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Ann Rheum Dis. 2014 Oct;73(10):1811-8. doi: 10.1136/annrheumdis-2013-203435. Epub 2013 Jul 29.

Insights into the efficacy of golimumab plus methotrexate in patients with active rheumatoid arthritis who discontinued prior anti-tumour necrosis factor therapy: post-hoc analyses from the GO-AFTER study.

Author information

  • 1Division of Rheumatology, Department of Medicine III, Medical University of Vienna, and 2nd Department of Medicine, Hietzing Hospital, Vienna, Austria.
  • 2Division of Rheumatology, Department of Medicine, University of Massachusetts Medical School and UMass Memorial Medical Center, Worcester, Massachusetts, USA.
  • 3Division of Rheumatology, Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota, USA.
  • 4Division of Rheumatology, Academic Medical Center, Amsterdam and Atrium Medical Center, Heerlen, The Netherlands.
  • 5Clinical Immunology, Janssen Research & Development, LLC., Spring House Pennsylvania, USA Division of Rheumatology, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
  • 6Biologics Biostatistics, Janssen Research & Development, LLC., Spring House, Pennsylvania, USA.
  • 7Translational Medicine Group, Alexion Pharmaceuticals, Cambridge, Massachusetts, USA.

Abstract

OBJECTIVE:

Evaluate golimumab in patients with active rheumatoid arthritis (RA) and previous tumour necrosis factor-α (TNF) inhibitor use.

METHODS:

Patients (n=461) previously receiving ≥1 TNF inhibitor were randomised to subcutaneous injections of placebo, golimumab 50 mg or golimumab 100 mg q4 weeks. Primary endpoint (≥20% improvement in American College of Rheumatology (ACR20) criteria at week 14) findings have been reported for all patients in the trial. Reported herein are further assessments of efficacy/safety among patients receiving golimumab+methotrexate (MTX).

RESULTS:

Among efficacy-evaluable patients who received MTX at baseline, more receiving golimumab+MTX (n=201) than placebo+MTX (n=103) achieved ACR20 (40.8% vs 14.6%), ACR50 (20.9% vs 3.9%), and ACR70 (11.4% vs 2.9%) responses at week 24. Among the 137 patients who had received only one prior TNF inhibitor (adalimumab, n=33; etanercept, n=47; and infliximab, n=57), week 24 ACR20 rates were 30.3%, 46.8% and 50.9%, respectively, and thus lowest among those who previously used adalimumab. ACR20 response rates were 44.5% (61/137), 36.2% (17/47) and 23.5% (4/17) among patients who had received one, two or three TNF inhibitors, respectively. Adverse event (AE) rates were comparable across type/number of prior anti-TNF agents, but appeared somewhat higher among patients who discontinued previous TNF inhibitor(s) due to intolerance (37/49, 75.5%) versus lack of efficacy (LOE, 113/191, 59.2%).

CONCLUSIONS:

Patients with active RA previously treated with ≥1 TNF inhibitor had clinically relevant improvement with golimumab+MTX, which appeared somewhat enhanced among those who received only etanercept or infliximab as their prior TNF inhibitor. Golimumab+MTX safety appeared similar across patients, regardless of TNF inhibitor(s) previously used, with fewer AEs occurring among patients who discontinued prior therapy for LOE.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

KEYWORDS:

Anti-TNF; DAS28; Rheumatoid Arthritis

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