ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 0588

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

Laura Coates1, Carlo Selmi2, Philip Mease3, Alexis Ogdie4, Francois Nantel5, Frederic Lavie6, Mohamed Sharaf7, Oyediran Adelakun8, Emmanouil Rampakakis9, Laura Pina Vegas10 and Lihi Eder11, 1University of Oxford, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Oxford, United Kingdom, 2Department of Biomedical Sciences, Humanitas University, Rozzano, Italy, 3Swedish Medical Center/Providence St. Joseph Health; University of Washington School of Medicine, Seattle, WA, 4Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, 5Nantel MedSci Consult, Montreal, QC, Canada, 6Janssen Cilag Global Medical Affairs, Immunology Global Medical Affairs, Issy les Moulineaux, France, 7Johnson & Johnson, Middle East FZ LLC, Dubai, UAE, Dubai, United Arab Emirates, 8Janssen Research & Development, LLC, Titusville, NJ, 9McGill University, Department of Pediatrics / Scientific Affairs, JSS Medical Research Inc., Montreal, QC, Canada, 10Leiden University Medical Center, Leiden, Netherlands, 11University of Toronto, Women’s College Hospital and Department of Medicine, Toronto, ON, Canada

Meeting: ACR Convergence 2024

Keywords: , , ,

Session Information

Date: Saturday, November 16, 2024

Title: SpA Including PsA – Treatment Poster I

Session Type: Poster Session A

Session Time: 10:30AM-12:30PM

Background/Purpose: Although 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) symptoms1-5. Despite observed sex-specific differences in PsA, few randomized controlled trials (RCTs) report sex-disaggregated results6. Here, we 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 (see Table 1).

Results: Among 1405 pts with PsA, 48.7% were female. At BL, female pts were older than males (mean: 48.2 vs 46.1y; p=0.0007), had longer PsA disease duration (6.9 vs 6.0y; p=0.0086) and a higher BMI (29.9 vs 28.8 kg/m2; 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 HAQ–Disability Index [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 (see Eder L, et al. ACR 2024; AB1840951).

References:

  1. Gossec. J Rheumatol 2023;50:192-6
  2. Duruöz. Joint Bone Spine 2021;88:105177
  3. Nas. Mod Rheumatol 2017;27:345-9
  4. Eder. Ann Rheum Dis 2013;72:578-82
  5. Kojanova. Dermatol Ther 2021;34:e14849
  6. Eder. Lancet Rheum 2023; 5:e716-27

Supporting image 1

Disclosures: L. Coates: AbbVie, 2, 5, 6, Amgen, 2, 5, 6, Biogen, 6, Bristol Myers Squibb, 2, Celgene, 2, 5, 6, Eli Lilly, 2, 5, 6, Galapagos, 2, 6, Gilead, 2, 6, GSK, 6, Janssen, 2, 5, 6, Medac, 6, MoonLake, 2, Novartis, 2, 5, 6, Pfizer, 2, 5, 6, UCB Pharma, 2, 5, 6; C. Selmi: AbbVie, 2, 5, Alfa-Wasserman, 2, Amgen, 2, 5, Biogen, 2, Eli Lilly, 2, EUSA, 2, Galapagos, 2, Janssen, 2, Novartis, 2, Pfizer, 5, SOBI, 2; P. Mease: AbbVie, 2, 5, Aclaris Therapeutics, 2, 5, Aclyrin, 2, 5, Amgen, 2, 5, Boehringer Ingelheim, 2, 5, Bristol Myers Squibb, 2, 5, CorEvitas, 2, 5, Galápagos, 2, 5, Gilead, 2, 5, Inmagene, 2, 5, Janssen, 2, 5, Lilly, 2, 5, MoonLake Immunotherapeutics, 2, 5, Novartis, 2, 5, Pfizer Inc, 2, 5, Sun Pharma, 2, 5, UCB, 2, 5; A. Ogdie: AbbVie, 2, 5, Amgen, 2, 5, Bristol-Myers Squibb(BMS), 5, Celgene, 2, CorEvitas, 2, Eli Lilly, 2, Gilead, 2, GlaxoSmithKlein(GSK), 5, Happify Health, 2, Janssen, 2, 5, Novartis, 2, 5, Pfizer, 2, 5, UCB, 2; F. Nantel: Janssen, 2, Johnson & Johnson, 11; F. Lavie: Immunology Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, 3, Johnson & Johnson, 11; M. Sharaf: Janssen Pharmaceutical Companies of Johnson & Johnson, 3, Johnson & Johnson, 11; O. Adelakun: Janssen, 3, Johnson & Johnson, 11; E. Rampakakis: Janssen, 2, JSS Medical Research, 3; L. Pina Vegas: Novartis, 5; L. Eder: AbbVie, 2, 5, 6, Bristol-Myers Squibb (BMS), 2, Eli Lilly, 2, 5, Fresenius Kabi, 5, Johnson & Johnson, 2, 5, Novartis, 1, 5, Pfizer, 5, 6, UCB, 5, 6.

To cite this abstract in AMA style:

Coates L, Selmi C, Mease P, Ogdie A, Nantel F, Lavie F, Sharaf M, Adelakun O, Rampakakis E, Pina Vegas L, Eder L. 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 [abstract]. Arthritis Rheumatol. 2024; 76 (suppl 9). https://acrabstracts.org/abstract/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-arth/. Accessed .

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