Background/Purpose: Biologic sex can impact both clinical phenotype and therapeutic response in PsA.1–3 Previous studies have suggested that male patients (pts) may achieve better treatment outcomes with biologic agents including TNFi and IL-17 inhibitor therapies compared with female pts.1–3 This post hoc analysis evaluated potential differences in the efficacy of upadacitinib (UPA), an oral Janus kinase inhibitor, between male and female pts with PsA.

Methods: Data were drawn from 2 phase 3 studies, SELECT-PsA 1 (NCT03104400) and SELECT-PsA 2 (NCT03104374).4,5 In SELECT-PsA 1, pts were randomized to UPA 15 or 30 mg once daily (QD), adalimumab 40 mg every other week, or placebo (PBO); in SELECT-PsA 2, pts were randomized to UPA 15 or 30 mg or PBO QD. In both studies, pts receiving PBO switched to UPA 15 or 30 mg QD at Week (W) 24. UPA 15 mg QD data were analyzed for the current analysis. Efficacy endpoints were assessed at W12 and W24, stratified by sex. Statistical analyses included the Cochran–Mantel–Haenszel test for binary endpoints and mixed-effect model for repeated measurement for continuous endpoints. Response rates for binary endpoints were calculated using non-responder imputation. UPA vs PBO in both studies, and UPA vs adalimumab in SELECT-PsA 1, was assessed within each sex by relative risk (RR) or mean difference, and treatment comparison between sexes was assessed by the RR ratio (RRR) or difference between differences, with 95% confidence intervals (CIs) (comparability is indicated where intervals cover 0 [RR] or 1 [RRR]).

Results: 1,386 pts were included, of whom 640 (289/351 male/female), 317 (162/155), and 429 (207/222) received UPA, PBO, and adalimumab, respectively. At baseline, male and female pts generally have comparable disease characteristics, with some numeric differences between sexes across most scores (Table 1). Higher efficacy was observed with UPA vs PBO in both sexes for the majority of endpoints (Figure & Table 2). At W12 and W24, efficacy of UPA was consistent between male and female pts for all efficacy endpoints analyzed (Figure & Table 2). The proportion of male and female pts achieving ACR20, the primary efficacy outcome, was similar in both studies and at both W12 (SELECT-PsA 1: RRR [95% CI] 1.33 [0.89–1.98]; SELECT-PsA 2: 1.69 [0.70–4.07]) and W24 (1.39 [0.99–1.95] and 1.38 [0.53–3.62], respectively). Comparable percentages of male and female pts achieved ACR50, ACR70, minimal disease activity, and Leeds Enthesitis Index=0 with similar improvements in PASI75, Visual Analog Scale pain, and HAQ-DI at both W12 and W24; numerically greater improvements for male vs female pts were observed across most endpoints (UPA vs PBO; Figure & Table 2).

Conclusion: UPA was associated with higher efficacy vs PBO in both sexes among pts with PsA. UPA was associated with consistent efficacy between male and female pts across SELECT-PsA 1 and 2 at W12 and W24 for the majority of endpoints evaluated in this post hoc analysis.References1. Koehm M, et al. RMD OPEN. 2023;9:e003538.2. Eder L, et al. Lancet Rheumatol. 2023;5:e716–27.3. Eder L, et al. RMD OPEN. 2023;9:e002718.4. McInnes IB, et al. N Eng J Med. 2021;384:1227–39.5. Mease PJ, et al. Ann Rheum Dis. 2021;80:312–20.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/efficacy-of-upadacitinib-in-male-and-female-patients-with-psa-results-from-the-select-psa-1-and-2-trials/