SAT0152 EFFICACY OF BARICITINIB IN PATIENTS WITH MODERATE-TO-SEVERE RHEUMATOID ARTHRITIS WITH 3 YEARS OF TREATMENT: RESULTS FROM A LONG-TERM STUDY

Background: Upadacitinib (UPA), an oral, selective JAK-1 inhibitor was effective in global ph 3 trials in rheumatoid arthritis (RA) patients with inadequate response (IR)/intolerance to csDMARDs and bDMARDs. Objectives: This Phase 3, randomized, double-blind, placebo (PBO)-controlled study assessed the efficacy and safety of UPA in combination with csDMARDs in csDMARD-IR patients with RA from China, Brazil, and South Korea. Methods: Patients were randomized 1:1 to receive UPA 15 mg once daily (QD) or PBO in combination with csDMARDs. The primary endpoint was ACR20 response at Week 12, using non-responder imputation. Results: 338 patients were randomized, and 310 (91.7%) completed Week 12. At Week 12, statistically significantly more patients receiving UPA vs PBO achieved the primary endpoint of ACR20 (71.6% vs 31.4%, p Conclusion: Efficacy of UPA was demonstrated in this csDMARD-IR population from China, Brazil, and South Korea. The safety of UPA was comparable with the global Phase 3 program. Disclosure of Interests: : Xiaofeng Zeng Consultant of: MSD Pharmaceuticals, Dongbao Zhao: None declared, Sebastiao Radominski: None declared, MAURO KEISERMAN Speakers bureau: Pfizer, Abbott, Actelion, AstraZeneca, Amgen, Roche, Bristol Myers Squibb, and Janssen and has received clinical trial honoraria from Pfizer, Amgen, AstraZeneca, Anthera Pharmaceuticals, Bristol-Myers Squibb, Biogen Idec Inc, Celltrion Inc., Eli Lilly, Human Genome Sciences, Novartis, Roche, Sanofi, UCB Inc., Chang-Keun Lee: None declared, Sebastian Meerwein Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Jeffrey Enejosa Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Yunxia Sui Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Mohamed-Eslam Mohamed Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Won Park: None declared