Spondyloarthritis & psoriatic arthritis

Efficacy and safety of iguratimod combined with celecoxib in active axial spondyloarthritis: a randomized, double-blind, placebo-controlled study

Scand J RheumatolPublished Randomised controlled trial

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

OutcomeIguratimodPlaceboP value
Improvement in SPARCC scores for sacroiliac jointsMore improvement with iguratimod71% (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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