title: Long-term safety and effectiveness of adalimumab for the treatment of Japanese patients with rheumatoid arthritis: 3-year results from a postmarketing surveillance of 552 patients.
abstract: OBJECTIVE
  To determine the safety and effectiveness of and identify associated factors in long-term adalimumab (ADA) treatment of Japanese patients with rheumatoid arthritis (RA).
  
  
  METHODS
  Of 7740 patients participating in the all-case postmarketing surveillance study, 552 were enrolled in the present study and observed for 3 years. The safety and effectiveness of ADA were analyzed in 509 and 430 patients, respectively.
  
  
  RESULTS
  Adverse drug reactions (ADRs) were reported in 34.2% of patients (23.3/100 person-years [PYs]); serious ADRs (SADRs) were reported in 10.6% (5.9/100 PYs). The most common ADRs and SADRs were infection (16.5%) and serious infection (6.1%), respectively. Seven patients (1.4%) developed malignancies. Multivariate analysis revealed that the risk factors for SADRs were age ≥65 years and respiratory disorder at baseline. The proportion of patients who achieved remission (28-joint count Disease Activity Score based on four erythrocyte sedimentation rates <2.6) increased from 3.3% at baseline to 49.2% at 36 months. Significant predictors of failure to achieve remission were female sex, age ≥65 years, blood disorders and advanced structural change at baseline.
  
  
  CONCLUSIONS
  Overall, no unknown safety issues were noted during the 3-year treatment with ADA in Japanese patients with RA.
authors.affiliation: a Division of Epidemiology and Pharmacoepidemiology of Rheumatic Diseases , Institute of Rheumatology, Tokyo Women's Medical University , Tokyo , Japan.
authors.forename: Masayoshi
authors.initials: M
authors.lastname: Harigai
authors.affiliation: b Medical, AbbVie GK , Tokyo , Japan.
authors.forename: Tsuyoshi
authors.initials: T
authors.lastname: Tsuchiya
authors.affiliation: b Medical, AbbVie GK , Tokyo , Japan.
authors.forename: Katsuyoshi
authors.initials: K
authors.lastname: Kawana
authors.affiliation: b Medical, AbbVie GK , Tokyo , Japan.
authors.forename: Sarina
authors.initials: S
authors.lastname: Kurimoto
mesh_terms: D000068879:Adalimumab / Q000009:adverse effects* / Q000627:therapeutic use; D000328:Adult; D018501:Antirheumatic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing
chemical_list: D018501:Antirheumatic Agents; D000068879:Adalimumab
keywords: Adalimumab; long-term effects; observational study; postmarketing surveillance; rheumatoid arthritis