Evidence map›Paper›PMID 34104206›Full record

ArticleTherapeutic advances in gastroenterology2020

Clinical outcomes, predictors of prognosis and health economics consequences in IBD patients after discontinuation of the first biological therapy.

Uday N Shivaji, Alina Bazarova, Tamsin Critchlow, Samuel C L Smith, Olga Maria Nardone, Melanie Love, Joanne Davis, Subrata Ghosh, Marietta Iacucci

Open access · goldAbstract read
In one paragraph

Article in Therapeutic advances in gastroenterology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 2 pooled it
0.2field-weighted citation impact, top 36% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 2 syntheses or guidelines pooled it, 3 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. 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 at 2 institutions in 1 country.

Uday N ShivajiNational Institute for Health Research (NIHR) Birmingham Biomedical Research Centre, Birmingham, UK.ORCID https://orcid.org/0000-0002-6800-584X
Alina BazarovaInstitute of Translational Medicine, Birmingham, UK.
Tamsin CritchlowUniversity Hospitals Birmingham, Birmingham, UK.
Samuel C L SmithInstitute of Immunology and Immunotherapy, University of Birmingham, Birmingham, UK.ORCID https://orcid.org/0000-0001-8351-1081
Olga Maria NardoneInstitute of Immunology and Immunotherapy, University of Birmingham, UK.ORCID https://orcid.org/0000-0002-9554-4785
Melanie LoveUniversity Hospitals Birmingham, Birmingham, UK.
Joanne DavisUniversity Hospitals Birmingham, Birmingham, UK.
Subrata GhoshProfessor of Medicine and Gastroenterology, Director, Institute of Translational Medicine, University of Birmingham, Edgbaston, Birmingham, B15 2TH, UK.
Marietta IacucciNational Institute for Health Research (NIHR) Birmingham Biomedical Research Centre, Birmingham, UK.
NIHR Surgical Reconstruction and Microbiology Research Centre · GBNational Institute for Health Research · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn real-world clinical practice, biologics in inflammatory bowel diseases (IBD) may be discontinued for a variety of reasons, including discontinuation initiated by gastroenterologists. The aims of the study are to report outcomes after discontinuation and predictors of prognosis after a minimum follow-up of 24 months; outcomes of gastroenterologist-initiated discontinuation with resulting direct cost implications on the health system were also studied.

methodsIBD patients who discontinued their first-use biologics between January 2013 and December 2016 were identified at our tertiary centre. Reasons for discontinuation and pre-defined adverse outcomes (AO) were recorded. Data were analysed using univariable and multivariable logistic regressions within a machine learning technique to predict AO. Gastroenterologist-initiated discontinuations were analysed separately, and Kaplan-Meier survival analysis performed; direct costs of AO due to discontinuation were assessed.

resultsA total of 147 patients discontinued biologics (M = 74; median age 39 years; Crohn's Disease = 110) with median follow-up of 40 months (range 24-60 months). In the total cohort, there were fewer AO among gastroenterologist-initiated discontinuations compared with patient-initiated; 54% (of the total group) had AO within 6 months. Among 59 gastroenterologist-initiated discontinuations, 23 (40%) had IBD-related AO within 6 months and 53 (90%) patients had AO by end of follow-up. Some 44 (75%) patients needed to restart biologics during follow-up, and direct costs due to AO and restart of biologics were high.

conclusionsThe proportion of patients who have AO following discontinuation of biologics is high; clinicians need to carefully consider predictors of poor prognosis and high relapse rates when discussing discontinuation. The direct costs of managing AO probably offset theoretical economic gains, especially in the era where cost of biologics is reducing. Biologics should probably be continued without interruptions in most patients who have achieved remission for the duration these remain effective and safe.

Indexed as

biologics discontinuationbiologics withdrawalCrohn’s diseasedirect costshealth economicsIBDpredictors of prognosisulcerative colitis

Identifiers

PMID34104206
PMCPMC8162203
OpenAlexW3114192811

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.