AB0439 Efficacy at three years of daily clinical use of iguratimod in patients with rheumatoid arthritis
Authors: T Suto, Y Yonemoto, K Okamura, M Tachibana, C Okura, M Matsushita, K Takeuchi, K Otsuka, K Ayabe, T Kaneko, Y Tamura, M Inoue, H Inoue, H Chikuda
Journal: Annals of the Rheumatic Diseases (2017)

<h3>Background</h3> Iguratimod (IGU) is a small-molecule antirheumatic drug that was developed in Japan and is currently only approved for treatment of rheumatoid arthritis (RA) in Japan and China. IGU suppresses tumor necrosis factor-alpha-induced production of interleukin (IL)-6, IL-8 and monocyte chemoattractant protein 1 via the inhibition of nuclear factor-kappa B activation in cultured human synovial cells and human acute monocytic leukemia cells. There are some reports about the efficacy and safety of IGU in patients with RA. However, the assessment about efficacy of the clinical use of IGU has mainly been restricted to short-term (within one year) outcome. <h3>Objectives</h3> The purpose of this study was to assess the efficacy of IGU in 3 years <h3>Methods</h3> Sixty-nine RA patients (14 males and 55 females, mean age of 63.9 years, mean disease duration of 14.9 years) were enrolled in this study. The clinical course of RA was evaluated during 3 years. The patients who discontinued the IGU therapy were analyzed by the last observation carried forward method. <h3>Results</h3> The survival rate at 3 years was 49.3%, and 8 patients discontinued the IGU therapies due to insufficient response, 12 patients due to adverse events such as exanthema, pneumonitis or hepatic disorder, and other patients based on their requests. The DAS28-CRP, DAS28-ESR, SDAI and CDAI significantly decreased at 6 months, 1, 2, 3 years compared with baseline. The low DAS28-CRP at 3 months and younger age were associated to the continuation of IGU. Furthermore, 27 patients (39.1%) were in remission at 3 years. In the remission achievement group, the DAS28-CRP and the usage rate of prednisolone at baseline were significantly lower and patients9 age was younger. A logistic regression analysis revealed the low DAS28-CRP and low usage rate of prednisolone at baseline were significant factors contributing to the achievement of a clinical remission at 3 years. <h3>Conclusions</h3> We assessed middle-term outcome of the clinical use of iguratimod therapy in RA patients. The low DAS28-CRP and low usage rate of prednisolone at the initiation of IGU were significant factors of clinical remission achievement at 3 years. <h3>References</h3> Duan XW, Zhang XL, Mao SY, Shang JJ, Shi XD. Efficacy and safety evaluation of a combination of iguratimod and methotrexate therapy for active rheumatoid arthritis patients: a randomized controlled trial. Clin Rheumatol. 2015 Sep;34(9):1513–9. Mimori T, Harigai M, Atsumi T, Fujii T, Kuwana M, Matsuno H, Momohara S, Takei S, Tamura N, Takasaki Y, Ikeuchi S, Kushimoto S, Koike T. Safety and effectiveness of 24-week treatment with iguratimod, a new oral disease-modifying antirheumatic drug, for patients with rheumatoid arthritis: interim analysis of a post-marketing surveillance study of 2679 patients in Japan. Mod Rheumatol. 2016 Dec 21:1–11. Okamura K, Yonemoto Y, Suto T, Okura C, Takagishi K. Efficacy at 52 weeks of daily clinical use of iguratimod in patients with rheumatoid arthritis. Mod Rheumatol. 2015 Jul;25(4):534–9. <h3>Disclosure of Interest</h3> None declared