THU0202 Five-Year Safety and Efficacy of Golimumab in Patients with Active Rheumatoid Arthritis Despite Previous Anti-Tumor Necrosis Factor Therapy: Final Study Results of the Phase 3, Randomized, Placebo-Controlled Go-After Trial

Background GO-AFTER was the first multicenter, randomized, placebo (PBO)-controlled trial of the safety/efficacy of an anti-TNFα agent, GLM, in pts with active RA despite prior anti-TNFα therapy. Objectives Final safety/efficacy results through 5yrs are reported. Methods Pts were randomized (1:1:1) to PBO, GLM 50mg, or GLM 100mg q4w. At wk16, pts with inadequate treatment response entered double-blind early escape: PBO to GLM 50mg or GLM 50mg to 100mg. At wk24 (start of long-term extension), pts still receiving PBO switched to GLM 50mg, all other pts continued current treatment. After the last pt completed the wk24 visit, unblinding occurred, and a one-time GLM dose increase (50 to 100mg) or decrease (100 to 50mg) was permitted at investigator’s discretion. The last GLM injection was at wk252. Observed efficacy results (ACR20/50/70, DAS28-CRP, CDAI) by randomized treatment group and cumulative safety data are reported through wks 256 and 268, respectively. Efficacy data from 1 site (16 pts) were excluded (protocol violations). Results 461 pts were randomized, and 459 received study agent; 183 pts continued treatment through wk252, and 276 pts withdrew (86 for AE, 107 for lack of efficacy, 9 lost to follow-up, 69 for other reasons, 5 deaths). 178 completed the safety follow-up through wk268. Efficacy results are shown in the table. Of pts with available data at wk256, 60.3% had an ACR20, 42.3% had an ACR50, 21.7% had an ACR70, 84.3% had DAS28-CRP EULAR response, 29.0% had DAS28-CRP