Abstract
BackgroundThe objective of the study was to evaluate the efficacy and safety of upadacitinib over 84 weeks in Japanese patients with active rheumatoid arthritis (RA) and an inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs.MethodsAll patients completing a 12-week, randomized, double-blind treatment period entered a blinded extension and continued upadacitinib 7.5, 15, or 30 mg once daily (QD), or were switched from placebo to upadacitinib 7.5, 15, or 30 mg QD. Efficacy and safety were assessed over 84 weeks.ResultsOf 197 randomized patients, 187 (94.9%) completed the 12-week period and entered the blinded extension; 152 (77.2%) patients were ongoing at week 84. At week 84, the proportions of patients achieving a 20% improvement in American College of Rheumatology criteria (ACR20) were 85.7%, 77.6%, and 58.0% with continued upadacitinib 7.5, 15, and 30 mg, respectively (nonresponder imputation), and were similar in patients who had switched from placebo. Favorable response rates were also observed for more stringent measures of response (ACR50/70) and remission (defined by the Disease Activity Score of 28 joints with C-reactive protein, Clinical Disease Activity Index, or Simplified Disease Activity Index). The 15 mg and 30 mg doses of upadacitinib were associated with more rapid and numerically higher initial responses for some measures of disease activity and remission compared with the 7.5 mg dose. Rates of adverse events, infection, opportunistic infection, serious infection, and herpes zoster were lower with upadacitinib 7.5 and 15 mg versus 30 mg.ConclusionsUpadacitinib demonstrated sustained efficacy and was well tolerated over 84 weeks in Japanese patients with RA, with upadacitinib 15 mg offering the most favorable benefit–risk profile.Trial registrationClinicalTrials.gov NCT02720523. Registered on March 22, 2016.
Highlights
The objective of the study was to evaluate the efficacy and safety of upadacitinib over 84 weeks in Japanese patients with active rheumatoid arthritis (RA) and an inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs
Patients Of the 197 Japanese patients randomized in SELECTSUNRISE, 187 (94.9%) completed 12 weeks on the study drug and entered the blinded extension period (Fig. 1)
Comparable trends were demonstrated for ACR50 and ACR70 responses, the 15 mg and 30 mg doses of upadacitinib were associated with more rapid and numerically higher initial ACR50/70 responses compared with the 7.5 mg dose (Fig. 2b, c)
Summary
The objective of the study was to evaluate the efficacy and safety of upadacitinib over 84 weeks in Japanese patients with active rheumatoid arthritis (RA) and an inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs. 3 JAK inhibitors are approved for the treatment of RA in the USA, EU, and Japan: tofacitinib, baricitinib, and most recently upadacitinib. These treatments have shown efficacy and an acceptable safety profile in global populations in the phase 3 clinical trial programs, as well as in trials run in Japanese patients with RA, higher rates of herpes zoster have been reported in Japan and other Asian countries versus the global population [7–11]. We report the results of the long-term extension phase of the SELECT-SUNRISE study, with efficacy and safety data up to week 84
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