Evaluate the safety and efficacy of golimumab through 5 years in adults with active RA who had not previously received methotrexate (MTX).
In GO-BEFORE, 637 MTX-naïve adult patients with active RA were randomized (1:1:1:1) to placebo+MTX (Group 1), golimumab 100mg+placebo (Group 2), golimumab 50mg+MTX (Group 3), or golimumab 100mg+MTX (Group 4). Inadequate responders in Groups 1, 2, and 3 entered early escape at week28 to golimumab 50mg+MTX, golimumab 100mg+MTX, or golimumab 100mg +MTX, respectively; remaining patients in Group 1 could crossover to golimumab 50mg+MTX at week52. Assessments included ACR20/50/70 response, DAS28-CRP scores, and vdH-mTSS. Efficacy was analyzed using an intent-to-treat analysis. Pharmacokinetics and immunogenicity were evaluated at selected visits.
A total of 422 patients completed golimumab treatment through week256. At week256, 72.8%, 54.6%, and 38.0% of all patients in the full ITT population (n=637) had an ACR20/50/70 response, respectively, 84.1% had a good or moderate DAS28-CRP response, and 72.7% had a clinically meaningful improvement in physical function. Radiographic progression was minimal in all treatment groups through week256, and the overall mean change from baseline in vdH-mTSS was 1.36. Serum trough golimumab concentrations were approximately dose proportional and maintained through week256. Antibodies to golimumab occurred in 9.6% of patients through week256. Infections were the most common type of AE; 204/616 patients (33.1%) had ≥1 serious AE.
Clinical efficacy with golimumab treatment was maintained through week256 of the GO-BEFORE trial of MTX-naïve RA patients. No unexpected AEs occurred; safety results through 5 years are consistent with earlier reports. This article is protected by copyright. All rights reserved.