Guselkumab provides durable improvement across psoriatic arthritis disease domains: post hoc analysis of a phase 3, randomised, double-blind, placebo-controlled study

• Published in: Rheumatic & musculoskeletal diseases open Vol. 10; no. 1; p. e003977
• Main Authors: Coates, Laura C, Gossec, Laure, Zimmermann, Miriam, Shawi, May, Rampakakis, Emmanouil, Shiff, Natalie J, Kollmeier, Alexa P, Xu, Xie L, Nash, Peter, Mease, Philip J, Helliwell, Philip S
• Format: Journal Article
• Language: English
• Published: England EULAR 26.03.2024; BMJ Publishing Group LTD; BMJ Publishing Group
• Series: Original research
• Subjects: Antibodies, Monoclonal, Humanized; Arthritis, Psoriatic - drug therapy; Biological Products - therapeutic use; Biological Therapy; Cytokines; Double-Blind Method; Enthesopathy; Humans; Inflammatory bowel disease; Inflammatory Bowel Diseases; Joint Diseases; Kinases; Pain; Patient assessment; Psoriasis; Psoriatic Arthritis; Remission (Medicine); Severity of Illness Index; Skin diseases; Uveitis; United States > US; Severity of Illness Index; Psoriatic Arthritis; Biological Therapy
• ISSN: 2056-5933; 2056-5933
• DOI: 10.1136/rmdopen-2023-003977

ObjectiveEvaluate long-term guselkumab effectiveness across Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)-recognised domains/related conditions of psoriatic arthritis (PsA).MethodsPost hoc analyses used data from DISCOVER-2 (NCT03158285) biologic/Janus-kinase inhibitor-naïve participants with active PsA (≥5 swollen/≥5 tender joints, C-reactive protein ≥0.6 mg/dL), randomised (1:1:1) to guselkumab every 4 or 8 weeks (Q4W/Q8W) or placebo with crossover to guselkumab. Outcomes aligned with key GRAPPA-recognised domains of overall disease activity, peripheral arthritis, axial disease, enthesitis/dactylitis and skin psoriasis (nail psoriasis was not evaluated). PsA-related conditions (inflammatory bowel disease (IBD)/uveitis) were assessed via adverse events through W112. Least squares mean changes from baseline through W100 in continuous outcomes employed repeated measures mixed-effects models adjusting for baseline scores. Binary measure response rates were determined with non-responder imputation for missing data.Results442/493 (90%) of guselkumab-randomised patients completed treatment through W100. Following early reductions in disease activity with guselkumab, durable improvements were observed across key PsA domains (swollen/tender joints, psoriasis, spinal pain, enthesitis/dactylitis) through W100. Response rates of therapeutically relevant targets generally increased through W100 with guselkumab Q4W/Q8W: Disease Activity Index for PsA low disease activity (LDA) 62%/59%, enthesitis resolution 61%/70%, dactylitis resolution 72%/83%, 100% improvement in Psoriasis Area and Severity Index 59%/53%, Psoriatic Arthritis Disease Activity Score LDA 51%/49% and minimal disease activity 38%/40%. Through W112, no cases of IBD developed among guselkumab-randomised patients and one case of uveitis was reported.ConclusionIn biologic-naïve patients with active PsA, guselkumab provided early and durable improvements in key GRAPPA-recognised domains through 2 years, with substantial proportions achieving important treatment targets.