Long-term safety and efficacy of upadacitinib compared with adalimumab in patients with rheumatoid arthritis: 7-year data from the SELECT-COMPARE study
Authors' conclusion
The safety profile of upadacitinib remained consistent with previous analyses, with no new safety concerns through 7 years. Upadacitinib and adalimumab (continuous or rescue treatment) maintained disease activity targets throughout the 7-year treatment period.
Study context
- Population
- Patients with rheumatoid arthritis (RA) and inadequate response to methotrexate (MTX)
- Comparison
- Upadacitinib 15 mg once daily vs adalimumab 40 mg every other week
Methodological detailsplacebo-controlled, on background MTX, rescue to alternate therapy, 10-year extension, NRI and as observed analyses
- Placebo-controlled
- On background MTX
- Rescue to alternate therapy
- 10-year extension
- NRI and as observed analyses
Primary result
As reported in the abstract
week 372
- Upadacitinib generally well tolerated, TEAE rates comparable to adalimumab
- Responses with continuous upadacitinib or adalimumab maintained through 372 weeks
Further findings
| Outcome | Upadacitinib | Adalimumab |
|---|---|---|
| CDAI remission (≤2.8) · week 372Events/value as observed (AO) | 63.0% | 53.5% |
| NRI | 142/651 (21.8%) | 43/327 (13.1%) |
| DAS28-CRP <2.6 · week 372Events/value as observed (AO) | 83.2% | 72.8% |
| NRI | 172/651 (26.4%) | 55/327 (16.8%) |
Initial non-responders/incomplete responders switched · week 336 post switch
- Benefited from switching, improvements maintained through week 336 post switch, without additional safety concerns
Safety
Treatment-emergent adverse events (TEAEs) · 7 years
- Upadacitinib TEAE rates comparable to adalimumab
- Numerically higher rates with upadacitinib of herpes zoster, CPK elevation, non-melanoma skin cancer, lymphopenia and hepatic disorders
Original publication
Long-term safety and efficacy of upadacitinib compared with adalimumab in patients with rheumatoid arthritis: 7-year data from the SELECT-COMPARE study. RMD Open. Published 24 June 2026. doi:10.
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