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Safety and efficacy of upadacitinib in patients with active rheumatoid arthritis refractory to biologic disease-modifying anti-rheumatic drugs (SELECT-BEYOND): a double-blind, randomised controlled phase 3 trial

Genovese, Mark C, Fleischmann, Roy, Combe, Bernard, Hall, Stephen, Rubbert-Roth, Andrea, Zhang, Ying, Zhou, Yijie, Mohamed, Mohamed-Eslam F, Meerwein, Sebastian, Pangan, Aileen L·2018·The Lancet
DOI 10.1016/s0140-6736(18)31116-4
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Abstract

Background Phase 2 studies with upadacitinib, a selective Janus kinase 1 (JAK1) inhibitor, have shown safety and efficacy in the treatment of patients with active rheumatoid arthritis. We did this study to further assess the safety and efficacy of upadacitinib in patients with an inadequate response to biologic disease-modifying anti-rheumatic drugs (bDMARDs). Methods We did this double-blind, randomised controlled phase 3 trial at 153 sites in 26 countries. Patients were aged 18 years or older, had active rheumatoid arthritis and previous inadequate response or intolerance to bDMARDs, and were receiving concomitant background conventional synthetic DMARDS (csDMARDs). We randomly assigned patients (2:2:1:1) by interactive response technology to receive once-daily oral extended-release upadacitinib 15 mg or 30 mg or placebo for 12 weeks, followed by upadacitinib 15 mg or 30 mg from week 12 onwards. The two separate primary endpoints were the proportions of patients achieving a 20% improvement in American College of Rheumatology criteria (ACR20) at week 12 and the proportion of patients achieving a 28-joint disease activity score using C-reactive protein (DAS28[CRP]) of 3·2 or less at week 12. Efficacy and safety analyses were done in the modified intention-to-treat population of all patients who received at least one dose of study drug. Data are presented up to week 24 of this ongoing study. The trial is registered with ClinicalTrials.gov (NCT02706847). Findings Between March…

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Metadata

Authors
Genovese, M. C., Fleischmann, R., Combe, B., Hall, S., Rubbert-Roth, A., Zhang, Y., Zhou, Y., Mohamed, M.-E. F., Meerwein, S., & Pangan, A. L.
Venue
The Lancet
Publisher
Elsevier BV
Published
2018-06
Volume
391
Issue
10139
Pages
2513-2524
ISSN
0140-6736
DOI
10.1016/s0140-6736(18)31116-4
Cited by
422
References
0
Language
en
Licence
www.elsevier.com/tdm/userlicense/1.0/ (tdm)

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