Spondyloarthritis & psoriatic arthritis
Efficacy and safety of upadacitinib in patients with ankylosing spondylitis refractory to biologic therapy: 1-year results from the open-label extension of a phase III study
Authors' conclusion
Upadacitinib 15 mg QD demonstrated sustained improvement up to 52 weeks in bDMARD-IR patients with AS. Efficacy was generally similar in patients with lack of efficacy versus intolerance to bDMARDs and prior TNFi versus IL-17i exposure.
Study context
- Population
- Patients ≥ 18 years with active ankylosing spondylitis (AS) meeting modified New York criteria and bDMARD-IR366 completed 52 weeks
- Participants
- 420 patients
- Comparison
- Continuous upadacitinib 15 mg QD vs placebo switched to upadacitinib 15 mg QD
- Continuous upadacitinibn = 181
- Placebo to upadacitinibn = 185reference
Methodological detailsdouble-blind placebo-controlled period for 14 weeks, non-responder imputation with multiple imputation (NRI-MI) and as observed analyses, MMRM
- Double-blind placebo-controlled period for 14 weeks
- NRI-MI and as observed analyses
- MMRM
Primary result
As reported in the abstract
ASAS40 (NRI-MI) · week 52
Further findings
ASDAS LDA (NRI-MI) · week 52
ASDAS ID (NRI-MI) · week 52
| Outcome | Continuous upadacitinib | Placebo to upadacitinib |
|---|---|---|
| Change from baseline in total back pain (MMRM) · week 52 | −4.5 | −4.3 |
| Change from baseline in nocturnal back pain (MMRM) · week 52 | −4.6 | −4.4 |
| Change from baseline in BASFI (MMRM) · week 52 | −3.6 | −3.5 |
Subgroups (bDMARD lack of efficacy vs intolerance; prior TNFi vs IL-17i)
- Subgroup analyses were consistent with the overall study population
Safety
Adverse events · week 52
- No new safety risks were identified
Original publication
Efficacy and safety of upadacitinib in patients with ankylosing spondylitis refractory to biologic therapy: 1-year results from the open-label extension of a phase III study. Arthritis Res Ther. Published 18 September 2023. doi:10.
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