Background Golimumab(GLM) has demonstrated significant and sustained clinical efficacy and an acceptable safety profile through 2yrs of the phase 3, randomized, PBO-controlled, GO-RAISE study in pts with ankylosing spondylitis (AS).
Objectives To evaluate GLM safety/efficacy in AS pts receiving GLM50mg and/or 100mg through 5yrs.
Methods 356pts with AS were randomized to SC PBO, GLM50mg, or GLM100mg q4w. At wk16, pts with inadequate response early escaped (EE) with blinded dose adjustments (PBO→GLM50mg, GLM50mg→ 100mg). At wk24, pts still receiving PBO crossed over to GLM50mg. Pts continued double-blind treatment through wk100. The long-term extension started with the wk104 GLM injection. Pts received GLM q4w for ~5yrs (final injection at wk252). After unblinding at wk104 and at the investigator’s discretion, pts receiving GLM50mg could increase their dose to 100mg; pts receiving GLM100mg could decrease dose to 50mg; concomitant DMARD, corticosteroid, and NSAID therapy could be adjusted.
Results Among 356 randomized pts, 254 pts continued treatment through wk252; 242 completed the safety follow-up through wk268. 101 pts withdrew (33 [9.3%] due to AEs, 35 [9.8%] lack of efficacy, 11 [3.1%] lost to follow-up, 22 [6.2%] for other reasons); 1pt was untreated. Reductions in AS-related signs/symptoms and improvements in physical function and range of motion observed at wk14 (primary endpoint visit; previously reported) were maintained through 5yrs (Table). Serious AEs were reported for 17.1% of GLM50mg, 24.7% of GLM100mg, and 22.0% of all GLM-treated pts. One pt died (GLM50mg, B cell lymphoma after 3yrs in the study, followed by pancreatic cancer).
Conclusions In pts with active AS, SC GLM50 and 100mg q4w improved AS signs/symptoms, physical function, and range of motion and demonstrated an acceptable safety profile that was consistent with previously reported results for GLM through wk160 and with other anti-TNF biologics. There were no differences between the two GLM dosages.
Disclosure of Interest A. Deodhar Grant/research support from: Janssen R&D, LLC, J. Braun Grant/research support from: Janssen R&D, LLC, R. Inman Grant/research support from: Janssen R&D, LLC, D. van der Heijde Grant/research support from: Janssen R&D, LLC, Y. Zhou Shareholder of: Johnson & Johnson, Employee of: Janssen R&D, LLC, B. Hsu Shareholder of: Johnson & Johnson, Employee of: Janssen R&D, LLC