Evidence map›Paper›PMID 31228100›Full record

ArticleRheumatology and therapy2019

Relative Impact of Pain and Fatigue on Work Productivity in Patients with Rheumatoid Arthritis from the RA-BEAM Baricitinib Trial.

Kaleb Michaud, Janet E Pope, Paul Emery, Baojin Zhu, Carol L Gaich, Amy M DeLozier, Xiang Zhang, Christina L Dickson, Josef S Smolen

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Rheumatology and therapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01710358 (A Randomized, Double-Blind, Placebo- and Active-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy), which is not on this map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing 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.

NCT01710358 phase3completednot on this map

A Randomized, Double-Blind, Placebo- and Active-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy

TypeinterventionalSponsorEli Lilly and CompanyRan2012 to 2015Enrolled1,307ConditionsRheumatoid ArthritisArmsAdalimumab, Baricitinib, Methotrexate, Adalimumab Placebo, Baricitinib Placebo
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Impact of fatigue on work productivity and health-related job loss.Occupational medicine (Oxford, England) · 2024
    Article
  6. Article
  7. Review
  8. Article
  9. Review
  10. Article
  11. Work Ability and Quality of Life in Patients with Rheumatoid Arthritis.International journal of environmental research and public health · 2022
    Article
  12. Review
  13. Article
  14. Repositioned Drugs for COVID-19-the Impact on Multiple Organs.SN comprehensive clinical medicine · 2021
    Review
  15. Review
  16. 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.

Kaleb MichaudUniversity of Nebraska Medical Center, Omaha, NE, USA. kmichaud@unmc.edu.ORCID http://orcid.org/0000-0002-5350-3934
Janet E PopeDivision of Rheumatology, Department of Medicine, St. Joseph's Health Care, London, Canada.
Paul EmeryLeeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds and NIHR Leeds Biomedical Research Centre, The Leeds Teaching Hospitals Trust, Leeds, UK.
Baojin ZhuLilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA.
Carol L GaichLilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA.
Amy M DeLozierLilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA.
Xiang ZhangLilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA.
Christina L DicksonLilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA.
Josef S SmolenDivision of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria.

Funding

Eli Lilly and Company Not ApplicableIncyte Corporation Not Applicable
6 · The paper itself

Abstract

introductionTo explore the relationship of pain and fatigue with daily activity and work productivity in rheumatoid arthritis (RA) patients from the baricitinib clinical trial, RA-BEAM.

methodsIn RA-BEAM, a double-blind phase 3 study, patients were randomized 3:3:2 to placebo (n = 488), baricitinib 4 mg once daily (n = 487), or adalimumab 40 mg biweekly (n = 330) with background methotrexate. The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) measured fatigue and the pain visual analog scale (0-100 mm) assessed pain. Work Productivity and Activity Impairment Questionnaire-RA measured daily activity and work productivity. At weeks 12 and 24, pain was assessed using pain reduction (< 30%, 30% to < 50%, ≥ 50%) and overall pain score; clinically relevant FACIT-F changes were assessed by values < 3.56 and ≥ 3.56 and the FACIT-F normative value score (< 40.1, ≥ 40.1). Pairwise comparisons between pain/fatigue reduction groups were assessed using ANCOVA with pooled data on daily activity and work productivity. A mediator analysis with pain, fatigue, and disease activity measured their contribution to daily activity and work productivity. Data were pooled from all patients for most analyses, and baricitinib-treated patients were assessed as a sensitivity analysis.

resultsReductions in pain (≥ 50%) and fatigue (≥ 3.56) had significant (p ≤ 0.001) effects on daily activity and work productivity improvement at weeks 12 and 24. Reductions in pain, fatigue, and disease activity accounted for most of the improvements in daily activity and work productivity. At the lowest levels of remaining pain (≤ 10 mm) at weeks 12 and 24, however, fatigue did not appear to impact work productivity. Similar trends were observed with baricitinib-treated patients.

conclusionsReductions in pain and fatigue were associated with improved daily activity and work productivity for all RA patients and for baricitinib-treated patients in RA-BEAM.

trial registrationClinicalTrials.gov identifier, NCT01710358.

fundingIncyte Corporation and Eli Lilly and Company.

Indexed as

BaricitinibHealth-related quality of lifePatient-reported outcomesWork impairment

Identifiers

PMID31228100
PMCPMC6702585

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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.