Efficacy and safety of subcutaneous golimumab in @entity1499 -na  ve @entity1 with XXXX : 5-year results of the GO-BEFORE trial.

@entity6822 @entity1 @entity1499 @entity309
OBJECTIVE: Evaluate the safety and efficacy of golimumab through 5 years in adults with active @entity309 who had not previously received @entity1499 ( @entity6822 ). METHODS: In GO-BEFORE, 637 @entity6822 -na  ve adult @entity1 with active @entity309 were randomized (1:1:1:1) to placebo+ @entity6822 (Group 1), golimumab 100mg+placebo (Group 2), golimumab 50mg+ @entity6822 (Group 3), or golimumab 100mg+ @entity6822 (Group 4). Inadequate responders in Groups 1, 2, and 3 entered early escape at week28 to golimumab 50mg+ @entity6822 , golimumab 100mg+ @entity6822 , or golimumab 100mg + @entity6822 , respectively; remaining @entity1 in Group 1 could crossover to golimumab 50mg+ @entity6822 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. RESULTS: A total of 422 @entity1 completed golimumab treatment through week256. At week256, 72.8%, 54.6%, and 38.0% of all @entity1 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 @entity1 through week256. Infections were the most common type of AE; 204/616 @entity1 (33.1%) had >= 1 serious AE. CONCLUSIONS: Clinical efficacy with golimumab treatment was maintained through week256 of the GO-BEFORE trial of @entity6822 -na  ve @entity309 @entity1 . No unexpected AEs occurred; safety results through 5 years are consistent with earlier reports. This article is protected by copyright. All rights reserved.
