Evidence map›Paper›PMID 31990422›Full record

SynthesisAlimentary pharmacology & therapeutics2020

Systematic review: hepatosplenic T-cell lymphoma on biologic therapy for inflammatory bowel disease, including data from the Food and Drug Administration Adverse Event Reporting System.

Eric D Shah, Elliot S Coburn, Anil Nayyar, Kerry Jo Lee, Jenna L Koliani-Pace, Corey A Siegel

Open access · greenAbstract readSystematic Review
In one paragraph

Synthesis in Alimentary pharmacology & therapeutics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the 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
5.2field-weighted citation impact, top 3% 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

23 citing papers in PubMed, 1 synthesis or guideline pooled it, 47 citations in OpenAlex.

  1. Guideline
  2. Trial
  3. Review
  4. Article
  5. Review
  6. Review
  7. Review
  8. Article
  9. Review
  10. Article
  11. Choosing Therapies in Ulcerative Colitis.Journal of the Canadian Association of Gastroenterology · 2024
    Article
  12. Review
  13. The Role of Therapeutic Drug Monitoring in Children.Gastroenterology clinics of North America · 2023
    Review
  14. Review
  15. Felty's syndrome.Frontiers in medicine · 2023
    Review
  16. Sex- and gender-related differences in inflammatory bowel diseases.Frontiers in gastroenterology (Lausanne, Switzerland) · 2023
    Review
  17. Article
  18. Managing IBD in patients with previous cancers.Frontline gastroenterology · 2022
    Article
  19. Tumor Necrosis Factor Inhibitors and the Risk of Cancer among Older Americans with Rheumatoid Arthritis.Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology · 2021
    Article
  20. Review
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

6 authors at 2 institutions in 1 country.

Eric D ShahSection of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA.ORCID 0000-0003-3611-8628
Elliot S CoburnSection of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA.
Anil NayyarFood and Drug Administration, Silver Spring, MD, USA.
Kerry Jo LeeFood and Drug Administration, Silver Spring, MD, USA.
Jenna L Koliani-PaceSection of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA.
Corey A SiegelSection of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA.
Dartmouth–Hitchcock Medical Center · USUnited States Food and Drug Administration · US

Funding

Training Program in Gastrointestinal EpidemiologyT32DK062708 · NIDDK · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI Peter D.R. Higgins, Elliot Tapper · 2003 to 2026
$3.9M
Evaluating a Prediction Tool and Decision Aid for Patients with Crohn's DiseaseR01HS021747 · AHRQ · DARTMOUTH COLLEGE · PI SIEGEL, COREY · 2012 to 2016
$2.3M
AHRQ HHS R01 HS021747NIDDK NIH HHS T32 DK062708
6 · The paper itself

Abstract

backgroundHepatosplenic T-cell lymphoma (HSTCL) is a rare, poorly treatable malignancy associated with therapy for IBD. Current knowledge of HSTCL risk in IBD comes from an era of step-up therapy, before earlier use of biologics or combination therapy was advocated to achieve deep mucosal healing. HSTCL risk among newer biologic classes has also not been evaluated.

aimsTo systematically characterise the association of HSTCL with biologic therapy for IBD.

methodsWe conducted a literature search and query of the Food and Drug Administration Adverse Event Reporting System to summarise HSTCL cases among IBD patients with prior biologic exposure. Demographics and immunosuppression exposure were extracted. Patients were stratified by current regimen (combination therapy, biologic monotherapy or no biologic), and biologic class (anti-TNF, anti-integrin, anti-interleukin 12/23).

resultsSixty-two cases of HSTCL were identified from 2486 abstracts and 181 FDA Adverse Events Reporting System reports. The median age of affected patients was 28 years (range 12-81), and 83.6% were male, 84.7% had Crohn's disease. Five of 62 patients had no reported azathioprine/mercaptopurine exposure. Three patients within the cohort developed HSTCL after exposure to natalizumab, vedolizumab or ustekinumab; all three also had anti-TNF and azathioprine/mercaptopurine exposure. Forty-three of 49 (87.8%) patients with known outcomes died with a median survival of 5 months.

conclusionsConsistent with existing data, almost all identified HSTCL cases among IBD patients on biologic therapy had azathioprine/mercaptopurine exposure, and all cases on patients exposed to biologics had anti-TNF exposure. These data suggest initiating a patient-centred discussion before starting anti-TNF therapy or other biologics.

Indexed as

AdolescentAdultAdverse Drug Reaction Reporting SystemsAgedAged, 80 and overBiological ProductsChildDrug-Related Side Effects and Adverse ReactionsFemaleHumansInflammatory Bowel DiseasesLiver NeoplasmsLymphoma, T-CellMaleMiddle AgedSplenic NeoplasmsBiological Products

Identifiers

PMID31990422
PMCPMC7018581
OpenAlexW3003721197

What OpenQuestion holds

Textmetadata
LicenceTDM
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.