Vol.23 No.3

Original Article

Concomitant iguratimod therapy in patients with active rheumatoid arthritis despite stable doses of methotrexate: a randomized, double-blind, placebo-controlled trial

Authors

Naoki Ishiguro1 , Kazuhiko Yamamoto2 , Kou Katayama3 , Masakazu Kondo4 , Takayuki Sumida5 , Tsuneyo Mimori6 , Satoshi Soen7 , Kota Nagai8 , Tomonobu Yamaguchi9 , Masako Hara10 , Iguratimod-Clinical Study Group

  • Department of Orthopaedic Surgery and Rheumatology, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
  • Department of Allergy and Rheumatology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
  • Katayama Orthopedic Rheumatology Clinic, Asahikawa, Japan
  • Kondo Clinic of Rheumatology and Orthopaedic Surgery, Fukuoka, Japan
  • Department of Internal Medicine, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan
  • Department of Rheumatology and Clinical Immunology, Graduate School of Medicine, Kyoto University, Kyoto, Japan
  • Department of Orthopaedic Surgery and Rheumatology, Nara Hospital, Kinki University School of Medicine, Ikoma, Japan
  • Eisai Co., Ltd, Tokyo, Japan
  • Toyama Chemical Co., Ltd, Tokyo, Japan
  • Institute of Rheumatology, Tokyo Women’s Medical University, Tokyo, Japan
Received:

25 May 2012

Accepted:

27 June 2012

Published online:

26 July 2012

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Abstract

Objectives
To investigate the efficacy and safety of iguratimod (T-614) in Japanese patients with active rheumatoid arthritis who had inadequate response to stable background methotrexate (MTX) alone.
Methods
In this multicenter, double-blind, controlled trial, a total of 253 patients were randomized at 2:1 ratio to either the iguratimod group or the placebo group. Iguratimod was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for the subsequent 20 weeks (25 mg twice daily). MTX at dosage of 6 or 8 mg/week was administered to patients in both groups.
Results
The rate of 20 % improvement in American College of Rheumatology criteria (ACR20) at week 24 was 69.5 % in the iguratimod group compared with 30.7 % in the placebo group (P < 0.001). Significant improvements in the ACR50, ACR70, Health Assessment Questionnaire Disability Index, Disease Activity Score 28 <3.2, and rheumatoid factor were also observed. The most commonly reported adverse events (AEs) were blood iron decrease, nasopharyngitis, and lymphocyte decrease. These AEs were mild or moderate in severity. No deaths occurred.
Conclusion
The study results suggest that iguratimod in combination with MTX was efficacious and had a manageable safety profile.

Key words

Disease-modifying antirheumatic drug, Iguratimod, Methotrexate, Rheumatoid arthritis, T-614