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Study Identifies Risk Factors for Development of Psoriasis To Clinical PsA
Key clinical point: Risk factors for psoriasis developing into clinical psoriatic arthritis (PsA) include higher age, nail involvement, increased erythrocyte sedimentation rate (ESR), and elevated high-sensitivity C-reactive protein (hs-CRP) levels.
Major finding: Age ≥ 40 years (odds ratio [OR], 1.04; P < .01), nail involvement (OR, 1.17; P < .01), increased ESR (OR, 1.03; P < .05), and elevated hs-CRP levels (OR, 1.31; P < .01) increased the risk for incident PsA in patients with psoriasis. Moreover, MRI-detected enthesitis and tenosynovitis combined with these risk factors vs the risk factors alone showed better specificity (94.3% vs 69.0%) and similar sensitivity (89.0% vs 84.6%) in diagnosing PsA.
Study details: This longitudinal case-control study included 75 patients diagnosed with clinical PsA who were compared with 345 patients with psoriasis and without PsA, all of whom were aged 18-65 years.
Disclosures: This study was supported by the Beijing Municipal Science and Technology Project. The authors declared no conflict of interests.
Source: Yao A, Wang L, Qi F, et al. Risk factors and early detection of joint damage in patients with psoriasis: A case–control study. Int J Dermatol. Published online April 29, 2024. Source
Key clinical point: Risk factors for psoriasis developing into clinical psoriatic arthritis (PsA) include higher age, nail involvement, increased erythrocyte sedimentation rate (ESR), and elevated high-sensitivity C-reactive protein (hs-CRP) levels.
Major finding: Age ≥ 40 years (odds ratio [OR], 1.04; P < .01), nail involvement (OR, 1.17; P < .01), increased ESR (OR, 1.03; P < .05), and elevated hs-CRP levels (OR, 1.31; P < .01) increased the risk for incident PsA in patients with psoriasis. Moreover, MRI-detected enthesitis and tenosynovitis combined with these risk factors vs the risk factors alone showed better specificity (94.3% vs 69.0%) and similar sensitivity (89.0% vs 84.6%) in diagnosing PsA.
Study details: This longitudinal case-control study included 75 patients diagnosed with clinical PsA who were compared with 345 patients with psoriasis and without PsA, all of whom were aged 18-65 years.
Disclosures: This study was supported by the Beijing Municipal Science and Technology Project. The authors declared no conflict of interests.
Source: Yao A, Wang L, Qi F, et al. Risk factors and early detection of joint damage in patients with psoriasis: A case–control study. Int J Dermatol. Published online April 29, 2024. Source
Key clinical point: Risk factors for psoriasis developing into clinical psoriatic arthritis (PsA) include higher age, nail involvement, increased erythrocyte sedimentation rate (ESR), and elevated high-sensitivity C-reactive protein (hs-CRP) levels.
Major finding: Age ≥ 40 years (odds ratio [OR], 1.04; P < .01), nail involvement (OR, 1.17; P < .01), increased ESR (OR, 1.03; P < .05), and elevated hs-CRP levels (OR, 1.31; P < .01) increased the risk for incident PsA in patients with psoriasis. Moreover, MRI-detected enthesitis and tenosynovitis combined with these risk factors vs the risk factors alone showed better specificity (94.3% vs 69.0%) and similar sensitivity (89.0% vs 84.6%) in diagnosing PsA.
Study details: This longitudinal case-control study included 75 patients diagnosed with clinical PsA who were compared with 345 patients with psoriasis and without PsA, all of whom were aged 18-65 years.
Disclosures: This study was supported by the Beijing Municipal Science and Technology Project. The authors declared no conflict of interests.
Source: Yao A, Wang L, Qi F, et al. Risk factors and early detection of joint damage in patients with psoriasis: A case–control study. Int J Dermatol. Published online April 29, 2024. Source
Elevated Risk for PsA in Patients With Psoriasis and Arthralgia
Key clinical point: Patients with psoriasis who had subclinical psoriatic arthritis (PsA) based on the presence of arthralgia had a higher likelihood of developing PsA than those with only psoriasis.
Major finding: At a mean follow-up of 33 months, 80.9% of patients had subclinical PsA, with the incidence rate of new-onset PsA being 7.7 per 100 patients-years in this group and the most predominant presentation being peripheral arthritis (82.1%). The risk of developing PsA was significantly higher in patients with subclinical PsA vs psoriasis (hazard ratio, 11.7; P = .016).
Study details: This study included 384 patients with psoriasis from two European cohorts of whom 56 patients developed new-onset PsA.
Disclosures: This study did not disclose any specific funding. Six authors declared being consultants for or having other ties with various sources. The other authors declared no conflict of interests.
Source: Zabotti A, Fagni F, Gossec L, et al. Risk of developing psoriatic arthritis in psoriasis cohorts with arthralgia: Exploring the subclinical psoriatic arthritis stage. RMD Open. 2024;10:e004314. Source
Key clinical point: Patients with psoriasis who had subclinical psoriatic arthritis (PsA) based on the presence of arthralgia had a higher likelihood of developing PsA than those with only psoriasis.
Major finding: At a mean follow-up of 33 months, 80.9% of patients had subclinical PsA, with the incidence rate of new-onset PsA being 7.7 per 100 patients-years in this group and the most predominant presentation being peripheral arthritis (82.1%). The risk of developing PsA was significantly higher in patients with subclinical PsA vs psoriasis (hazard ratio, 11.7; P = .016).
Study details: This study included 384 patients with psoriasis from two European cohorts of whom 56 patients developed new-onset PsA.
Disclosures: This study did not disclose any specific funding. Six authors declared being consultants for or having other ties with various sources. The other authors declared no conflict of interests.
Source: Zabotti A, Fagni F, Gossec L, et al. Risk of developing psoriatic arthritis in psoriasis cohorts with arthralgia: Exploring the subclinical psoriatic arthritis stage. RMD Open. 2024;10:e004314. Source
Key clinical point: Patients with psoriasis who had subclinical psoriatic arthritis (PsA) based on the presence of arthralgia had a higher likelihood of developing PsA than those with only psoriasis.
Major finding: At a mean follow-up of 33 months, 80.9% of patients had subclinical PsA, with the incidence rate of new-onset PsA being 7.7 per 100 patients-years in this group and the most predominant presentation being peripheral arthritis (82.1%). The risk of developing PsA was significantly higher in patients with subclinical PsA vs psoriasis (hazard ratio, 11.7; P = .016).
Study details: This study included 384 patients with psoriasis from two European cohorts of whom 56 patients developed new-onset PsA.
Disclosures: This study did not disclose any specific funding. Six authors declared being consultants for or having other ties with various sources. The other authors declared no conflict of interests.
Source: Zabotti A, Fagni F, Gossec L, et al. Risk of developing psoriatic arthritis in psoriasis cohorts with arthralgia: Exploring the subclinical psoriatic arthritis stage. RMD Open. 2024;10:e004314. Source
Risankizumab Shows Long-Term Efficacy in PsA Regardless of Baseline Characteristics
Key clinical point: Risankizumab showed consistent long-term efficacy in patients with active psoriatic arthritis (PsA) regardless of baseline demographic, disease characteristics, and prior medication use.
Major finding: At week 24, a higher number of patients receiving risankizumab vs placebo achieved ≥ 20% improvement in the American College of Rheumatology response (ACR20; 46.3%-60.1% vs 15.5%-36.2%) despite varying demographic and disease characteristics. At week 52, similar proportions of patients who were randomized to risankizumab (48.6%-75.8%) or who switched from placebo to risankizumab (43.7%-63.9%) achieved ACR20.
Study details: This post hoc integrated analysis of the phase 3 KEEPsAKE 1 and KEEPsAKE 2 trials included 1235 patients with active PsA and prior inadequate response or intolerance to conventional synthetic or biologic disease-modifying antirheumatic drugs who received risankizumab or placebo with crossover to risankizumab at week 24.
Disclosures: This study was funded by AbbVie. Four authors declared being employees of and holding stocks or stock options with AbbVie. The other authors declared having ties with AbbVie and various sources.
Source: Merola JF, Armstrong A, Khattri S, et al. Efficacy of risankizumab across subgroups in patients with active psoriatic arthritis: A post hoc integrated analysis of the phase 3 KEEPsAKE 1 and KEEPsAKE 2 randomized controlled trials. J Dermatolog Treat. 2024;35:2342383. Source
Key clinical point: Risankizumab showed consistent long-term efficacy in patients with active psoriatic arthritis (PsA) regardless of baseline demographic, disease characteristics, and prior medication use.
Major finding: At week 24, a higher number of patients receiving risankizumab vs placebo achieved ≥ 20% improvement in the American College of Rheumatology response (ACR20; 46.3%-60.1% vs 15.5%-36.2%) despite varying demographic and disease characteristics. At week 52, similar proportions of patients who were randomized to risankizumab (48.6%-75.8%) or who switched from placebo to risankizumab (43.7%-63.9%) achieved ACR20.
Study details: This post hoc integrated analysis of the phase 3 KEEPsAKE 1 and KEEPsAKE 2 trials included 1235 patients with active PsA and prior inadequate response or intolerance to conventional synthetic or biologic disease-modifying antirheumatic drugs who received risankizumab or placebo with crossover to risankizumab at week 24.
Disclosures: This study was funded by AbbVie. Four authors declared being employees of and holding stocks or stock options with AbbVie. The other authors declared having ties with AbbVie and various sources.
Source: Merola JF, Armstrong A, Khattri S, et al. Efficacy of risankizumab across subgroups in patients with active psoriatic arthritis: A post hoc integrated analysis of the phase 3 KEEPsAKE 1 and KEEPsAKE 2 randomized controlled trials. J Dermatolog Treat. 2024;35:2342383. Source
Key clinical point: Risankizumab showed consistent long-term efficacy in patients with active psoriatic arthritis (PsA) regardless of baseline demographic, disease characteristics, and prior medication use.
Major finding: At week 24, a higher number of patients receiving risankizumab vs placebo achieved ≥ 20% improvement in the American College of Rheumatology response (ACR20; 46.3%-60.1% vs 15.5%-36.2%) despite varying demographic and disease characteristics. At week 52, similar proportions of patients who were randomized to risankizumab (48.6%-75.8%) or who switched from placebo to risankizumab (43.7%-63.9%) achieved ACR20.
Study details: This post hoc integrated analysis of the phase 3 KEEPsAKE 1 and KEEPsAKE 2 trials included 1235 patients with active PsA and prior inadequate response or intolerance to conventional synthetic or biologic disease-modifying antirheumatic drugs who received risankizumab or placebo with crossover to risankizumab at week 24.
Disclosures: This study was funded by AbbVie. Four authors declared being employees of and holding stocks or stock options with AbbVie. The other authors declared having ties with AbbVie and various sources.
Source: Merola JF, Armstrong A, Khattri S, et al. Efficacy of risankizumab across subgroups in patients with active psoriatic arthritis: A post hoc integrated analysis of the phase 3 KEEPsAKE 1 and KEEPsAKE 2 randomized controlled trials. J Dermatolog Treat. 2024;35:2342383. Source
Secukinumab Safe and Effective in Challenging-to-Treat Patients With PsA
Key clinical point: Secukinumab demonstrated rapid improvements in clinical outcomes and showed a consistent safety profile in challenging-to-treat patients with psoriatic arthritis (PsA) who had high BMI and showed higher tender and swollen joints despite previous treatment.
Major finding: At week 16, patients receiving secukinumab 300 mg and 150 mg with loading dose vs placebo had a higher rate of achieving the American College of Rheumatology 20 response (59.7% and 43.4%, respectively, vs 15.6%; both P < .0001) and the Psoriasis Area and Severity Index 90 response (47.1% and 22.2%, respectively, vs 5.3%; both P < .05).
Study details: This subgroup analysis of four phase 3 FUTURE studies included 279 patients with challenging-to-treat PsA from the United States who received secukinumab or placebo and had undergone prior treatment with nonsteroidal anti-inflammatory drugs, disease-modifying antirheumatic drugs, or corticosteroids.
Disclosures: This study was supported by Novartis Pharmaceuticals Corporation, United States. Luminita Pricop declared being an employee and stockholder of Novartis. The other authors declared receiving research grants from or having other ties with Novartis or others.
Source: Kivitz AJ, Kremer JM, Legerton CW 3rd, Pricop L, Singhal A. Efficacy and safety of secukinumab in US patients with psoriatic arthritis: A subgroup analysis of the phase 3 FUTURE studies. Rheumatol Ther. Published online April 16, 2024. Source
Key clinical point: Secukinumab demonstrated rapid improvements in clinical outcomes and showed a consistent safety profile in challenging-to-treat patients with psoriatic arthritis (PsA) who had high BMI and showed higher tender and swollen joints despite previous treatment.
Major finding: At week 16, patients receiving secukinumab 300 mg and 150 mg with loading dose vs placebo had a higher rate of achieving the American College of Rheumatology 20 response (59.7% and 43.4%, respectively, vs 15.6%; both P < .0001) and the Psoriasis Area and Severity Index 90 response (47.1% and 22.2%, respectively, vs 5.3%; both P < .05).
Study details: This subgroup analysis of four phase 3 FUTURE studies included 279 patients with challenging-to-treat PsA from the United States who received secukinumab or placebo and had undergone prior treatment with nonsteroidal anti-inflammatory drugs, disease-modifying antirheumatic drugs, or corticosteroids.
Disclosures: This study was supported by Novartis Pharmaceuticals Corporation, United States. Luminita Pricop declared being an employee and stockholder of Novartis. The other authors declared receiving research grants from or having other ties with Novartis or others.
Source: Kivitz AJ, Kremer JM, Legerton CW 3rd, Pricop L, Singhal A. Efficacy and safety of secukinumab in US patients with psoriatic arthritis: A subgroup analysis of the phase 3 FUTURE studies. Rheumatol Ther. Published online April 16, 2024. Source
Key clinical point: Secukinumab demonstrated rapid improvements in clinical outcomes and showed a consistent safety profile in challenging-to-treat patients with psoriatic arthritis (PsA) who had high BMI and showed higher tender and swollen joints despite previous treatment.
Major finding: At week 16, patients receiving secukinumab 300 mg and 150 mg with loading dose vs placebo had a higher rate of achieving the American College of Rheumatology 20 response (59.7% and 43.4%, respectively, vs 15.6%; both P < .0001) and the Psoriasis Area and Severity Index 90 response (47.1% and 22.2%, respectively, vs 5.3%; both P < .05).
Study details: This subgroup analysis of four phase 3 FUTURE studies included 279 patients with challenging-to-treat PsA from the United States who received secukinumab or placebo and had undergone prior treatment with nonsteroidal anti-inflammatory drugs, disease-modifying antirheumatic drugs, or corticosteroids.
Disclosures: This study was supported by Novartis Pharmaceuticals Corporation, United States. Luminita Pricop declared being an employee and stockholder of Novartis. The other authors declared receiving research grants from or having other ties with Novartis or others.
Source: Kivitz AJ, Kremer JM, Legerton CW 3rd, Pricop L, Singhal A. Efficacy and safety of secukinumab in US patients with psoriatic arthritis: A subgroup analysis of the phase 3 FUTURE studies. Rheumatol Ther. Published online April 16, 2024. Source
Poor Use of ICD-10 Rheumatology Codes Suggests New Approach Needed for ICD-11 Adoption
Inflammatory arthritis codes increased 30-fold in the transition from the ninth to the 10th revision of the International Classification of Diseases (ICD-9 and -10), yet few were used in clinical practice, according to new research.
Most of the new codes for inflammatory arthritis in ICD-10 were rarely used, if at all, from 2015 to 2021.
“About 10-20 codes were comprising the majority of usage for inflammatory arthritis patients in ICD-10,” first author Justin Zhu, a researcher and medical student at Yale University in New Haven, Connecticut, told this news organization. “The other 380 or 400 codes just weren’t seeing a lot of use.”
The findings show the difficulties of transitioning to a new system, he added, and emphasize the need for additional training to improve adoption of ICD-11. The new coding system launched globally in January 2022, but it is not clear when it will be implemented in the United States.
ICD-10 was launched in the United States in 2015, with the goal of enabling greater specificity in identifying health conditions. For example, the new coding system allowed users to include information on laterality and anatomic location for the first time. The total number of codes increased from 14,500 with ICD-9 to 70,000 with ICD-10, with the number of inflammatory arthritis diagnosis codes growing from 14 to 425.
To see how these ICD-10 codes were utilized compared with ICD-9, Zhu and colleagues used national multi-insurance administrative claims data to find inflammatory arthritis diagnostic codes for over 5.1 million patients. About half were coded in ICD-9, while the remaining half were coded in ICD-10. Mr. Zhu and colleagues defined “higher-usage codes” as those that were used more than 1% of the time.
The findings were published in a research letter in JAMA Network Open on April 18.
For ICD-9, four of the available 14 codes (28.6%) were higher-usage codes. In contrast, only nine of the 425 ICD-10 codes (2.1%) were frequently used. Though ICD-10 allowed for increased granularity in diagnosis, data showed that nonspecific codes were most popular. Of the 20 most used ICD-10 arthritis codes, 65% contained “unspecified or other specified” in its wording.
The researchers also found that there was no significant change in these higher-usage codes throughout the study period from 2015 to 2021, suggesting there was not a detectable learning curve in ICD-10 usage among physicians and coders. They also found that clinician specialty did not change code usage patterns.
“The percentage of codes used was not better for rheumatologists (who might be expected to be more refined users of such codes) than primary care clinicians,” Mr. Zhu and colleagues wrote.
Moving to ICD-11 Brings Challenges as Well as Opportunities
Mr. Zhu noted that the study highlights the challenges of adopting new technological systems into daily practice, which can inform the eventual transition to ICD-11.
“There is this need to emphasize training as well as just invest more in improving adoption of ICD-11,” he said.
Michael Pine, MD, MBA, of MJP Healthcare Innovations, LLC in Evanston, Illinois, added that ICD-11 needs to be more user-friendly to be useful in practice. While ICD-10 allowed for greater granularity in coding, it did not result in “usable granularity, in terms of the things doctors really want to communicate,” he told this news organization.
And the transition to ICD-11 could pose greater challenges; rather than ICD-10’s taxonomy system, ICD-11 is formatted as an ontology.
“Although ICD-11 retains some precoordinated codes that convey multifaceted compound concepts, its structure and syntax also provide for post-coordination, a new feature to the ICD that supports the customized combination of concepts and modifier codes to capture previously inaccessible clinical nuance,” he wrote in a coauthored invited commentary.
This added clinical nuance, however, will potentially make coding more complex, he said. One solution is to automate coding, such that clinicians could input information in a natural clinical format that makes sense to them, which would then be translated into ICD-11 code by a program. (This would then be translated back to the user in the natural clinical format to ensure accuracy.)
This type of process would limit how much any one person would need to know about ICD-11 to code diagnoses effectively, while also taking full advantage of the increasing specificity of the new coding system, he said.
Such a program does not yet exist but could be possible with intensive investment in the transition to ICD-11.
The findings of this study serve as a cautionary tale for future transitions to new systems without considering the importance of user experience and usability, Dr. Pine noted. If the United States takes an approach for the adoption of ICD-11 that is similar to that used for ICD-10, it is likely to be “just another overhyped transition” that will make users unwilling to adopt any new system moving forward out of frustration.
But if the United States takes a different, innovative approach, the opposite could be true.
“In short, the US must decide whether it is time to invest considerable resources and effort into a 21st-century information system that could overcome such hindrances as asymmetric information for decision-making, faulty risk adjustment in performance evaluations and payment formulas, and burdens imposed by current coding and documentation practices,” the commentary reads.
“It will allow us to make the best of what computers do and the best of what clinicians do,” Dr. Pine added, “and get them to work together in ways which would not have been conceivable 50 years ago.”
No information on study funding was provided. Mr. Zhu and Dr. Pine did not disclose any competing interests.
A version of this article appeared on Medscape.com.
Inflammatory arthritis codes increased 30-fold in the transition from the ninth to the 10th revision of the International Classification of Diseases (ICD-9 and -10), yet few were used in clinical practice, according to new research.
Most of the new codes for inflammatory arthritis in ICD-10 were rarely used, if at all, from 2015 to 2021.
“About 10-20 codes were comprising the majority of usage for inflammatory arthritis patients in ICD-10,” first author Justin Zhu, a researcher and medical student at Yale University in New Haven, Connecticut, told this news organization. “The other 380 or 400 codes just weren’t seeing a lot of use.”
The findings show the difficulties of transitioning to a new system, he added, and emphasize the need for additional training to improve adoption of ICD-11. The new coding system launched globally in January 2022, but it is not clear when it will be implemented in the United States.
ICD-10 was launched in the United States in 2015, with the goal of enabling greater specificity in identifying health conditions. For example, the new coding system allowed users to include information on laterality and anatomic location for the first time. The total number of codes increased from 14,500 with ICD-9 to 70,000 with ICD-10, with the number of inflammatory arthritis diagnosis codes growing from 14 to 425.
To see how these ICD-10 codes were utilized compared with ICD-9, Zhu and colleagues used national multi-insurance administrative claims data to find inflammatory arthritis diagnostic codes for over 5.1 million patients. About half were coded in ICD-9, while the remaining half were coded in ICD-10. Mr. Zhu and colleagues defined “higher-usage codes” as those that were used more than 1% of the time.
The findings were published in a research letter in JAMA Network Open on April 18.
For ICD-9, four of the available 14 codes (28.6%) were higher-usage codes. In contrast, only nine of the 425 ICD-10 codes (2.1%) were frequently used. Though ICD-10 allowed for increased granularity in diagnosis, data showed that nonspecific codes were most popular. Of the 20 most used ICD-10 arthritis codes, 65% contained “unspecified or other specified” in its wording.
The researchers also found that there was no significant change in these higher-usage codes throughout the study period from 2015 to 2021, suggesting there was not a detectable learning curve in ICD-10 usage among physicians and coders. They also found that clinician specialty did not change code usage patterns.
“The percentage of codes used was not better for rheumatologists (who might be expected to be more refined users of such codes) than primary care clinicians,” Mr. Zhu and colleagues wrote.
Moving to ICD-11 Brings Challenges as Well as Opportunities
Mr. Zhu noted that the study highlights the challenges of adopting new technological systems into daily practice, which can inform the eventual transition to ICD-11.
“There is this need to emphasize training as well as just invest more in improving adoption of ICD-11,” he said.
Michael Pine, MD, MBA, of MJP Healthcare Innovations, LLC in Evanston, Illinois, added that ICD-11 needs to be more user-friendly to be useful in practice. While ICD-10 allowed for greater granularity in coding, it did not result in “usable granularity, in terms of the things doctors really want to communicate,” he told this news organization.
And the transition to ICD-11 could pose greater challenges; rather than ICD-10’s taxonomy system, ICD-11 is formatted as an ontology.
“Although ICD-11 retains some precoordinated codes that convey multifaceted compound concepts, its structure and syntax also provide for post-coordination, a new feature to the ICD that supports the customized combination of concepts and modifier codes to capture previously inaccessible clinical nuance,” he wrote in a coauthored invited commentary.
This added clinical nuance, however, will potentially make coding more complex, he said. One solution is to automate coding, such that clinicians could input information in a natural clinical format that makes sense to them, which would then be translated into ICD-11 code by a program. (This would then be translated back to the user in the natural clinical format to ensure accuracy.)
This type of process would limit how much any one person would need to know about ICD-11 to code diagnoses effectively, while also taking full advantage of the increasing specificity of the new coding system, he said.
Such a program does not yet exist but could be possible with intensive investment in the transition to ICD-11.
The findings of this study serve as a cautionary tale for future transitions to new systems without considering the importance of user experience and usability, Dr. Pine noted. If the United States takes an approach for the adoption of ICD-11 that is similar to that used for ICD-10, it is likely to be “just another overhyped transition” that will make users unwilling to adopt any new system moving forward out of frustration.
But if the United States takes a different, innovative approach, the opposite could be true.
“In short, the US must decide whether it is time to invest considerable resources and effort into a 21st-century information system that could overcome such hindrances as asymmetric information for decision-making, faulty risk adjustment in performance evaluations and payment formulas, and burdens imposed by current coding and documentation practices,” the commentary reads.
“It will allow us to make the best of what computers do and the best of what clinicians do,” Dr. Pine added, “and get them to work together in ways which would not have been conceivable 50 years ago.”
No information on study funding was provided. Mr. Zhu and Dr. Pine did not disclose any competing interests.
A version of this article appeared on Medscape.com.
Inflammatory arthritis codes increased 30-fold in the transition from the ninth to the 10th revision of the International Classification of Diseases (ICD-9 and -10), yet few were used in clinical practice, according to new research.
Most of the new codes for inflammatory arthritis in ICD-10 were rarely used, if at all, from 2015 to 2021.
“About 10-20 codes were comprising the majority of usage for inflammatory arthritis patients in ICD-10,” first author Justin Zhu, a researcher and medical student at Yale University in New Haven, Connecticut, told this news organization. “The other 380 or 400 codes just weren’t seeing a lot of use.”
The findings show the difficulties of transitioning to a new system, he added, and emphasize the need for additional training to improve adoption of ICD-11. The new coding system launched globally in January 2022, but it is not clear when it will be implemented in the United States.
ICD-10 was launched in the United States in 2015, with the goal of enabling greater specificity in identifying health conditions. For example, the new coding system allowed users to include information on laterality and anatomic location for the first time. The total number of codes increased from 14,500 with ICD-9 to 70,000 with ICD-10, with the number of inflammatory arthritis diagnosis codes growing from 14 to 425.
To see how these ICD-10 codes were utilized compared with ICD-9, Zhu and colleagues used national multi-insurance administrative claims data to find inflammatory arthritis diagnostic codes for over 5.1 million patients. About half were coded in ICD-9, while the remaining half were coded in ICD-10. Mr. Zhu and colleagues defined “higher-usage codes” as those that were used more than 1% of the time.
The findings were published in a research letter in JAMA Network Open on April 18.
For ICD-9, four of the available 14 codes (28.6%) were higher-usage codes. In contrast, only nine of the 425 ICD-10 codes (2.1%) were frequently used. Though ICD-10 allowed for increased granularity in diagnosis, data showed that nonspecific codes were most popular. Of the 20 most used ICD-10 arthritis codes, 65% contained “unspecified or other specified” in its wording.
The researchers also found that there was no significant change in these higher-usage codes throughout the study period from 2015 to 2021, suggesting there was not a detectable learning curve in ICD-10 usage among physicians and coders. They also found that clinician specialty did not change code usage patterns.
“The percentage of codes used was not better for rheumatologists (who might be expected to be more refined users of such codes) than primary care clinicians,” Mr. Zhu and colleagues wrote.
Moving to ICD-11 Brings Challenges as Well as Opportunities
Mr. Zhu noted that the study highlights the challenges of adopting new technological systems into daily practice, which can inform the eventual transition to ICD-11.
“There is this need to emphasize training as well as just invest more in improving adoption of ICD-11,” he said.
Michael Pine, MD, MBA, of MJP Healthcare Innovations, LLC in Evanston, Illinois, added that ICD-11 needs to be more user-friendly to be useful in practice. While ICD-10 allowed for greater granularity in coding, it did not result in “usable granularity, in terms of the things doctors really want to communicate,” he told this news organization.
And the transition to ICD-11 could pose greater challenges; rather than ICD-10’s taxonomy system, ICD-11 is formatted as an ontology.
“Although ICD-11 retains some precoordinated codes that convey multifaceted compound concepts, its structure and syntax also provide for post-coordination, a new feature to the ICD that supports the customized combination of concepts and modifier codes to capture previously inaccessible clinical nuance,” he wrote in a coauthored invited commentary.
This added clinical nuance, however, will potentially make coding more complex, he said. One solution is to automate coding, such that clinicians could input information in a natural clinical format that makes sense to them, which would then be translated into ICD-11 code by a program. (This would then be translated back to the user in the natural clinical format to ensure accuracy.)
This type of process would limit how much any one person would need to know about ICD-11 to code diagnoses effectively, while also taking full advantage of the increasing specificity of the new coding system, he said.
Such a program does not yet exist but could be possible with intensive investment in the transition to ICD-11.
The findings of this study serve as a cautionary tale for future transitions to new systems without considering the importance of user experience and usability, Dr. Pine noted. If the United States takes an approach for the adoption of ICD-11 that is similar to that used for ICD-10, it is likely to be “just another overhyped transition” that will make users unwilling to adopt any new system moving forward out of frustration.
But if the United States takes a different, innovative approach, the opposite could be true.
“In short, the US must decide whether it is time to invest considerable resources and effort into a 21st-century information system that could overcome such hindrances as asymmetric information for decision-making, faulty risk adjustment in performance evaluations and payment formulas, and burdens imposed by current coding and documentation practices,” the commentary reads.
“It will allow us to make the best of what computers do and the best of what clinicians do,” Dr. Pine added, “and get them to work together in ways which would not have been conceivable 50 years ago.”
No information on study funding was provided. Mr. Zhu and Dr. Pine did not disclose any competing interests.
A version of this article appeared on Medscape.com.
FROM JAMA NETWORK OPEN
Commentary: Comparisons Among PsA Therapies, May 2024
Papers on psoriatic arthritis (PsA) published this month have focused on the clinical characteristics of PsA and pharmacologic treatment. Persistent inflammation leads to joint damage that is initially evident on imaging. Hen and colleagues evaluated 122 newly diagnosed, disease-modifying antirheumatic drug (DMARD)–naive patients with early PsA from the Leeds Spondyloarthropathy Register for Research and Observation cohort using conventional radiography and ultrasonography. Overall, 4655 hand and feet joints were assessed in 122 patients, of whom 24.6% had bone erosions at baseline; higher disease activity was observed in patients who did vs those who did not have bone erosions (P < .05). The prevalence of erosions was less in patients who had PsA symptoms < 8 months vs > 24 months (17.5% vs 24.3%, respectively). The agreement between conventional radiography and ultrasonography was high, with conventional radiography detecting more erosions. Thus, joint damage is seen early in patients with PsA; making a diagnosis within 8 months of symptoms is likely to lead to less joint damage and better outcomes.
Bimekizumab is a novel biologic therapy that inhibits interleukin (IL)–17A and IL-17F and is efficacious in the treatment of psoriasis, PsA, and axial spondyloarthritis. In the absence of a formal head-to-head study, matching-adjusted indirect comparison is a method to evaluate comparative effectiveness. Warren and colleagues ran a study that included biological DMARD-naive patients and patients with inadequate response to tumor necrosis factor inhibitors (TNFi-IR) with PsA who received bimekizumab (160 mg every 4 weeks; 431 and 267 patients, respectively) and guselkumab (100 mg every 4 weeks or every 8 weeks; 495 and 189 patients, respectively). They demonstrate that in biological DMARD-naive patients, bimekizumab was associated with a greater likelihood of achieving ≥70% improvement in American College of Rheumatology (ACR) response and minimal disease activity outcome at week 52 compared with guselkumab. Similar outcomes were observed in the TNFi-IR subgroup. Thus, bimekizumab may be more effective than guselkumab in PsA. Formal head-to-head studies comparing bimekizumab vs guselkumab are required.
With the availability of multiple targeted therapies for PsA, choosing the most effective and safe drug for a patient is difficult, especially in the absence of many head-to-head clinical trials. To help address this problem, Lin and Ren conducted a network meta-analysis of head-to-head active comparison studies in PsA. They included 17 studies in their analysis and demonstrated that Janus kinase inhibitors had the highest probability of achieving ACR 20/50/70 response. Treatment with IL-17A inhibitors was more likely than TNFi therapy to lead to resolution of enthesitis and dactylitis and achieving combined ACR 50 and Psoriasis Area Severity Index 100 response. Patients receiving phosphodiesterase 4 inhibitors were least likely to have adverse events. They conclude that when both efficacy and safety are considered, IL-17A inhibitors may be the better agent for initial therapy for PsA. IL-17A inhibitors are indeed safe and efficacious in PsA; more direct head-to-head comparisons as well as strategy trials are required to determine choice of first and subsequent therapy in PsA.
Infections are the most important adverse effects of targeted therapies. The risk for infection in PsA in real-world settings is not well known. In a cohort study that included 12,071 patients with PsA from the French national health insurance database who were new users of targeted therapies (adalimumab, etanercept, golimumab, certolizumab pegol, infliximab, secukinumab, ixekizumab, ustekinumab, and tofacitinib), Bastard and colleagues demonstrated that the incidence of serious infections in users of targeted therapies was 17.0 per 1000 person-years. Compared with new users of adalimumab, the risk for serious infections was significantly lower in new users of etanercept (weighted hazard ratio [wHR] 0.72; 95% CI 0.53-0.97) and ustekinumab (wHR 0.57; 95% CI 0.35-0.93). Thus, the overall risk for serious infections is low, with etanercept and ustekinumab being safer treatment options than adalimumab.
Papers on psoriatic arthritis (PsA) published this month have focused on the clinical characteristics of PsA and pharmacologic treatment. Persistent inflammation leads to joint damage that is initially evident on imaging. Hen and colleagues evaluated 122 newly diagnosed, disease-modifying antirheumatic drug (DMARD)–naive patients with early PsA from the Leeds Spondyloarthropathy Register for Research and Observation cohort using conventional radiography and ultrasonography. Overall, 4655 hand and feet joints were assessed in 122 patients, of whom 24.6% had bone erosions at baseline; higher disease activity was observed in patients who did vs those who did not have bone erosions (P < .05). The prevalence of erosions was less in patients who had PsA symptoms < 8 months vs > 24 months (17.5% vs 24.3%, respectively). The agreement between conventional radiography and ultrasonography was high, with conventional radiography detecting more erosions. Thus, joint damage is seen early in patients with PsA; making a diagnosis within 8 months of symptoms is likely to lead to less joint damage and better outcomes.
Bimekizumab is a novel biologic therapy that inhibits interleukin (IL)–17A and IL-17F and is efficacious in the treatment of psoriasis, PsA, and axial spondyloarthritis. In the absence of a formal head-to-head study, matching-adjusted indirect comparison is a method to evaluate comparative effectiveness. Warren and colleagues ran a study that included biological DMARD-naive patients and patients with inadequate response to tumor necrosis factor inhibitors (TNFi-IR) with PsA who received bimekizumab (160 mg every 4 weeks; 431 and 267 patients, respectively) and guselkumab (100 mg every 4 weeks or every 8 weeks; 495 and 189 patients, respectively). They demonstrate that in biological DMARD-naive patients, bimekizumab was associated with a greater likelihood of achieving ≥70% improvement in American College of Rheumatology (ACR) response and minimal disease activity outcome at week 52 compared with guselkumab. Similar outcomes were observed in the TNFi-IR subgroup. Thus, bimekizumab may be more effective than guselkumab in PsA. Formal head-to-head studies comparing bimekizumab vs guselkumab are required.
With the availability of multiple targeted therapies for PsA, choosing the most effective and safe drug for a patient is difficult, especially in the absence of many head-to-head clinical trials. To help address this problem, Lin and Ren conducted a network meta-analysis of head-to-head active comparison studies in PsA. They included 17 studies in their analysis and demonstrated that Janus kinase inhibitors had the highest probability of achieving ACR 20/50/70 response. Treatment with IL-17A inhibitors was more likely than TNFi therapy to lead to resolution of enthesitis and dactylitis and achieving combined ACR 50 and Psoriasis Area Severity Index 100 response. Patients receiving phosphodiesterase 4 inhibitors were least likely to have adverse events. They conclude that when both efficacy and safety are considered, IL-17A inhibitors may be the better agent for initial therapy for PsA. IL-17A inhibitors are indeed safe and efficacious in PsA; more direct head-to-head comparisons as well as strategy trials are required to determine choice of first and subsequent therapy in PsA.
Infections are the most important adverse effects of targeted therapies. The risk for infection in PsA in real-world settings is not well known. In a cohort study that included 12,071 patients with PsA from the French national health insurance database who were new users of targeted therapies (adalimumab, etanercept, golimumab, certolizumab pegol, infliximab, secukinumab, ixekizumab, ustekinumab, and tofacitinib), Bastard and colleagues demonstrated that the incidence of serious infections in users of targeted therapies was 17.0 per 1000 person-years. Compared with new users of adalimumab, the risk for serious infections was significantly lower in new users of etanercept (weighted hazard ratio [wHR] 0.72; 95% CI 0.53-0.97) and ustekinumab (wHR 0.57; 95% CI 0.35-0.93). Thus, the overall risk for serious infections is low, with etanercept and ustekinumab being safer treatment options than adalimumab.
Papers on psoriatic arthritis (PsA) published this month have focused on the clinical characteristics of PsA and pharmacologic treatment. Persistent inflammation leads to joint damage that is initially evident on imaging. Hen and colleagues evaluated 122 newly diagnosed, disease-modifying antirheumatic drug (DMARD)–naive patients with early PsA from the Leeds Spondyloarthropathy Register for Research and Observation cohort using conventional radiography and ultrasonography. Overall, 4655 hand and feet joints were assessed in 122 patients, of whom 24.6% had bone erosions at baseline; higher disease activity was observed in patients who did vs those who did not have bone erosions (P < .05). The prevalence of erosions was less in patients who had PsA symptoms < 8 months vs > 24 months (17.5% vs 24.3%, respectively). The agreement between conventional radiography and ultrasonography was high, with conventional radiography detecting more erosions. Thus, joint damage is seen early in patients with PsA; making a diagnosis within 8 months of symptoms is likely to lead to less joint damage and better outcomes.
Bimekizumab is a novel biologic therapy that inhibits interleukin (IL)–17A and IL-17F and is efficacious in the treatment of psoriasis, PsA, and axial spondyloarthritis. In the absence of a formal head-to-head study, matching-adjusted indirect comparison is a method to evaluate comparative effectiveness. Warren and colleagues ran a study that included biological DMARD-naive patients and patients with inadequate response to tumor necrosis factor inhibitors (TNFi-IR) with PsA who received bimekizumab (160 mg every 4 weeks; 431 and 267 patients, respectively) and guselkumab (100 mg every 4 weeks or every 8 weeks; 495 and 189 patients, respectively). They demonstrate that in biological DMARD-naive patients, bimekizumab was associated with a greater likelihood of achieving ≥70% improvement in American College of Rheumatology (ACR) response and minimal disease activity outcome at week 52 compared with guselkumab. Similar outcomes were observed in the TNFi-IR subgroup. Thus, bimekizumab may be more effective than guselkumab in PsA. Formal head-to-head studies comparing bimekizumab vs guselkumab are required.
With the availability of multiple targeted therapies for PsA, choosing the most effective and safe drug for a patient is difficult, especially in the absence of many head-to-head clinical trials. To help address this problem, Lin and Ren conducted a network meta-analysis of head-to-head active comparison studies in PsA. They included 17 studies in their analysis and demonstrated that Janus kinase inhibitors had the highest probability of achieving ACR 20/50/70 response. Treatment with IL-17A inhibitors was more likely than TNFi therapy to lead to resolution of enthesitis and dactylitis and achieving combined ACR 50 and Psoriasis Area Severity Index 100 response. Patients receiving phosphodiesterase 4 inhibitors were least likely to have adverse events. They conclude that when both efficacy and safety are considered, IL-17A inhibitors may be the better agent for initial therapy for PsA. IL-17A inhibitors are indeed safe and efficacious in PsA; more direct head-to-head comparisons as well as strategy trials are required to determine choice of first and subsequent therapy in PsA.
Infections are the most important adverse effects of targeted therapies. The risk for infection in PsA in real-world settings is not well known. In a cohort study that included 12,071 patients with PsA from the French national health insurance database who were new users of targeted therapies (adalimumab, etanercept, golimumab, certolizumab pegol, infliximab, secukinumab, ixekizumab, ustekinumab, and tofacitinib), Bastard and colleagues demonstrated that the incidence of serious infections in users of targeted therapies was 17.0 per 1000 person-years. Compared with new users of adalimumab, the risk for serious infections was significantly lower in new users of etanercept (weighted hazard ratio [wHR] 0.72; 95% CI 0.53-0.97) and ustekinumab (wHR 0.57; 95% CI 0.35-0.93). Thus, the overall risk for serious infections is low, with etanercept and ustekinumab being safer treatment options than adalimumab.
Combined Pediatric Derm-Rheum Clinics Supported by Survey Respondents
TOPLINE:
.
METHODOLOGY:
- Combined pediatric dermatology-rheumatology clinics can improve patient outcomes and experiences, particularly for pediatric autoimmune conditions presenting with both cutaneous and systemic manifestations.
- The researchers surveyed 208 pediatric dermatologists working in combined pediatric dermatology-rheumatology clinics.
- A total of 13 member responses were recorded from three countries: 10 from the United States, two from Mexico, and one from Canada.
TAKEAWAY:
- Perceived benefits of combined clinics were improved patient care through coordinated treatment decisions and timely communication between providers.
- Patient satisfaction was favorable, and patients and families endorsed the combined clinic approach.
- Barriers to clinic establishment included differences in the pace between dermatology and rheumatology clinic flow, the need to generate more relative value units, resistance from colleagues, and limited time.
- Areas that needed improvement included more time for patient visits, dedicated research assistants, new patient referrals, additional patient rooms, resources for research, and patient care infrastructure.
IN PRACTICE:
The insights from this survey “will hopefully inspire further development of these combined clinics,” the authors wrote.
SOURCE:
The investigation, led by Olga S. Cherepakhin, BS, University of Washington, Seattle, Washington, was published in Pediatric Dermatology.
LIMITATIONS:
Limitations included the subjective nature, lack of some information, selection bias, and small number of respondents, and the survey reflected the perspective of the pediatric dermatologists only.
DISCLOSURES:
The study was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health. One author reported full-time employment at Janssen R&D, and the other authors had no disclosures.
A version of this article appeared on Medscape.com.
TOPLINE:
.
METHODOLOGY:
- Combined pediatric dermatology-rheumatology clinics can improve patient outcomes and experiences, particularly for pediatric autoimmune conditions presenting with both cutaneous and systemic manifestations.
- The researchers surveyed 208 pediatric dermatologists working in combined pediatric dermatology-rheumatology clinics.
- A total of 13 member responses were recorded from three countries: 10 from the United States, two from Mexico, and one from Canada.
TAKEAWAY:
- Perceived benefits of combined clinics were improved patient care through coordinated treatment decisions and timely communication between providers.
- Patient satisfaction was favorable, and patients and families endorsed the combined clinic approach.
- Barriers to clinic establishment included differences in the pace between dermatology and rheumatology clinic flow, the need to generate more relative value units, resistance from colleagues, and limited time.
- Areas that needed improvement included more time for patient visits, dedicated research assistants, new patient referrals, additional patient rooms, resources for research, and patient care infrastructure.
IN PRACTICE:
The insights from this survey “will hopefully inspire further development of these combined clinics,” the authors wrote.
SOURCE:
The investigation, led by Olga S. Cherepakhin, BS, University of Washington, Seattle, Washington, was published in Pediatric Dermatology.
LIMITATIONS:
Limitations included the subjective nature, lack of some information, selection bias, and small number of respondents, and the survey reflected the perspective of the pediatric dermatologists only.
DISCLOSURES:
The study was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health. One author reported full-time employment at Janssen R&D, and the other authors had no disclosures.
A version of this article appeared on Medscape.com.
TOPLINE:
.
METHODOLOGY:
- Combined pediatric dermatology-rheumatology clinics can improve patient outcomes and experiences, particularly for pediatric autoimmune conditions presenting with both cutaneous and systemic manifestations.
- The researchers surveyed 208 pediatric dermatologists working in combined pediatric dermatology-rheumatology clinics.
- A total of 13 member responses were recorded from three countries: 10 from the United States, two from Mexico, and one from Canada.
TAKEAWAY:
- Perceived benefits of combined clinics were improved patient care through coordinated treatment decisions and timely communication between providers.
- Patient satisfaction was favorable, and patients and families endorsed the combined clinic approach.
- Barriers to clinic establishment included differences in the pace between dermatology and rheumatology clinic flow, the need to generate more relative value units, resistance from colleagues, and limited time.
- Areas that needed improvement included more time for patient visits, dedicated research assistants, new patient referrals, additional patient rooms, resources for research, and patient care infrastructure.
IN PRACTICE:
The insights from this survey “will hopefully inspire further development of these combined clinics,” the authors wrote.
SOURCE:
The investigation, led by Olga S. Cherepakhin, BS, University of Washington, Seattle, Washington, was published in Pediatric Dermatology.
LIMITATIONS:
Limitations included the subjective nature, lack of some information, selection bias, and small number of respondents, and the survey reflected the perspective of the pediatric dermatologists only.
DISCLOSURES:
The study was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health. One author reported full-time employment at Janssen R&D, and the other authors had no disclosures.
A version of this article appeared on Medscape.com.
Second Ustekinumab Biosimilar Gets FDA Approval
The US Food and Drug Administration (FDA) has approved the biosimilar ustekinumab-aekn (Selarsdi) for the treatment of moderate to severe plaque psoriasis and psoriatic arthritis in adults and pediatric patients aged 6 years or older.
This is the second ustekinumab biosimilar approved by the regulatory agency and is the second biosimilar approval in the United States for the Icelandic pharmaceutical company Alvotech in partnership with Teva Pharmaceuticals.
Ustekinumab (Stelara) is a human monoclonal antibody targeting interleukin (IL)–12 and IL-23. The drug, manufactured by Johnson & Johnson, totaled nearly $7 billion in sales in 2023 alone, according a press release.
“Bringing Selarsdi to market in the US early next year presents a significant opportunity to improve patient access to a vital biologic in inflammatory disease and contribute to the reduction of inflationary pressure in healthcare costs,” the chairman and CEO of Alvotech said in the release.
The first ustekinumab biosimilar, ustekinumab-auub (Wezlana), was approved by the FDA in on October 31, 2023 and is interchangeable with the reference product. This allows pharmacists to substitute the biosimilar for the reference product without involving the prescribing clinician (according to state law). Besides psoriasis and psoriatic arthritis, ustekinumab-auub was also approved for treating moderate to severely active Crohn’s disease and ulcerative colitis. Ustekinumab-aekn does not have an interchangeability designation and was not approved for Crohn’s disease or ulcerative colitis.
The approval of ustekinumab-aekn was based on two clinical studies. A randomized, double blind, multicenter, 52-week study of 581 patients with moderate to severe plaque psoriasis demonstrated that the biosimilar was as effective as the reference product, with equivalent safety and immunogenicity profiles. A phase 1, randomized, double-blind, single-dose, parallel-group, three-arm study also compared the pharmacokinetic profile of the biosimilar to ustekinumab in 294 healthy adults.
Ustekinumab-aekn is expected to be marketed in the United States on or after February 21, 2025 per a settlement and license agreement with Johnson & Johnson.
A version of this article appeared on Medscape.com.
The US Food and Drug Administration (FDA) has approved the biosimilar ustekinumab-aekn (Selarsdi) for the treatment of moderate to severe plaque psoriasis and psoriatic arthritis in adults and pediatric patients aged 6 years or older.
This is the second ustekinumab biosimilar approved by the regulatory agency and is the second biosimilar approval in the United States for the Icelandic pharmaceutical company Alvotech in partnership with Teva Pharmaceuticals.
Ustekinumab (Stelara) is a human monoclonal antibody targeting interleukin (IL)–12 and IL-23. The drug, manufactured by Johnson & Johnson, totaled nearly $7 billion in sales in 2023 alone, according a press release.
“Bringing Selarsdi to market in the US early next year presents a significant opportunity to improve patient access to a vital biologic in inflammatory disease and contribute to the reduction of inflationary pressure in healthcare costs,” the chairman and CEO of Alvotech said in the release.
The first ustekinumab biosimilar, ustekinumab-auub (Wezlana), was approved by the FDA in on October 31, 2023 and is interchangeable with the reference product. This allows pharmacists to substitute the biosimilar for the reference product without involving the prescribing clinician (according to state law). Besides psoriasis and psoriatic arthritis, ustekinumab-auub was also approved for treating moderate to severely active Crohn’s disease and ulcerative colitis. Ustekinumab-aekn does not have an interchangeability designation and was not approved for Crohn’s disease or ulcerative colitis.
The approval of ustekinumab-aekn was based on two clinical studies. A randomized, double blind, multicenter, 52-week study of 581 patients with moderate to severe plaque psoriasis demonstrated that the biosimilar was as effective as the reference product, with equivalent safety and immunogenicity profiles. A phase 1, randomized, double-blind, single-dose, parallel-group, three-arm study also compared the pharmacokinetic profile of the biosimilar to ustekinumab in 294 healthy adults.
Ustekinumab-aekn is expected to be marketed in the United States on or after February 21, 2025 per a settlement and license agreement with Johnson & Johnson.
A version of this article appeared on Medscape.com.
The US Food and Drug Administration (FDA) has approved the biosimilar ustekinumab-aekn (Selarsdi) for the treatment of moderate to severe plaque psoriasis and psoriatic arthritis in adults and pediatric patients aged 6 years or older.
This is the second ustekinumab biosimilar approved by the regulatory agency and is the second biosimilar approval in the United States for the Icelandic pharmaceutical company Alvotech in partnership with Teva Pharmaceuticals.
Ustekinumab (Stelara) is a human monoclonal antibody targeting interleukin (IL)–12 and IL-23. The drug, manufactured by Johnson & Johnson, totaled nearly $7 billion in sales in 2023 alone, according a press release.
“Bringing Selarsdi to market in the US early next year presents a significant opportunity to improve patient access to a vital biologic in inflammatory disease and contribute to the reduction of inflationary pressure in healthcare costs,” the chairman and CEO of Alvotech said in the release.
The first ustekinumab biosimilar, ustekinumab-auub (Wezlana), was approved by the FDA in on October 31, 2023 and is interchangeable with the reference product. This allows pharmacists to substitute the biosimilar for the reference product without involving the prescribing clinician (according to state law). Besides psoriasis and psoriatic arthritis, ustekinumab-auub was also approved for treating moderate to severely active Crohn’s disease and ulcerative colitis. Ustekinumab-aekn does not have an interchangeability designation and was not approved for Crohn’s disease or ulcerative colitis.
The approval of ustekinumab-aekn was based on two clinical studies. A randomized, double blind, multicenter, 52-week study of 581 patients with moderate to severe plaque psoriasis demonstrated that the biosimilar was as effective as the reference product, with equivalent safety and immunogenicity profiles. A phase 1, randomized, double-blind, single-dose, parallel-group, three-arm study also compared the pharmacokinetic profile of the biosimilar to ustekinumab in 294 healthy adults.
Ustekinumab-aekn is expected to be marketed in the United States on or after February 21, 2025 per a settlement and license agreement with Johnson & Johnson.
A version of this article appeared on Medscape.com.
Clinical Characteristics of Severe PsA
Key clinical point: Patients with psoriatic arthritis (PsA) who had severe vs non-severe disease according to the modified Composite Psoriatic Disease Activity Index (mCPDAI) showed higher disease activity, experienced more pain, and had higher disease impact both at baseline and during follow-up.
Major finding: At baseline, 36.1% of patients had severe PsA as assessed by mCPDAI. A significantly higher disease activity, disease impact, number of tender or swollen joints, and pain and reduced function were observed in patients with severe vs non-severe disease at baseline and follow-up (all P < .01). Male sex and severity of skin involvement at baseline were the factors associated with the severe PsA at last follow-up (both P ≤ .01).
Study details: This retrospective analysis of a longitudinal study included 177 patients with peripheral PsA who were followed for at least 1 year.
Disclosures: This study did not receive any funding or sponsorship. Ennio Lubrano and Fabio Perrotta declared being members of the editorial board of Rheumatology and Therapy. Silvia Scriffignano declared no conflicts of interest.
Source: Lubrano E, Scriffignano S, Perrotta FM. Clinical characteristics of "severe" peripheral psoriatic arthritis: A retrospective analysis of a longitudinal cohort. Rheumatol Ther. 2024 (Apr 9). doi: 10.1007/s40744-024-00667-0 Source
Key clinical point: Patients with psoriatic arthritis (PsA) who had severe vs non-severe disease according to the modified Composite Psoriatic Disease Activity Index (mCPDAI) showed higher disease activity, experienced more pain, and had higher disease impact both at baseline and during follow-up.
Major finding: At baseline, 36.1% of patients had severe PsA as assessed by mCPDAI. A significantly higher disease activity, disease impact, number of tender or swollen joints, and pain and reduced function were observed in patients with severe vs non-severe disease at baseline and follow-up (all P < .01). Male sex and severity of skin involvement at baseline were the factors associated with the severe PsA at last follow-up (both P ≤ .01).
Study details: This retrospective analysis of a longitudinal study included 177 patients with peripheral PsA who were followed for at least 1 year.
Disclosures: This study did not receive any funding or sponsorship. Ennio Lubrano and Fabio Perrotta declared being members of the editorial board of Rheumatology and Therapy. Silvia Scriffignano declared no conflicts of interest.
Source: Lubrano E, Scriffignano S, Perrotta FM. Clinical characteristics of "severe" peripheral psoriatic arthritis: A retrospective analysis of a longitudinal cohort. Rheumatol Ther. 2024 (Apr 9). doi: 10.1007/s40744-024-00667-0 Source
Key clinical point: Patients with psoriatic arthritis (PsA) who had severe vs non-severe disease according to the modified Composite Psoriatic Disease Activity Index (mCPDAI) showed higher disease activity, experienced more pain, and had higher disease impact both at baseline and during follow-up.
Major finding: At baseline, 36.1% of patients had severe PsA as assessed by mCPDAI. A significantly higher disease activity, disease impact, number of tender or swollen joints, and pain and reduced function were observed in patients with severe vs non-severe disease at baseline and follow-up (all P < .01). Male sex and severity of skin involvement at baseline were the factors associated with the severe PsA at last follow-up (both P ≤ .01).
Study details: This retrospective analysis of a longitudinal study included 177 patients with peripheral PsA who were followed for at least 1 year.
Disclosures: This study did not receive any funding or sponsorship. Ennio Lubrano and Fabio Perrotta declared being members of the editorial board of Rheumatology and Therapy. Silvia Scriffignano declared no conflicts of interest.
Source: Lubrano E, Scriffignano S, Perrotta FM. Clinical characteristics of "severe" peripheral psoriatic arthritis: A retrospective analysis of a longitudinal cohort. Rheumatol Ther. 2024 (Apr 9). doi: 10.1007/s40744-024-00667-0 Source
Meta-Analysis Identifies IL17A Inhibitor as a Better Treatment Option in Biologic-Naive Patients with PsA
Key clinical point: Treatment with an interleukin-17A inhibitor (IL-17Ai) may be desirable in biologic-naive patients with psoriatic arthritis (PsA) as it proved to be more effective and safer compared with other biologics.
Major finding: A higher number of patients achieved the composite endpoint of ≥50% improvement in American College of Rheumatology and 100% improvement in Psoriasis Area Severity Index (pooled risk ratio [RR] 1.56; 95% CI 1.29-1.88; P < .001) and enthesitis resolution (pooled RR 1.22; 95% CI 1.02-1.47) with IL17Ai vs TNFi. The probability of adverse events was the lowest with phosphodiesterase-4 inhibitor (PDE4i) followed by IL-17Ai.
Study details: Findings are from a network meta-analysis of 17 studies including biologic-naive patients with PsA treated with IL inhibitor, TNFi, PDE4i, and Janus kinase inhibitors.
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Lin J, Ren Y. Different biologics for biological-naïve patients with psoriatic arthritis: A systematic review and network meta-analysis. Front Pharmacol. 2024;15:1279525 (Mar 12). doi: 10.3389/fphar.2024.1279525 Source
Key clinical point: Treatment with an interleukin-17A inhibitor (IL-17Ai) may be desirable in biologic-naive patients with psoriatic arthritis (PsA) as it proved to be more effective and safer compared with other biologics.
Major finding: A higher number of patients achieved the composite endpoint of ≥50% improvement in American College of Rheumatology and 100% improvement in Psoriasis Area Severity Index (pooled risk ratio [RR] 1.56; 95% CI 1.29-1.88; P < .001) and enthesitis resolution (pooled RR 1.22; 95% CI 1.02-1.47) with IL17Ai vs TNFi. The probability of adverse events was the lowest with phosphodiesterase-4 inhibitor (PDE4i) followed by IL-17Ai.
Study details: Findings are from a network meta-analysis of 17 studies including biologic-naive patients with PsA treated with IL inhibitor, TNFi, PDE4i, and Janus kinase inhibitors.
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Lin J, Ren Y. Different biologics for biological-naïve patients with psoriatic arthritis: A systematic review and network meta-analysis. Front Pharmacol. 2024;15:1279525 (Mar 12). doi: 10.3389/fphar.2024.1279525 Source
Key clinical point: Treatment with an interleukin-17A inhibitor (IL-17Ai) may be desirable in biologic-naive patients with psoriatic arthritis (PsA) as it proved to be more effective and safer compared with other biologics.
Major finding: A higher number of patients achieved the composite endpoint of ≥50% improvement in American College of Rheumatology and 100% improvement in Psoriasis Area Severity Index (pooled risk ratio [RR] 1.56; 95% CI 1.29-1.88; P < .001) and enthesitis resolution (pooled RR 1.22; 95% CI 1.02-1.47) with IL17Ai vs TNFi. The probability of adverse events was the lowest with phosphodiesterase-4 inhibitor (PDE4i) followed by IL-17Ai.
Study details: Findings are from a network meta-analysis of 17 studies including biologic-naive patients with PsA treated with IL inhibitor, TNFi, PDE4i, and Janus kinase inhibitors.
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Lin J, Ren Y. Different biologics for biological-naïve patients with psoriatic arthritis: A systematic review and network meta-analysis. Front Pharmacol. 2024;15:1279525 (Mar 12). doi: 10.3389/fphar.2024.1279525 Source