Satoshi Mizutani1,2,3, Hitoshi Kodera4, Yoshiko Sato4, Toshihiro Nanki5, Shunji Yoshida6, Hidekata Yasuoka6. 1. Division of Rheumatology, Department of Internal Medicine, School of Medicine, Fujita Health University, Toyoake, 470-1192, Aichi, Japan. satoshi.mizutani@med.toho-u.ac.jp. 2. Department of Internal Medicine, Yokkaichi Hazu Medical Center, Yokkaichi, 510-0016, Mie, Japan. satoshi.mizutani@med.toho-u.ac.jp. 3. Division of Rheumatology, Department of Internal Medicine, Toho University School of Medicine, Ota-ku, 143-8541, Tokyo, Japan. satoshi.mizutani@med.toho-u.ac.jp. 4. Department of Internal Medicine, Yokkaichi Hazu Medical Center, Yokkaichi, 510-0016, Mie, Japan. 5. Division of Rheumatology, Department of Internal Medicine, Toho University School of Medicine, Ota-ku, 143-8541, Tokyo, Japan. 6. Division of Rheumatology, Department of Internal Medicine, School of Medicine, Fujita Health University, Toyoake, 470-1192, Aichi, Japan.
Abstract
OBJECTIVES: Iguratimod (IGU) is a conventional synthetic disease-modifying drug that has been approved based on its additive effects with methotrexate (MTX) for the treatment of rheumatoid arthritis (RA). The objective of the study is to establish the effectiveness of IGU with versus IGU without MTX irrespective of whether MTX is well tolerated or not by the patients. METHODS: Disease activity scores in 177 RA patients treated using IGU were retrospectively evaluated at baseline and after 4, 12, and 24 weeks, and adverse events (AEs) were noted. RESULTS: IGU reduced the disease activity parameters, disease activity score (DAS)-ESR, DAS-CRP, the simplified disease activity index (SDAI), and clinical disease activity index (CDAI) in the concomitant MTX and non-MTX, female and male, and young and elderly patient groups after 24 weeks. Multivariate analysis demonstrated that IGU was more effective with concomitant MTX and in elderly and male patients. Severe AEs were observed only in the elderly group: two cases of pneumonia, 1 of pneumocystis pneumonia, 1 of heart failure, and 1 of salivary gland adenoma. CONCLUSIONS: IGU is effective for RA, especially with concomitant MTX, and in elderly and male patients. Key Points • Iguratimod is effective for RA, especially with concomitant MTX, and in elderly and male patients. • Since all serious adverse events were in the elderly group in this study, sufficient monitoring for adverse events, especially for elderly RA patients, is needed during iguratimod therapy.
OBJECTIVES: Iguratimod (IGU) is a conventional synthetic disease-modifying drug that has been approved based on its additive effects with methotrexate (MTX) for the treatment of rheumatoid arthritis (RA). The objective of the study is to establish the effectiveness of IGU with versus IGU without MTX irrespective of whether MTX is well tolerated or not by the patients. METHODS: Disease activity scores in 177 RApatients treated using IGU were retrospectively evaluated at baseline and after 4, 12, and 24 weeks, and adverse events (AEs) were noted. RESULTS: IGU reduced the disease activity parameters, disease activity score (DAS)-ESR, DAS-CRP, the simplified disease activity index (SDAI), and clinical disease activity index (CDAI) in the concomitant MTX and non-MTX, female and male, and young and elderly patient groups after 24 weeks. Multivariate analysis demonstrated that IGU was more effective with concomitant MTX and in elderly and male patients. Severe AEs were observed only in the elderly group: two cases of pneumonia, 1 of pneumocystis pneumonia, 1 of heart failure, and 1 of salivary gland adenoma. CONCLUSIONS: IGU is effective for RA, especially with concomitant MTX, and in elderly and male patients. Key Points • Iguratimod is effective for RA, especially with concomitant MTX, and in elderly and male patients. • Since all serious adverse events were in the elderly group in this study, sufficient monitoring for adverse events, especially for elderly RApatients, is needed during iguratimod therapy.
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