAS) scores of 90-100 mm corresponded with Dermatology Life Quality Index (DLQI) scores categorized as having a very large effect on a patient's life. An improvement of ≥ 3 points in ISI, ≥ 2 points in PGA-PsO, and ≥ 40 mm in PGJS-VAS translated to a clinically meaningful improvement in DLQI scores; improvements from baseline of ≥4/≥3/≥40-mm in the above scores, respectively, were also associated with clinically meaningful improvements across SF-36v2 (Short-Form Health Survey) domains. Thus, dermatologic symptoms are substantially associated with QOL in patients with active PsA, and improvements in skin measures could translate to clinically meaningful improvements in their QOL.

There is also increasing scrutiny on sex differences in PsA. Eder and colleagues conducted a post hoc analysis of two phase 3 trials that included 679 patients with active PsA who were either biologic-naive (SPIRIT-P1) or showed an inadequate response to one or two tumor necrosis factor inhibitors (TNFi) (SPIRIT-P2) and were randomly assigned to receive ixekizumab, an IL-17A inhibitor (IL-17Ai), or placebo. They demonstrated that at baseline female vs male patients had significantly higher Health Assessment Questionnaire Disability Index scores (P ≤ .003), with a significantly higher proportion of male vs female patients in the ixekizumab every-4-weeks treatment arm (53.8% vs 38.3%) and ixekizumab every-2-weeks treatment arm(41.2% vs 28.1%) achieving ≥50% and ≥70% improvement in the American College of Rheumatology response criteria, respectively (both P < .05). Thus, female patients with PsA exhibited significantly higher disease activity at baseline and a poorer response to ixekizumab.

Janus kinase (JAK) inhibitors have been shown to improve inflammatory and other types of pain in rheumatoid arthritis. To further evaluate the effect of inhibition of JAK1 on pain, McInnes and colleagues aimed to evaluate the effect of upadacitinib on pain outcomes in patients with active PsA or ankylosing spondylitis across three randomized trials (SELECT-PsA-1 and -2 for PsA; SELECT-AXIS 1 for ankylosing spondylitis). A significantly higher proportion of patients receiving 15 mg upadacitinib vs placebo achieved ≥30%, ≥50%, and ≥70% reductions in pain as early as 2 weeks (P < .05), with improvements sustained up to week 56. Further research on whether improvement in pain is at least partially independent of improvement in musculoskeletal inflammation is required.

Persistence of drug treatment is an important outcome and is a surrogate measure of safety and effectiveness. Vegas and colleagues assessed the long-term persistence of different biologic classes in a nationwide cohort study that included 16,892 adults with psoriasis and 6531 adults with PsA who initiated first-line treatment with a TNFi, IL-12/23 inhibitors (IL-12/23i), or an IL-17i. Treatment persistence was higher with IL-17i than with TNFi (weighted hazard ratio [HR] 0.70; P < .001) or IL-12/23i (weighted HR 0.69; P < .001); however, IL-12/23i and TNFi showed similar persistence (P = .70). Thus, IL-17i may be associated with higher treatment persistence in PsA compared with TNFi.

Although most patients with psoriatic arthritis (PsA) have concomitant psoriasis, many with PsA who are enrolled in clinic trials as well as in rheumatology clinic do not have severe psoriasis. Therefore, an unanswered question is how much psoriasis symptoms contribute to impaired quality of life (QOL) in PsA patients. This question was addressed in a recent study by Taylor and colleagues. This post hoc analysis of two phase 3 studies, OPAL Broaden and OPAL Beyond, included 816 patients with active PsA and an inadequate response to previous therapies who received tofacitinib, adalimumab, or placebo. The analyses demonstrated that Itch Severity Item (ISI) scores of 7-10, Physician's Global Assessment of Psoriasis (PGA-PsO) scores of 4, and Patient's Global Joint and Skin Assessment-Visual Analog Scale (PGJS-VAS) scores of 90-100 mm corresponded with Dermatology Life Quality Index (DLQI) scores categorized as having a very large effect on a patient's life. An improvement of ≥ 3 points in ISI, ≥ 2 points in PGA-PsO, and ≥ 40 mm in PGJS-VAS translated to a clinically meaningful improvement in DLQI scores; improvements from baseline of ≥4/≥3/≥40-mm in the above scores, respectively, were also associated with clinically meaningful improvements across SF-36v2 (Short-Form Health Survey) domains. Thus, dermatologic symptoms are substantially associated with QOL in patients with active PsA, and improvements in skin measures could translate to clinically meaningful improvements in their QOL.

There is also increasing scrutiny on sex differences in PsA. Eder and colleagues conducted a post hoc analysis of two phase 3 trials that included 679 patients with active PsA who were either biologic-naive (SPIRIT-P1) or showed an inadequate response to one or two tumor necrosis factor inhibitors (TNFi) (SPIRIT-P2) and were randomly assigned to receive ixekizumab, an IL-17A inhibitor (IL-17Ai), or placebo. They demonstrated that at baseline female vs male patients had significantly higher Health Assessment Questionnaire Disability Index scores (P ≤ .003), with a significantly higher proportion of male vs female patients in the ixekizumab every-4-weeks treatment arm (53.8% vs 38.3%) and ixekizumab every-2-weeks treatment arm(41.2% vs 28.1%) achieving ≥50% and ≥70% improvement in the American College of Rheumatology response criteria, respectively (both P < .05). Thus, female patients with PsA exhibited significantly higher disease activity at baseline and a poorer response to ixekizumab.

Janus kinase (JAK) inhibitors have been shown to improve inflammatory and other types of pain in rheumatoid arthritis. To further evaluate the effect of inhibition of JAK1 on pain, McInnes and colleagues aimed to evaluate the effect of upadacitinib on pain outcomes in patients with active PsA or ankylosing spondylitis across three randomized trials (SELECT-PsA-1 and -2 for PsA; SELECT-AXIS 1 for ankylosing spondylitis). A significantly higher proportion of patients receiving 15 mg upadacitinib vs placebo achieved ≥30%, ≥50%, and ≥70% reductions in pain as early as 2 weeks (P < .05), with improvements sustained up to week 56. Further research on whether improvement in pain is at least partially independent of improvement in musculoskeletal inflammation is required.

Persistence of drug treatment is an important outcome and is a surrogate measure of safety and effectiveness. Vegas and colleagues assessed the long-term persistence of different biologic classes in a nationwide cohort study that included 16,892 adults with psoriasis and 6531 adults with PsA who initiated first-line treatment with a TNFi, IL-12/23 inhibitors (IL-12/23i), or an IL-17i. Treatment persistence was higher with IL-17i than with TNFi (weighted hazard ratio [HR] 0.70; P < .001) or IL-12/23i (weighted HR 0.69; P < .001); however, IL-12/23i and TNFi showed similar persistence (P = .70). Thus, IL-17i may be associated with higher treatment persistence in PsA compared with TNFi.

Key clinical point: Ultrasound (US), magnetic resonance imaging (MRI), and X-ray could differentiate psoriatic arthritis (PsA) from psoriasis and hand osteoarthritis (OA) based on the degree of structural involvement in the distal interphalangeal (DIP)-joint and synovio-entheseal complex (SEC).

Major finding: US-detected new bone formation (NBF; risk ratio [RR] 0.52; P < .001) and DIP-joint synovial hypertrophy (RR 0.66; P = .005) along with PsA MRI scores (all P < .001) were associated with a lower risk for PsA vs. OA. Patients with PsA vs. psoriasis had a higher prevalence of X-ray entheseal change (mean difference 0.42; P = .024) and a higher trend toward US-detected NBF and erosions.

Study details: This prospective, cross-sectional study included 50 patients with DIP-joint PsA and nail involvement, 12 patients with psoriasis and nail involvement, and 13 patients with erosive and nonerosive OA.

Disclosures: The study was funded by Novartis, The Oak Foundation, and others. Some authors declared receiving speaker/consulting fees, research grants, or honoraria or serving as members of advisory board or consultants for several sources.

Source: Guldberg-Møller J et al. Multimodal imaging of the distal interphalangeal-joint synovio-entheseal complex in psoriatic arthritis (MIDAS): A cross-sectional study on the diagnostic accuracy of different imaging modalities comparing psoriatic arthritis to psoriasis and osteoarthritis. RMD Open. 2022;8:e002109 (Mar 28). Doi: 10.1136/rmdopen-2021-002109

Key clinical point: Ultrasound (US), magnetic resonance imaging (MRI), and X-ray could differentiate psoriatic arthritis (PsA) from psoriasis and hand osteoarthritis (OA) based on the degree of structural involvement in the distal interphalangeal (DIP)-joint and synovio-entheseal complex (SEC).

Major finding: US-detected new bone formation (NBF; risk ratio [RR] 0.52; P < .001) and DIP-joint synovial hypertrophy (RR 0.66; P = .005) along with PsA MRI scores (all P < .001) were associated with a lower risk for PsA vs. OA. Patients with PsA vs. psoriasis had a higher prevalence of X-ray entheseal change (mean difference 0.42; P = .024) and a higher trend toward US-detected NBF and erosions.

Study details: This prospective, cross-sectional study included 50 patients with DIP-joint PsA and nail involvement, 12 patients with psoriasis and nail involvement, and 13 patients with erosive and nonerosive OA.

Disclosures: The study was funded by Novartis, The Oak Foundation, and others. Some authors declared receiving speaker/consulting fees, research grants, or honoraria or serving as members of advisory board or consultants for several sources.

Source: Guldberg-Møller J et al. Multimodal imaging of the distal interphalangeal-joint synovio-entheseal complex in psoriatic arthritis (MIDAS): A cross-sectional study on the diagnostic accuracy of different imaging modalities comparing psoriatic arthritis to psoriasis and osteoarthritis. RMD Open. 2022;8:e002109 (Mar 28). Doi: 10.1136/rmdopen-2021-002109

Key clinical point: Ultrasound (US), magnetic resonance imaging (MRI), and X-ray could differentiate psoriatic arthritis (PsA) from psoriasis and hand osteoarthritis (OA) based on the degree of structural involvement in the distal interphalangeal (DIP)-joint and synovio-entheseal complex (SEC).

Major finding: US-detected new bone formation (NBF; risk ratio [RR] 0.52; P < .001) and DIP-joint synovial hypertrophy (RR 0.66; P = .005) along with PsA MRI scores (all P < .001) were associated with a lower risk for PsA vs. OA. Patients with PsA vs. psoriasis had a higher prevalence of X-ray entheseal change (mean difference 0.42; P = .024) and a higher trend toward US-detected NBF and erosions.

Study details: This prospective, cross-sectional study included 50 patients with DIP-joint PsA and nail involvement, 12 patients with psoriasis and nail involvement, and 13 patients with erosive and nonerosive OA.

Disclosures: The study was funded by Novartis, The Oak Foundation, and others. Some authors declared receiving speaker/consulting fees, research grants, or honoraria or serving as members of advisory board or consultants for several sources.

Source: Guldberg-Møller J et al. Multimodal imaging of the distal interphalangeal-joint synovio-entheseal complex in psoriatic arthritis (MIDAS): A cross-sectional study on the diagnostic accuracy of different imaging modalities comparing psoriatic arthritis to psoriasis and osteoarthritis. RMD Open. 2022;8:e002109 (Mar 28). Doi: 10.1136/rmdopen-2021-002109

Two-year follow-up data from an international, multicenter, randomized trial of ixekizumab in pediatric patients with moderate to severe psoriasis demonstrate prolonged efficacy and no new safety signals with the interleukin (IL)-17 inhibitor, investigators reported.

In addition, findings of a substudy, which evaluated randomized withdrawal of treatment after 60 weeks, suggest patients were able to regain benefit after not being treated for a period.

Ixekizumab (Taltz) was approved by the U.S. Food and Drug Administration for treating pediatric psoriasis in March 2020 for patients aged 6 years and older with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

The trial (IXORA-PEDS) involved 171 patients aged 6-17 years (mean age, 13.5 years; 99 females and 72 males), who were randomly assigned to receive ixekizumab via subcutaneous administration every 4 weeks (115) or placebo for 12 weeks (56). Thereafter, 166 patients continued in an open-label maintenance period in which they were treated every 4 weeks for 12-60 weeks. This was followed by an extension period of up to 108 weeks, which was completed by 139 patients (83.7%). At baseline, the patients’ Psoriasis Area and Severity Index (PASI) score was 12 or higher, the static Physician’s Global Assessment (sPGA) score was 3 or higher, and 10% or more of body surface area was affected.

In the study, at 12 weeks, treatment with ixekizumab was superior to placebo, with sustained responses through 48 weeks. In the follow-up phase, primary and secondary endpoints were sustained through week 108, with patients achieving or maintaining PASI 75 (91.7%), PASI 90 (79%), PASI 100 (55.1%), sPGA 0 or 1 (78.3%), and sPGA 0 (52.4%). Significant improvements in itch were seen at 12 weeks and were sustained with “meaningful improvements in itch for 78.5% of these patients at week 108,” the investigators report.

Among the patients who received ixekizumab, clearance rates in areas that are difficult to treat increased from week 12 to week 108 among those affected. During this time, clearance of nail psoriasis increased from 22.8% to 68.1%, clearance of palmoplantar psoriasis increased from 46.2% to 90%, clearance of scalp psoriasis increased from 70.7% to 76.2%, and clearance of genital psoriasis increased from 83.3% to 87.5%.

No new safety findings during weeks 48-108 of the trial were reported, including no new cases of inflammatory bowel disease (IBD) or Candida infections. The results were reported in JAMA Dermatology.

“Safety is really what we think of most when we are talking about pediatric patients, especially since they may be on these for decades and ... since they most commonly start these therapies in adolescence,” said Amy Paller, MD, the study’s lead author, in an interview. “To be able to take this out 108 weeks, 2 years, is starting to get to a point where we are getting more comfortable with safety. Clearly, no new signals arose.” Dr. Paller is chair of the department of dermatology and professor of dermatology and pediatrics, Northwestern University, Chicago.

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

Two-year follow-up data from an international, multicenter, randomized trial of ixekizumab in pediatric patients with moderate to severe psoriasis demonstrate prolonged efficacy and no new safety signals with the interleukin (IL)-17 inhibitor, investigators reported.

In addition, findings of a substudy, which evaluated randomized withdrawal of treatment after 60 weeks, suggest patients were able to regain benefit after not being treated for a period.

Ixekizumab (Taltz) was approved by the U.S. Food and Drug Administration for treating pediatric psoriasis in March 2020 for patients aged 6 years and older with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

The trial (IXORA-PEDS) involved 171 patients aged 6-17 years (mean age, 13.5 years; 99 females and 72 males), who were randomly assigned to receive ixekizumab via subcutaneous administration every 4 weeks (115) or placebo for 12 weeks (56). Thereafter, 166 patients continued in an open-label maintenance period in which they were treated every 4 weeks for 12-60 weeks. This was followed by an extension period of up to 108 weeks, which was completed by 139 patients (83.7%). At baseline, the patients’ Psoriasis Area and Severity Index (PASI) score was 12 or higher, the static Physician’s Global Assessment (sPGA) score was 3 or higher, and 10% or more of body surface area was affected.

In the study, at 12 weeks, treatment with ixekizumab was superior to placebo, with sustained responses through 48 weeks. In the follow-up phase, primary and secondary endpoints were sustained through week 108, with patients achieving or maintaining PASI 75 (91.7%), PASI 90 (79%), PASI 100 (55.1%), sPGA 0 or 1 (78.3%), and sPGA 0 (52.4%). Significant improvements in itch were seen at 12 weeks and were sustained with “meaningful improvements in itch for 78.5% of these patients at week 108,” the investigators report.

Among the patients who received ixekizumab, clearance rates in areas that are difficult to treat increased from week 12 to week 108 among those affected. During this time, clearance of nail psoriasis increased from 22.8% to 68.1%, clearance of palmoplantar psoriasis increased from 46.2% to 90%, clearance of scalp psoriasis increased from 70.7% to 76.2%, and clearance of genital psoriasis increased from 83.3% to 87.5%.

No new safety findings during weeks 48-108 of the trial were reported, including no new cases of inflammatory bowel disease (IBD) or Candida infections. The results were reported in JAMA Dermatology.

“Safety is really what we think of most when we are talking about pediatric patients, especially since they may be on these for decades and ... since they most commonly start these therapies in adolescence,” said Amy Paller, MD, the study’s lead author, in an interview. “To be able to take this out 108 weeks, 2 years, is starting to get to a point where we are getting more comfortable with safety. Clearly, no new signals arose.” Dr. Paller is chair of the department of dermatology and professor of dermatology and pediatrics, Northwestern University, Chicago.

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

Two-year follow-up data from an international, multicenter, randomized trial of ixekizumab in pediatric patients with moderate to severe psoriasis demonstrate prolonged efficacy and no new safety signals with the interleukin (IL)-17 inhibitor, investigators reported.

In addition, findings of a substudy, which evaluated randomized withdrawal of treatment after 60 weeks, suggest patients were able to regain benefit after not being treated for a period.

Ixekizumab (Taltz) was approved by the U.S. Food and Drug Administration for treating pediatric psoriasis in March 2020 for patients aged 6 years and older with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

The trial (IXORA-PEDS) involved 171 patients aged 6-17 years (mean age, 13.5 years; 99 females and 72 males), who were randomly assigned to receive ixekizumab via subcutaneous administration every 4 weeks (115) or placebo for 12 weeks (56). Thereafter, 166 patients continued in an open-label maintenance period in which they were treated every 4 weeks for 12-60 weeks. This was followed by an extension period of up to 108 weeks, which was completed by 139 patients (83.7%). At baseline, the patients’ Psoriasis Area and Severity Index (PASI) score was 12 or higher, the static Physician’s Global Assessment (sPGA) score was 3 or higher, and 10% or more of body surface area was affected.

In the study, at 12 weeks, treatment with ixekizumab was superior to placebo, with sustained responses through 48 weeks. In the follow-up phase, primary and secondary endpoints were sustained through week 108, with patients achieving or maintaining PASI 75 (91.7%), PASI 90 (79%), PASI 100 (55.1%), sPGA 0 or 1 (78.3%), and sPGA 0 (52.4%). Significant improvements in itch were seen at 12 weeks and were sustained with “meaningful improvements in itch for 78.5% of these patients at week 108,” the investigators report.

Among the patients who received ixekizumab, clearance rates in areas that are difficult to treat increased from week 12 to week 108 among those affected. During this time, clearance of nail psoriasis increased from 22.8% to 68.1%, clearance of palmoplantar psoriasis increased from 46.2% to 90%, clearance of scalp psoriasis increased from 70.7% to 76.2%, and clearance of genital psoriasis increased from 83.3% to 87.5%.

No new safety findings during weeks 48-108 of the trial were reported, including no new cases of inflammatory bowel disease (IBD) or Candida infections. The results were reported in JAMA Dermatology.

“Safety is really what we think of most when we are talking about pediatric patients, especially since they may be on these for decades and ... since they most commonly start these therapies in adolescence,” said Amy Paller, MD, the study’s lead author, in an interview. “To be able to take this out 108 weeks, 2 years, is starting to get to a point where we are getting more comfortable with safety. Clearly, no new signals arose.” Dr. Paller is chair of the department of dermatology and professor of dermatology and pediatrics, Northwestern University, Chicago.

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

American patients with psoriatic arthritis (PsA) and psoriasis who received the interleukin-17A inhibitor secukinumab (Cosentyx) as their first biologic treatment achieved the best response rate with a 300-mg dose regimen when compared with placebo, and those who up-titrated to 300 mg from the lower approved dose of 150 mg also saw benefits obtained at that level.

Researchers conducted a postmarketing trial of secukinumab in patients at U.S. centers, called CHOICE, after it was approved for psoriasis and PsA in 2015 and 2016 based on trials mainly conducted outside of the United States. The American patients in those studies “had a baseline clinical profile indicating harder-to-treat disease than the total study population, including higher body mass index (BMI), higher tender and swollen joint counts, increased prevalence of enthesitis and dactylitis, and more tumor necrosis factor inhibitor (TNFi) experience,” Tien Q. Nguyen, MD, a dermatologist in private practice in Irvine, Calif., and colleagues wrote in the Journal of Rheumatology.

In order to get a better sense of how secukinumab performs in U.S. patients who have not been treated with biologics, the researchers conducted the multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 4 CHOICE trial. It recruited patients for about 26 months at 67 U.S. centers during 2016-2018. The 258 patients randomized in the study to 300 mg (n = 103), 150 mg secukinumab (n = 103), or placebo (n = 52) had a mean time since PsA diagnosis of 3.0-3.9 years and all had a mean BMI of greater than 30 kg/m², with dactylitis present in 48% and enthesitis in 73%. About one-third were taking methotrexate at baseline.

At week 16, patients taking secukinumab 300 mg were about 3.5 times more likely to have 20% improvement in American College of Rheumatology response criteria than with placebo (51.5% vs. 23.1%), whereas the response rate with 150 mg was not significantly different from placebo (36.9%). Rates of achieving ACR50 were significantly greater for both 300- and 150-mg doses versus placebo (28.2% and 24.3% vs. 5.8%), but only 300 mg led to a statistically significant difference in the rate of ACR70 responses, compared with placebo (17.5% vs. 1.9%).

In general, efficacy based on ACR20/50/70 responses and either remission or low disease activity on the Disease Activity in Psoriatic Arthritis index was lower among patients with less than 10 tender joints and less than 10 swollen joints at baseline. Methotrexate use at baseline did not affect ACR20 rates at week 16 in patients taking secukinumab, but the effect of methotrexate on ACR20 rates was noticeable among placebo-treated patients (38.9% vs. 14.7%). Enthesitis appeared to resolve significantly more often among patients on secukinumab, and more patients on secukinumab also had their dactylitis resolve, but the difference was not statistically significant.

Patients with psoriasis affecting more than 3% of their body surface area experienced higher response rates on the Psoriasis Area Severity Index (PASI) for 75%, 90%, and 100% skin lesion clearance than did patients taking placebo.

Patients who switched from 150 mg to 300 mg secukinumab after week 16 in the second treatment period of the trial more often achieved ACR20/50/70 responses by week 52, going from 2.4% to 65.9% of the up-titration subset for ACR20 and from 0% to 34.1% for ACR50 and to 12.2% for ACR70. Patients on placebo who switched also experienced increases in these response rates out to week 52. However, BMI above 30 kg/m² led to numerically lower ACR50, ACR70, and PASI response rates at week 52.

The researchers noted that the response rates observed in CHOICE were lower than for the pivotal trials used for Food and Drug Administration approval for PsA, which “may have been due to patients in CHOICE having higher disease activity scores at baseline, compared with TNFi-naive patients” in the pivotal trials.

The safety profile of secukinumab appeared to be no different from what has been reported previously. The researchers said that, throughout the 52-week study, the most common adverse events in patients receiving secukinumab were upper respiratory tract infection in about 13% and diarrhea in about 7%. Most adverse events were mild or moderate, with serious adverse events occurring in 9.6% of patients taking secukinumab 300 mg and in 7.8% of patients taking secukinumab 150 mg over the 52 weeks.

“Overall, the findings from CHOICE were consistent with previous studies and demonstrated that secukinumab provides significant and sustained improvements in signs and symptoms of psoriatic arthritis. Our findings suggest that secukinumab 300 mg is safe and efficacious as a first-line biologic treatment for patients with PsA. Further studies will also help determine the optimal dose of secukinumab for treating overweight patients or those with high disease activity at treatment initiation,” the authors wrote.

The study was funded by Novartis, which manufactures secukinumab. Dr. Nguyen and some coauthors reported serving as a consultant, investigator, and/or speaker for numerous pharmaceutical companies, including Novartis.

American patients with psoriatic arthritis (PsA) and psoriasis who received the interleukin-17A inhibitor secukinumab (Cosentyx) as their first biologic treatment achieved the best response rate with a 300-mg dose regimen when compared with placebo, and those who up-titrated to 300 mg from the lower approved dose of 150 mg also saw benefits obtained at that level.

Researchers conducted a postmarketing trial of secukinumab in patients at U.S. centers, called CHOICE, after it was approved for psoriasis and PsA in 2015 and 2016 based on trials mainly conducted outside of the United States. The American patients in those studies “had a baseline clinical profile indicating harder-to-treat disease than the total study population, including higher body mass index (BMI), higher tender and swollen joint counts, increased prevalence of enthesitis and dactylitis, and more tumor necrosis factor inhibitor (TNFi) experience,” Tien Q. Nguyen, MD, a dermatologist in private practice in Irvine, Calif., and colleagues wrote in the Journal of Rheumatology.

In order to get a better sense of how secukinumab performs in U.S. patients who have not been treated with biologics, the researchers conducted the multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 4 CHOICE trial. It recruited patients for about 26 months at 67 U.S. centers during 2016-2018. The 258 patients randomized in the study to 300 mg (n = 103), 150 mg secukinumab (n = 103), or placebo (n = 52) had a mean time since PsA diagnosis of 3.0-3.9 years and all had a mean BMI of greater than 30 kg/m², with dactylitis present in 48% and enthesitis in 73%. About one-third were taking methotrexate at baseline.

At week 16, patients taking secukinumab 300 mg were about 3.5 times more likely to have 20% improvement in American College of Rheumatology response criteria than with placebo (51.5% vs. 23.1%), whereas the response rate with 150 mg was not significantly different from placebo (36.9%). Rates of achieving ACR50 were significantly greater for both 300- and 150-mg doses versus placebo (28.2% and 24.3% vs. 5.8%), but only 300 mg led to a statistically significant difference in the rate of ACR70 responses, compared with placebo (17.5% vs. 1.9%).

In general, efficacy based on ACR20/50/70 responses and either remission or low disease activity on the Disease Activity in Psoriatic Arthritis index was lower among patients with less than 10 tender joints and less than 10 swollen joints at baseline. Methotrexate use at baseline did not affect ACR20 rates at week 16 in patients taking secukinumab, but the effect of methotrexate on ACR20 rates was noticeable among placebo-treated patients (38.9% vs. 14.7%). Enthesitis appeared to resolve significantly more often among patients on secukinumab, and more patients on secukinumab also had their dactylitis resolve, but the difference was not statistically significant.

Patients with psoriasis affecting more than 3% of their body surface area experienced higher response rates on the Psoriasis Area Severity Index (PASI) for 75%, 90%, and 100% skin lesion clearance than did patients taking placebo.

Patients who switched from 150 mg to 300 mg secukinumab after week 16 in the second treatment period of the trial more often achieved ACR20/50/70 responses by week 52, going from 2.4% to 65.9% of the up-titration subset for ACR20 and from 0% to 34.1% for ACR50 and to 12.2% for ACR70. Patients on placebo who switched also experienced increases in these response rates out to week 52. However, BMI above 30 kg/m² led to numerically lower ACR50, ACR70, and PASI response rates at week 52.

The researchers noted that the response rates observed in CHOICE were lower than for the pivotal trials used for Food and Drug Administration approval for PsA, which “may have been due to patients in CHOICE having higher disease activity scores at baseline, compared with TNFi-naive patients” in the pivotal trials.

The safety profile of secukinumab appeared to be no different from what has been reported previously. The researchers said that, throughout the 52-week study, the most common adverse events in patients receiving secukinumab were upper respiratory tract infection in about 13% and diarrhea in about 7%. Most adverse events were mild or moderate, with serious adverse events occurring in 9.6% of patients taking secukinumab 300 mg and in 7.8% of patients taking secukinumab 150 mg over the 52 weeks.

“Overall, the findings from CHOICE were consistent with previous studies and demonstrated that secukinumab provides significant and sustained improvements in signs and symptoms of psoriatic arthritis. Our findings suggest that secukinumab 300 mg is safe and efficacious as a first-line biologic treatment for patients with PsA. Further studies will also help determine the optimal dose of secukinumab for treating overweight patients or those with high disease activity at treatment initiation,” the authors wrote.

The study was funded by Novartis, which manufactures secukinumab. Dr. Nguyen and some coauthors reported serving as a consultant, investigator, and/or speaker for numerous pharmaceutical companies, including Novartis.

American patients with psoriatic arthritis (PsA) and psoriasis who received the interleukin-17A inhibitor secukinumab (Cosentyx) as their first biologic treatment achieved the best response rate with a 300-mg dose regimen when compared with placebo, and those who up-titrated to 300 mg from the lower approved dose of 150 mg also saw benefits obtained at that level.

Researchers conducted a postmarketing trial of secukinumab in patients at U.S. centers, called CHOICE, after it was approved for psoriasis and PsA in 2015 and 2016 based on trials mainly conducted outside of the United States. The American patients in those studies “had a baseline clinical profile indicating harder-to-treat disease than the total study population, including higher body mass index (BMI), higher tender and swollen joint counts, increased prevalence of enthesitis and dactylitis, and more tumor necrosis factor inhibitor (TNFi) experience,” Tien Q. Nguyen, MD, a dermatologist in private practice in Irvine, Calif., and colleagues wrote in the Journal of Rheumatology.

In order to get a better sense of how secukinumab performs in U.S. patients who have not been treated with biologics, the researchers conducted the multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 4 CHOICE trial. It recruited patients for about 26 months at 67 U.S. centers during 2016-2018. The 258 patients randomized in the study to 300 mg (n = 103), 150 mg secukinumab (n = 103), or placebo (n = 52) had a mean time since PsA diagnosis of 3.0-3.9 years and all had a mean BMI of greater than 30 kg/m², with dactylitis present in 48% and enthesitis in 73%. About one-third were taking methotrexate at baseline.

At week 16, patients taking secukinumab 300 mg were about 3.5 times more likely to have 20% improvement in American College of Rheumatology response criteria than with placebo (51.5% vs. 23.1%), whereas the response rate with 150 mg was not significantly different from placebo (36.9%). Rates of achieving ACR50 were significantly greater for both 300- and 150-mg doses versus placebo (28.2% and 24.3% vs. 5.8%), but only 300 mg led to a statistically significant difference in the rate of ACR70 responses, compared with placebo (17.5% vs. 1.9%).

In general, efficacy based on ACR20/50/70 responses and either remission or low disease activity on the Disease Activity in Psoriatic Arthritis index was lower among patients with less than 10 tender joints and less than 10 swollen joints at baseline. Methotrexate use at baseline did not affect ACR20 rates at week 16 in patients taking secukinumab, but the effect of methotrexate on ACR20 rates was noticeable among placebo-treated patients (38.9% vs. 14.7%). Enthesitis appeared to resolve significantly more often among patients on secukinumab, and more patients on secukinumab also had their dactylitis resolve, but the difference was not statistically significant.

Patients with psoriasis affecting more than 3% of their body surface area experienced higher response rates on the Psoriasis Area Severity Index (PASI) for 75%, 90%, and 100% skin lesion clearance than did patients taking placebo.

Patients who switched from 150 mg to 300 mg secukinumab after week 16 in the second treatment period of the trial more often achieved ACR20/50/70 responses by week 52, going from 2.4% to 65.9% of the up-titration subset for ACR20 and from 0% to 34.1% for ACR50 and to 12.2% for ACR70. Patients on placebo who switched also experienced increases in these response rates out to week 52. However, BMI above 30 kg/m² led to numerically lower ACR50, ACR70, and PASI response rates at week 52.

The researchers noted that the response rates observed in CHOICE were lower than for the pivotal trials used for Food and Drug Administration approval for PsA, which “may have been due to patients in CHOICE having higher disease activity scores at baseline, compared with TNFi-naive patients” in the pivotal trials.

The safety profile of secukinumab appeared to be no different from what has been reported previously. The researchers said that, throughout the 52-week study, the most common adverse events in patients receiving secukinumab were upper respiratory tract infection in about 13% and diarrhea in about 7%. Most adverse events were mild or moderate, with serious adverse events occurring in 9.6% of patients taking secukinumab 300 mg and in 7.8% of patients taking secukinumab 150 mg over the 52 weeks.

“Overall, the findings from CHOICE were consistent with previous studies and demonstrated that secukinumab provides significant and sustained improvements in signs and symptoms of psoriatic arthritis. Our findings suggest that secukinumab 300 mg is safe and efficacious as a first-line biologic treatment for patients with PsA. Further studies will also help determine the optimal dose of secukinumab for treating overweight patients or those with high disease activity at treatment initiation,” the authors wrote.

The study was funded by Novartis, which manufactures secukinumab. Dr. Nguyen and some coauthors reported serving as a consultant, investigator, and/or speaker for numerous pharmaceutical companies, including Novartis.

Key clinical point: This follow-up comparison of fluorescence optical imaging (FOI) with musculoskeletal ultrasound (MSUS) showed that FOI can be considered a useful screening tool for the early diagnosis of psoriatic arthritis (PsA).

Major finding: Patients diagnosed with PsA after the baseline evaluation had a higher prevalence of joints with pathological enhancement in FOI during follow-up (P = .046), notably in phase 2 FOI (P = .037). Similar to MSUS (area under the curve [AUC] 0.77), detecting newly affected joints by FOI (phase 2 in PrimaVista Mode; AUC 0.78) was positively linked with the shift of diagnosis from suspected to confirmed PsA.

Study details: In this follow-up study of 30 patients with psoriasis who had tender or swollen joints, the FOI of both the hands and the grayscale/power Doppler MSUS of the clinically dominant hand were compared.

Disclosures: This study was supported by the BMBF, German Ministry for Education and Research. The authors declared no conflict of interests.

Source: Buttner J et al. Follow-up comparison of fluorescence optical imaging with musculoskeletal ultrasound for early detection of psoriatic arthritis. Front Med. 2022;9:845545 (Mar 18). Doi: 10.3389/fmed.2022.845545

Key clinical point: This follow-up comparison of fluorescence optical imaging (FOI) with musculoskeletal ultrasound (MSUS) showed that FOI can be considered a useful screening tool for the early diagnosis of psoriatic arthritis (PsA).

Major finding: Patients diagnosed with PsA after the baseline evaluation had a higher prevalence of joints with pathological enhancement in FOI during follow-up (P = .046), notably in phase 2 FOI (P = .037). Similar to MSUS (area under the curve [AUC] 0.77), detecting newly affected joints by FOI (phase 2 in PrimaVista Mode; AUC 0.78) was positively linked with the shift of diagnosis from suspected to confirmed PsA.

Study details: In this follow-up study of 30 patients with psoriasis who had tender or swollen joints, the FOI of both the hands and the grayscale/power Doppler MSUS of the clinically dominant hand were compared.

Disclosures: This study was supported by the BMBF, German Ministry for Education and Research. The authors declared no conflict of interests.

Source: Buttner J et al. Follow-up comparison of fluorescence optical imaging with musculoskeletal ultrasound for early detection of psoriatic arthritis. Front Med. 2022;9:845545 (Mar 18). Doi: 10.3389/fmed.2022.845545

Key clinical point: This follow-up comparison of fluorescence optical imaging (FOI) with musculoskeletal ultrasound (MSUS) showed that FOI can be considered a useful screening tool for the early diagnosis of psoriatic arthritis (PsA).

Major finding: Patients diagnosed with PsA after the baseline evaluation had a higher prevalence of joints with pathological enhancement in FOI during follow-up (P = .046), notably in phase 2 FOI (P = .037). Similar to MSUS (area under the curve [AUC] 0.77), detecting newly affected joints by FOI (phase 2 in PrimaVista Mode; AUC 0.78) was positively linked with the shift of diagnosis from suspected to confirmed PsA.

Study details: In this follow-up study of 30 patients with psoriasis who had tender or swollen joints, the FOI of both the hands and the grayscale/power Doppler MSUS of the clinically dominant hand were compared.

Disclosures: This study was supported by the BMBF, German Ministry for Education and Research. The authors declared no conflict of interests.

Source: Buttner J et al. Follow-up comparison of fluorescence optical imaging with musculoskeletal ultrasound for early detection of psoriatic arthritis. Front Med. 2022;9:845545 (Mar 18). Doi: 10.3389/fmed.2022.845545

Key clinical point: Serum levels of certain collagen degradation biomarkers were elevated in patients with psoriatic arthritis (PsA) vs. healthy controls (HC) and could be effectively lowered with guselkumab.

Major finding: Baseline serum concentrations of collagen degradation biomarkers C1M, C3M, C4M, and C6M were ≥1.25-times higher in patients with PsA vs. HC (adjusted P < .05). At week 24, 100 mg guselkumab every 4 weeks vs. placebo significantly reduced C1M, C3M, and C4M levels, whereas guselkumab 100 mg every 8 weeks vs. placebo significantly reduced C3M, C4M, and C6M levels (all adjusted P < .05), with improvements maintained up to week 52 (all adjusted P ≤ .0001).

Study details: Findings are from an exploratory analysis of the phase 3 DISCOVER 2 study that included 260 patients with active PsA and an inadequate response to standard and 76 HC.

Disclosures: This study was supported by Janssen Research & Development, LLC. Eight authors declared being employees of Janssen and owned stock in Johnson & Johnson, the parent company for Janssen. The other authors reported ties with several sources, including Janssen.

Source: Schett G et al. collagen turnover biomarkers associate with active psoriatic arthritis and decrease with guselkumab treatment in a phase 3 clinical trial (DISCOVER-2). Rheumatol Ther. 2022 (Mar 30). Doi: 10.1007/s40744-022-00444-x

Key clinical point: Serum levels of certain collagen degradation biomarkers were elevated in patients with psoriatic arthritis (PsA) vs. healthy controls (HC) and could be effectively lowered with guselkumab.

Major finding: Baseline serum concentrations of collagen degradation biomarkers C1M, C3M, C4M, and C6M were ≥1.25-times higher in patients with PsA vs. HC (adjusted P < .05). At week 24, 100 mg guselkumab every 4 weeks vs. placebo significantly reduced C1M, C3M, and C4M levels, whereas guselkumab 100 mg every 8 weeks vs. placebo significantly reduced C3M, C4M, and C6M levels (all adjusted P < .05), with improvements maintained up to week 52 (all adjusted P ≤ .0001).

Study details: Findings are from an exploratory analysis of the phase 3 DISCOVER 2 study that included 260 patients with active PsA and an inadequate response to standard and 76 HC.

Disclosures: This study was supported by Janssen Research & Development, LLC. Eight authors declared being employees of Janssen and owned stock in Johnson & Johnson, the parent company for Janssen. The other authors reported ties with several sources, including Janssen.

Source: Schett G et al. collagen turnover biomarkers associate with active psoriatic arthritis and decrease with guselkumab treatment in a phase 3 clinical trial (DISCOVER-2). Rheumatol Ther. 2022 (Mar 30). Doi: 10.1007/s40744-022-00444-x

Key clinical point: Serum levels of certain collagen degradation biomarkers were elevated in patients with psoriatic arthritis (PsA) vs. healthy controls (HC) and could be effectively lowered with guselkumab.

Major finding: Baseline serum concentrations of collagen degradation biomarkers C1M, C3M, C4M, and C6M were ≥1.25-times higher in patients with PsA vs. HC (adjusted P < .05). At week 24, 100 mg guselkumab every 4 weeks vs. placebo significantly reduced C1M, C3M, and C4M levels, whereas guselkumab 100 mg every 8 weeks vs. placebo significantly reduced C3M, C4M, and C6M levels (all adjusted P < .05), with improvements maintained up to week 52 (all adjusted P ≤ .0001).

Study details: Findings are from an exploratory analysis of the phase 3 DISCOVER 2 study that included 260 patients with active PsA and an inadequate response to standard and 76 HC.

Disclosures: This study was supported by Janssen Research & Development, LLC. Eight authors declared being employees of Janssen and owned stock in Johnson & Johnson, the parent company for Janssen. The other authors reported ties with several sources, including Janssen.

Source: Schett G et al. collagen turnover biomarkers associate with active psoriatic arthritis and decrease with guselkumab treatment in a phase 3 clinical trial (DISCOVER-2). Rheumatol Ther. 2022 (Mar 30). Doi: 10.1007/s40744-022-00444-x