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Guselkumab provides durable improvement across psoriatic arthritis disease domains: post hoc analysis of a phase 3, randomised, double-blind, placebo-controlled study.
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.
Affiliation
  • 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.
  • Zimmermann M; Rheumatology Department, AP-HP, Pitié-Salpêtrière Hospital, Paris, France.
  • Shawi M; Immunology, Janssen Medical Affairs, LLC, Zug, Switzerland.
  • Rampakakis E; Immunology, Janssen Research & Development LLC, Titusville, New Jersey, USA.
  • Shiff NJ; Scientific Affairs, JSS Medical Research Inc, Montreal, Quebec, Canada.
  • Kollmeier AP; McGill University, Montreal, Quebec, Canada.
  • Xu XL; Department of Community Health & Epidemiology, University of Saskatchewan, Saskatoon, Saskatchewan, Canada.
  • Nash P; Janssen Scientific Affairs, LLC, Horsham, Pennsylvania, USA.
  • Mease PJ; Janssen Research & Development LLC, San Diego, California, USA.
  • Helliwell PS; Janssen Research & Development LLC, San Diego, California, USA.
RMD Open ; 10(1)2024 Mar 26.
Article in En | MEDLINE | ID: mdl-38531621
ABSTRACT

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 (111) 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.
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Full text: 1 Database: MEDLINE Main subject: Psoriasis / Uveitis / Biological Products / Inflammatory Bowel Diseases / Arthritis, Psoriatic / Antibodies, Monoclonal, Humanized / Enthesopathy / Joint Diseases Limits: Humans Language: En Journal: RMD Open Year: 2024 Type: Article

Full text: 1 Database: MEDLINE Main subject: Psoriasis / Uveitis / Biological Products / Inflammatory Bowel Diseases / Arthritis, Psoriatic / Antibodies, Monoclonal, Humanized / Enthesopathy / Joint Diseases Limits: Humans Language: En Journal: RMD Open Year: 2024 Type: Article