Upadacitinib as monotherapy in patients with rheumatoid arthritis and prior inadequate response to methotrexate: results at 260 weeks from the SELECT-MONOTHERAPY randomised study
Authors' conclusion
No new safety risks were identified with long-term UPA treatment. UPA monotherapy was efficacious in treating rheumatoid arthritis through week 260.
Study context
- Population
- Patients with RA and inadequate response to MTX598 entered long-term extension
- Participants
- 648 patients
- Comparison
- Upadacitinib (UPA) 15 mg vs UPA 30 mg monotherapy
Methodological detailsphase III, open-label long-term extension, non-responder imputation, Following a protocol amendment, all cohorts switched to open-label UPA15
- Phase III
- Open-label long-term extension
- Non-responder imputation
- Following a protocol amendment, all cohorts switched to open-label UPA15
Primary result
As reported in the abstract
Low disease activity (non-responder imputation (NRI)) in patients treated continuously with UPA · week 260
| Group | Value | CDAI ≤10 | DAS28-CRP ≤3.2 |
|---|---|---|---|
| UPA15 | 93 events | 93/217 | 90/217 |
| UPA30 | 91 events | 91/215 | 94/215 |
Value
UPA1593 events
UPA3091 events
CDAI ≤10
UPA1593/217
UPA3091/215
DAS28-CRP ≤3.2
UPA1590/217
UPA3094/215
- Patients treated continuously with UPA achieving low disease activity
- >39%
Further findings
- Efficacy was similar among patients switching from methotrexate to UPA
Safety
Discontinuation of study drug by week 260
- Discontinued study drug
- 249 (41.6%)
- Due to adverse events
- 14.5%
- Consent withdrawal
- 9.9%
- Lost to follow-up
- 3.3%
- Lack of efficacy
- 2.2%
- COVID-19
- 0.7%
- Other reasons
- 11.0%
Herpes zoster, non-melanoma skin cancer, hepatic disorder, neutropenia, lymphopenia, creatine kinase elevation
- Rates higher with UPA30 vs UPA15
- Exposure-adjusted event and incidence rates
Original publication
Upadacitinib as monotherapy in patients with rheumatoid arthritis and prior inadequate response to methotrexate: results at 260 weeks from the SELECT-MONOTHERAPY randomised study. RMD Open. Published 11 May 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →