SAN DIEGO, CA—The final 5-year results from the GO-FORWARD trial showed a high retention rate and improvements in signs/symptoms of rheumatoid arthritis (RA) and in physical function were maintained long-term with golimumab + methotrexate therapy, investigators presented at the 2013 ACR/ARHP Annual Meeting.
GO-FORWARD, a Phase 3, 2-year randomized trial, evaluated the safety and efficacy of subcutaneous golimumab ± methotrexate in patients with active RA despite methotrexate therapy. Patients were randomized to placebo + methotrexate, golimumab 100mg + placebo, golimumab 50mg + methotrexate, or golimumab 100mg + methotrexate every 4 weeks. At Week 16, the placebo + methotrexate group crossed over to golimumab + methotrexate (“blinded early escape”) or at Week 24 (“crossover”). At Week 52, patients continued treatment with the start of the long-term extension. The last golimumab injection was at Week 252.
Edward Keystone, MD, of the University of Toronto/Mount Sinai Hospital, Toronto, Ontario, Canada, and colleagues analyzed the final safety and efficacy results through 5 years. Observed efficacy results (ACR20/50/70, DAS28-CRP, HAQ-DI, radiographic) by randomized treatment group and cumulative safety data were reported through Week 256 and Week 268, respectively.
Of the 444 patients randomized, 313 continued treatment through Week 52 and 301 patients completed the safety follow-up through Week 268.
At Week 256, 76.0% (241/317) of all patients achieved ACR20, 89.5% (281/314) had a DAS28-CRP EULAR response, and 68.5% (217/317) had improvement in HAQ-DI ≥0.25. Changes from baseline in mean total vdH-S scores were small (3.3±9.4); 54% of patients randomized to golimumab + methotrexate had no radiographic progression (ΔvdH-S≤0).
The most common adverse events (AEs) were upper respiratory tract infection (32.9%), nasopharyngitis (17.1%), and bronchitis (17.1%); 9.2% of patients had an injection-site reaction. Through Week 268, 172/434 patients (39.6%) had a serious AE and 14.1% of patients discontinued the study drug due to AEs.
“The retention rate was high (70.5%) through 5 years, and improvements in signs/symptoms of RA and in physical function were maintained long-term in patients continuing golimumab + methotrexate therapy,” Dr. Keystone concluded. Overall, researchers noted long-term safety of golimumab is consistent with other anti-tumor necrosis factor-α agents.