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Objective: Investigate effects of gender on disease characteristics and treatment impact in patients with PsA., Methods: PsABio is a non-interventional European study in patients with PsA starting a biological DMARD [bDMARD; ustekinumab or TNF inhibitor (TNFi)]. This post-hoc analysis compared persistence, disease activity, patient-reported outcomes and safety between male and female patients at baseline and 6 and 12 months of treatment., Results: At baseline, disease duration was 6.7 and 6.9 years for 512 females and 417 males respectively. Mean (95% CI) scores for females vs males were: clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA), 32.3 (30.3, 34.2) vs 26.8 (24.8, 28.9); HAQ-Disability Index (HAQ-DI), 1.3 (1.2, 1.4) vs 0.93 (0.86, 0.99); total PsA Impact of Disease-12 (PsAID-12) score, 6.0 (5.8, 6.2) vs 5.1 (4.9, 5.3), respectively. Improvements in scores were smaller in female than male patients. At 12 months, 175/303 (57.8%) female and 212/264 (80.3%) male patients achieved cDAPSA low disease activity, 96/285 (33.7%) and 137/247 (55.5%), achieved minimal disease activity (MDA), respectively. HAQ-DI scores were 0.85 (0.77, 0.92) vs 0.50 (0.43, 0.56), PsAID-12 scores 3.5 (3.3, 3.8) vs 2.4 (2.2, 2.6), respectively. Treatment persistence was lower in females than males (P ≤ 0.001). Lack of effectiveness was the predominant reason to stop, irrespective of gender and bDMARD., Conclusions: Before starting bDMARDs, females had more severe disease than males and a lower percentage reached favourable disease states, with lower persistence of treatment after 12 months. A better understanding of the mechanisms underlying these differences may improve therapeutic management in females with PsA., Trial Registration: ClinicalTrials.gov, https://clinicaltrials.gov, NCT02627768., (© The Author(s) 2023. Published by Oxford University Press on behalf of the British Society for Rheumatology.)

Background: To evaluate the real-world effect of the IL-12/23 inhibitor ustekinumab or of a tumour necrosis factor inhibitor (TNFi) on patient-reported outcomes (PRO) and their association with effectiveness endpoints in psoriatic arthritis (PsA) patients over 3 years., Methods: In PsABio (NCT02627768), a prospective, observational study, patients with PsA that were prescribed first- to third-line ustekinumab or a TNFi, and remained on that drug for 3 years, were analysed for change in baseline in PROs (EuroQol-5 dimensions health state VAS [EQ-5D VAS], 12-item Psoriatic Arthritis Impact of Disease questionnaire [PsAID-12; range 0-10], Work Productivity and Activity Impairment for Psoriatic Arthritis questionnaire [WPAI; results expressed as a percentage for each domain]), and the association between PROs and WPAI with effectiveness endpoints, clinical disease activity index for psoriatic arthritis (cDAPSA), low disease activity (LDA)/remission, minimal disease activity (MDA) and very low disease activity (VLDA)., Results: In 437 patients (mean age 49.1 years, 47.8% female), at 3 years, ustekinumab and TNFi treatment led to comparable improvements in EQ-5D VAS; mean change from baseline (95% confidence intervals [CI]) was 11.0 (6.5; 15.4) and 18.9 (14.0; 23.9), respectively. Both groups improved PsAID-12 after 3 years; mean change from baseline (95% CI) was -2.9 (-3.2; -2.5) and -3.5 (-3.9; -3.2), respectively. At baseline, due to their PsA, TNFi-treated patients had lower work productivity compared to ustekinumab-treated patients; mean productivity reduction (95% CI) was 58.8 [52.4; 65.2] and 43.3 [35.6; 51.1]. Over 3 years, TNFi-treated patients had a greater improvement in work productivity compared to ustekinumab-treated patients, ultimately leaving work productivity to be comparable between groups; mean improvement (95% CI) was 44.5% (38.4; 50.6) and 24.9% (15.8; 34.0), respectively. A similar trend was observed in activity impairment. Patients in both treatment groups who achieved effectiveness endpoints, cDAPSA LDA/remission, MDA, and VLDA had greater improvement in PROs and WPAI than patients who did not achieve these endpoints., Conclusions: At 3 years, improvements in PROs following ustekinumab or TNFi treatment were generally comparable; however, TNFi-treated patients achieved a greater improvement in work productivity, although this group started from a lower baseline. Achievement of effectiveness endpoints, independent of treatment group, also improved PROs., Trial Registration: ClinicalTrials.gov, NCT02627768. Registered on 11 December 2015., (© 2023. The Author(s).)

Objectives: To evaluate real-world persistence and effectiveness of the IL-12/23 inhibitor, ustekinumab or a tumour necrosis factor inhibitor (TNFi) for psoriatic arthritis over 3 years., Methods: PsABio (NCT02627768), a prospective, observational study, followed patients with PsA prescribed first-line to third-line ustekinumab or a TNFi. Persistence and effectiveness (achievement of clinical Disease Activity for PSA (cDAPSA) low disease activity (LDA)/remission and minimal disease activity/very LDA (MDA/VLDA)) were assessed every 6 months. Safety data were collected over 3 years. Analyses to compare the modes of action were adjusted on baseline differences by propensity scores (PS)., Results: In 895 patients (mean age 49.8 years, 44.7% males), at 3 years, the proportion of patients still on their initial treatments was similar with ustekinumab (49.9%) and TNFi (47.8%). No difference was seen in the risk of stopping/switching; PS-adjusted hazard ratio (95% CI) for stopping/switching ustekinumab versus TNFi was 0.87 (0.68 to 1.11). In the overall population, cDAPSA LDA/remission was achieved in 58.6%/31.4% ustekinumab-treated and 69.8%/45.0% TNFi-treated patients; PS-adjusted ORs (95% CI) were 0.89 (0.63 to 1.26) for cDAPSA LDA; 0.72 (0.50 to 1.05) for remission. MDA/VLDA was achieved in 41.4%/19.2% of ustekinumab-treated and 54.2%/26.9% of TNFi-treated patients with overlapping PS-adjusted ORs. A greater percentage of TNFi-treated patients achieved effectiveness outcomes. Both treatments exhibited good long-term safety profiles, although ustekinumab-treated patients had a lower rate of adverse events (AEs) versus TNFi., Conclusion: At 3 years, there was generally comparable persistence after ustekinumab or TNFi treatment, but AE rates were lower with ustekinumab., Competing Interests: Competing interests: LG reports personal fees from Janssen during the conduct of the study, grants from Amgen, Galapagos, Lilly, Pfizer, Sandoz, UCB, personal fees from AbbVie, Amgen, BMS, Celltrion, Galapagos, Gilead, GSK, Janssen, Lilly, Novartis, Pfizer, UCB outside the submitted work. SS reports non-financial support from Janssen during the conduct of the study, personal fees from AbbVie, grants and personal fees from Amgen (previously Celgene), personal fees from Biogen, grants from Boehringer-Ingelheim, grants from Bristol-Myers-Squibb, personal fees from GlaxoSmithKline, grants and personal fees from Janssen, personal fees from Novartis, grants and personal fees from UCB outside the submitted work. PB reports personal fees from Janssen and personal fees from Johnson & Johnson during the conduct of the study. KdV reports personal and consulting fees from Janssen. EG reports payment or honoraria from AbbVie, AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Galapagos, GSK, Janssen, Novartis, Pfizer and Sanofi. BJ-I reports consulting fees from Amgen, Janssen and UCB and payment or honoraria from AbbVie, Eli Lilly, Janssen, Novartis and UCB. TVK reports consulting fees from AbbVie, Amgen, BIOCAD, Eli Lilly, Janssen, MCD, Novartis, Pfizer, Sandoz and UCB, and payment or honoraria from AbbVie, Amgen, BIOCAD, Eli Lilly, Janssen, MCD, Novartis, Pfizer, Sandoz and UCB. FL reports non-financial support from Janssen during the conduct of the study. WM is a full-time employee of and owns stock at Johnson & Johnson. MTN reports grants and non-financial support from Janssen during the conduct of the study, grants and personal fees from AbbVie, grants from BMS, grants and personal fees from Eli Lilly, grants from Amgen, grants from Pfizer, and grants from Galapagos outside the submitted work. PPS reports non-financial support from Janssen during the conduct of the study, grants and personal fees from AbbVie, grants from UCB, grants and personal fees from Eli Lilly, grants and personal fees from Pfizer, grants and personal fees from Novartis, and personal fees from MSD outside the submitted work. MS reports non-financial support from Janssen during the conduct of the study. ET was an employee of Janssen during the conduct of the study and preparation of this paper. JSS has nothing to disclose. LG and MTN are editorial board members at the Annals of the Rheumatic Diseases., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

The aim was to identify patient- and disease-related characteristics predicting moderate-to-high disease activity in recent-onset psoriatic arthritis (PsA). We performed a multicenter observational prospective study (2-year follow-up, regular annual visits) in patients aged ≥18 years who fulfilled the CASPAR criteria and had less than 2 years since the onset of symptoms. The moderate-to-high activity of PsA was defined as DAPSA > 14. We trained a logistic regression model and random forest-type and XGBoost machine learning algorithms to analyze the association between the outcome measure and the variables selected in the bivariate analysis. The sample comprised 158 patients. At the first follow-up visit, 20.8% of the patients who attended the clinic had a moderate-to-severe disease. This percentage rose to 21.2% on the second visit. The variables predicting moderate-high activity were the PsAID score, tender joint count, level of physical activity, and sex. The mean values of the measures of validity of the machine learning algorithms were all high, especially sensitivity (98%; 95% CI: 86.89-100.00). PsAID was the most important variable in the prediction algorithms, reinforcing the convenience of its inclusion in daily clinical practice. Strategies that focus on the needs of women with PsA should be considered.

Objectives: To evaluate the effect of potential confounders on the association between sex and disease impact in recent-onset psoriatic arthritis., Methods: We performed a multicentre observational prospective study (2-year follow-up, regular annual visits). The study population comprised patients aged ≥18 years who fulfilled the CASPAR criteria and less than 2 years since the onset of symptoms. The dataset was generated using data for each patient at the 3 visits (baseline, first year, and second year of follow-up) matched with the PsAID values at each of the 3 visits. Once variables associated with both PsAID ≥4 and sex were selected, those that led to a difference of >10% between the adjusted and crude estimations were identified as potential confounders in the association between sex and PsAID. Lastly, the final multivariate logistic regression model estimating the association between sex and PsAID was defined., Results: The dataset contained 418 observations (158 at baseline, 135 at the first follow-up visit, and 125 at the second visit). The confounders identified in the multivariate model were HAQ, global pain, level of physical activity, and joint pattern at diagnosis. After adjustment for these variables, no statistically significant association was observed between female sex and PsAID ≥4., Conclusions: The association between female sex and greater disease impact could be explained by the influence of other variables, specifically higher HAQ score, greater intensity of pain, differences in the level of physical activity and in the joint pattern at diagnosis (lower frequency of the spondylitis pattern in women).

Objective: We evaluated real-world treatment persistence and effectiveness at 1 year following initiation of IL-12/23 inhibitor ustekinumab or a tumour necrosis factor inhibitor (TNFi) for psoriatic arthritis (PsA)., Methods: PsABio (NCT02627768), a prospective, observational study, followed patients with PsA prescribed first-line to third-line ustekinumab or TNFi. Drug persistence, effectiveness (achievement of clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA) low disease activity (LDA)/remission and minimal disease activity/very low disease activity (MDA/VLDA)), and safety were assessed every 6 months. In addition to descriptive statistics, propensity score (PS)-adjusted comparisons across cohorts were performed., Results: At 1 year, overall persistence was similar in the ustekinumab (n=317/438, 72.4%) and TNFi (n=321/455, 70.5%) groups. PS-adjusted HR (95% CI) for stopping/switching ustekinumab versus TNFi was 0.82 (0.60; 1.13). cDAPSA LDA (including remission)/remission was achieved in 55.9%/22.1% of ustekinumab-treated and 67.1%/31.7% of TNFi-treated patients; PS-adjusted ORs (95% CI) were 0.80 (0.57; 1.10) for cDAPSA LDA and 0.73 (0.49; 1.07) for remission. MDA/VLDA was achieved in 34.2%/11.9% of ustekinumab-treated and 43.1%/12.6% of TNFi-treated patients; PS-adjusted ORs (95% CI) were 0.89 (0.63; 1.26) for MDA and 0.90 (0.54; 1.49) for VLDA. The safety profiles were similar in both groups., Conclusion: In the real-world PsABio Study, after 1 year of treatment, although unadjusted persistence was numerically slightly higher for ustekinumab versus TNFi and unadjusted effectiveness was numerically slightly higher for TNFi versus ustekinumab, the PS-adjusted comparisons demonstrated comparable overall persistence, effectiveness and safety for both modes of action in PsA., Competing Interests: Competing interests: LG reports research grants from: Amgen, Galapagos, Lilly, Pfizer, Sandoz, Sanofi; consulting fees from: AbbVie, Amgen, Bristol-Myers Squibb, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, Samsung Bioepis, Sanofi-Aventis, UCB. SS reports non-financial support from Janssen during the conduct of the study; grants from: Boehringer-Ingelheim, Bristol-Myers Squibb; personal fees from: AbbVie, Biogen, Novartis; grants and personal fees from: Amgen (previously Celgene), GlaxoSmithKline, Janssen, UCB; all outside the submitted work. PB is a full-time employee of Janssen and owns stock at Johnson & Johnson. KdV reports personal fees from Janssen. EG reports payment or honoraria from AbbVie, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Janssen, Novartis, Pfizer, Sanofi. BJI has nothing to disclose. TVK reports consulting fees from MCD, Pfizer, Janssen, BiOCAD, AbbVie, Novartis, Sandoz, Lilly. FL reports non-financial support, full-time employment and restricted share units from Janssen during the conduct of the study. WN is a full-time employee of and owns stock at Johnson & Johnson. MTN reports grants and non-financial support from Janssen during the conduct of the study; grants from: Bristol-Myers Squibb, Amgen, Pfizer; grants and personal fees from: AbbVie, Eli Lilly; all outside the submitted work. PPS reports non-financial support from Janssen during the conduct of the study; grants from: UCB; personal fees from: Merck Sharpe & Dohme; grants and personal fees from: AbbVie, Lilly, Pfizer, Novartis; all outside the submitted work. ET is a full-time employee of Janssen. JSS reports grants to his institution from: AbbVie, Astro, AstraZeneca, Janssen, Lilly, Merck Sharpe & Dohme, Pfizer, and Roche; providing expert advice for or had symposia speaking engagements with: AbbVie, Amgen, AstraZeneca, Astro, Bristol-Myers Squibb, Celgene, Celltrion, Chugai, Gilead, ILTOO Pharma, Janssen, Lilly, Merck Sharp & Dohme, Novartis-Sandoz, Pfizer, R-Pharm, Roche, Samsung, Sanofi, and UCB., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: To identify patient- and disease-related characteristics that make it possible to predict higher disease severity in recent-onset PsA., Methods: We performed a multicenter observational prospective study (2-year follow-up, regular annual visits). The study population comprised patients aged ≥ 18 years who fulfilled the CASPAR criteria and less than 2 years since the onset of symptoms. Severe disease was defined at each visit as fulfillment of at least 1 of the following criteria: need for systemic treatment, Health Assessment Questionnaire (HAQ) > 0.5, polyarthritis. The dataset contained data for the independent variables from the baseline visit and follow-up visit number 1. These were matched with the outcome measures from follow-up visits 1 and 2, respectively. We trained a logistic regression model and random forest-type and XGBoost machine learning algorithms to analyze the association between the outcome measure and the variables selected in the bivariate analysis., Results: The sample comprised 158 patients. At the first follow-up visit, 78.2% of the patients who attended the clinic had severe disease. This percentage decreased to 76.4% at the second visit. The variables predicting severe disease were patient global pain, treatment with synthetic DMARDs, clinical form at diagnosis, high CRP, arterial hypertension, and psoriasis affecting the gluteal cleft and/or perianal area. The mean values of the measures of validity of the machine learning algorithms were all ≥ 80%., Conclusion: Our prediction model of severe disease advocates rigorous control of pain and inflammation, also addressing cardiometabolic comorbidities, in addition to actively searching for hidden psoriasis., Competing Interests: DS-M received honoraria from Galapagos for an educational event. AL received payment or honoraria for speakers’ bureaus and educational events, support for attending meetings, and participation on Advisory Boards from Novartis, Pfizer, Amgen, Janssen, and Lilly. EG received payment for presentations, support for attending meetings, and participation on Advisory Boards from Novartis, Pfizer, Amgen, Janssen, Lilly, AbbVie, MSD, Roche, and UCB. JP received payment for presentations, support for attending meetings, and participation on Advisory Boards from Janssen, Novartis, and Lilly. JB received payment for a presentation from Amgen and support for attending meetings from AbbVie and Pfizer. BJ received payment for speaker bureau, support for attending meetings, and participation on Advisory Boards from Novartis, UCB, and Amgen. JR received consulting fees, payment for presentations, support for attending meetings, and participation on Advisory Boards from MSD, Novartis, AbbVie, Pfizer, Janssen, Amgen, UCB, and Lilly. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Queiro, Seoane-Mato, Laiz, Galindez Agirregoikoa, Montilla, Park, Pinto Tasende, Bethencourt Baute, Joven Ibáñez, Toniolo, Ramírez and Pruenza García-Hinojosa.)

Objectives: To evaluate 6-month effectiveness of ustekinumab versus tumour necrosis factor inhibitor (TNFi), analysing predictors of low disease activity (LDA)/remission., Methods: PsABio is a prospective, observational cohort study of patients with psoriatic arthritis (PsA) at 92 sites in eight European countries, who received first-line to third-line ustekinumab or a TNFi. Comparative achievement at 6 months of clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA) LDA/remission, and minimal disease activity (MDA)/very LDA using propensity score (PS)-adjusted multivariate logistic regression was assessed., Results: In the final analysis set of 868 participants with 6-month follow-up data (ustekinumab, n=426; TNFi, n=442), with long-standing disease and a high mean cDAPSA score (31.0 vs 29.8, respectively), proportions of patients in ustekinumab/TNFi treatment groups achieving cDAPSA LDA at 6 months were 45.7%/50.7%. cDAPSA remission was achieved in 14.9%/19.2%, and MDA in 26.4%/30.8% of patients. PS-adjusted odds ratios (OR; 95% confidence interval (CI)) of reaching cDAPSA LDA and MDA were 0.73 (0.46 to 1.15) and 0.87 (0.61 to 1.25) with ustekinumab versus TNFi, indicating no significant difference. High baseline body mass index or high cDAPSA were associated with a lower chance (OR (95% CI)) of reaching cDAPSA LDA with TNFi (0.94 (0.89 to 0.99) and 0.64 (0.52 to 0.79), respectively). Predictive factors were similar to previously published evidence, with cDAPSA and 12-item Psoriatic Arthritis Impact of Disease scores and chronic widespread pain at baseline appearing as new risk factors for unfavourable outcome. Safety data were similar between groups., Conclusion: Treatment targets were reached similarly after 6 months of treatment with ustekinumab and TNFi., Competing Interests: Competing interests: JSS reports grant/research support from: AbbVie, AstraZeneca, Eli Lilly, Roche and Novartis, and personal fees from: AbbVie, Amgen, AstraZeneca, Astro, Bristol-Myers Squibb, Celgene, Celltrion, Chugai, Eli Lilly, Gilead, ILTOO, Janssen, MSD, Novartis, Sandoz, Pfizer, Roche, Samsung, Sanofi and USB. SS reports grant/research support from: AbbVie, Boehringer Ingelheim, Celgene, GSK, Janssen, Novartis, Pfizer and UCB, and personal fees from: AbbVie, BIOCAD, Boehringer Ingelheim, Janssen, Novartis, Pfizer and UCB. TVK reports grant/research support from: Pfizer, and personal fees from: AbbVie, Amgen, BIOCAD, Celgene, Eli Lilly, Janssen, MSD, Novartis, Novartis-Sandoz, Pfizer and UCB. CS reports grant/research support from: AbbVie, Amgen, Janssen and Pfizer, and personal fees from: AbbVie, Alfa-Wassermann, Biogen Celgene, Eli Lilly, Gilead, Janssen, MSD, Novartis, Sanofi-Genzyme and Pfizer. PB reports share ownership in Johnson & Johnson, and is a full-time employee of Janssen. KdV reports grant/research support from: Celgene, and personal fees from: AbbVie, Amgen, Eli Lilly, Galapagos, Johnson & Johnson, Novartis and UCB. EG reports personal fees from: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, MSD, Novartis, Sanofi, UCB, Roche and Pfizer. BJI reports personal fees from: AbbVie, Celgene, Janssen, MSD, Novartis and Pfizer. GK reports personal fees from: AbbVie, Aenorasis, Genesis Pharma, Janssen, MSD, Novartis, Pfizer, Roche and UCB. WN is a full-time employee of Janssen. MTN reports grant/research support from: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Gilead/Galapagos, Janssen, Menarini, MSD, Mundipharma, Pfizer, Roche, Sanofi and UCB, and personal fees from: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Gilead/Galapagos, Janssen, Menarini, MSD, Mundipharma, Pfizer, Roche, Sanofi and UCB. PR reports personal fees from: AbbVie, Celgene, Janssen, MSD, Novartis, Pfizer and UCB. PPS has no conflicts of interest to report. ET is a full-time employee of Janssen. LG reports grant/research support from: Amgen, Galapagos, Janssen, Eli Lilly, Pfizer, Sanofi-Aventis and Sandoz, and personal fees from: AbbVie, Amgen, Biogen, Bristol-Myers Squibb, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, Samsung-Bioepis, Sandoz, Sanofi-Aventis and UCB., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Aims: To describe the methodology of REAPSER (Spanish Registry of Recent-onset Psoriatic Arthritis), its strengths and limitations. The aim of this study is to identify prognostic factors for the clinical and radiographic course in a cohort of patients with psoriatic arthritis (PsA) diagnosed within 2years of symptom evolution., Methods: Multicenter, observational and prospective study (with 2-year follow-up including annual visits). Baseline visit intended to reflect patient situation before the disease course was modified by treatments prescribed in rheumatology departments. Patients were invited to participate consecutively in one of their routine visits to the rheumatologist. 211 patients were included. Following data were collected: sociodemographic variables; employment situation; family history; personal history and comorbidities; anthropometric data; lifestyle; use of healthcare services; clinical situation at the time of PsA diagnosis; joint involvement and spinal pain; pain and overall assessment; enthesitis, dactylitis and uveitis; skin and nail involvement; functional situation and quality of life; radiographic evaluation; analytical determinations; treatment; axial and peripheral flare-ups., Conclusions: The REAPSER study includes a cohort of patients with recent-onset PsA, before the disease course was modified by disease-modifying antirheumatic drugs prescribed in rheumatology departments. Exhaustive information collected in each visit is expected to be an important data source for future analysis., (Copyright © 2018 Elsevier España, S.L.U. and Sociedad Española de Reumatología y Colegio Mexicano de Reumatología. All rights reserved.)