Evidence map›Paper›PMID 28144917›Full record

Observational studyAdvances in therapy2017

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

Registry-linked trialAbstract readObservational Study
In one paragraph

Observational study in Advances in therapy, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01346488 (The Documentation of the Effects on Quality of Life), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01346488 completednot on this map

The Documentation of the Effects on Quality of Life (QOL) and Working Productivity and Activity Impairment (WPAI) in Patients With Rheumatoid Arthritis (RA) Under HUMIRA® (Adalimumab) in Routine Clinical Practice

TypeobservationalSponsorAbbVie (prior sponsor, Abbott)Ran2011 to 2016Enrolled2,088ConditionsRheumatoid Arthritis
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Article
  6. Observational
  7. Article
  8. Article
  9. Observational
  10. Article
  11. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Tsutomu TakeuchiDivision of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan. tsutake@z5.keio.jp.
Ryo NakajimaAbbVie GK, Tokyo, Japan.
Shuichi KomatsuAbbVie GK, Tokyo, Japan.
Kiyotaka YamazakiAbbVie GK, Tokyo, Japan.
Tomohiro NakamuraAbbVie GK, Tokyo, Japan.
Naoki AgataAbbVie GK, Tokyo, Japan.
Ataru IgarashiDepartment of Drug Policy and Management, Graduate School of Pharmaceutical Sciences, The University of Tokyo, Tokyo, Japan.
Toshiro TangoCenter for Medical Statistics, Tokyo, Japan.
Yoshiya TanakaThe First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyusyu, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe 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.

methodsPatients 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.

resultsOf 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%.

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

fundingAbbVie GK and Eisai Co., Ltd.

trial registrationClinicalTrials.gov identifier, NCT01346488.

Indexed as

AdalimumabArthritis, RheumatoidWork PerformanceAdultAntirheumatic AgentsFemaleHumansJapanMaleMiddle AgedPatient AcuityPhysical FitnessProspective StudiesRemission InductionSurveys and QuestionnairesTreatment OutcomeAdalimumabAntirheumatic AgentsPatient safetyPost-marketing surveillance studyRheumatoid arthritisTNF inhibitorWork productivity and activity impairment

Identifiers

PMID28144917
PMCPMC5350205

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.