Spondyloarthritis & psoriatic arthritis
Efficacy and safety of iguratimod combined with celecoxib in active axial spondyloarthritis: a randomized, double-blind, placebo-controlled study
Authors' conclusion
In the treatment of active axSpA, iguratimod has a potential NSAID-sparing effect, and may also reduce magnetic resonance imaging-assessed bone marrow oedema in sacroiliac joints.
Study context
- Population
- Adults with active axial spondyloarthritis (axSpA)35 completed and analysed
- Comparison
- Iguratimod 25 mg twice daily vs placebo, both with celecoxib
- Primary endpoint
- Co-primary: ASAS20 at 4 weeks and non-steroidal anti-inflammatory drug (NSAID) index at 28 weeks
- Follow-up
- 4 and 28 weeks
Methodological detailsdouble-blind, placebo-controlled
- Double-blind
- Placebo-controlled
Primary result
As reported in the abstract
NSAID index · 28 weeks
Iguratimod
43.8
median · IQR 34.9–51.8
Placebo
68.9
median · IQR 42.5–86.4
P = 0.025
Further findings
Median
| Outcome | Iguratimod | Placebo | P value |
|---|---|---|---|
| Improvement in SPARCC scores for sacroiliac jointsMore improvement with iguratimod | 71% (IQR 54–100%) | 40% (IQR 0–52%) | P = 0.006 |
Disease activity score changes
- Similar between iguratimod and placebo
Safety
- Severe adverse events
- 0
- Iguratimod + celecoxib not associated with greater risk of adverse effects than celecoxib monotherapy
Original publication
Efficacy and safety of iguratimod combined with celecoxib in active axial spondyloarthritis: a randomized, double-blind, placebo-controlled study. Scand J Rheumatol. Published 4 June 2024. doi:10. 1080/ 03009742. 2024. 2346411
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