Efficacy and safety of iguratimod compared with placebo and salazosulfapyridine in active rheumatoid arthritis: a controlled, multicenter, double-blind, parallel-group study.
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.
Hara
Masako
M
Institute of Rheumatology, Tokyo Women's Medical University, Tokyo 162-0054, Japan. mhara@ior.twmu.ac.jp
Abe
Tohru
T
Sugawara
Sachiko
S
Mizushima
Yutaka
Y
Hoshi
Keiko
K
Irimajiri
Shoichiro
S
Hashimoto
Hiroshi
H
Yoshino
Shinichi
S
Matsui
Nobuo
N
Nobunaga
Masashi
M
Nakano
Shigeyuki
S
D000328:Adult; D018501:Antirheumatic Agents / Q000494:pharmacology*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D002867:Chromones / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D012720:Severity of Illness Index; D012460:Sulfasalazine / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D013449:Sulfonamides / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*
D018501:Antirheumatic Agents; D002867:Chromones; D007166:Immunosuppressive Agents; D013449:Sulfonamides; D012460:Sulfasalazine; C519076:iguratimod