title: Impact of Adalimumab on Work Productivity and Activity Impairment in Japanese Patients with Rheumatoid Arthritis: Large-Scale, Prospective, Single-Cohort ANOUVEAU Study.
abstract: The Adalimumab Non-interventional Trial for Up-verified Effects and Utility (ANOUVEAU) was a large-scale, multicenter, prospective, observational, single-cohort study that evaluated the effects of adalimumab (ADA) on rheumatoid arthritis (RA)-related work productivity and activity impairment (RA-related WPAI) and disease activity in routine rheumatology care in Japan.
  
  
  
  Patients with RA were categorized as paid workers (PWs, ≥35 h/week), part-time workers (PTWs, <35 h/week), or homemakers (HMs, unemployed) and were administered the WPAI for RA (WPAI/RA) questionnaire. All patients who received ADA were followed for 48 weeks to evaluate safety and effectiveness.
  
  
  
  Of the 1808 patients analyzed, 825, 243, and 740 patients were PWs, PTWs, and HMs, respectively. WPAI/RA domain scores significantly improved at weeks 12, 24, and 48 in all groups, with maximum improvement observed for PWs (p < 0.05). Additionally, remission rates (according to Disease Activity Score 28, erythrocyte sedimentation rate, Simplified Disease Activity Index, or Health Assessment Questionnaire-Disability Index scores) and EuroQol 5-Dimension 3-Level scores significantly increased from baseline to 48 weeks in all groups (p < 0.0001). Analysis of patient subgroups revealed better WPAI/RA outcomes for patients who were biologic-naïve, treated with concomitant methotrexate, or with RA duration of ≤2 years (p < 0.05). The rate of serious adverse events over 48 weeks of ADA treatment was 5.23%.
  
  
  
  Treatment with ADA provided sustained improvement in WPAI and had an acceptable safety profile in patients with RA.
  
  
  
  AbbVie GK and Eisai Co., Ltd.
  
  
  
  ClinicalTrials.gov identifier, NCT01346488.
authors.affiliation: Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan. tsutake@z5.keio.jp.
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Takeuchi
authors.affiliation: AbbVie GK, Tokyo, Japan.
authors.forename: Ryo
authors.initials: R
authors.lastname: Nakajima
authors.affiliation: AbbVie GK, Tokyo, Japan.
authors.forename: Shuichi
authors.initials: S
authors.lastname: Komatsu
authors.affiliation: AbbVie GK, Tokyo, Japan.
authors.forename: Kiyotaka
authors.initials: K
authors.lastname: Yamazaki
authors.affiliation: AbbVie GK, Tokyo, Japan.
authors.forename: Tomohiro
authors.initials: T
authors.lastname: Nakamura
authors.affiliation: AbbVie GK, Tokyo, Japan.
authors.forename: Naoki
authors.initials: N
authors.lastname: Agata
authors.affiliation: Department of Drug Policy and Management, Graduate School of Pharmaceutical Sciences, The University of Tokyo, Tokyo, Japan.
authors.forename: Ataru
authors.initials: A
authors.lastname: Igarashi
authors.affiliation: Center for Medical Statistics, Tokyo, Japan.
authors.forename: Toshiro
authors.initials: T
authors.lastname: Tango
authors.affiliation: The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyusyu, Japan.
authors.forename: Yoshiya
authors.initials: Y
authors.lastname: Tanaka
mesh_terms: D000068879:Adalimumab / Q000008:administration & dosage / Q000009:adverse effects; D000328:Adult; D018501:Antirheumatic Agents / Q000008:administration & dosage / Q000009:adverse effects; D001172:Arthritis, Rheumatoid / Q000188:drug therapy / Q000453:epidemiology / Q000503:physiopathology; D005260:Female; D006801:Humans; D007564:Japan / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D062072:Patient Acuity; D010809:Physical Fitness / Q000502:physiology*; D011446:Prospective Studies; D012074:Remission Induction / Q000379:methods; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D000066477:Work Performance
chemical_list: D018501:Antirheumatic Agents; D000068879:Adalimumab
keywords: Patient safety; Post-marketing surveillance study; Rheumatoid arthritis; TNF inhibitor; Work productivity and activity impairment