Maintenance of clinical and radiographic benefit with intravenous golimumab therapy in @entity1 with active XXXX despite methotrexate therapy: Week-112 efficacy and safety results of the open-label long-term extension of the GO-FURTHER trial.

@entity1 @entity1499 @entity1500 @entity309
UNASSIGNED: Objective: To evaluate the safety, efficacy, pharmacokinetics, immunogenicity, and radiographic progression through 2 years of treatment with intravenous (IV) golimumab + @entity1499 ( @entity1500 ) in open-label extension of a phase 3 trial of @entity1 with active @entity309 ( @entity309 ) despite @entity1500 therapy. Methods: In the phase 3, double-blind, randomized, placebo-controlled, GO-FURTHER trial, 592 @entity1 with active @entity309 were randomized (2:1) to IV golimumab 2mg/kg+ @entity1500 (Group1) or placebo+ @entity1500 (Group2) at wks 0 and 4, then q8w; placebo @entity1 crossed over to golimumab at wk16 (early escape) or wk24 (crossover). The final golimumab infusion was at wk100. Assessments included ACR20/50/70 response, DAS28-CRP score, physical function and quality of life measures, and changes in van der Heijde-Sharp (vdH-S) scores. Safety was monitored through wk112. Results: In total, 486 @entity1 (82.1%) continued treatment through wk100, and 68.1%, 43.8%, and 23.5% had an ACR20/50/70 response, respectively, at wk100. Clinical response and improvements in physical function and quality of life were generally maintained from wk24 through 2 years. Mean change from baseline to wk100 in vdH-S score was 0.74 in Group1 and 2.10 in Group2 (p=0.005); progression from wk52 to wk100 was clinically insignificant in both groups. A total of 481 @entity1 completed the safety follow-up through week 112; 79.1% had an AE, and 18.2% had a SAE. Conclusions: Clinical response to IV golimumab + @entity1500 was maintained through wk100. Radiographic progression following golimumab treatment was clinically insignificant between wk52 and wk100.No unexpected AEs occurred through wk112; the safety profile was consistent with anti-TNF therapy. This article is protected by copyright. All rights reserved.
