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Extended report
Clinical efficacy, radiographic and safety findings through 2 years of golimumab treatment in patients with active psoriatic arthritis: results from a long-term extension of the randomised, placebo-controlled GO-REVEAL study
  1. Arthur Kavanaugh1,
  2. Iain B McInnes2,
  3. Philip J Mease3,
  4. Gerald G Krueger4,
  5. Dafna D Gladman5,
  6. Désirée van der Heijde6,
  7. Surekha Mudivarthy7,
  8. Weichun Xu7,
  9. Michael Mack7,
  10. Zhenhua Xu8,
  11. Anna Beutler9
  1. 1Division of Rheumatology, Allergy, Immunology, University of California, San Diego, La Jolla, California, USA
  2. 2Institute of Immunology, Infection and Inflammation University of Glasgow, Glasgow, UK
  3. 3Rheumatology Clinical Research Division, Swedish Medical Center, University of Washington, Seattle, Washington, USA
  4. 4Department of Dermatology, University of Utah, Salt Lake City, Utah, USA
  5. 5University of Toronto, Toronto Western Research Institute, Toronto, Ontario, Canada
  6. 6Department of 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, Division of Rheumatology, Allergy, Immunology, University of California, San Diego, 9500 Gilman Drive, Room A-112, La Jolla,CA 92093-0943, USA; akavanaugh{at}ucsd.edu

Abstract

Objectives To assess long-term golimumab efficacy/safety in patients with active psoriatic arthritis (PsA).

Methods Adult PsA patients (≥3 swollen, ≥3 tender joints, active psoriasis) were randomly assigned to subcutaneous injections of placebo, golimumab 50 mg or 100 mg every 4 weeks (q4wks) through week 20. All patients received golimumab 50 or 100 mg beginning week 24. Findings through 2 years are reported. Efficacy evaluations included ≥20% improvement in American College of Rheumatology (ACR20) response, good/moderate response in Disease Activity Scores incorporating 28 joints and C-reactive protein (DAS28-CRP), ≥75% improvement in Psoriasis Area and Severity Index (PASI75) and changes in PsA-modified Sharp/van der Heijde scores (SHS).

Results Golimumab treatment through 2 years was effective in maintaining clinical response (response rates: ACR20 63%–70%, DAS28-CRP 77%–86%, PASI75 56%–72%) and inhibiting radiographic progression (mean change in PsA-modified SHS in golimumab-treated patients: −0.36), with no clear difference between doses. No new safety signals were identified through 2 years. With the study's tuberculosis screening and prophylactic measures, no patient developed active tuberculosis through 2 years.

Conclusions Golimumab 50 and 100 mg for up to 2 years yielded sustained clinical and radiographic efficacy when administered to patients with active PsA. Increasing the golimumab dose from 50 to 100 mg q4wks added limited benefit. Golimumab safety through up to 2 years was consistent with other antitumour necrosis factor α agents used to treat PsA. Treatment of patients with latent tuberculosis identified at baseline appeared to be effective in inhibiting the development of active tuberculosis.

  • Psoriatic Arthritis
  • Anti-TNF
  • Spondyloarthritis

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/

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