The Safety Profile of Iguratimod in Real Clinical Practice: Analysis of 491 Patients with Rheumatoid Arthritis

Yukihiko Ikeda¹, Ryo Rokutanda¹, Sho Fukui¹, Haruki Sawada², Mitsuru Watanabe³, Ayako Koido³, Yuko Kataoka¹, Rui Kawato⁴, Haruyuki Yanaoka⁵, Masei Suda⁶, Yuri Ohara⁷, Hiromichi Tamaki¹, Hisanori Shimizu⁶, Tokutaro Tsuda¹, Ken-ichi Yamaguchi⁸, Mitsumasa Kishimoto¹ and Masato Okada¹, ¹Immuno-Rheumatology Center, St. Luke's International Hospital, Tokyo, Japan, ²Immuno-rheumatology Center, St. Luke's International Hospital, Tokyo, Japan, ³Immune-Rheumatology Center, St. Luke's International Hospital, Tokyo, Japan, ⁴Immuno rheumatology center, St. Luke's International Hospital, Tokyo, Japan, ⁵St. Luke's International Hospital, Tokyo, Japan, ⁶Immuno-Rheumatology Center, St luke's International hospital, Tokyo, Japan, ⁷Allergy & Rheumatology, St. Luke's International Hospital, Tokyo, Japan, ⁸Allergy and Rheumatology, St. Luke's International Hospital, Tokyo, Japan

Meeting: 2018 ACR/ARHP Annual Meeting

Keywords: adverse events and rheumatoid arthritis (RA), DMARDs

Session Information

Date: Monday, October 22, 2018

Session Title: Rheumatoid Arthritis – Treatments Poster II: PROs, Safety and Comorbidity

Session Type: ACR Poster Session B

Session Time: 9:00AM-11:00AM

The retention rate and safty profile of iguratimod in real clinical practice: Analysis of 456 patients with Rheumatoid arthritis.

Abstract

Background/Purpose:

Iguratimod is one of the disease modifying anti-rheumatic drugs (DMARDs) with anti-inflammatory and immunomodulatory actions. Previous RCTs shows the efficacy, but tolerance in daily practice is unknown. The aim of our study is to show the tolerability of iguratimod in real clinical practice.

Methods:

We retrospectively collected data of all the 456 RA patients treated with iguratimod from the electrical chart of St Luke’s International Hospital, Tokyo, Japan. We extracted following parametors during the period between April 2012 and March 2018; patients baseline characteristics, duration of using iguratimod, and reasons of discontiuation. To assess the safety of in iguratimod in patients with various complications, we further evaluated whether concomitant conditions such as, malignancy, tuberculosis, and interstitial lung disease, affect retention rate or not. Drug retention rates were calculated using the Kaplan-Meier method, which were analyzed using SPSS software version21.

Results:

During the study period, 74(16.2%) patients discontinued iguratimod. The reasons are 19(4.1%) renal injury, 15(3.2%) liver function abnormality, 13(2.9%) GI symptoms, 9(2.0%) skin, 3(0.6%) interstitial lung disease, 1 edema, 1 IgG depletion. All the adverse events recovered after discontinuation. The number of the patients who have malignancy, tuberculosis, and interstitial lung disease is 35(7.7%), 39(8.6%), and 38(8.3%), respectively. The retention rates show no significant difference between the groups with concomitant conditionsand without them.

Conclusion:

Iguratimod shows considerable retention rate in real clinical practice. Although adverse events of renal injury and liver function abnormality are common, all of them recovered after discontinuation. In addition, iguratimod is well tolerated even in patients with complications such as malignancy, tuberculosis, and interstitial lung disease.

Disclosure: Y. Ikeda, None; R. Rokutanda, None; S. Fukui, None; H. Sawada, None; M. Watanabe, None; A. Koido, None; Y. Kataoka, None; R. Kawato, None; H. Yanaoka, None; M. Suda, None; Y. Ohara, None; H. Tamaki, None; H. Shimizu, None; T. Tsuda, None; K. I. Yamaguchi, None; M. Kishimoto, None; M. Okada, None.

To cite this abstract in AMA style:

Ikeda Y, Rokutanda R, Fukui S, Sawada H, Watanabe M, Koido A, Kataoka Y, Kawato R, Yanaoka H, Suda M, Ohara Y, Tamaki H, Shimizu H, Tsuda T, Yamaguchi KI, Kishimoto M, Okada M. The Safety Profile of Iguratimod in Real Clinical Practice: Analysis of 491 Patients with Rheumatoid Arthritis [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/the-safety-profile-of-iguratimod-in-real-clinical-practice-analysis-of-491-patients-with-rheumatoid-arthritis/. Accessed March 27, 2023.

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