Evidence map›Paper›PMID 29383030›Full record

ArticleTherapeutic advances in gastroenterology2018

Immunogenicity of biologics in inflammatory bowel disease.

Séverine Vermeire, Ann Gils, Paola Accossato, Sadiq Lula, Amy Marren

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Therapeutic advances in gastroenterology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07495644 (Efficacy of Different Biological Treatments in Patients With Inflammatory Bowel Disease After One Year of Treatment in Upper Egypt), which is not on this map. Cited by 122 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
122citing papers in PubMed, 6 pooled it
21.7field-weighted citation impact, top 1% 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.

NCT07495644 not yet recruitingnot on this mapstarted 2026, after this paper: background citation

Efficacy of Different Biological Treatments in Patients With Inflammatory Bowel Disease After One Year of Treatment in Upper Egypt

TypeobservationalSponsorAssiut UniversityRan2026 to 2027Enrolled95ConditionsInflamatory Bowel Disease (Crohn&#39, s and Ulcerative Colitis)Armsadalimumab, infliximab, ustekinumab, golimumab, and vedolizumab
3 · Its place in the literature

Who cites it

122 citing papers in PubMed, 6 syntheses or guidelines pooled it, 225 citations in OpenAlex.

  1. Pooled it
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  4. Guideline
  5. Reversal of anti-drug antibodies against tumor necrosis factor inhibitors with addition of immunomodulators: A systematic review and meta-analysis.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2020
    Pooled it
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  7. Trial
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  20. Anti-emicizumab antibodies and their relevance in clinical practice.Research and practice in thrombosis and haemostasis · 2026
    Article

62 more citing papers are in PubMed but not listed here.

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

5 authors at 3 institutions in 3 countries.

Séverine VermeireDepartment of Gastroenterology, University Hospitals Leuven, Herestraat 49, 3000 Leuven, Belgium.
Ann GilsDepartment of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.
Paola AccossatoPfizer Innovative Health, Pfizer S.r.l, Rome, Italy.
Sadiq LulaMarket Access Solutions, Envision Pharma Group Ltd, London, UK.
Amy MarrenPfizer Innovative Health, Pfizer Inc, Collegeville, PA, USA.
KU Leuven · BEPfizer (Italy) · ITPfizer (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Crohn's disease and ulcerative colitis are chronic inflammatory disorders of the gastrointestinal tract. Treatment options include biologic therapies; however, a proportion of patients lose response to biologics, partly due to the formation of anti-drug antibodies (ADAbs). Concomitant immunosuppressive agents reduce the development of ADAbs. This review article aims to assess the immunogenicity of biologic therapies and their clinical implications. A comprehensive literature search was conducted for articles published January 2009 to August 2015 reporting immunogenicity to adalimumab (ADM), certolizumab pegol (CZP), golimumab, infliximab (IFX), ustekinumab, and vedolizumab in inflammatory bowel disease (IBD). Eligible articles were reviewed and quality assessed by independent reviewers. Overall, 122 publications reporting 114 studies were assessed. ADAbs were reported for all agents, but the percentage of patients developing ADAbs was extremely variable, with the highest (65.3%) being for IFX administration to patients with IBD. ADAb presence was frequently associated with a reduction in primary efficacy and a loss of response, and, for IFX, an increase in adverse events (AEs). Lower serum levels of ADM, CZP and IFX were seen in ADAbs-positive rather than ADAbs-negative patients; pharmacokinetic data were unavailable for other therapies. Little information was available regarding the timing of ADAb development; studies reported their detection from as early as 10-14 days up to months after treatment initiation. Biologic therapies carry an intrinsic risk of immunogenicity, although reported rates of ADAbs vary considerably. The clinical implications of immunogenicity are a concern for effective treatment; further research, particularly into the more recently approved biologics, is required.

Indexed as

anti-drug antibodiesbiologic therapyCrohn’s diseaseimmunogenicityulcerative colitis

Identifiers

PMID29383030
PMCPMC5784568
OpenAlexW2784524664

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.