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

Abstract

Abstract Background The current treatment options for axial spondyloarthritis (axSpA) are limited. The purpose of this study was to assess the efficacy and safety of iguratimod in adult patients with active axSPA.Methods The cohort of this randomized, double-blind, placebo-controlled clinical trial comprised adult patients who fulfilled the 2009 Assessment of SpondyloArthritis International Society (ASAS) criteria for axSpA or the 1984 New York criteria for ankylosing spondylitis. The trial lasted for 28 weeks. Patients 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 Weeks 4 to 28. The primary endpoint was the non-steroidal anti-inflammatory drug (NSAID) index in the two treatment groups. Other assessment variables included ASAS20, ASAS40, and ASAS5/6 response rates, Bath Ankylosing Spondylitis Disease Activity Index and Ankylosing Spondylitis Disease Activity Scores, Spondyloarthritis Research Consortium of Canada (SPARCC) scores, and adverse events.Results A total of 31 patients completed the study and were included for analyses. The NSAID index was 43.8 (34.9–51.8) in the iguratimod group, which is significantly lower than the 68.9 (42.5–86.4) in the placebo group (p = 0.025). ASAS response rates and changes in disease activity scores were all similar between the iguratimod and placebo groups. Patients in the iguratimod group had more improvement in SPARCC scores for sacroiliac joints than did those in the placebo group (73% [68–100%] vs. 40% [0–54%], p = 0.013). 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 Iguratimod may be an effective and safe treatment for adult patients with active axSPA, helping to reduce the dose of NSAIDs and alleviate inflammation in sacroiliac joints. Iguratimod provides an additional treatment option for patients with active axSPA.