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  • 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)

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Clinical and epidemiological research
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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)
  1. Arthur Kavanaugh1,
  2. Iain B McInnes2,
  3. Philip Mease3,
  4. Gerald G Krueger4,
  5. Dafna Gladman5,
  6. Désirée van der Heijde6,
  7. Yiying Zhou7,
  8. Jiandong Lu7,
  9. Jocelyn H Leu8,
  10. Neil Goldstein9,
  11. Anna Beutler9
  1. 1Division of Rheumatology, Allergy, Immunology, University of California, San Diego, La Jolla, California, USA
  2. 2Institute of Infection, Immunity, and Inflammation, University of Glasgow, Glasgow, UK
  3. 3Department of Rheumatology, Swedish Medical Center, University of Washington, Seattle, Washington, USA
  4. 4Department of Dermatology, University of Utah, Salt Lake City, Utah, USA
  5. 5Toronto Western Research Institute, Toronto, Ontario, Canada
  6. 6Director of Imaging Rheumatology, Leiden University Medical Center, Leiden, The Netherlands
  7. 7Department of Biostatistics, Janssen Research & Development, LLC., Spring House, Pennsylvania, USA
  8. 8Biologics Clinical Pharmacology, Janssen Research & Development, LLC., Spring House, Pennsylvania, USA
  9. 9Department of Immunology, Janssen Research & Development, LLC., Spring House, Pennsylvania, USA
  1. Correspondence to Professor Arthur Kavanaugh, University of California, San Diego, 9500 Gilman Drive, La Jolla, CA 92093-0943, USA; akavanaugh{at}ucsd.edu

Abstract

Objectives Assess golimumab's long-term efficacy/safety in psoriatic arthritis (PsA).

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).

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).

Conclusions Long-term golimumab safety/efficacy in PsA was demonstrated through 5 years.

Trial registration number NCT00265096.

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/3.0/

https://doi.org/10.1136/annrheumdis-2013-204902

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