Clinical efficacy, radiographic and safety findings through 5 years of subcutaneous golimumab treatment in patients with active psoriatic arthritis: results from a long-term extension of a randomised, placebo-controlled trial (the GO-REVEAL study)

Kavanaugh, A. et al. (2014) Clinical efficacy, radiographic and safety findings through 5 years of subcutaneous golimumab treatment in patients with active psoriatic arthritis: results from a long-term extension of a randomised, placebo-controlled trial (the GO-REVEAL study). Annals of the Rheumatic Diseases, 73(9), pp. 1689-1694. (doi: 10.1136/annrheumdis-2013-204902) (PMID:24748630)

Abstract

Objectives: Assess golimumab's long-term efficacy/safety in psoriatic arthritis (PsA).<p></p> Methods: Adults with active PsA (≥3 swollen and tender joints, active psoriasis) were randomly assigned to subcutaneous placebo, golimumab 50 mg, or golimumab 100 mg every 4 weeks (q4wks) through wk20. All patients received golimumab 50 mg or 100 mg q4wks from wk24 forward. Methotrexate was allowed and taken by approximately half the patients. Findings through 5 years are reported herein. Efficacy assessments included ≥20% improvement in American College of Rheumatology (ACR20) response, C-reactive-protein-based, 28-joint-count Disease Activity Score (DAS28-CRP) response, ≥75% improvement in Psoriasis Area and Severity Index (PASI75) scores, and PsA-modified Sharp/van der Heijde scores (SHSs).<p></p> Results: 126/405 (31%) randomised patients discontinued treatment through wk252. Golimumab was effective in maintaining clinical improvement through year-5 (ACR20: 62.8–69.9%, DAS28-CRP: 75.2-84.9% for randomised patients; PASI75: 60.8–72.2% among randomised patients with ≥3% body surface area involvement) and inhibiting radiographic progression (mean changes in PsA-modified SHS: 0.1–0.3) among patients with radiographic data. While concomitant methotrexate did not affect ACR20/PASI75, it appeared to reduce radiographic progression. No new safety signals were identified. Antibodies-to-golimumab occurred in 1.8%/10.0% of patients with/without methotrexate).<p></p> Conclusions: Long-term golimumab safety/efficacy in PsA was demonstrated through 5 years.

• Item Type: Articles
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: McInnes, Professor Iain
• Authors: Kavanaugh, A., McInnes, I. B., Mease, P., Krueger, G. G., Gladman, D., van der Heijde, D., Zhou, Y., Lu, J., Leu, J. H., Goldstein, N., and Beutler, A.
• College/School: College of Medical Veterinary and Life Sciences > School of Infection & Immunity
• Journal Name: Annals of the Rheumatic Diseases
• Publisher: BMJ Group
• ISSN: 0003-4967
• ISSN (Online): 1468-2060
• Copyright Holders: Copyright © 2014 The Authors
• First Published: First published in Annals of the Rheumatic Diseases 73(9):1689-1694
• Publisher Policy: Reproduced under a Creative Commons License