Long-term safety and efficacy of upadacitinib in Japanese patients with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying antirheumatic drugs: 5-year results from the SELECT-SUNRISE randomised controlled trial
Authors' conclusion
Upadacitinib showed sustained efficacy with no new safety signals identified through 5 years of treatment
Study context
- Population
- Japanese patients with moderate-to-severe active RA and inadequate response to stable doses of csDMARDs (csDMARDs-IR)121 (64.7%) completed
- Participants
- 187 patients
- Comparison
- Upadacitinib 7.5, 15 or 30 mg once daily vs placebo for 12 weeks, then long-term extension on upadacitinib
- Primary endpoint
- Long-term safety and efficacy of upadacitinib
- Follow-up
- Week 260
Methodological detailsdouble-blind, placebo-controlled phase of 12 weeks, Blinding maintained until dose switching from upadacitinib 30 mg to 15 mg; earliest switch at week 132
- Double-blind
- Placebo-controlled phase of 12 weeks
- Blinding maintained until dose switching from upadacitinib 30 mg to 15 mg; earliest switch at week 132
Primary result
As reported in the abstract
CDAI clinical remission · 5 years
Safety
Adverse events · week 260
- Types and frequency of AEs comparable with week 84 and other upadacitinib studies
- Incidences of any AEs, serious AEs, infection and serious infection numerically higher on upadacitinib 15 and 30 mg than on 7.5 mg
Original publication
Long-term safety and efficacy of upadacitinib in Japanese patients with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying antirheumatic drugs: 5-year results from the SELECT-SUNRISE randomised controlled trial. RMD Open. Published 4 November 2025. doi:10.
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