メトトレキサートに効果不十分な関節リウマチ患者における バリシチニブ: Phase 3試験結果
Li Z, Hu J, Bao C, Li X, Li X, Xu J, Spindler AJ, Zhang X, Xu J, He D, Li Z, Wang G, Yang Y, Wu H, Ji F, Tao H, Zhan L, Bai F, Rooney TP, Zerbini CAF. - Clin Exp Rheumatol . Jul-Aug 2020;38(4):732-741. Epub 2020 May 20.
This study conducted mainly in Chinese patients with RA, and an inadequate response to MTX, showed that baricitinib 4mg was associated with significant improvements and consistent with the findings from previous clinical trials.
The efficacy and safety of baricitinib have been assessed in several clinical trials, predominantly in Caucasian populations. However, evidence on the efficacy and safety of baricitinib in Chinese patients is limited, with only one of the main clinical trial program studies enrolling a small number of patients from China. The clinical picture in China may differ from elsewhere in the world, with unique patterns of management and access.
RA-BALANCE was a Phase 3, double-blind, placebo-controlled study in 290 MTX-IR RA patients, conducted mainly in China, Brazil and Argentina. Patients were randomised 1:1 to receive placebo or baricitinib 4 mg with concomitant stable background MTX. At week 16, rescue treatment (open-label baricitinib 4 mg) was available for patients whose TJC and SJC improved by <20% at both Week 14 and 16; at Week 24, patients receiving placebo were switched to baricitinib. The primary endpoint was ACR20 response at Week 12.
Efficacy results showed that at Week 12, the ACR20 response rate for baricitinib was significantly higher than for placebo. Statistically significant improvements were also observed for secondary endpoints, including measures of LDA, although there were no significant differences in the proportion of patients achieving remission at week 24. Safety results were consistent with other clinical trials in the baricitinib and JAKi programs – with few serious infections in either group.