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Extended report
Radiographic benefit and maintenance of clinical benefit with intravenous golimumab therapy in patients with active rheumatoid arthritis despite methotrexate therapy: results up to 1 year of the phase 3, randomised, multicentre, double blind, placebo controlled GO-FURTHER trial
  1. Michael E Weinblatt1,
  2. Rene Westhovens2,3,
  3. Alan M Mendelsohn4,
  4. Lilianne Kim4,
  5. Kim Hung Lo4,
  6. Shihong Sheng4,
  7. Lenore Noonan4,
  8. Jiandong Lu4,
  9. Zhenhua Xu4,
  10. Jocelyn Leu4,
  11. Daniel Baker4,
  12. Clifton O Bingham5
  13. on behalf of the GO-FURTHER investigators
  1. 1Division of Rheumatology, Immunology and Allergy, Brigham and Women's Hospital, Boston, Massachusetts, USA
  2. 2Department of Development and Regeneration KU Leuven, Skeletal Biology and Engineering Research Centre, Leuven, Belgium
  3. 3Department of Rheumatology, University Hospitals Leuven, Leuven, Belgium
  4. 4Janssen Research & Development, LLC, Spring House, Pennsylvania, USA
  5. 5Johns Hopkins University Baltimore, Baltimore, Maryland, USA
  1. Correspondence to Dr M E Weinblatt, Harvard Medical School, Division of Rheumatology, Immunology and Allergy, Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115, USA; mweinblatt{at}partners.org

Abstract

Objective Report on radiographic effects and maintenance of clinical benefit with intravenous golimumab 2 mg/kg+methotrexate (MTX) for up to week (wk) 52 in active rheumatoid arthritis (RA).

Methods Patients (n=592) with active RA (≥6/66 swollen, ≥6/68 tender joints, C reactive protein (CRP) ≥1.0 mg/dL and positive for rheumatoid factor and/or anticyclic citrullinated protein antibody at screening) despite MTX ≥3 months (stable dose of 15–25 mg/week for ≥4 weeks) participated in this multicentre, international, randomised, 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 then every 8 weeks; patients continued their stable MTX regimen. Placebo patients started golimumab 2 mg/kg at wk16 (early escape; <10% improvement in tender and swollen joints) or wk24 (crossover by design). Week 24 and wk52 radiographic (van der Heijde-Sharp (vdH-S) scores), clinical efficacy and safety data up to 1 year are reported here.

Results Significant and rapid clinical improvement was observed up to wk24 of intravenous golimumab therapy. Golimumab+MTX treated patients demonstrated less radiographic progression than placebo treated patients at wk24 (vdH-S score mean change 0.03 vs 1.09; p<0.001) and wk52 (0.13 vs 1.22; p=0.001). Among patients with ≥20% improvement in the American College of Rheumatology response criteria or who achieved a ‘good’ or ‘moderate’ response according to the 28 joint Disease Activity Score employing CRP at wk24, approximately 80% maintained this response up until wk52. Through an average of 43.5 weeks of follow-up, 64.6% of patients receiving golimumab+MTX reported adverse events, most commonly non-serious infections.

Conclusions In patients with active RA despite MTX, intravenous golimumab+MTX yielded significant inhibition of structural damage at wk24 and wk52, and sustained clinical improvement in signs and symptoms with no new safety signals up to 1 year.

ClinicalTrials.gov NCT00973479, EudraCT 2008–006 064–11.

  • Rheumatoid Arthritis
  • TNF-alpha
  • Methotrexate

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