Upadacitinib monotherapy versus methotrexate monotherapy in patients with rheumatoid arthritis: efficacy and safety through 5 years in the SELECT-EARLY randomized controlled trial
Authors' conclusion
Upadacitinib showed better clinical responses versus MTX in patients with RA throughout the 5-year trial. Higher rates of several AEs were observed with upadacitinib, especially in the 30 mg group, compared to MTX.
Study context
- Population
- MTX-naïve patients with moderately to severely active rheumatoid arthritis (RA)775 (82%) entered long-term extension (LTE)
- Participants
- 945 patients
- Comparison
- Upadacitinib 15 mg or 30 mg monotherapy vs MTX monotherapy
Methodological detailsrescue therapy at week 26, as observed and non-responder imputation analyses
- Rescue therapy at week 26
- As observed and non-responder imputation analyses
Primary result
As reported in the abstract
CDAI remission (as observed) · week 260
Further findings
| Outcome | P value |
|---|---|
| CDAI, DAS28(CRP) and ACR responses (NRI) · week 260Upadacitinib vs MTX · better responses with upadacitinib; all comparisons · non-responder imputation | nominal P < .001 |
Structural joint progression · through week 260
- Numerically greater inhibition with upadacitinib vs MTX
Safety
Treatment-emergent adverse events (TEAEs), serious AEs and AEs leading to discontinuation · 5 years
- Most numerically higher with upadacitinib 30 mg
Serious infections, herpes zoster, creatine phosphokinase elevation, nonmelanoma skin cancer, neutropenia · 5 years
- Rates numerically higher with upadacitinib than MTX
Original publication
Upadacitinib monotherapy versus methotrexate monotherapy in patients with rheumatoid arthritis: efficacy and safety through 5 years in the SELECT-EARLY randomized controlled trial. Arthritis Res Ther. Published 29 July 2024. doi:10.
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