Efficacy and safety of upadacitinib in patients with rheumatoid arthritis and inadequate response or intolerance to biological treatments: results through 5 years from the SELECT-BEYOND study
Authors' conclusion
Upadacitinib 15/30 mg continued to be effective in treating clinical and functional outcomes in patients with RA. The safety profile observed over 5 years was consistent with earlier study-specific and integrated assessments of upadacitinib treatment.
Study context
- Population
- Patients with rheumatoid arthritis (RA) refractory to ≥1 bDMARD418 (84%) entered the long-term extension (LTE)
- Participants
- 498 patients
- Comparison
- Upadacitinib 15 mg vs 30 mg once daily
- Upadacitinib 15 mgn = 80
- Upadacitinib 30 mgn = 81
Methodological detailsplacebo-controlled through week 12, as observed and non-responder imputation analyses
- Placebo-controlled through week 12
- As observed and non-responder imputation analyses
Primary result
As reported in the abstract
CDAI remission / low disease activity (as observed) · week 260
| Outcome | Upadacitinib 15 mg | Upadacitinib 30 mg |
|---|---|---|
| CDAI remission / low disease activity (as observed) · week 260 | 36% | 36% |
| CDAI low disease activity | 81% | 77% |
Further findings
Clinical Disease Activity Index (CDAI) improvement >12 among patients starting in high disease activity · week 260
- ≈47% with upadacitinib 15/30 mg
Functional and pain-related outcomes
- Comparable improvements with both doses
Safety
Anaemia, herpes zoster and creatine phosphokinase elevation · up to 5 years
- Numerically higher rates with upadacitinib 30 mg vs 15 mg
- No new safety issues identified
Original publication
Efficacy and safety of upadacitinib in patients with rheumatoid arthritis and inadequate response or intolerance to biological treatments: results through 5 years from the SELECT-BEYOND study. RMD Open. Published 25 July 2024. doi:10. 1136/ rmdopen-2023-003918
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