Session Type: Poster Session D
Session Time: 8:30AM-10:30AM
Background/Purpose: Iguratimod, also known as T-614, is a new type of small molecule compound with anti-inflammatory and immunomodulatory effects; It was listed in China(2011) and Japan(2012) for the treatment of rheumatoid arthritis；its safety and effectiveness have been verified in patients with rheumatoid arthritis. As Iguratimod could inhibit the production of inflammatory cytokines, such as IL-1 and TNF; block the IL-17 signalling pathway and inhibit cyclooxygenase, Iguratimod may be effective in the treatment of SPA/AS. However, no rigorous clinical research exists to confirm this speculation. Therefore, this study aimed to evaluate the efficacy and safety of Iguratimod in patients with active SpA.
Methods: Subjects with active SpA were enrolled and randomly divided into two groups at a ratio of 1:2 (placebo vs. Iguratimod). On the basis of non-steroidal anti-inflammatory drugs, combined treatment with Iguratimod or placebo, followed by follow-up every 4 weeks for 24 weeks. The primary efficacy endpoint was to evaluate the alleviation rate of ASAS20; the important improvement of ASDAS and the efficacy of spinal mobility, physical function and quality of life at the 24th week.
Results: A total of 48 cases in the Iguratimod group and 25 cases in the placebo group were included in the final analysis. On the 24th week, the percentage of responders to ASAS20 (80% vs. 44%) and ASAS40 (56% vs. 20%) treated with Iguratimod were significantly higher than that in the placebo group (P < 0.05). Twelve cases had gastrointestinal discomfort, of which eight were in the Iguratimod group (16.7%, one case withdrew from the study due to diarrhoea) and four were in the placebo group (16.0%). No significant difference was found between the two groups (P < 0.05). Three cases of elevated transaminase were observed in the Iguratimod group and none in the placebo group, with no significant difference (P < 0.05).
Conclusion: Iguratimod could significantly reduce the symptoms and signs of patients with active SpA. It could improve the physical function and quality of life of these patients and the overall safety and tolerance are good.
To cite this abstract in AMA style:li y, Li K, Zhao Z, wang y, Jin J, zhang j, Zhu J, huang f. Randomised, Double-blind, Placebo-controlled Study of Iguratimod in the Treatment of Active Spondyloarthritis [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 10). https://acrabstracts.org/abstract/randomised-double-blind-placebo-controlled-study-of-iguratimod-in-the-treatment-of-active-spondyloarthritis/. Accessed August 8, 2022.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/randomised-double-blind-placebo-controlled-study-of-iguratimod-in-the-treatment-of-active-spondyloarthritis/