Evidence map›Paper›PMID 28981846›Full record

Trial reportJournal of Crohn's & colitis2017

Effect of Adalimumab on Clinical Outcomes and Health-related Quality of Life Among Patients With Ulcerative Colitis in a Clinical Practice Setting: Results From InspirADA.

Simon Travis, Brian G Feagan, Laurent Peyrin-Biroulet, Remo Panaccione, Silvio Danese, Andreas Lazar, Anne M Robinson, Joel Petersson, Brandee L Pappalardo, Mareike Bereswill and 5 more

Registry-linked trialOpen access · bronzeAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Journal of Crohn's & colitis, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01550965 (An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting), which is not on this map. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 1 pooled it
3.7field-weighted citation impact, top 7% of its field
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.

NCT01550965 phase3completednot on this map

An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting

TypeinterventionalSponsorAbbVie (prior sponsor, Abbott)Ran2012 to 2015Enrolled463ConditionsUlcerative ColitisArmsAdalimumab
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 1 synthesis or guideline pooled it, 43 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Article
  6. Review
  7. Article
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  11. Observational
  12. Review
  13. Role of Quality of Life as Endpoint for Inflammatory Bowel Disease Treatment.International journal of environmental research and public health · 2021
    Review
  14. Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. Effectiveness and safety of adalimumab biosimilar in inflammatory bowel disease: A multicenter study.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2019
    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

15 authors at 7 institutions in 6 countries.

Simon TravisTranslational Gastroenterology Unit, Oxford University Hospitals, Oxford, UK.
Brian G FeaganRobarts Research Institute, Western University, London, ON, Canada.
Laurent Peyrin-BirouletDepartment of Gastroenterology, University Hospital of Nancy, Les Nancy, France.
Remo PanaccioneDepartment of Medicine, University of Calgary, Calgary, AB, Canada.
Silvio DaneseIBD Unit, Istituto Clinico Humanitas, Milan, Italy.
Andreas LazarAbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany.
Anne M RobinsonAbbVie Inc., North Chicago, IL, USA.
Joel PeterssonAbbVie Inc., North Chicago, IL, USA.
Brandee L PappalardoAbbVie Inc., North Chicago, IL, USA.
Mareike BereswillAbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany.
Naijun ChenAbbVie Inc., North Chicago, IL, USA.
Song WangAbbVie Inc., North Chicago, IL, USA.
Martha SkupAbbVie Inc., North Chicago, IL, USA.
Roopal B ThakkarAbbVie Inc., North Chicago, IL, USA.
Jingdong ChaoAbbVie Inc., North Chicago, IL, USA.
AbbVie (United States) · USAbbVie (Germany) · DECentre Hospitalier Régional et Universitaire de Nancy · FRFondazione Humanitas per la Ricerca · ITOxford University Hospitals NHS Trust · GBRobarts Clinical Trials · CAUniversity of Calgary · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

aimsRandomised trials have described the benefits of adalimumab [ADA] for ulcerative colitis [UC]; however, few data are available on health-related quality of life [HRQL] and health care costs in clinical practice.

methodsInspirADA, a multicentre, prospective study, evaluated the effect of ADA in patients with moderate to severe UC treated according to usual clinical practice. Outcomes assessed were: Simple Clinical Colitis Activity Index [SCCAI] response/remission rates; changes in HRQL; all-cause direct costs; and UC-related direct and indirect costs from baseline to Week 26.

resultsData from 463 patients were analysed. At Week 26, 67% (95% confidence interval [CI]: 62%, 71%) of patients achieved response; 48% [95% CI: 44%, 53%] were in remission. For the overall population, significant [all p < 0.001] improvements from baseline to Week 26 were observed for the Short Inflammatory Bowel Disease Questionnaire [SIBDQ] (mean change ± standard deviation [SD]: 17.4 ± 14.5) and the European Quality of Life-5 Dimensions-5 Level [EQ-5D-5L] (index: 0.1 ± 0.2; visual analogue scale [VAS]: 19.5 ± 25.8). Parallel improvements were seen in work productivity [11% absolute decrease in absenteeism; 25% absolute decrease in impairment while working; and 27% absolute decrease in impairment of ability to perform daily activities, all p < 0.001]. Among study completers, cumulative all-cause medical costs and UC-related medical costs were significantly [both p < 0.001] reduced by 59% and 77%, respectively, 6 months after initiation of therapy compared with the preceding 6 months. The safety profile of ADA was consistent with that observed in previous clinical trials.

conclusionsADA therapy in usual clinical practice is effective at improving and maintaining symptomatic control, improving HRQL, and decreasing costs of medical care among patients with UC.

Indexed as

Quality of LifeAdalimumabAdultColitis, UlcerativeFemaleHumansImmunosuppressive AgentsMaleProspective StudiesTreatment OutcomeAdalimumabImmunosuppressive Agentshealth care costspatient outcomesUlcerative colitis

Identifiers

PMID28981846
PMCPMC5881702
OpenAlexW2734938682

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.