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.

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.

CLINICALTRIALSGOV:

NCT00973479, EudraCT 2008-006 064-11.

• Authors: Michael E Weinblatt, Rene Westhovens, Alan M Mendelsohn, Lilianne Kim, Kim Hung Lo, Shihong Sheng, Lenore Noonan, Jiandong Lu, Zhenhua Xu, Jocelyn Leu, Daniel Baker, Clifton O Bingham, GO-FURTHER investigators
• Journal: Annals of the rheumatic diseases (Ann Rheum Dis) Vol. 73 Issue 12 Pg. 2152-9 (Dec 2014) ISSN: 1468-2060 [Electronic] England
• PMID: 24001888 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: 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.

Chemical References

• Antibodies, Monoclonal
• Antirheumatic Agents
• golimumab
• Methotrexate

Topics

• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Antibodies, Monoclonal (therapeutic use)
• Antirheumatic Agents (therapeutic use)
• Arthritis, Rheumatoid (diagnostic imaging, drug therapy)
• Double-Blind Method
• Drug Therapy, Combination
• Female
• Foot Joints (diagnostic imaging)
• Hand Joints (diagnostic imaging)
• Humans
• Maintenance Chemotherapy (methods)
• Male
• Methotrexate (therapeutic use)
• Middle Aged
• Radiography
• Treatment Outcome
• Young Adult