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

Tsutomu Takeuchi, Ryo Nakajima, Shuichi Komatsu, Kiyotaka Yamazaki, Tomohiro Nakamura, Naoki Agata, Ataru Igarashi, Toshiro Tango, Yoshiya Tanaka

Research output: Contribution to journalArticle

10 Citations (Scopus)

Abstract

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: ClinicalTrials.gov identifier, NCT01346488.

Original languageEnglish
Pages (from-to)686-702
Number of pages17
JournalAdvances in Therapy
Volume34
Issue number3
DOIs
Publication statusPublished - 2017 Mar 1

Keywords

  • Patient safety
  • Post-marketing surveillance study
  • Rheumatoid arthritis
  • TNF inhibitor
  • Work productivity and activity impairment

ASJC Scopus subject areas

  • Pharmacology (medical)

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