Impact of Adalimumab on Work Productivity and Activity Impairment in Japanese Patients with Rheumatoid Arthritis: Large-Scale, Prospective, Single-Cohort ANOUVEAU Study

Adv Ther. 2017 Mar;34(3):686-702. doi: 10.1007/s12325-017-0477-z. Epub 2017 Jan 31.


Introduction: 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.

Methods: 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.

Results: 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%.

Conclusions: Treatment with ADA provided sustained improvement in WPAI and had an acceptable safety profile in patients with RA.

Funding: AbbVie GK and Eisai Co., Ltd.

Trial registration: identifier, NCT01346488.

Keywords: Patient safety; Post-marketing surveillance study; Rheumatoid arthritis; TNF inhibitor; Work productivity and activity impairment.

Publication types

  • Observational Study

MeSH terms

  • Adalimumab* / administration & dosage
  • Adalimumab* / adverse effects
  • Adult
  • Antirheumatic Agents / administration & dosage
  • Antirheumatic Agents / adverse effects
  • Arthritis, Rheumatoid* / drug therapy
  • Arthritis, Rheumatoid* / epidemiology
  • Arthritis, Rheumatoid* / physiopathology
  • Female
  • Humans
  • Japan / epidemiology
  • Male
  • Middle Aged
  • Patient Acuity
  • Physical Fitness / physiology*
  • Prospective Studies
  • Remission Induction / methods
  • Surveys and Questionnaires
  • Treatment Outcome
  • Work Performance*


  • Antirheumatic Agents
  • Adalimumab

Associated data