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Guselkumab in patients with PsA and TNFi-IR: Results from the phase IIIb COSMOS trial
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The phase IIIb COSMOS trial evaluated the efficacy of guselkumab, an interleukin-23 inhibitor, in patients with active PsA and TNFi-IR. Responses, including PROs, were measured at Week 24 and Week 48. Patients who were originally randomized to placebo were switched to guselkumab at Week 16 and Week 24, with a total of 285 patients randomized; 189 assigned to guselkumab and 96 assigned to placebo. |
| Key learnings |
| At Week 24, guselkumab improved ACR 20 (50% vs 28%; odds ratio [OR], 2.6; 95% confidence interval [CI], 1.5–4.6) and ACR 50 responses (23% vs 8%; OR, 3.2; 95% CI, 1.4–8.3) compared with placebo; improvements were sustained through Week 48. |
| Guselkumab vs placebo resulted in higher rates of PASI 90 (58% vs 11%) and PASI 100 (35% vs 8%), enthesitis (47% vs 23%) and dactylitis resolution (57% vs 36%), and patient-reported FACIT-Fatigue response (49% vs 26%) and HAQ-DI score (42% vs 24%). |
| The benefits of achieving ACR 20 were consistent across patient subgroups, regardless of demographics, disease severity, or prior treatments (including the number of prior TNFi therapies). Responses to guselkumab increased or were maintained through Week 48, illustrating its long-term effectiveness. |
| Guselkumab provides a reliable treatment option for diverse subgroups of patients with PsA and TNFi-IR, addressing an unmet need for effective, durable therapies in this patient population. |
Abbreviations: ACR, American College of Rheumatology response; FACIT, Functional Assessment of Chronic Illness Therapy; HAQ-DI, Health Assessment Questionnaire–Disability Index; IL, interleukin; PASI, Psoriasis Area and Severity Index; PRO, patient-reported outcomes; PsA, psoriatic arthritis; TNFi-IR, inadequate response or intolerance to prior tumour necrosis factor inhibitor.
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