What is golimumab and is it effective in treating rheumatoid arthritis (RA)?

Updated: Aug 22, 2019
  • Author: Howard R Smith, MD; Chief Editor: Herbert S Diamond, MD  more...
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Answer

Golimumab is a human anti−TNF-α monoclonal antibody that inhibits TNF-α bioactivity, thereby modulating immune activity in patients with RA. Using a modified intention-to-treat analysis, researchers demonstrated that golimumab plus MTX is more efficacious than MTX alone (and that golimumab alone is about as efficacious as MTX alone) in reducing disease signs and symptoms in MTX-naive patients. [102]

In this 52-week, randomized, double-blind, placebo-controlled study, which was was followed by an open-label extension through 5 years, 637 patients were randomized to receive placebo plus MTX (group 1), golimumab 100 mg SC plus placebo (group 2), golimumab 50 mg SC plus MTX (group 3), or golimumab 100 mg SC plus MTX (group 4). [102] Intent-to-treat analysis showed no significant differences in the primary endpoint between group 1 and groups 3 and 4 combined, indicating efficacy of subcutaneous golimumab. The incidence of serious adverse events was similar across all groups.

In July 2013, the FDA approved golimumab IV. [103, 104, 105] Approval was supported by a phase 3 study of 592 patients with moderately to severely active RA who had been receiving background MTX for at least 3 months.

In this study, 58.5% (n = 231/395) of patients receiving treatment with golimumab IV plus MTX experienced significant improvements in signs and symptoms at week 14 compared with 24.9% of patients receiving placebo plus MTX (n = 49/197). [105] Improvement was demonstrated by at least a 20% increase in ACR 20 score, the study’s primary endpoint. A higher proportion of patients receiving golimumab plus methotrexate achieved at least a 50% improvement in ACR criteria (ACR 50) at week 14 (30%) compared with patients receiving placebo plus MTX (9%).

The rate of adverse events and serious adverse events, respectively, at week 24 were 53% and 4% in the golimumab group and 49% and 2% in the placebo group. [103, 104] The most common adverse events were "infections and infestations," including upper respiratory tract infection (>5% of patients), urinary tract infection, and nasopharyngitis. Exacerbation of RA occurred in 5.6% of patients receiving placebo plus MTX. [103]

At week 52, the rate of adverse events and serious adverse events in the golimumab group were 65% and 9%, respectively. [103] No serious opportunistic infections occurred through week 52. However, in the golimumab group, a single case of tuberculosis was reported, and a patient died from a myocardial infarction secondary to community-acquired pneumonia. [103]


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