Efficacy and safety of upadacitinib in japanese patients with rheumatoid arthritis (SELECT-SUNRISE): A placebo-controlled phase IIb/III study
Rheumatology Apr 16, 2020
Kameda H, Takeuchi T, Yamaoka K, et al. - This study was undertaken to investigate upadacitinib efficacy and safety dose response in Japanese patients with active RA and an inadequate response to conventional synthetic DMARDs (csDMARDs). Researchers performed a multicentre, phase IIb/III, dose-ranging study in Japan, in which patients on previously stable csDMARDs were randomized to receive upadacitinib 7.5, 15 or 30 mg once daily or matching placebo for a 12-week double-blind period. One-hundred eighty-seven out of 197 patients treated, completed the double-blind period. The results reveal that effectiveness of upadacitinib was indicated in this population of Japanese individuals with RA and an inadequate response to csDMARDs. With other upadacitinib RA studies, safety and tolerability were consistent. The most favourable benefit–risk profile was found by 15 mg dose of upadacitinib.
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