title: Safety and effectiveness of 24-week treatment with iguratimod, a new oral disease-modifying antirheumatic drug, for patients with rheumatoid arthritis: interim analysis of a post-marketing surveillance study of 2679 patients in Japan.
abstract: OBJECTIVE
  To determine the real-world safety and effectiveness of iguratimod (IGU) for rheumatoid arthritis (RA), a 52-week, Japanese, post-marketing surveillance study was conducted. An interim analysis at week 24 was performed.
  
  
  METHODS
  This study included all RA patients who received IGU following its introduction to the market. All adverse events (AEs) and adverse drug reactions (ADRs) were collected. Effectiveness was evaluated by the change in Disease Activity Score 28-C-reactive protein (DAS28-CRP) from baseline to week 24.
  
  
  RESULTS
  Safety was analyzed in 2679 patients. The overall incidences of AEs, ADRs, and serious ADRs were 38.41, 31.65, and 3.21%, respectively; the most commonly reported serious ADRs were pneumonia/bacterial pneumonia, interstitial lung disease, and Pneumocystis jiroveci pneumonia. Concomitant glucocorticoid use and comorbid conditions associated with respiratory disease were identified as risk factors for serious infections. Pulmonary alveolar hemorrhage and increased international normalized ratio of prothrombin time were observed with concomitant use of IGU and warfarin. The DAS28-CRP decreased from baseline to week 24.
  
  
  CONCLUSIONS
  Although a safety concern was identified with concomitant use of IGU and warfarin, this real-world study showed no other new safety concerns and similar effectiveness to clinical trials. IGU is a new therapeutic option for RA patients.
authors.affiliation: a Department of Rheumatology and Clinical Immunology , Graduate School of Medicine, Kyoto University , Kyoto , Japan.
authors.forename: Tsuneyo
authors.initials: T
authors.lastname: Mimori
authors.affiliation: b Institute of Rheumatology, Tokyo Women's Medical University , Tokyo , Japan.
authors.forename: Masayoshi
authors.initials: M
authors.lastname: Harigai
authors.affiliation: c Division of Rheumatology, Endocrinology and Nephrology , Hokkaido University Graduate School of Medicine , Hokkaido , Japan.
authors.forename: Tatsuya
authors.initials: T
authors.lastname: Atsumi
authors.affiliation: d Department of Rheumatology and Clinical Immunology , Wakayama Medical University , Wakayama , Japan.
authors.forename: Takao
authors.initials: T
authors.lastname: Fujii
authors.affiliation: e Department of Allergy and Rheumatology , Nippon Medical School Graduate School of Medicine , Tokyo , Japan.
authors.forename: Masataka
authors.initials: M
authors.lastname: Kuwana
authors.affiliation: f Matsuno Clinic for Rheumatic Diseases , Toyama , Japan.
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Matsuno
authors.affiliation: g Hakkeikai Incorporated Medical Institution , Shizuoka , Japan.|h Department of Orthopaedic Surgery , Keio University , Tokyo , Japan.
authors.forename: Shigeki
authors.initials: S
authors.lastname: Momohara
authors.affiliation: i Department of Pediatric Rheumatology, Faculty of Medicine , School of Health Sciences, Medical Center for Children, Kagoshima University , Kagoshima , Japan.
authors.forename: Syuji
authors.initials: S
authors.lastname: Takei
authors.affiliation: j Department of Internal Medicine and Rheumatology, Faculty of Medicine , Juntendo University , Tokyo , Japan.
authors.forename: Naoto
authors.initials: N
authors.lastname: Tamura
authors.affiliation: k Faculty of Medicine , Juntendo University Koshigaya Hospital, Juntendo University , Saitama , Japan.
authors.forename: Yoshinari
authors.initials: Y
authors.lastname: Takasaki
authors.affiliation: l Frontier PMS Section, Neurology Medical Department , Medical Division, Eisai Co, Ltd , Tokyo , Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Ikeuchi
authors.affiliation: m Post-Marketing Surveillance Group, Data Science and Administration Department , Toyama Chemical Co, Ltd , Tokyo , Japan , and.
authors.forename: Satoru
authors.initials: S
authors.lastname: Kushimoto
authors.affiliation: n Sapporo Medical Center NTT EC , Hokkaido , Japan.
authors.forename: Takao
authors.initials: T
authors.lastname: Koike
mesh_terms: D000328:Adult; D018501:Antirheumatic Agents / Q000008:administration & dosage / Q000009:adverse effects; D001172:Arthritis, Rheumatoid / Q000175:diagnosis / Q000188:drug therapy / Q000453:epidemiology; D002097:C-Reactive Protein / Q000032:analysis; D002867:Chromones / Q000008:administration & dosage / Q000009:adverse effects; D016903:Drug Monitoring / Q000379:methods; D004359:Drug Therapy, Combination / Q000379:methods; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D007564:Japan / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing / Q000379:methods; D012307:Risk Factors; D013449:Sulfonamides / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D002867:Chromones; D005938:Glucocorticoids; D013449:Sulfonamides; C519076:iguratimod; D002097:C-Reactive Protein
keywords: Iguratimod; Post-marketing surveillance; Rheumatoid arthritis; Safety