Upadacitinib in Rheumatoid Arthritis and Inadequate Response to Conventional Synthetic Disease-Modifying Antirheumatic Drugs: Efficacy and Safety Through 5 Years (SELECT-NEXT)
Authors' conclusion
The 5-year benefit-risk profile for UPA in RA remains favorable.
Study context
- Population
- Patients with rheumatoid arthritis (RA) on stable csDMARDs611 (92%) entered the long-term extension (LTE)
- Comparison
- Upadacitinib (UPA) 15 mg QD vs UPA 30 mg QD
Methodological detailsphase III, placebo-controlled for 12 weeks, blinded until dose switching, as observed, Earliest switch from UPA 30 mg QD to UPA 15 mg QD at week 168
- Phase III
- Placebo-controlled for 12 weeks
- Blinded until dose switching
- As observed
- Earliest switch from UPA 30 mg QD to UPA 15 mg QD at week 168
Primary result
As reported in the abstract
CDAI remission and DAS28-CRP <2.6, initially randomised to UPA · 5 years
| Outcome | UPA 15 mg QD | UPA 30 mg QD |
|---|---|---|
| CDAI remission | 51% | 43% |
| DAS28-CRP < 2.6 | 75% | 66% |
Further findings
ACR20/50/70 responses · week 60 through 5 years
- Proportions increased from week 60 through 5 years
- Results similar regardless of initial randomisation to UPA or placebo
Safety
Discontinuation of study drug by 5 years
- Discontinued study drug
- 271 (44%)
- Discontinued because of adverse events
- 16%
Treatment-emergent adverse events (TEAEs), malignancies (excluding NMSC), MACE, VTE · 5 years
- TEAEs consistent with earlier analyses and other SELECT studies
- Malignancies (excluding NMSC), MACE and VTE reported infrequently
- No new safety signals
Original publication
Upadacitinib in Rheumatoid Arthritis and Inadequate Response to Conventional Synthetic Disease-Modifying Antirheumatic Drugs: Efficacy and Safety Through 5 Years (SELECT-NEXT). J Rheumatol. Published 15 April 2024. doi:10.
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