title: Postmarketing surveillance of the safety profile of infliximab in 5000 Japanese patients with rheumatoid arthritis.
abstract: OBJECTIVE
  A large-scale postmarketing surveillance (PMS) study was carried out to determine the safety profile of infliximab in Japanese patients with rheumatoid arthritis (RA).
  
  
  METHODS
  The PMS study was performed for all patients with RA who were treated with infliximab. They were consecutively registered in the PMS study at the initiation of infliximab treatment and were prospectively monitored with all adverse events noted for a period of 6 months. All case reports, which include safety-related events, were collected monthly.
  
  
  RESULTS
  Adverse drug reactions (ADRs) were assessed for 6 months in 5000 patients who were consecutively enrolled in the PMS study. The incidence rates of total and serious ADRs were 28.0% and 6.2%, respectively. "Infections" or "respiratory disorders" were most commonly observed among serious ADRs. Bacterial pneumonia developed in 2.2%, tuberculosis in 0.3%, suspected Pneumocystis jiroveci pneumonia (PCP) in 0.4% and interstitial pneumonitis in 0.5%. Bacterial pneumonia (for which individuals of male gender, of older age and those with advanced rheumatoid arthritis and comorbid respiratory disease were most at risk) began to develop immediately after the start of treatment, while tuberculosis, PCP and interstitial pneumonitis developed about 1 month later. Serious infusion reactions were observed in 0.5% and were more likely to occur in patients who had participated in previous clinical trials of infliximab.
  
  
  CONCLUSIONS
  This postmarketing surveillance study of patients treated with infliximab showed that infliximab in combination with low-dose MTX was well tolerated in Japanese patients with active RA.
authors.affiliation: Division of Rheumatology and Clinical Immunology, Saitama Medical Center, Saitama Medical University, 1981 Kamoda, Kawagoe, Saitama 350-8550, Japan. tsutake@saitama-med.ac.jp
authors.forename: T
authors.initials: T
authors.lastname: Takeuchi
authors.forename: Y
authors.initials: Y
authors.lastname: Tatsuki
authors.forename: Y
authors.initials: Y
authors.lastname: Nogami
authors.forename: N
authors.initials: N
authors.lastname: Ishiguro
authors.forename: Y
authors.initials: Y
authors.lastname: Tanaka
authors.forename: H
authors.initials: H
authors.lastname: Yamanaka
authors.forename: N
authors.initials: N
authors.lastname: Kamatani
authors.forename: M
authors.initials: M
authors.lastname: Harigai
authors.forename: J
authors.initials: J
authors.lastname: Ryu
authors.forename: K
authors.initials: K
authors.lastname: Inoue
authors.forename: H
authors.initials: H
authors.lastname: Kondo
authors.forename: S
authors.initials: S
authors.lastname: Inokuma
authors.forename: T
authors.initials: T
authors.lastname: Ochi
authors.forename: T
authors.initials: T
authors.lastname: Koike
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000009:adverse effects*; D018501:Antirheumatic Agents / Q000009:adverse effects*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D005260:Female; D006801:Humans; D000069285:Infliximab; D007564:Japan; D008297:Male; D008875:Middle Aged; D018410:Pneumonia, Bacterial / Q000209:etiology; D011358:Product Surveillance, Postmarketing / Q000706:statistics & numerical data; D011446:Prospective Studies; D018570:Risk Assessment; D016896:Treatment Outcome; D014397:Tuberculosis, Pulmonary / Q000209:etiology
chemical_list: D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; D000069285:Infliximab