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Abstract Number: 1541

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

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Session Information

Date: Monday, October 22, 2018

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 .
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