ORIGINAL ARTICLE

Efficacy and safety of iguratimod compared with placebo and salazosulfapyridine in active rheumatoid arthritis: a controlled, multicenter, double-blind, parallel-group study

Authors

Masako Hara¹, Tohru Abe², Sachiko Sugawara³, Yutaka Mizushima⁴, Keiko Hoshi⁵, Shoichiro Irimajiri⁶, Hiroshi Hashimoto⁷, Shinichi Yoshino⁸, Nobuo Matsui⁹, Masashi Nobunaga¹⁰ and Shigeyuki Nakano¹¹

1. Institute of Rheumatology, Tokyo Women's Medical University, 10-22 Kawadacho, Shinjuku-ku, Tokyo 162-0054, Japan
2. Saitama Medical Center, Saitama Medical School, Saitama, Japan
3. Tokyo Women's Medical University, Japan, Tokyo
4. Institute of Medical Science, St. Marianna University School of Medicine, Kawasaki, Japan
5. Showa Pharmaceutical University, Tokyo, Japan
6. Department of Internal Medicine and Rheumatology, Kawasaki Municipal Hospital, Kawasaki, Japan
7. Juntendo Koshigaya Hospital, Koshigaya, Japan
8. Nippon Medical School, Tokyo, Japan
9. Nagoya City Rehabilitation and Sports Center, Nagoya, Japan
10. Medical Institute of Bioregulation, Kyushu University, Beppu, Japan
11. Oita University Faculty of Medicine, Oita, Japan

Received:

09 June 2006

Accepted:

11 October 2006

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Abstract

We conducted a 28-week, randomized, double-blind, parallel-group study of iguratimod in 376 Japanese patients with active rheumatoid arthritis to compare the efficacy and safety of the drug with those of placebo and salazosulfapyridine. In the American College of Rheumatology (ACR) 20 response rate, iguratimod was superior to placebo (53.8% versus 17.2%; Fisher's exact test, P < 0.001) and was not inferior to salazosulfapyridine (63.1% versus 57.7%, 95% confidence interval for the rate difference, −7.9% to 18.7%). Iguratimod began exhibiting its therapeutic effect within 8 weeks after the initiation of treatment and was effective even in patients who had a poor response to previous treatment with disease-modifying antirheumatic drugs. No statistically significant difference was noted in the incidence of adverse reactions between iguratimod and salazosulfapyridine. The study results suggest that iguratimod could become a new option for the treatment of rheumatoid arthritis.

Key words

Controlled study - Iguratimod - Rheumatoid arthritis - Salazosulfapyridine