Spondyloarthritis & psoriatic arthritis
Upadacitinib in active non-radiographic axial spondyloarthritis: 2-year data from the phase 3 SELECT-AXIS 2 study
Authors' conclusion
Treatment with upadacitinib demonstrated consistent improvement and maintenance of treatment effect across efficacy endpoints through 2 years; no new safety signals were identified with additional exposure.
Study context
- Population
- Adults with active non-radiographic axial spondyloarthritis (nr-axSpA) meeting 2009 ASAS classification criteria with objective signs of inflammation on sacroiliac joint magnetic resonance imaging (MRI) and/or high-sensitivity CRP224 completed 104 weeks
- Participants
- 313 adults
- Comparison
- Continuous upadacitinib 15 mg QD vs placebo switched to upadacitinib at week 52
Methodological detailsdouble-blind, placebo-controlled to week 52, open-label upadacitinib 15 mg QD after week 52
- Double-blind
- Placebo-controlled to week 52
- Open-label upadacitinib 15 mg QD after week 52
Primary result
As reported in the abstract
Efficacy with continuous upadacitinib (AO-NRI) · week 104
| Group | Value | ASAS40 response | ASDAS low disease activity | ASDAS inactive disease |
|---|---|---|---|---|
| Continuous upadacitinib | 57.1% | 57.1% | 59.0% | 31.4% |
Continuous upadacitinib
Value57.1%
ASAS40 response57.1%
ASDAS low disease activity59.0%
ASDAS inactive disease31.4%
Safety
Exposure-adjusted event rates (events/100 patient-years (PY)), all upadacitinib-exposed patients through week 104
- Treatment-emergent adverse events (TEAEs)
- 207.5
- Serious adverse events (AEs)
- 8.7
- AEs leading to study drug discontinuation
- 5.3
- TEAEs of special interest broadly consistent with those reported through week 52
- 286 patients exposed to ≥ 1 dose of upadacitinib
- 378.3 PY of exposure
Original publication
Upadacitinib in active non-radiographic axial spondyloarthritis: 2-year data from the phase 3 SELECT-AXIS 2 study. Arthritis Res Ther. Published 4 February 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →