Guselkumab Similarly Efficacious Among Male, Female Patients With PsA

Guselkumab had similar efficacy among both female and male participants with psoriatic arthritis (PsA) in post-hoc analyses of 3 phase 3 studies.¹

Findings from the analyses were presented by Lihi Eder, MD, associate professor of medicine, Women’s College Hospital and University of Toronto, Canada, at the American College of Rheumatology (ACR) Convergence 2024, held November 14-19 in Washington, DC.

Notably, female participants in randomized controlled studies have shown lower treatment efficacy based on composite scores, especially pertaining to biologic DMARD treatments, marking the importance of the new findings.²

“Our group has shown that women experience a longer period of early signs and symptoms than men prior to a PsA diagnosis,” Eder said in a statement.² “During this timeframe, people experience musculoskeletal symptoms with minimal objective findings on physical exams, making diagnosis challenging.”

Eder also gave a talk during the meeting about the different characteristics and outcomes of PsA seen between female and male patients. Hormonal changes, confounding comorbidities that may lead to delays in diagnosis, more impactful symptoms, and worse responses to biologic therapies number among factors that impact female patients with PsA more than male patients.²

“Unconscious biases in the medical community may also play a role, with studies showing that men and women are treated differently when it comes to ordering advanced diagnostic tests, potentially resulting in delays,” Eder said.²

The post-hoc analyses included 381 participants with PsA from DISCOVER-1 (NCT03162796), 739 from DISCOVER-2 (NCT03158285), and 285 from COSMOS (NCT03796858). Eder and colleagues found that among 564 PsA pts treated with guselkumab once every 8 weeks, there were no significant difference in efficacy was observed between female and male participants as measured by ACR20 response and across PsA domains at week 24.

These findings were supported by adjusting for age, disease duration, and BMI, which yielded a 50.5% vs 59.0% proportion of ACR20 responders for female and male participants, respectively (odds ratio [OR], 0.77 [95% CI, 0.55-1.09]); not significant [ns]). Achievement rates were also similar for cDAPSA LDA/REM (female, 31.0 vs male, 39.6%; OR, 0.79 [95% CI, 0.54-1.14]; ns), dactylitis resolution (female, 54.9 vs male, 55.2%; OR, 1.18 [95% CI, 0.67-2.08]; ns), enthesitis resolution (female, 42.1 vs male, 50.6%; OR, 0.81 [95% CI, 0.52-1.25]; ns), PASI75 (female, 71.0 vs male, 72.1%; OR, 1.16 [95% CI, 0.72-1.87]; ns) and PASI90 (female, 57.4 vs male, 59.9%; OR, 1.13 [95% CI, 0.73-1.75]; ns). Female and male patients also similarly experienced clinically meaningful improvements in patient-reported outcomes (FACIT-F: female, 53.4% vs male, 52.7%; OR, 0.93 [95% CI, 0.64-1.34]; ns and HAQ-DI: female, 43.5 vs male, 48.4%; OR, 0.69 [95% CI, 0.47-1.02]; ns).¹

“Societal expectations, stressors, coping mechanisms and support systems all impact how men and women perceive and cope with PsA,” Eder added.² “Our ongoing study called SAGE-PSA conducted through the Group for Research and Assessment of Psoriasis and PsA (GRAPPA), aims to answer some of these questions.”

REFERENCES
1. Eder L, Selmi C, Mease P, et al. 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. Presented at: ACR Convergence 2024; November 14-19; Washington, DC. Abstract #2342

2. Women with Psoriatic Arthritis Experience More Intense Symptoms and a Longer Time to Diagnosis than Men. News release. ACR. November 14, 2024.