Dataset Information

Efficacy and safety of upadacitinib over 84?weeks in Japanese patients with rheumatoid arthritis (SELECT-SUNRISE).

ABSTRACT:

Background

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.

Methods

All 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.

Results

Of 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.

Conclusions

Upadacitinib 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 registration

ClinicalTrials.gov NCT02720523 . Registered on March 22, 2016.

SUBMITTER: Kameda H

PROVIDER: S-EPMC7789301 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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Efficacy and safety of upadacitinib over 84 weeks in Japanese patients with rheumatoid arthritis (SELECT-SUNRISE).

Kameda Hideto H Takeuchi Tsutomu T Yamaoka Kunihiro K Oribe Motohiro M Kawano Mitsuhiro M Yokoyama Masayuki M Pangan Aileen L AL Konishi Yuko Y Meerwein Sebastian S Tanaka Yoshiya Y

Arthritis research & therapy 20210106 1

<h4>Background</h4>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.<h4>Methods</h4>All 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, ...[more]

PMID: 33407801

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