Objective: The Phase 3 GO-FORWARD study examined the efficacy and safety of golimumab in patients with active rheumatoid arthritis (RA) despite methotrexate (MTX) therapy.
Methods: Patients were randomly assigned in a 3:3:2:2 ratio to receive placebo injections plus MTX capsules (Group 1, n=133), golimumab 100 mg injections plus placebo capsules (Group 2, n=133), golimumab 50 mg injections plus MTX capsules (Group 3, n=89), or golimumab 100 mg injections plus MTX capsules (Group 4, n=89). Injections were administered subcutaneously every 4 weeks. The co-primary endpoints were the proportion of patients with ≥20% improvement in the American College of Rheumatology criteria (ACR20) at week 14 and the change from baseline in the Health Assessment Questionnaire-disability index (HAQ-DI) score at week 24.
Results: The proportion of patients who achieved an ACR20 response at week 14 was 33.1% in the placebo plus MTX group, 44.4% (p=0.059) in the golimumab 100 mg plus placebo group, 55.1% (p=0.001) in the golimumab 50 mg plus MTX group, and 56.2% (p<0.001) in the golimumab 100 mg plus MTX group. At week 24, median improvements from baseline in HAQ-DI scores were 0.13, 0.13 (p=0.240), 0.38 (p<0.001), and 0.50 (p<0.001), respectively. During the placebo-controlled portion of the study (through week 16), serious adverse events occurred in 2.3%, 3.8%, 5.6%, and 9.0% of patients and serious infections occurred in 0.8%, 0.8%, 2.2%, and 5.6%, respectively.
Conclusion: The addition of golimumab to MTX in patients with active RA despite MTX significantly reduced the signs and symptoms of RA and improved physical function.
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.