Guselkumab Shows Similar Domain-Specific Efficacy in Females and Males with Active Psoriatic Arthritis: Post Hoc Analyses of Three Phase 3, Randomized, Double-blind, Placebo-Controlled Studies

Lihi Eder¹, Carlo Selmi², Philip Mease³, Alexis Ogdie⁴, Francois Nantel⁵, Frederic Lavie⁶, Mohamed Sharaf⁷, Oyediran Adelakun⁸, Emmanouil Rampakakis⁹, Laura PINA VEGAS¹⁰ and Laura Coates¹¹, ¹University of Toronto, Women’s College Hospital and Department of Medicine, Toronto, ON, Canada, ²IRCCS Istituto Clinico Humanitas, 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 Oxford, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Oxford, United Kingdom

Meeting: ACR Convergence 2024

Keywords: clinical trial, Cohort Study, gender, Psoriatic arthritis

Session Information

Date: Monday, November 18, 2024

Title: SpA Including PsA – Treatment Poster III

Session Type: Poster Session C

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

Background/Purpose: PsA occurs in males and females at similar rates. Females participating in randomized controlled trials (RCTs) have shown lower treatment efficacy based on composite scores, especially pertaining to biologic DMARD treatments¹. Important sex differences in baseline (BL) patient (pt) characteristics were identified in a large, pooled cohort of PsA pts from 3 Phase 3 RCTs of guselkumab (GUS), where females exhibited longer PsA duration; higher BMI, tender joint count (TJC) and Leeds Enthesitis Index (LEI) score; and more severe PsA impact on quality of life². Given the importance of achieving low levels of disease activity across PsA domains, we assessed sex-disaggregated GUS efficacy across multiple PsA signs and symptoms at Week (W) 24 in this same pooled cohort.

Methods: Post-hoc analyses included 381 PsA pts from DISCOVER-1 (NCT03162796), 739 from DISCOVER-2 (NCT03158285), and 285 from COSMOS (NCT03796858). Rates of achievement of ACR20, Clinical Disease Activity Index for PsA (cDAPSA) low disease activity (LDA)/remission (REM), dactylitis and enthesitis resolution, Psoriasis Area Severity Index improvement from baseline of at least 75% (PASI75), PASI90, as well as Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) and HAQ-Disability Index (DI) response at W24 were evaluated by sex in pts receiving GUS at W0, W4 and every 8 weeks (Q8W). Non-responder imputation was applied for missing data. Achievement of clinical response at W24 was compared between GUS Q8W-treated male and female pts via adjusted logistic regression (see Fig 1).

Results: Among 564 PsA pts treated with GUS Q8W, no significant difference in GUS efficacy was observed between female and male pts as measured by the primary efficacy outcome common to the 3 RCTs (ACR20) and across PsA domains at W24 (Fig 1). After adjusting for BL characteristics with sex-specific differences in the pooled cohort, including age (female vs male; mean: 48.2 vs 46.1y; p=0.0007), PsA duration (6.9 vs 6.0y; p=0.0086), and BMI (29.9 vs 28.8 kg/m²; p=0.0007; Coates et al, ACR 2024), GUS efficacy was found to be comparable between sexes in terms of achieving ACR20 response (female vs male; 50.5 vs 59.0%; odds ratio [OR] [95% confidence interval (CI)]: 0.77 [0.55-1.09]; not significant [ns]; Fig 1A); composite measure indicating low levels of joint disease activity (cDAPSA LDA/REM: 31.0 vs 39.6%; OR [95% CI]: 0.79 [0.54-1.14]; ns; Fig 1B); dactylitis resolution (54.9 vs 55.2%; OR [95% CI]: 1.18 [0.67-2.08]; ns; Fig 1C); enthesitis resolution (42.1 vs 50.6%; OR [95% CI]: 0.81 [0.52-1.25]; ns; Fig 1D); skin disease improvement (PASI75: 71.0 vs 72.1%; OR [95% CI]: 1.16 [0.72-1.87]; ns and PASI90: 57.4 vs 59.9%; OR [95% CI]: 1.13 [0.73-1.75]; ns; Fig 1E); and clinically meaningful improvements in pt-reported outcomes (FACIT-F: 53.4 vs 52.7%; OR [95% CI]: 0.93 [0.64-1.34]; ns and HAQ-DI: 43.5 vs 48.4%; OR [95% CI]: 0.69 [0.47-1.02]; ns; Fig 1F).

Conclusion: In a large, pooled cohort of PsA pts from 3 RCTs, sex has no significant impact on GUS efficacy as measured by ACR20 and across PsA domains, after adjusting for the sex differences in BL characteristics.

References:

Eder. Lancet Rheum 2023;5:e716-27.
Coates et al, ACR 2024; AB1832254.

Disclosures: 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; C. Selmi: AbbVie, 2, 5, 6, Alfa-Wassermann, 2, 6, Amgen, 2, 5, 6, Biogen, 2, 6, Eli Lilly, 2, 6, EUSA, 2, 6, Galapagos, 2, 6, Janssen, 2, 6, Novartis, 2, 6, Pfizer, 2, 5, 6, SOBI, 2, 6; 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. 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.

To cite this abstract in AMA style:

Eder L, Selmi C, Mease P, Ogdie A, Nantel F, Lavie F, Sharaf M, Adelakun O, Rampakakis E, PINA VEGAS L, Coates L. Guselkumab Shows Similar Domain-Specific Efficacy in Females and Males with Active Psoriatic Arthritis: Post Hoc Analyses of Three Phase 3, Randomized, Double-blind, Placebo-Controlled Studies [abstract]. Arthritis Rheumatol. 2024; 76 (suppl 9). https://acrabstracts.org/abstract/guselkumab-shows-similar-domain-specific-efficacy-in-females-and-males-with-active-psoriatic-arthritis-post-hoc-analyses-of-three-phase-3-randomized-double-blind-placebo-controlled-studies/. Accessed .

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