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.