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Clinical effectiveness of iguratimod based on real-world data of patients with rheumatoid arthritis

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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.

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Authors and Affiliations

  1. Division of Rheumatology, Department of Internal Medicine, School of Medicine, Fujita Health University, Toyoake, 470-1192, Aichi, Japan

    Satoshi Mizutani, Shunji Yoshida & Hidekata Yasuoka

  2. Department of Internal Medicine, Yokkaichi Hazu Medical Center, Yokkaichi, 510-0016, Mie, Japan

    Satoshi Mizutani, Hitoshi Kodera & Yoshiko Sato

  3. Division of Rheumatology, Department of Internal Medicine, Toho University School of Medicine, Ota-ku, 143-8541, Tokyo, Japan

    Satoshi Mizutani & Toshihiro Nanki

Authors
  1. Satoshi Mizutani
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Correspondence to Satoshi Mizutani.

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Conflict of interest

SM received lectures fees from Janssen Pharmaceutical K.K.; Bristol-Myers Squibb K.K.; Chugai Pharmaceutical Co.; Mitsubishi-Tanabe Pharma Co.; Novartis Pharma K.K.; and Ono Pharmaceutical Co. TN received grant/research support from Chugai Pharmaceutical Co.; Eisai Co., Ltd.; Takeda Pharmaceutical Co., Ltd.; Teijin Pharma Ltd.; Eli Lilly Japan K.K.; Bristol-Myers Squibb K.K.; AbbVie GK.; Ono Pharmaceutical Co., Ltd.; Novartis Pharma K.K.; Asahikasei Pharma Corp.; Mitsubishi-Tanabe Pharma Co.; Astellas Pharma Inc.; Ayumi Pharmaceutical Corporation; Pfizer Japan Inc.; Daiichi Sankyo Co., Ltd.; Shionogi & Co., Ltd.; Sanofi K.K.; Nippon Kayaku Co., Ltd.; Yutoku Pharmaceutical Ind. Co., Ltd.; and Actelion Pharmaceutical Japan Ltd.; consultant fees from UCB Japan Co., Ltd.; Eisai Co., Ltd.; Ono Pharmaceutical Co., Ltd.; Gilead Science Inc.; and Chugai Pharmaceutical Co.; and speaker fees from Mitsubishi-Tanabe Pharma Co.; Chugai Pharmaceutical Co.; Eisai Co., Ltd.; Astellas Pharma Inc.; Janssen Pharmaceutical K.K.; Ayumi Pharmaceutical Corporation; Pfizer Japan Inc.; Asahikasei Pharma Corp.; Sanofi K.K., Daiichi Sankyo Co., Ltd.; Otsuka Pharmaceutical Co., Ltd.; and AbbVie GK. HY received consulting fees, speaking fees, and/or honoraria from AbbVie GK.; Asahikasei Pharma Corp.; Astellas Pharma Inc.; Daiichi Sankyo Co., Ltd.; Eisai Co., Ltd.; Kissei Pharmaceutical Co., Ltd.; Takeda Pharmaceutical Co., Ltd.; Mitsubishi-Tanabe Pharma Co.; Chugai Pharmaceutical Co.; Novartis Pharma K.K.; Eli Lilly Japan K.K.; Pfizer Japan Inc.; Janssen Pharmaceutical K.K.; Sanofi K.K.; Teijin Pharma Ltd.; Boehringer Ingelheim International GmbH; and Bayer Yakuhin, Ltd.; and research grants from Mitsubishi-Tanabe Pharma Co.; Takeda Pharmaceutical Co.; Daiichi Sankyo Co., Ltd.; Chugai Pharmaceutical Co.; Bristol-Myers Squibb K.K.; MSD K.K.; and Astellas Pharma Inc. HK, YS, and SY have no conflicts of interest to declare.

Ethical standards

We declare that this article has not been published and is not under consideration for publication elsewhere, and that there is no prior publication or the submission elsewhere of any part of the work. All the authors read and approved the final manuscript. This study was approved by the Ethics Committee for Clinical Investigation of the Fujita Health University School of Medicine (no. HM19-193) and the Yokkaichi Hazu Medical Center (no. 108) and was undertaken following the Principles of the Declaration of Helsinki amended during the 64th WMA General Assembly, Fortaleza, Brazil 2013.

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Mizutani, S., Kodera, H., Sato, Y. et al. Clinical effectiveness of iguratimod based on real-world data of patients with rheumatoid arthritis. Clin Rheumatol 40, 123–132 (2021). https://doi.org/10.1007/s10067-020-05208-y

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