- 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 previously exhibited inadequate response or intolerance to biological DMARDs (bDMARDs).
Why this matters
- Results could lead to new drug approval for patients with moderate-to-severe RA.
- Randomized, double-blind, placebo-controlled trial (SELECT-BEYOND) of 499 patients with active RA receiving stable csDMARDs 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 (65% of the 15-mg and 56% of the 30-mg groups) than placebo (28%; P<.0001 for each dose vs placebo>
- Upadacitinib recipients were more likely to achieve DAS28[CRP] ≤3.2 (43% of the 15-mg and 42% of the 30-mg groups) than placebo (14%; P<.0001 for each dose vs placebo>
- Upadacitinib 30 mg recipients had more severe infections, herpes zoster, and adverse events resulting in discontinuation than the 15 mg or placebo recipients.
- Short duration of study.