Spondyloarthritis & psoriatic arthritis
Efficacy and safety of upadacitinib in patients with active ankylosing spondylitis refractory to biologic therapy: 2-year clinical and radiographic results from the open-label extension of the SELECT-AXIS 2 study
Authors' conclusion
Upadacitinib efficacy, including very low rates of radiographic progression, was demonstrated through 104 weeks in treatment-refractory patients with active AS. Treatment was well tolerated, with no newly identified safety signals.
Study context
- Population
- Patients with active ankylosing spondylitis (AS) and inadequate response/intolerance to bDMARDs (bDMARD-IR)409 entered open-label extension (OLE)
- Participants
- 420 patients
- Comparison
- Continuous upadacitinib vs placebo switched to upadacitinib at week 14
- Continuous upadacitinibn = 163
- Placebo to upadacitinibn = 168reference
Methodological detailsas observed with non-responder imputation (AO with non-responder imputation (AO-NRI)), AO-MMRM, subgroup analyses by prior TNF/IL-17 inhibitor exposure
- As observed with non-responder imputation (AO-NRI)
- AO-MMRM
- Subgroup analyses by prior TNF/IL-17 inhibitor exposure
Primary result
As reported in the abstract
ASAS 40% response (AO-NRI) · week 104
Further findings
Mean
| Outcome | Continuous upadacitinib | Placebo to upadacitinib |
|---|---|---|
| ASDAS, mean change from baseline (AO-MMRM) · week 104AO-MMRM | −2.1 | −2.0 |
| Total back pain, mean change from baseline (AO-MMRM) · week 104AO-MMRM | −4.9 | −4.6 |
No radiographic progression (modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) mean change from baseline < 2) · week 104
- Patients with no radiographic progression
- Over 93.0%
Safety
Overall TEAE rate (≥ 1 upadacitinib dose through week 104)
- Overall TEAE rate
- 165.2 E/100 patient-years (PY)
MACE and VTE · week 104
E/100 PY
- MACE
- 0.3
- VTE
- 0.3
Original publication
Efficacy and safety of upadacitinib in patients with active ankylosing spondylitis refractory to biologic therapy: 2-year clinical and radiographic results from the open-label extension of the SELECT-AXIS 2 study. Arthritis Res Ther. Published 12 November 2024. doi:10.
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