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

Autor:	Coates LC; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK laura.coates@ndorms.ox.ac.uk., Gossec L; INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Sorbonne Universite, Paris, France.; Rheumatology Department, AP-HP, Pitié-Salpêtrière Hospital, Paris, France., Zimmermann M; Immunology, Janssen Medical Affairs, LLC, Zug, Switzerland., Shawi M; Immunology, Janssen Research & Development LLC, Titusville, New Jersey, USA., Rampakakis E; Scientific Affairs, JSS Medical Research Inc, Montreal, Quebec, Canada.; McGill University, Montreal, Quebec, Canada., Shiff NJ; Department of Community Health & Epidemiology, University of Saskatchewan, Saskatoon, Saskatchewan, Canada.; Janssen Scientific Affairs, LLC, Horsham, Pennsylvania, USA., Kollmeier AP; Janssen Research & Development LLC, San Diego, California, USA., Xu XL; Janssen Research & Development LLC, San Diego, California, USA., Nash P; Griffith University, Nathan, Queensland, Australia.; The University of Queensland, Brisbane, Queensland, Australia., Mease PJ; Rheumatology Research, Providence Swedish Medical Center, Seattle, Washington, USA.; University of Washington, Seattle, Washington, USA., Helliwell PS; Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.
Jazyk:	angličtina
Zdroj:	RMD open [RMD Open] 2024 Mar 26; Vol. 10 (1). Date of Electronic Publication: 2024 Mar 26.
DOI:	10.1136/rmdopen-2023-003977
Abstrakt:	Objective: Evaluate long-term guselkumab effectiveness across Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)-recognised domains/related conditions of psoriatic arthritis (PsA). Methods: Post 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. Results: 442/493 (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. Conclusion: In 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. Competing Interests: Competing interests: LCC: received grants/research support from AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Novartis, Pfizer and UCB; worked as a paid consultant for AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly, Gilead, Galapagos, Janssen, Moonlake, Novartis, Pfizer and UCB; and has been paid as a speaker for AbbVie, Amgen, Biogen, Celgene, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Janssen, Medac, Novartis, Pfizer and UCB. LCC is supported by the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (BRC). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health. LCC is an associate editor at RMD Open. LG: received research grants from AbbVie, Biogen, Eli Lilly, Novartis, UCB; consulting fees from AbbVie, Amgen, BMS, Celltrion, Galapagos, Janssen, Eli Lilly, MSD, Novartis, Pfizer, Sandoz and UCB. MZ: employee of Janssen EMEA Medical Affairs Immunology, LLC, Zug, Switzerland; owns stock or stock options in Johnson & Johnson. MS: employee of Janssen Research & Development, LLC; owns stock or stock options in Johnson & Johnson. ER: employee of JSS Medical Research; paid consultant of Janssen. NJS: employee of Janssen Scientific Affairs, LLC; owns or has owned stock in AbbVie, Gilead, Iovance, Johnson & Johnson, Novo-Nordisk and Pfizer within the past 3 years. Current stock ownership: AbbVie, Gilead, Iovance, Jazz, Johnson & Johnson, Novavax and Viatris. APK: employee of Janssen Research & Development, LLC, a wholly owned subsidiary of Johnson & Johnson, and own stocks in Johnson & Johnson. XLX: employee of Janssen Research & Development, LLC, a wholly owned subsidiary of Johnson & Johnson; owns stock in Johnson & Johnson. PN: received funding for research and clinical trials and honoraria for advice and lectures on behalf of AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Galapagos, GlaxoSmithKline, Janssen, Novartis, Pfizer, Sun Pharma and UCB. PN is an editorial board member at RMD Open. PJM: received research grants from AbbVie, Acelyrin, Amgen, Bristol Myers Squibb, Eli Lilly, Janssen, Novartis, Pfizer, SUN Pharma and UCB; consulting fees from AbbVie, Acelyrin, Aclaris, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Immagene, Janssen, Novartis, Pfizer, SUN, UCB, Ventyx; and speaker fees from AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer and UCB. PSH: received consulting fees from Eli Lilly and fees for educational services from AbbVie, Amgen, Janssen and Novartis. (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
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