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Ann Rheum Dis doi:10.1136/annrheumdis-2012-201411
  • Basic and translational research
  • Extended report

Intravenous golimumab is effective in patients with active rheumatoid arthritis despite methotrexate therapy with responses as early as week 2: results of the phase 3, randomised, multicentre, double-blind, placebo-controlled GO-FURTHER trial

Open Access
  1. Rene Westhovens4
  1. 1Department of Rheumatology, Brigham and Women's Hospital, Boston, Massachusetts, USA
  2. 2Department of Rheumatology, Johns Hopkins, Baltimore, Maryland, USA
  3. 3Janssen Research & Development, LLC, Spring House, Pennsylvania, USA
  4. 4Department of Musculoskeletal Sciences, KU Leuven, Leuven, Belgium
  1. Correspondence to Dr Michael E Weinblatt, Department of Rheumatology, Brigham and Women's Hospital, 75 Francis St, Boston, Massachusetts MA 02115, USA; mweinblatt{at}partners.org
  1. Contributors All authors were involved in the study design, trial conduct and/or data analysis and interpretation for the GO-FURTHER trial. All authors contributed to the development of this manuscript and approved the final version for submission.

  • Accepted 9 April 2012
  • Published Online First 1 June 2012

Abstract

Objectives Evaluate the efficacy of intravenous golimumab 2 mg/kg+methotrexate (MTX) in patients with active rheumatoid arthritis (RA) receiving MTX.

Methods Patients (n=592) with active disease (≥6/66 swollen, ≥6/68 tender joints, C-reactive protein ≥1.0 mg/dl, rheumatoid factor positive and/or anticyclic citrullinated protein antibody positive at screening) despite MTX (15–25 mg/week) participated in this double-blind, placebo-controlled, phase 3 study. Patients were randomised (2:1) to receive intravenous golimumab 2 mg/kg, or placebo infusions at weeks 0 and 4 and every (q) 8 weeks; patients continued MTX. Placebo patients with <10% improvement in combined swollen/tender joint counts at week 16 could early escape to intravenous golimumab 2 mg/kg. The primary endpoint was week 14 American College of Rheumatology 20% (ACR20) response. Analyses employed non-responder imputation and last-observation-carried-forward.

Results At week 14, significantly (p<0.001) larger proportions of golimumab+MTX than placebo+MTX patients achieved ACR20 response (59% vs 25%, respectively), a disease activity score of good/moderate (EULAR) response (81% vs 40%), and greater median improvement in health assessment questionnaire scores (0.500 vs 0.125). Improvements versus placebo+MTX were observed by week 2. Similar proportions of patients receiving golimumab+MTX and placebo+MTX, respectively, reported adverse events through week 16 (47% and 44%) and week 24 (53% and 49%). Serious adverse events were reported by more golimumab+MTX (4.1%) than placebo+MTX (2%) patients at week 24.

Conclusion The addition of intravenous golimumab rapidly and significantly improved signs and symptoms in patients with active RA despite ongoing MTX, in some patients by week 2.

Footnotes

  • Funding Janssen Research & Development LLC, and Merck/Schering-Plough provided support for this study.

  • Competing interests None.

  • Provenance and peer review Not commissioned; externally peer reviewed.

This paper is freely available online under the BMJ Journals unlocked scheme, see http://ard.bmj.com/info/unlocked.dtl