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Improvement in patient-reported outcomes comparable with ustekinumab and TNFi in PsA
Key clinical point: Improvements in patient-reported outcomes were generally comparable with ustekinumab and tumor necrosis factor inhibitor (TNFi) treatments in patients with psoriatic arthritis (PsA).
Major finding: At 3 years, ustekinumab and TNFi were associated with comparable improvements in EuroQol-5 dimensions health state visual analogue scale scores (ustekinumab: mean change from baseline [Δ], 11.0 [95% CI, 6.5-15.4]; TNFi: Δ, 18.9 [95% CI, 14.0-23.9]) and work productivity (ustekinumab: Δ, 24.9% [95% CI, 15.8%-34.0%]; TNFi: Δ, 44.5% [95% CI, 38.4%-50.6%]).
Study details: This study evaluated 437 patients with PsA from the PsABio study who initiated first- to third-line ustekinumab (n=219) or TNFi (n=218) and continued the initial treatment for 3 years.
Disclosures: This study was sponsored by Janssen. Several authors reported ties with various sources, including Janssen. E Theander reported being a former employee of Janssen. M Sharaf and W Noel declared being employees of or owning stocks in Johnson & Johnson.
Source: Gossec L et al. Improvement in patient-reported outcomes and work productivity following 3-year ustekinumab or tumour necrosis factor inhibitor treatment in patients with psoriatic arthritis: Results from the PsABio real-world study. Arthritis Res Ther. 2023;25(1):109 (Jun 23). Doi: 10.1186/s13075-023-03058-y.
Key clinical point: Improvements in patient-reported outcomes were generally comparable with ustekinumab and tumor necrosis factor inhibitor (TNFi) treatments in patients with psoriatic arthritis (PsA).
Major finding: At 3 years, ustekinumab and TNFi were associated with comparable improvements in EuroQol-5 dimensions health state visual analogue scale scores (ustekinumab: mean change from baseline [Δ], 11.0 [95% CI, 6.5-15.4]; TNFi: Δ, 18.9 [95% CI, 14.0-23.9]) and work productivity (ustekinumab: Δ, 24.9% [95% CI, 15.8%-34.0%]; TNFi: Δ, 44.5% [95% CI, 38.4%-50.6%]).
Study details: This study evaluated 437 patients with PsA from the PsABio study who initiated first- to third-line ustekinumab (n=219) or TNFi (n=218) and continued the initial treatment for 3 years.
Disclosures: This study was sponsored by Janssen. Several authors reported ties with various sources, including Janssen. E Theander reported being a former employee of Janssen. M Sharaf and W Noel declared being employees of or owning stocks in Johnson & Johnson.
Source: Gossec L et al. Improvement in patient-reported outcomes and work productivity following 3-year ustekinumab or tumour necrosis factor inhibitor treatment in patients with psoriatic arthritis: Results from the PsABio real-world study. Arthritis Res Ther. 2023;25(1):109 (Jun 23). Doi: 10.1186/s13075-023-03058-y.
Key clinical point: Improvements in patient-reported outcomes were generally comparable with ustekinumab and tumor necrosis factor inhibitor (TNFi) treatments in patients with psoriatic arthritis (PsA).
Major finding: At 3 years, ustekinumab and TNFi were associated with comparable improvements in EuroQol-5 dimensions health state visual analogue scale scores (ustekinumab: mean change from baseline [Δ], 11.0 [95% CI, 6.5-15.4]; TNFi: Δ, 18.9 [95% CI, 14.0-23.9]) and work productivity (ustekinumab: Δ, 24.9% [95% CI, 15.8%-34.0%]; TNFi: Δ, 44.5% [95% CI, 38.4%-50.6%]).
Study details: This study evaluated 437 patients with PsA from the PsABio study who initiated first- to third-line ustekinumab (n=219) or TNFi (n=218) and continued the initial treatment for 3 years.
Disclosures: This study was sponsored by Janssen. Several authors reported ties with various sources, including Janssen. E Theander reported being a former employee of Janssen. M Sharaf and W Noel declared being employees of or owning stocks in Johnson & Johnson.
Source: Gossec L et al. Improvement in patient-reported outcomes and work productivity following 3-year ustekinumab or tumour necrosis factor inhibitor treatment in patients with psoriatic arthritis: Results from the PsABio real-world study. Arthritis Res Ther. 2023;25(1):109 (Jun 23). Doi: 10.1186/s13075-023-03058-y.
Apremilast offers a safe long-term oral treatment option for psoriatic arthritis
Key clinical point: Apremilast appeared safe for long-term use with a consistent safety profile in patients with psoriatic arthritis (PsA), indicating a favorable benefit-risk profile.
Major finding: The overall incidence of serious treatment-emergent adverse events (TEAEs; exposure-adjusted incidence rate/100 patient-years, 6.9 and 8.9, respectively) and special interest TEAEs, such as major adverse cardiac events (0.1% and 0.1%, respectively), serious opportunistic infections (0.1% and 0.1%, respectively), and malignancies (0.3% and 0.4%, respectively), were similar in the apremilast and placebo groups and remained low throughout the apremilast exposure period.
Study details: This pooled analysis of 15 randomized trials included patients with plaque psoriasis (n=2,881), PsA (n=1,564), and Behçet’s syndrome (n=318) who received either apremilast or placebo.
Disclosures: This study was sponsored by Amgen Inc. Seven authors declared being employees and stockholders of Amgen. The other authors reported receiving honoraria, grants, or research funding as speakers, investigators, or advisory board members from various sources, including Amgen.
Source: Mease PJ et al. Apremilast long-term safety up to 5 years from 15 pooled randomized, placebo-controlled studies of psoriasis, psoriatic arthritis, and Behçet's syndrome. Am J Clin Dermatol. 2023;1-12 (Jun 14). Doi: 10.1007/s40257-023-00783-7.
Key clinical point: Apremilast appeared safe for long-term use with a consistent safety profile in patients with psoriatic arthritis (PsA), indicating a favorable benefit-risk profile.
Major finding: The overall incidence of serious treatment-emergent adverse events (TEAEs; exposure-adjusted incidence rate/100 patient-years, 6.9 and 8.9, respectively) and special interest TEAEs, such as major adverse cardiac events (0.1% and 0.1%, respectively), serious opportunistic infections (0.1% and 0.1%, respectively), and malignancies (0.3% and 0.4%, respectively), were similar in the apremilast and placebo groups and remained low throughout the apremilast exposure period.
Study details: This pooled analysis of 15 randomized trials included patients with plaque psoriasis (n=2,881), PsA (n=1,564), and Behçet’s syndrome (n=318) who received either apremilast or placebo.
Disclosures: This study was sponsored by Amgen Inc. Seven authors declared being employees and stockholders of Amgen. The other authors reported receiving honoraria, grants, or research funding as speakers, investigators, or advisory board members from various sources, including Amgen.
Source: Mease PJ et al. Apremilast long-term safety up to 5 years from 15 pooled randomized, placebo-controlled studies of psoriasis, psoriatic arthritis, and Behçet's syndrome. Am J Clin Dermatol. 2023;1-12 (Jun 14). Doi: 10.1007/s40257-023-00783-7.
Key clinical point: Apremilast appeared safe for long-term use with a consistent safety profile in patients with psoriatic arthritis (PsA), indicating a favorable benefit-risk profile.
Major finding: The overall incidence of serious treatment-emergent adverse events (TEAEs; exposure-adjusted incidence rate/100 patient-years, 6.9 and 8.9, respectively) and special interest TEAEs, such as major adverse cardiac events (0.1% and 0.1%, respectively), serious opportunistic infections (0.1% and 0.1%, respectively), and malignancies (0.3% and 0.4%, respectively), were similar in the apremilast and placebo groups and remained low throughout the apremilast exposure period.
Study details: This pooled analysis of 15 randomized trials included patients with plaque psoriasis (n=2,881), PsA (n=1,564), and Behçet’s syndrome (n=318) who received either apremilast or placebo.
Disclosures: This study was sponsored by Amgen Inc. Seven authors declared being employees and stockholders of Amgen. The other authors reported receiving honoraria, grants, or research funding as speakers, investigators, or advisory board members from various sources, including Amgen.
Source: Mease PJ et al. Apremilast long-term safety up to 5 years from 15 pooled randomized, placebo-controlled studies of psoriasis, psoriatic arthritis, and Behçet's syndrome. Am J Clin Dermatol. 2023;1-12 (Jun 14). Doi: 10.1007/s40257-023-00783-7.
Real-world study confirms clinical efficacy of ixekizumab in PsA
Key clinical point: Ixekizumab improved musculoskeletal disease activity and patient-reported outcomes in a real-world cohort of patients with psoriatic arthritis.
Major finding: The Clinical Disease Activity Index improved significantly at 6 months (mean change [Δ], −3.5) and 12 months (Δ, −4.3; both P < .0001) after ixekizumab initiation, along with significant improvements in tender joint count, swollen joint count, and Physician’s Global Assessment scores (all P < .05). All patient-reported outcomes, including Patient’s Global Assessment, pain Visual Analog Scale, and Multidimensional Health Assessment Questionnaire Functional Index scores, improved at both time points.
Study details: This retrospective study included 1,812 patients with PsA from the OM1 PremiOMTM PsA dataset who initiated ixekizumab.
Disclosures: This study was sponsored by Eli Lilly and Company Pharmaceuticals. Three authors declared being employees and shareholders of Eli Lilly and Company, and 3 other authors declared being employees of OM1, Inc. W Tillett declared being a paid consultant for various sources, including Eli Lilly. The other authors declared no conflict of interests.
Source: Tillett W et al. Changes in musculoskeletal disease activity and patient-reported outcomes in patients with psoriatic arthritis treated with ixekizumab: Results from a real-world US cohort. Front Med (Lausanne). 2023;10:1184028 (Jun 21). Doi: 10.3389/fmed.2023.1184028.
Key clinical point: Ixekizumab improved musculoskeletal disease activity and patient-reported outcomes in a real-world cohort of patients with psoriatic arthritis.
Major finding: The Clinical Disease Activity Index improved significantly at 6 months (mean change [Δ], −3.5) and 12 months (Δ, −4.3; both P < .0001) after ixekizumab initiation, along with significant improvements in tender joint count, swollen joint count, and Physician’s Global Assessment scores (all P < .05). All patient-reported outcomes, including Patient’s Global Assessment, pain Visual Analog Scale, and Multidimensional Health Assessment Questionnaire Functional Index scores, improved at both time points.
Study details: This retrospective study included 1,812 patients with PsA from the OM1 PremiOMTM PsA dataset who initiated ixekizumab.
Disclosures: This study was sponsored by Eli Lilly and Company Pharmaceuticals. Three authors declared being employees and shareholders of Eli Lilly and Company, and 3 other authors declared being employees of OM1, Inc. W Tillett declared being a paid consultant for various sources, including Eli Lilly. The other authors declared no conflict of interests.
Source: Tillett W et al. Changes in musculoskeletal disease activity and patient-reported outcomes in patients with psoriatic arthritis treated with ixekizumab: Results from a real-world US cohort. Front Med (Lausanne). 2023;10:1184028 (Jun 21). Doi: 10.3389/fmed.2023.1184028.
Key clinical point: Ixekizumab improved musculoskeletal disease activity and patient-reported outcomes in a real-world cohort of patients with psoriatic arthritis.
Major finding: The Clinical Disease Activity Index improved significantly at 6 months (mean change [Δ], −3.5) and 12 months (Δ, −4.3; both P < .0001) after ixekizumab initiation, along with significant improvements in tender joint count, swollen joint count, and Physician’s Global Assessment scores (all P < .05). All patient-reported outcomes, including Patient’s Global Assessment, pain Visual Analog Scale, and Multidimensional Health Assessment Questionnaire Functional Index scores, improved at both time points.
Study details: This retrospective study included 1,812 patients with PsA from the OM1 PremiOMTM PsA dataset who initiated ixekizumab.
Disclosures: This study was sponsored by Eli Lilly and Company Pharmaceuticals. Three authors declared being employees and shareholders of Eli Lilly and Company, and 3 other authors declared being employees of OM1, Inc. W Tillett declared being a paid consultant for various sources, including Eli Lilly. The other authors declared no conflict of interests.
Source: Tillett W et al. Changes in musculoskeletal disease activity and patient-reported outcomes in patients with psoriatic arthritis treated with ixekizumab: Results from a real-world US cohort. Front Med (Lausanne). 2023;10:1184028 (Jun 21). Doi: 10.3389/fmed.2023.1184028.
Predictors of treatment response in PsA patients initiating a first TNFi
Key clinical point: In biologic-naïve patients with psoriatic arthritis (PsA) who initiated a first tumor necrosis factor inhibitor (TNFi), sex, disease duration, C-reactive protein level, age at treatment initiation, and fatigue predicted the achievement of the Disease Activity index for PsA in 28 joints (DAPSA28) remission at 6 months.
Major finding: Male sex (odds ratio [OR], 1.85; 95% CI, 1.54-2.23), longer disease duration (OR, 1.66; 95% CI, 1.26-2.20), and higher C-reactive protein (OR, 1.52; 95% CI, 1.22-1.89) positively predicted the achievement of DAPSA28 remission at 6 months, whereas older age at treatment initiation (OR, 0.97; 95% CI, 0.96-0.98) and higher fatigue score (OR, 0.99; 95% CI, 0.98-0.99) were negative predictors.
Study details: This study evaluated the data of 13,369 biologic-naïve patients registered with a PsA diagnosis from 13 European registries who initiated a first TNFi treatment.
Disclosures: This study was sponsored by Novartis Pharma AG. Several authors declared receiving speaker or consulting fees and research grants from various sources, including Novartis.
Source: Linde L et al. Predictors of DAPSA28 remission in patients with psoriatic arthritis initiating a first TNF inhibitor: Results from 13 European registries. Rheumatology (Oxford). 2023 (Jun 14). Doi: 10.1093/rheumatology/kead284.
Key clinical point: In biologic-naïve patients with psoriatic arthritis (PsA) who initiated a first tumor necrosis factor inhibitor (TNFi), sex, disease duration, C-reactive protein level, age at treatment initiation, and fatigue predicted the achievement of the Disease Activity index for PsA in 28 joints (DAPSA28) remission at 6 months.
Major finding: Male sex (odds ratio [OR], 1.85; 95% CI, 1.54-2.23), longer disease duration (OR, 1.66; 95% CI, 1.26-2.20), and higher C-reactive protein (OR, 1.52; 95% CI, 1.22-1.89) positively predicted the achievement of DAPSA28 remission at 6 months, whereas older age at treatment initiation (OR, 0.97; 95% CI, 0.96-0.98) and higher fatigue score (OR, 0.99; 95% CI, 0.98-0.99) were negative predictors.
Study details: This study evaluated the data of 13,369 biologic-naïve patients registered with a PsA diagnosis from 13 European registries who initiated a first TNFi treatment.
Disclosures: This study was sponsored by Novartis Pharma AG. Several authors declared receiving speaker or consulting fees and research grants from various sources, including Novartis.
Source: Linde L et al. Predictors of DAPSA28 remission in patients with psoriatic arthritis initiating a first TNF inhibitor: Results from 13 European registries. Rheumatology (Oxford). 2023 (Jun 14). Doi: 10.1093/rheumatology/kead284.
Key clinical point: In biologic-naïve patients with psoriatic arthritis (PsA) who initiated a first tumor necrosis factor inhibitor (TNFi), sex, disease duration, C-reactive protein level, age at treatment initiation, and fatigue predicted the achievement of the Disease Activity index for PsA in 28 joints (DAPSA28) remission at 6 months.
Major finding: Male sex (odds ratio [OR], 1.85; 95% CI, 1.54-2.23), longer disease duration (OR, 1.66; 95% CI, 1.26-2.20), and higher C-reactive protein (OR, 1.52; 95% CI, 1.22-1.89) positively predicted the achievement of DAPSA28 remission at 6 months, whereas older age at treatment initiation (OR, 0.97; 95% CI, 0.96-0.98) and higher fatigue score (OR, 0.99; 95% CI, 0.98-0.99) were negative predictors.
Study details: This study evaluated the data of 13,369 biologic-naïve patients registered with a PsA diagnosis from 13 European registries who initiated a first TNFi treatment.
Disclosures: This study was sponsored by Novartis Pharma AG. Several authors declared receiving speaker or consulting fees and research grants from various sources, including Novartis.
Source: Linde L et al. Predictors of DAPSA28 remission in patients with psoriatic arthritis initiating a first TNF inhibitor: Results from 13 European registries. Rheumatology (Oxford). 2023 (Jun 14). Doi: 10.1093/rheumatology/kead284.
Beta-defensin-2 may serve as a predictive biomarker for clinical response to secukinumab in PsA
Key clinical point: A significant quantitative association exists between baseline serum beta-defensin-2 (BD-2) levels and the clinical response to secukinumab in patients with psoriatic arthritis (PsA).
Major finding: Baseline serum BD-2 levels were significantly associated with the American College of Rheumatology (ACR) response to secukinumab (Spearman’s rho, 27%; P = 3.8e-5) but not to placebo at week 16, with the trend being consistent for ≥1 year. The addition of BD-2 to the clinical model improved the prediction of the 16-week ACR 20% improvement response to secukinumab by increasing the area under the receiver operating characteristic curve by 11 percentage points.
Study details: This retrospective analysis of the phase 3 FUTURE 1-5 trials included 1,989 patients with PsA who received secukinumab or placebo.
Disclosures: This study did not receive any funding. Seven authors declared being employees of or holding shares or stock options in Novartis AG, and M Cardner declared being an employee of AstraZeneca AB. Two authors reported ties unrelated to this study.
Source: Cardner M et al. Analysis of serum proteomics data identifies a quantitative association between beta-defensin 2 at baseline and clinical response to IL-17 blockade in psoriatic arthritis. RMD Open. 2023;9(2):e003042 (Jun 15). Doi: 10.1136/rmdopen-2023-003042.
Key clinical point: A significant quantitative association exists between baseline serum beta-defensin-2 (BD-2) levels and the clinical response to secukinumab in patients with psoriatic arthritis (PsA).
Major finding: Baseline serum BD-2 levels were significantly associated with the American College of Rheumatology (ACR) response to secukinumab (Spearman’s rho, 27%; P = 3.8e-5) but not to placebo at week 16, with the trend being consistent for ≥1 year. The addition of BD-2 to the clinical model improved the prediction of the 16-week ACR 20% improvement response to secukinumab by increasing the area under the receiver operating characteristic curve by 11 percentage points.
Study details: This retrospective analysis of the phase 3 FUTURE 1-5 trials included 1,989 patients with PsA who received secukinumab or placebo.
Disclosures: This study did not receive any funding. Seven authors declared being employees of or holding shares or stock options in Novartis AG, and M Cardner declared being an employee of AstraZeneca AB. Two authors reported ties unrelated to this study.
Source: Cardner M et al. Analysis of serum proteomics data identifies a quantitative association between beta-defensin 2 at baseline and clinical response to IL-17 blockade in psoriatic arthritis. RMD Open. 2023;9(2):e003042 (Jun 15). Doi: 10.1136/rmdopen-2023-003042.
Key clinical point: A significant quantitative association exists between baseline serum beta-defensin-2 (BD-2) levels and the clinical response to secukinumab in patients with psoriatic arthritis (PsA).
Major finding: Baseline serum BD-2 levels were significantly associated with the American College of Rheumatology (ACR) response to secukinumab (Spearman’s rho, 27%; P = 3.8e-5) but not to placebo at week 16, with the trend being consistent for ≥1 year. The addition of BD-2 to the clinical model improved the prediction of the 16-week ACR 20% improvement response to secukinumab by increasing the area under the receiver operating characteristic curve by 11 percentage points.
Study details: This retrospective analysis of the phase 3 FUTURE 1-5 trials included 1,989 patients with PsA who received secukinumab or placebo.
Disclosures: This study did not receive any funding. Seven authors declared being employees of or holding shares or stock options in Novartis AG, and M Cardner declared being an employee of AstraZeneca AB. Two authors reported ties unrelated to this study.
Source: Cardner M et al. Analysis of serum proteomics data identifies a quantitative association between beta-defensin 2 at baseline and clinical response to IL-17 blockade in psoriatic arthritis. RMD Open. 2023;9(2):e003042 (Jun 15). Doi: 10.1136/rmdopen-2023-003042.
Commentary: Evaluating new and established treatments for PsA, July 2023
Research papers published this month have focused on the therapeutics of psoriatic arthritis (PsA). Despite the availability of a number of targeted therapies, a significant proportion of patients have persistent disease activity and poor quality of life. Novel therapies are needed to address this unmet need. Janus kinase (JAK) inhibitors are now proven to be efficacious in the treatment of PsA. Brepocitinib is a novel inhibitor of both tyrosine kinase 2 (TYK2) and JAK1. Mease and colleagues reported results from a phase 2b, dose-ranging, parallel treatment group trial including 218 patients with active PsA who were randomly assigned to receive either brepocitinib (60, 30, or 10 mg once daily) or placebo. At week 16, American College of Rheumatology (ACR) 20 response was achieved by a significantly higher proportion of patients receiving brepocitinib at doses of 30 mg (66.7%; P = .0197) and 60 mg (74.6%; P = .0006) compared with placebo (43.3%), with the response being maintained through week 52. Overall, 12 serious adverse events were reported in the brepocitinib arm (30 mg and 60 mg) by week 52. No major adverse cardiovascular events or deaths were reported. Thus, brepocitinib (30 mg and 60 mg) shows promise and should be further evaluated in phase 3 trials. Head-to-head comparison with a JAK1 inhibitor (eg, upadacitinib) or a TYK2 inhibitor (eg, deucravacitinib) would be required to evaluate the safety and efficacy of dual TYK2-JAK1 inhibition compared with either one of the JAK inhibitors alone.
Despite using methotrexate (MTX) in the management of psoriasis and PsA for more than 50 years, there is paucity of data on its effectiveness in PsA. It is also largely assumed that MTX is more effective for rheumatoid arthritis (RA) than for PsA. To evaluate MTX effectiveness vis-à-vis RA, Lindström and colleagues conducted an observational study with disease-modifying antirheumatic drug (DMARD)–naive patients with newly diagnosed PsA (n = 3642) who initiated MTX and matched comparator patients with RA (n = 3642) from national Swedish registers. At 6 months, although both groups of patients had improvement in pain, global health, and remission, the rates were higher in RA compared with PsA. Overall, 71% of patients with PsA and 76% of patients with RA were still taking MTX 2 years after initiating MTX. The time to starting another DMARD was shorter in RA compared with PsA. Thus, in early PsA, MTX treatment seems to provide significant benefits. However, the improvements are less impressive than they are for RA.
Biologic agents are generally safe and effective in the treatment of PsA. However, there are limited data on the safety and effectiveness in older and younger populations with PsA. Gossec and colleagues conducted a post hoc analysis of the PsABio trial that included patients with PsA who received ustekinumab, an interleukin 12/23 inhibitor, and were subgrouped into those < 60 years (n = 336) and ≥ 60 years (n = 103). At 6 months, a numerically higher proportion of patients < 60 years achieved clinical Disease Activity Index for Psoriatic Arthritis low disease activity compared with those ≥ 60 years. The proportions of patients reporting at least one (32.7% vs 40.9%) or serious (5.3% vs 9.6%) adverse events were numerically higher in the older population. However, treatment persistence was numerically higher in the older subgroup. These differences were not clinically meaningful; thus, ustekinumab may be safely used in older populations.
There are also limited data on the effectiveness of biologics in patients with juvenile PsA (jPsA). To address this, Correll and colleagues evaluated the safety and effectiveness of etanercept, an anti–tumor necrosis factor agent, in patients with jPsA using data from the Childhood Arthritis and Rheumatology Research Alliance Registry. In 226 patients, the overall incidence of adverse events of special interest and serious adverse events were low and included three cases of uveitis (incidence rate [IR]/100 person-years 0.55; 95% CI 0.18-1.69), one of neuropathy (IR/100 person-years 0.18; 95% CI 0.03-1.29), and one of cancer (IR/100 person-years 0.13; 95% CI 0.02-0.90). The ACR provisional criteria for inactive disease were achieved by 51.9% and 43.8% of patients at 6 and 12 months. Thus, etanercept is safe and effective in jPsA.
Research papers published this month have focused on the therapeutics of psoriatic arthritis (PsA). Despite the availability of a number of targeted therapies, a significant proportion of patients have persistent disease activity and poor quality of life. Novel therapies are needed to address this unmet need. Janus kinase (JAK) inhibitors are now proven to be efficacious in the treatment of PsA. Brepocitinib is a novel inhibitor of both tyrosine kinase 2 (TYK2) and JAK1. Mease and colleagues reported results from a phase 2b, dose-ranging, parallel treatment group trial including 218 patients with active PsA who were randomly assigned to receive either brepocitinib (60, 30, or 10 mg once daily) or placebo. At week 16, American College of Rheumatology (ACR) 20 response was achieved by a significantly higher proportion of patients receiving brepocitinib at doses of 30 mg (66.7%; P = .0197) and 60 mg (74.6%; P = .0006) compared with placebo (43.3%), with the response being maintained through week 52. Overall, 12 serious adverse events were reported in the brepocitinib arm (30 mg and 60 mg) by week 52. No major adverse cardiovascular events or deaths were reported. Thus, brepocitinib (30 mg and 60 mg) shows promise and should be further evaluated in phase 3 trials. Head-to-head comparison with a JAK1 inhibitor (eg, upadacitinib) or a TYK2 inhibitor (eg, deucravacitinib) would be required to evaluate the safety and efficacy of dual TYK2-JAK1 inhibition compared with either one of the JAK inhibitors alone.
Despite using methotrexate (MTX) in the management of psoriasis and PsA for more than 50 years, there is paucity of data on its effectiveness in PsA. It is also largely assumed that MTX is more effective for rheumatoid arthritis (RA) than for PsA. To evaluate MTX effectiveness vis-à-vis RA, Lindström and colleagues conducted an observational study with disease-modifying antirheumatic drug (DMARD)–naive patients with newly diagnosed PsA (n = 3642) who initiated MTX and matched comparator patients with RA (n = 3642) from national Swedish registers. At 6 months, although both groups of patients had improvement in pain, global health, and remission, the rates were higher in RA compared with PsA. Overall, 71% of patients with PsA and 76% of patients with RA were still taking MTX 2 years after initiating MTX. The time to starting another DMARD was shorter in RA compared with PsA. Thus, in early PsA, MTX treatment seems to provide significant benefits. However, the improvements are less impressive than they are for RA.
Biologic agents are generally safe and effective in the treatment of PsA. However, there are limited data on the safety and effectiveness in older and younger populations with PsA. Gossec and colleagues conducted a post hoc analysis of the PsABio trial that included patients with PsA who received ustekinumab, an interleukin 12/23 inhibitor, and were subgrouped into those < 60 years (n = 336) and ≥ 60 years (n = 103). At 6 months, a numerically higher proportion of patients < 60 years achieved clinical Disease Activity Index for Psoriatic Arthritis low disease activity compared with those ≥ 60 years. The proportions of patients reporting at least one (32.7% vs 40.9%) or serious (5.3% vs 9.6%) adverse events were numerically higher in the older population. However, treatment persistence was numerically higher in the older subgroup. These differences were not clinically meaningful; thus, ustekinumab may be safely used in older populations.
There are also limited data on the effectiveness of biologics in patients with juvenile PsA (jPsA). To address this, Correll and colleagues evaluated the safety and effectiveness of etanercept, an anti–tumor necrosis factor agent, in patients with jPsA using data from the Childhood Arthritis and Rheumatology Research Alliance Registry. In 226 patients, the overall incidence of adverse events of special interest and serious adverse events were low and included three cases of uveitis (incidence rate [IR]/100 person-years 0.55; 95% CI 0.18-1.69), one of neuropathy (IR/100 person-years 0.18; 95% CI 0.03-1.29), and one of cancer (IR/100 person-years 0.13; 95% CI 0.02-0.90). The ACR provisional criteria for inactive disease were achieved by 51.9% and 43.8% of patients at 6 and 12 months. Thus, etanercept is safe and effective in jPsA.
Research papers published this month have focused on the therapeutics of psoriatic arthritis (PsA). Despite the availability of a number of targeted therapies, a significant proportion of patients have persistent disease activity and poor quality of life. Novel therapies are needed to address this unmet need. Janus kinase (JAK) inhibitors are now proven to be efficacious in the treatment of PsA. Brepocitinib is a novel inhibitor of both tyrosine kinase 2 (TYK2) and JAK1. Mease and colleagues reported results from a phase 2b, dose-ranging, parallel treatment group trial including 218 patients with active PsA who were randomly assigned to receive either brepocitinib (60, 30, or 10 mg once daily) or placebo. At week 16, American College of Rheumatology (ACR) 20 response was achieved by a significantly higher proportion of patients receiving brepocitinib at doses of 30 mg (66.7%; P = .0197) and 60 mg (74.6%; P = .0006) compared with placebo (43.3%), with the response being maintained through week 52. Overall, 12 serious adverse events were reported in the brepocitinib arm (30 mg and 60 mg) by week 52. No major adverse cardiovascular events or deaths were reported. Thus, brepocitinib (30 mg and 60 mg) shows promise and should be further evaluated in phase 3 trials. Head-to-head comparison with a JAK1 inhibitor (eg, upadacitinib) or a TYK2 inhibitor (eg, deucravacitinib) would be required to evaluate the safety and efficacy of dual TYK2-JAK1 inhibition compared with either one of the JAK inhibitors alone.
Despite using methotrexate (MTX) in the management of psoriasis and PsA for more than 50 years, there is paucity of data on its effectiveness in PsA. It is also largely assumed that MTX is more effective for rheumatoid arthritis (RA) than for PsA. To evaluate MTX effectiveness vis-à-vis RA, Lindström and colleagues conducted an observational study with disease-modifying antirheumatic drug (DMARD)–naive patients with newly diagnosed PsA (n = 3642) who initiated MTX and matched comparator patients with RA (n = 3642) from national Swedish registers. At 6 months, although both groups of patients had improvement in pain, global health, and remission, the rates were higher in RA compared with PsA. Overall, 71% of patients with PsA and 76% of patients with RA were still taking MTX 2 years after initiating MTX. The time to starting another DMARD was shorter in RA compared with PsA. Thus, in early PsA, MTX treatment seems to provide significant benefits. However, the improvements are less impressive than they are for RA.
Biologic agents are generally safe and effective in the treatment of PsA. However, there are limited data on the safety and effectiveness in older and younger populations with PsA. Gossec and colleagues conducted a post hoc analysis of the PsABio trial that included patients with PsA who received ustekinumab, an interleukin 12/23 inhibitor, and were subgrouped into those < 60 years (n = 336) and ≥ 60 years (n = 103). At 6 months, a numerically higher proportion of patients < 60 years achieved clinical Disease Activity Index for Psoriatic Arthritis low disease activity compared with those ≥ 60 years. The proportions of patients reporting at least one (32.7% vs 40.9%) or serious (5.3% vs 9.6%) adverse events were numerically higher in the older population. However, treatment persistence was numerically higher in the older subgroup. These differences were not clinically meaningful; thus, ustekinumab may be safely used in older populations.
There are also limited data on the effectiveness of biologics in patients with juvenile PsA (jPsA). To address this, Correll and colleagues evaluated the safety and effectiveness of etanercept, an anti–tumor necrosis factor agent, in patients with jPsA using data from the Childhood Arthritis and Rheumatology Research Alliance Registry. In 226 patients, the overall incidence of adverse events of special interest and serious adverse events were low and included three cases of uveitis (incidence rate [IR]/100 person-years 0.55; 95% CI 0.18-1.69), one of neuropathy (IR/100 person-years 0.18; 95% CI 0.03-1.29), and one of cancer (IR/100 person-years 0.13; 95% CI 0.02-0.90). The ACR provisional criteria for inactive disease were achieved by 51.9% and 43.8% of patients at 6 and 12 months. Thus, etanercept is safe and effective in jPsA.
High physical activity reduces visceral fat mass and percentage body fat in PsA
Key clinical point: The visceral fat mass and percentage body fat were significantly higher in patients with psoriatic arthritis (PsA) compared with control individuals, and moderate-to-high physical activity was associated with reduced visceral fat mass and percentage body fat.
Major finding: PsA was associated with a mean increase in visceral fat mass of 2.0 kg (95% CI 1.2-2.8 kg) and in percentage body fat of 2.7% (95% CI 1.6%-3.8%). Moderate and high vs low physical activity were associated with lower visceral fat mass and percentage body fat in patients with PsA and control individuals (P < .001).
Study details: The data come from a retrospective study including 356 patients with PsA and 47,470 control individuals.
Disclosures: This study was funded by the Faculty of Medicine and Health Sciences at Norwegian University of Science and Technology. M Hoff declared receiving speaker honoraria from AbbVie and Janssen Pharmaceuticals. No other conflicts of interest were declared.
Source: Osman AA et al. High physical activity in persons with psoriatic arthritis is associated with reduced visceral fat mass and percentage body fat: The Trøndelag Health study. Rheumatol Int. 2023 (Jun 5). doi: 10.1007/s00296-023-05348-9
Key clinical point: The visceral fat mass and percentage body fat were significantly higher in patients with psoriatic arthritis (PsA) compared with control individuals, and moderate-to-high physical activity was associated with reduced visceral fat mass and percentage body fat.
Major finding: PsA was associated with a mean increase in visceral fat mass of 2.0 kg (95% CI 1.2-2.8 kg) and in percentage body fat of 2.7% (95% CI 1.6%-3.8%). Moderate and high vs low physical activity were associated with lower visceral fat mass and percentage body fat in patients with PsA and control individuals (P < .001).
Study details: The data come from a retrospective study including 356 patients with PsA and 47,470 control individuals.
Disclosures: This study was funded by the Faculty of Medicine and Health Sciences at Norwegian University of Science and Technology. M Hoff declared receiving speaker honoraria from AbbVie and Janssen Pharmaceuticals. No other conflicts of interest were declared.
Source: Osman AA et al. High physical activity in persons with psoriatic arthritis is associated with reduced visceral fat mass and percentage body fat: The Trøndelag Health study. Rheumatol Int. 2023 (Jun 5). doi: 10.1007/s00296-023-05348-9
Key clinical point: The visceral fat mass and percentage body fat were significantly higher in patients with psoriatic arthritis (PsA) compared with control individuals, and moderate-to-high physical activity was associated with reduced visceral fat mass and percentage body fat.
Major finding: PsA was associated with a mean increase in visceral fat mass of 2.0 kg (95% CI 1.2-2.8 kg) and in percentage body fat of 2.7% (95% CI 1.6%-3.8%). Moderate and high vs low physical activity were associated with lower visceral fat mass and percentage body fat in patients with PsA and control individuals (P < .001).
Study details: The data come from a retrospective study including 356 patients with PsA and 47,470 control individuals.
Disclosures: This study was funded by the Faculty of Medicine and Health Sciences at Norwegian University of Science and Technology. M Hoff declared receiving speaker honoraria from AbbVie and Janssen Pharmaceuticals. No other conflicts of interest were declared.
Source: Osman AA et al. High physical activity in persons with psoriatic arthritis is associated with reduced visceral fat mass and percentage body fat: The Trøndelag Health study. Rheumatol Int. 2023 (Jun 5). doi: 10.1007/s00296-023-05348-9
Higher disease burden among women with PsA vs RA
Key clinical point: Patients with psoriatic arthritis (PsA), particularly women, have higher disease burden from the patient’s perspective than those with rheumatoid arthritis (RA).
Major finding: The mean Visual Analogue Scale scores for pain (34 vs 32; P < .001) and fatigue (35 vs 33; P = .001) were slightly higher in patients with PsA vs RA. Women with PsA vs RA across all age groups had significantly higher scores for pain (<50 years old: 28 vs 18; >70 years old: 48 vs 38) and fatigue (50-59 years old: 41 vs 31; >70 years old: 46 vs 36; all P < .05).
Study details: Findings are from a cross-sectional analysis including patients with PsA (n = 3598) and RA (n = 13,913).
Disclosures: This study was funded by State Research Funding, Kuopio University Hospital Catchment Area, Kuopio, Finland. The authors declared no conflicts of interest.
Source: Weman L et al. Disease burden measured by patient-reported outcomes: Does psoriatic arthritis feel worse than rheumatoid arthritis? A cross-sectional nationwide study. Clin Exp Rheumatol. 2023 (May 15). doi: 10.55563/clinexprheumatol/h9hn90
Key clinical point: Patients with psoriatic arthritis (PsA), particularly women, have higher disease burden from the patient’s perspective than those with rheumatoid arthritis (RA).
Major finding: The mean Visual Analogue Scale scores for pain (34 vs 32; P < .001) and fatigue (35 vs 33; P = .001) were slightly higher in patients with PsA vs RA. Women with PsA vs RA across all age groups had significantly higher scores for pain (<50 years old: 28 vs 18; >70 years old: 48 vs 38) and fatigue (50-59 years old: 41 vs 31; >70 years old: 46 vs 36; all P < .05).
Study details: Findings are from a cross-sectional analysis including patients with PsA (n = 3598) and RA (n = 13,913).
Disclosures: This study was funded by State Research Funding, Kuopio University Hospital Catchment Area, Kuopio, Finland. The authors declared no conflicts of interest.
Source: Weman L et al. Disease burden measured by patient-reported outcomes: Does psoriatic arthritis feel worse than rheumatoid arthritis? A cross-sectional nationwide study. Clin Exp Rheumatol. 2023 (May 15). doi: 10.55563/clinexprheumatol/h9hn90
Key clinical point: Patients with psoriatic arthritis (PsA), particularly women, have higher disease burden from the patient’s perspective than those with rheumatoid arthritis (RA).
Major finding: The mean Visual Analogue Scale scores for pain (34 vs 32; P < .001) and fatigue (35 vs 33; P = .001) were slightly higher in patients with PsA vs RA. Women with PsA vs RA across all age groups had significantly higher scores for pain (<50 years old: 28 vs 18; >70 years old: 48 vs 38) and fatigue (50-59 years old: 41 vs 31; >70 years old: 46 vs 36; all P < .05).
Study details: Findings are from a cross-sectional analysis including patients with PsA (n = 3598) and RA (n = 13,913).
Disclosures: This study was funded by State Research Funding, Kuopio University Hospital Catchment Area, Kuopio, Finland. The authors declared no conflicts of interest.
Source: Weman L et al. Disease burden measured by patient-reported outcomes: Does psoriatic arthritis feel worse than rheumatoid arthritis? A cross-sectional nationwide study. Clin Exp Rheumatol. 2023 (May 15). doi: 10.55563/clinexprheumatol/h9hn90
Patients with PsA, especially women, likely to have abnormal sleep behavior
Key clinical point: Many patients with psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA) have impaired sleep despite treatment, with female patients having worse sleep quality than male patients.
Major finding: Overall, 46.6% of patients in the entire cohort had abnormal sleep behavior, with sleep quality being worse in women vs men (P < .001). Depressive symptoms (P < .001), female sex (P = .014), and Disease Activity Score in 28 joints (P = .003) predicted insomnia in PsA.
Study details: The data come from a retrospective medical chart analysis of 330 patients with spondyloarthritis, including 168 patients with PsA and 162 patients with axSpA.
Disclosures: This study was partly funded by an unrestricted grant from Novartis Pharma GmbH, Germany. Several authors, including the lead author, reported receiving speaker honoraria or research or travel grants or serving on advisory boards for several sources, including Novartis.
Source: Frede N et al. Sleep behaviour differs in women and men with psoriatic arthritis and axial spondyloarthritis with impact on quality of life and depressive symptoms. RMD Open. 2023;9:e002912 (May 19). doi: 10.1136/rmdopen-2022-002912
Key clinical point: Many patients with psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA) have impaired sleep despite treatment, with female patients having worse sleep quality than male patients.
Major finding: Overall, 46.6% of patients in the entire cohort had abnormal sleep behavior, with sleep quality being worse in women vs men (P < .001). Depressive symptoms (P < .001), female sex (P = .014), and Disease Activity Score in 28 joints (P = .003) predicted insomnia in PsA.
Study details: The data come from a retrospective medical chart analysis of 330 patients with spondyloarthritis, including 168 patients with PsA and 162 patients with axSpA.
Disclosures: This study was partly funded by an unrestricted grant from Novartis Pharma GmbH, Germany. Several authors, including the lead author, reported receiving speaker honoraria or research or travel grants or serving on advisory boards for several sources, including Novartis.
Source: Frede N et al. Sleep behaviour differs in women and men with psoriatic arthritis and axial spondyloarthritis with impact on quality of life and depressive symptoms. RMD Open. 2023;9:e002912 (May 19). doi: 10.1136/rmdopen-2022-002912
Key clinical point: Many patients with psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA) have impaired sleep despite treatment, with female patients having worse sleep quality than male patients.
Major finding: Overall, 46.6% of patients in the entire cohort had abnormal sleep behavior, with sleep quality being worse in women vs men (P < .001). Depressive symptoms (P < .001), female sex (P = .014), and Disease Activity Score in 28 joints (P = .003) predicted insomnia in PsA.
Study details: The data come from a retrospective medical chart analysis of 330 patients with spondyloarthritis, including 168 patients with PsA and 162 patients with axSpA.
Disclosures: This study was partly funded by an unrestricted grant from Novartis Pharma GmbH, Germany. Several authors, including the lead author, reported receiving speaker honoraria or research or travel grants or serving on advisory boards for several sources, including Novartis.
Source: Frede N et al. Sleep behaviour differs in women and men with psoriatic arthritis and axial spondyloarthritis with impact on quality of life and depressive symptoms. RMD Open. 2023;9:e002912 (May 19). doi: 10.1136/rmdopen-2022-002912
Serum interleukin-36 alpha: A potential biomarker to differentiate PsA from Behçet’s syndrome
Key clinical point: Patients with psoriatic arthritis (PsA) and those with Behçet’s syndrome (BS) had significantly elevated levels of serum interleukin-36 alpha (IL-36α), although the extent was lesser in BS, highlighting the potential role of the serum IL-36α level in differential diagnosis between PsA and BS.
Major finding: The median serum IL-36α level in patients with BS (201.7 pg/mL) was significantly higher than that in control individuals (16.9 pg/mL; P < .001) but lower than that in patients with PsA (544 pg/mL; P < .001). An empirical cut-off level of 420.6 pg/mL for IL-36α showed a specificity of 0.93 and sensitivity of 0.70 to distinguish patients with PsA from those with BS.
Study details: The data come from a cross-sectional study including patients with PsA (n = 80) and BS (n = 90) and control individuals without immune-mediated inflammatory disease (n = 80) who were assessed for serum IL-36α levels.
Disclosures: This study did not receive any external funding. The authors declared no conflicts of interest.
Source: Bettiol A et al. Serum interleukin-36 α as a candidate biomarker to distinguish Behçet’s syndrome and psoriatic arthritis. Int J Mol Sci. 2023;24:8817 (May 16). doi: 10.3390/ijms24108817
Key clinical point: Patients with psoriatic arthritis (PsA) and those with Behçet’s syndrome (BS) had significantly elevated levels of serum interleukin-36 alpha (IL-36α), although the extent was lesser in BS, highlighting the potential role of the serum IL-36α level in differential diagnosis between PsA and BS.
Major finding: The median serum IL-36α level in patients with BS (201.7 pg/mL) was significantly higher than that in control individuals (16.9 pg/mL; P < .001) but lower than that in patients with PsA (544 pg/mL; P < .001). An empirical cut-off level of 420.6 pg/mL for IL-36α showed a specificity of 0.93 and sensitivity of 0.70 to distinguish patients with PsA from those with BS.
Study details: The data come from a cross-sectional study including patients with PsA (n = 80) and BS (n = 90) and control individuals without immune-mediated inflammatory disease (n = 80) who were assessed for serum IL-36α levels.
Disclosures: This study did not receive any external funding. The authors declared no conflicts of interest.
Source: Bettiol A et al. Serum interleukin-36 α as a candidate biomarker to distinguish Behçet’s syndrome and psoriatic arthritis. Int J Mol Sci. 2023;24:8817 (May 16). doi: 10.3390/ijms24108817
Key clinical point: Patients with psoriatic arthritis (PsA) and those with Behçet’s syndrome (BS) had significantly elevated levels of serum interleukin-36 alpha (IL-36α), although the extent was lesser in BS, highlighting the potential role of the serum IL-36α level in differential diagnosis between PsA and BS.
Major finding: The median serum IL-36α level in patients with BS (201.7 pg/mL) was significantly higher than that in control individuals (16.9 pg/mL; P < .001) but lower than that in patients with PsA (544 pg/mL; P < .001). An empirical cut-off level of 420.6 pg/mL for IL-36α showed a specificity of 0.93 and sensitivity of 0.70 to distinguish patients with PsA from those with BS.
Study details: The data come from a cross-sectional study including patients with PsA (n = 80) and BS (n = 90) and control individuals without immune-mediated inflammatory disease (n = 80) who were assessed for serum IL-36α levels.
Disclosures: This study did not receive any external funding. The authors declared no conflicts of interest.
Source: Bettiol A et al. Serum interleukin-36 α as a candidate biomarker to distinguish Behçet’s syndrome and psoriatic arthritis. Int J Mol Sci. 2023;24:8817 (May 16). doi: 10.3390/ijms24108817