ABS1069 SEX-RELATED DIFFERENCES IN BASELINE PATIENT AND DISEASE CHARACTERISTICS: POST HOC ANALYSES OF THREE PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDIES IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS

Background: Although psoriatic arthritis (PsA) occurs in males and females at similar rates, clinical manifestations and outcomes differ between sexes. Findings from real-world evidence (RWE) studies have found that females tend to have higher disease activity and functional impairment than males despite generally lower rates of radiographic joint damage and milder psoriasis (PsO) symptoms [1-5]. Despite observed sex-specific differences in PsA, few randomized controlled trials (RCTs) report sex-disaggregated results [6]. Objectives: To describe baseline (BL) patient (pt) and disease profiles by sex in a large, pooled cohort of clinical trial participants with active PsA. Methods: Post hoc analyses included PsA pts from 3 Phase 3 RCTs for guselkumab (GUS): 381 pts from DISCOVER-1 (NCT03162796), 739 from DISCOVER-2 (NCT03158285), and 285 from COSMOS (NCT03796858). BL pt characteristics were compared between sexes using a 2-sample t-test for continuous variables and a chi-square test for categorical variables (Table 1). Results: Among 1405 pts with PsA, 48.7% were female. At BL, female pts were older than males (mean: 48.2 vs 46.1 years [y]; p=0.0007), had longer PsA disease duration (6.9 vs 6.0 y; p=0.0086) and a higher body mass index ([BMI]: 29.9 vs 28.8 kg/m 2 ; p=0.0007; Table 1). Females had significantly milder PsO at BL than males (mean Psoriasis Area Severity Index [PASI]: 7.8 vs 11.5; body surface area [BSA]: 13.3 vs 18.8%; Investigator's Global Assessment [IGA]: 2.1 vs 2.5; p<0.0001). No difference was observed in BL composite measures of disease activity (Clinical Disease Activity Index for PsA [cDAPSA] and PsA Disease Activity Score [PASDAS]); however, several individual components showed differences between females and males, including lower BL CRP levels (mean: 1.4 vs 1.9 mg/dL; p<0.0001) and higher tender joint count (TJC: 21.2 vs 19.8; p=0.0467) and Leeds Enthesitis Index (LEI) score (2.9 vs 2.7; p=0.0115). Additionally, enthesitis was more prevalent in females (69.5 vs 61.8%; p=0.0026), while dactylitis was more common in males (45.0 vs 37.0%; p=0.0024). Females also reported significantly worse pt-reported outcomes than males at BL, with higher levels of fatigue (mean Functional Assessment of Chronic Illness Therapy-Fatigue [FACIT-F]: 28.3 vs 31.2; p<0.0001), functional impairment (mean Health Assessment Questionnaire-Disability Index [HAQ-DI]: 1.4 vs 1.1; 36‐item Short Form Health Survey Physical Component Summary [SF-36 PCS]: 32.5 vs 34.2; p<0.0001), and pain (mean: 63.1 vs 60.2; p=0.0044). Conclusion: Sex differences in pts with highly active PsA from 3 Phase 3 trials were consistent with findings from RWE cohorts. Female PsA pts exhibited less severe PsO, higher BMI, longer PsA duration, and reported a greater impact of PsA on quality of life. These findings highlight the importance of considering biological sex and associated clinical features in the management of PsA, including the evaluation of response to treatment [7]. REFERENCES: [1] Gossec, et al. J Rheumatol 2023;50:192-6. [2] Duruöz, et al. Joint Bone Spine 2021;88:105177. [3] Nas, et al. Mod Rheumatol 2017;27:345-9. [4] Eder, et al. Ann Rheum Dis 2013;72:578-82. [5] Kojanova, et al. Dermatol Ther 2021;34:e14849. [6] Eder, et al. Lancet Rheum 2023; 5:e716-27. [7] Eder, et al. ACR 2024; AB1840951. Acknowledgements: NIL . Disclosure of Interests: Laura C. Coates Paid speaker: AbbVie, Amgen, Biogen, Celgene, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Janssen, Medac, Novartis, Pfizer, and UCB, Paid consultant: AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly, Gilead, Galapagos, Janssen, Moonlake, Novartis, Pfizer, and UCB, Grants/research support: AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Novartis, Pfizer and UCB, Carlo Selmi Paid consultant: AbbVie, Alfa-Wassermann, Amgen, Biogen, Eli Lilly, EUSA, Galapagos, Janssen, Novartis, and SOBI, Grant/research support: AbbVie, Amgen, and Pfizer, Philip J. Mease Paid speaker: AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer, and UCB, Paid consultant: AbbVie, Acelyrin, Amgen, Bristol Myers Squibb, Eli Lilly, Immagene, Janssen, Novartis, Pfizer, UCB, and Ventyx, Grants/research support: AbbVie, Acelyrin, Amgen, Bristol Myers Squibb, Eli Lilly, Janssen, Novartis, and UCB, Alexis Ogdie Paid consultant/Advisory Boards: AbbVie, Amgen, Bristol Myers Squibb, Celgene, CorEvitas, Eli Lilly, Gilead, GlaxoSmithKline, Janssen, Novartis, Pfizer, UCB, Grants/research support: AbbVie to Penn, Amgen to Forward/NDB, Novartis to Penn, Pfizer to Penn, Other Funding: National Psoriasis Foundation, NIAMS, Rheumatology Research Foundation, University of Pennsylvania, Francois Nantel Shareholder of Johnson & Johnson, Paid consultant: Janssen, Frederic Lavie Owns stock in Johnson & Johnson, Employee of Immunology Global Medical Affairs, Janssen Pharmaceutical Companies, Mohamed Sharaf Owns stocks in Johnson & Johnson, Employee of EMEA Medical Affairs, Johnson & Johnson Middle East FZ LLC, Dubai, United Arab Emirates, Oyediran Adelakun Owns stock or stock options in Johnson & Johnson, Employee of Janssen Scientific Affairs, LLC, a Johnson & Johnson company, Emmanouil Rampakakis Employee of JSS Medical Research, Paid consultant: Janssen, Laura Pina Vegas Received support for attending meeting from Novartis, Lihi Eder Paid consultant: AbbVie, Eli Lilly, Janssen, Novartis, Pfizer, and UCB, Grants/research support: AbbVie, Eli Lilly, Janssen, Novartis, Pfizer, Sandoz, and UCB. © The Authors 2025. This abstract is an open access article published in Annals of Rheumatic Diseases under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). Neither EULAR nor the publisher make any representation as to the accuracy of the content. The authors are solely responsible for the content in their abstract including accuracy of the facts, statements, results, conclusion, citing resources etc.

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