ArticleRheumatology and therapy2026
Guselkumab Improves Patient-Reported Outcomes Among Participants with Psoriatic Arthritis and Inadequate Response to Tumor Necrosis Factor Inhibitors in the COSMOS Study.
Article in Rheumatology and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03796858 (Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis and an Inadequate Response to Anti-Tumor Necrosis Factor Alpha), which is not on this map. Not yet cited in PubMed.
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Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis and an Inadequate Response to Anti-Tumor Necrosis Factor Alpha (Anti-TNFα) Therapy
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Abstract
introductionThe aim of this work was to evaluate the achievement of minimal clinically important improvement (MCII) in patient-reported outcomes (PROs) with guselkumab among participants with active psoriatic arthritis (PsA) and inadequate response to tumor necrosis factor inhibitors (TNFi-IR).
methodsPost hoc analysis of phase 3b COSMOS study of participants with PsA and TNFi-IR randomized to guselkumab (N = 189) or placebo (N = 96) at week (W)0, W4 then every 8W through W44, with W16 (early escape) or W24 placebo-to-guselkumab transition. Time to MCII achievement (> 15-point) in patient global assessment of arthritis (PtGA Arthritis), PtGA Psoriasis, PtGA Arthritis + Psoriasis, and Patient Pain, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue, ≥ 4-point), Health Assessment Questionnaire-Disability Index (HAQ-DI, ≥ 0.35-point), 36-item Short-Form Health Survey physical component summary score (≥ 5-point), Dermatology Life Quality Index (DLQI, ≥ 5-point), and DLQI 0/1 with guselkumab vs. placebo was determined using Cox regression adjusting for baseline factors. Logistic regression compared MCII achievement rates between treatment groups. All p values are nominal.
resultsTime to MCII achievement across PROs through W24 was significantly faster with guselkumab vs. placebo (hazard ratio [HR] range 1.59 for PtGA Arthritis to 5.89 for DLQI), except for FACIT-Fatigue (HR 1.29, 95% confidence interval 0.93-1.81). Guselkumab treatment delivered significant improvements in PROs vs. placebo as early as W8 and through W24. Across all measures, odds of achieving MCII were higher with guselkumab vs. placebo at W8 (odds ratio [OR] range 1.43 for FACIT-Fatigue to 9.33 for DLQI) and W24 (OR range 3.12 for HAQ-DI to 19.42 for DLQI 0/1). MCII achievement rates for all PROs increased through W48 of guselkumab treatment, with consistent patterns following placebo-to-guselkumab transition.
conclusionsIn these hypothesis-generating analyses of a TNFi-IR PsA population, guselkumab demonstrated rapid (W8) MCII achievement in patient-reported skin and joint symptoms, and pain, followed by improvements in fatigue, functional status, and quality of life, with response rates increasing further through W48.
trial registrationClinicalTrials.gov identifier, NCT03796858.
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