- In this phase 3 trial, the experimental Janus kinase inhibitor upadacitinib is safe and effective in combination with conventional synthetic DMARDs (csDMARDs) in patients with moderately to severely active rheumatoid arthritis (RA) who had inadequate response to csDMARDs alone.
Why this matters
- Upadacitinib may soon become a new treatment option for moderate-to-severe RA.
- Randomized, double-blind, placebo-controlled trial (SELECT-NEXT) of 661 patients with active RA receiving stable csDMARDs (to which they had inadequate response) who received extended-release upadacitinib 15 mg, 30 mg, or placebo (once daily).
- Primary outcomes at 12 weeks were percentage of patients with 20% improvement on American College of Rheumatology criteria (ACR20) and a 28-joint disease activity score using C-reactive protein (DAS28[CRP]) ≤3.2.
- Funding: AbbVie Inc.
- Upadacitinib recipients were more likely to achieve ACR20 (64% of the 15-mg and 66% of the 30-mg groups) than placebo (36%; P<.0001 for each dose vs placebo>
- Upadacitinib recipients were more likely to achieve DAS28[CRP] ≤3.2 (48% of the 15-mg and 48% of the 30-mg groups) than placebo (17%; P<.0001 for each dose vs placebo>
- Upadacitinib recipients had more infections (29% of the 15-mg and 32% of the 30-mg groups) than placebo (21%), including herpes zoster.
- Short duration of study.