title: Safety and efficacy of combination therapy of iguratimod with methotrexate for patients with active rheumatoid arthritis with an inadequate response to methotrexate: an open-label extension of a randomized, double-blind, placebo-controlled trial.
abstract: OBJECTIVE
  To obtain safety and efficacy data on combination treatment with iguratimod and methotrexate (MTX) in an open-label extension study in patients with active rheumatoid arthritis (RA).
  
  
  METHODS
  Following a 28-week, randomized, double-blind trial of adding iguratimod or placebo to stable MTX therapy, patients entered a 24-week extension. Patients randomized to the iguratimod + MTX group continued treatment. Patients treated with placebo + MTX switched to iguratimod + MTX [the (placebo/iguratimod) + MTX group].
  
  
  RESULTS
  In the iguratimod + MTX group, the rate of 20% improvement in American College of Rheumatology criteria (ACR20) at week 52 (71.3%) was similar to that at week 24 (69.5%). ACR50, ACR70 and Health Assessment Questionnaire Disability Index at week 52 significantly improved compared with the values at week 24. In the (placebo/iguratimod + MTX) group, the switch to iguratimod treatment significantly improved ACR20 from 30.7% at week 24 to 72.1% at week 52. Frequent adverse events for 52 weeks in the iguratimod + MTX group were nasopharyngitis, upper respiratory tract inflammation, stomatitis, lymphocyte decrease, AST increase, ALT increase and blood iron decrease. These adverse events were predominantly mild or moderate in severity. No deaths occurred.
  
  
  CONCLUSIONS
  Efficacy and tolerance of iguratimod + MTX therapy was maintained to 52 weeks in patients with active RA with inadequate response to MTX.
authors.affiliation: Institute of Rheumatology, Tokyo Women's Medical University , Tokyo , Japan.
authors.forename: Masako
authors.initials: M
authors.lastname: Hara
authors.forename: Naoki
authors.initials: N
authors.lastname: Ishiguro
authors.forename: Kou
authors.initials: K
authors.lastname: Katayama
authors.forename: Masakazu
authors.initials: M
authors.lastname: Kondo
authors.forename: Takayuki
authors.initials: T
authors.lastname: Sumida
authors.forename: Tsuneyo
authors.initials: T
authors.lastname: Mimori
authors.forename: Satoshi
authors.initials: S
authors.lastname: Soen
authors.forename: Kota
authors.initials: K
authors.lastname: Nagai
authors.forename: Tomonobu
authors.initials: T
authors.lastname: Yamaguchi
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Yamamoto
mesh_terms: D000328:Adult; D000368:Aged; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D002867:Chromones / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008727:Methotrexate / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D019233:Retreatment; D013449:Sulfonamides / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D002867:Chromones; D013449:Sulfonamides; C519076:iguratimod; D008727:Methotrexate