Spondyloarthritis & psoriatic arthritis
Efficacy and safety of upadacitinib in patients with active psoriatic arthritis and axial involvement: results from two phase 3 studies
Authors' conclusion
PsA patients with axial involvement determined by predefined criteria showed greater BASDAI and ASDAS responses with UPA15 versus placebo, and numerically similar/greater responses versus ADA. Safety results were generally comparable between patients with or without axial involvement.
Study context
- Population
- Psoriatic arthritis (PsA) patients with axial involvement by investigator judgement alone, or investigator judgement and patient-reported outcome (PRO)-based criteria (BASDAI ≥ 4 and BASDAI Q2 ≥ 4)
- Comparison
- Upadacitinib 15 mg vs placebo or adalimumab 40 mg
- Primary endpoint
- BASDAI50 (≥ 50% improvement from baseline)
- Follow-up
- Week 24
Methodological detailsnominal P-values
- Nominal P-values
Primary result
As reported in the abstract
UPA15 vs Placebo: P < 0.0001 · UPA15 vs ADA: P = 0.015
Further findings
BASDAI50, SELECT-PsA 1, axial involvement by investigator judgement and PRO-based criteria · week 24 — UPA15 vs Placebo · nominal P-value
P < 0.0001
| Outcome | P value |
|---|---|
| BASDAI50, SELECT-PsA 1, axial involvement by investigator judgement and PRO-based criteria · week 24UPA15 vs ADA · nominal P-value | P = 0.074 |
BASDAI50, SELECT-PsA 2 · week 24
- Comparable findings in SELECT-PsA 2
Prevalence of axial involvement
- Investigator judgement alone, SELECT-PsA 1
- 30.9%
- Investigator judgement alone, SELECT-PsA 2
- 35.7%
- Investigator judgement and PRO-based criteria, SELECT-PsA 1
- 22.6%
- Investigator judgement and PRO-based criteria, SELECT-PsA 2
- 28.6%
Additional BASDAI and Ankylosing Spondylitis Disease Activity Score (ASDAS) endpoints · weeks 12 and 24; week 56
- Similar results with UPA15 at weeks 12 and 24, with improvements maintained at week 56
Safety
Treatment-emergent adverse events (TEAEs) · through week 56
- Rates of TEAEs generally similar across sub-groups irrespective of axial involvement status
Original publication
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