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

Abstract

Objective

To assess the efficacy and safety of iguratimod in adult patients with active axial spondyloarthritis (axSpA).

Method

This randomized, double-blind, placebo-controlled clinical trial lasted for 28 weeks. Patients with axSpA were randomized 1:1 to receive iguratimod 25 mg twice daily or a placebo. All patients also took celecoxib 200 mg twice daily for the first 4 weeks and on demand from 4 to 28 weeks. The primary endpoints were ASAS20 at 4 weeks and the non-steroidal anti-inflammatory drug (NSAID) index at 28 weeks. Other assessment variables included ASAS40, ASAS5/6 response rates, Spondyloarthritis Research Consortium of Canada (SPARCC) scores, and adverse events.

Results

In total, 35 patients completed the study and were included for analyses. The median (interquartile range) NSAID index was 43.8 (34.9–51.8) in the iguratimod group, which is significantly lower than 68.9 (42.5–86.4) in the placebo group (p = 0.025). ASAS response rates and changes in disease activity scores were similar between the iguratimod and placebo groups. Patients in the iguratimod group had more improvement in median (interquartile range) SPARCC scores for sacroiliac joints than did those in the placebo group [71% (54–100%) vs 40% (0–52%), p = 0.006]. Iguratimod combined with celecoxib was not associated with a greater risk of adverse effects than was monotherapy with celecoxib. No severe adverse events occurred.

Conclusions

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. Iguratimod provides an additional treatment option for patients with active axSpA.Clinical trial registration numberChiCTR2000029112, Chinese Clinical Trial Registry (http://www.chictr.org.cn)

Acknowledgements

The authors thank Dr Trish Reynolds, MBBS, FRACP, from Liwen Bianji (Edanz) (http://www.liwenbianji.cn/), for editing the English text of a draft of this manuscript. The authors would like to thank Dr Lihua Wang and Dr Qiyuan Wang (radiologists) for their contribution in conducting SPARCC score, and all physicians and patients who participated in this study.

Disclosure statement

The authors declare that they have no conflicts of interest.

Ethics statement

The study was approved by the Ethics Committee of the Second Affiliated Hospital of Zhejiang University School of Medicine and was performed in accordance with the Declaration of Helsinki. Informed consent was obtained from all patients before participation in the study.

Additional information

Funding

This work is supported by the National Natural Science Foundation of China [numbers 81501388 and 82271817] and the Natural Science Foundation of Zhejiang Province [numbers LY20H100007 and LY22H100004].