Evidence map›Paper›PMID 38768673›Full record

ArticleClinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association2025

Safety of Immunosuppression in a Prospective Cohort of Inflammatory Bowel Disease Patients With a HIstoRy of CancEr: SAPPHIRE Registry.

Steven H Itzkowitz, Yue Jiang, Cristina Villagra, Jean-Frederic Colombel, Keith Sultan, Dana J Lukin, David M Faleck, Ellen Scherl, Shannon Chang, LeaAnn Chen and 9 more

Abstract read
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In one paragraph

Article in Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–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.

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

7 citing papers in PubMed.

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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

19 authors.

Steven H ItzkowitzDivision of Gastroenterology, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: steven.itzkowitz@mountsinai.org.
Yue JiangDepartment of Statistical Science, Duke University, Durham, North Carolina.
Cristina VillagraDepartment of Population Health, Icahn School of Medicine at Mount Sinai, New York, New York.
Jean-Frederic ColombelDivision of Gastroenterology, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York.
Keith SultanDivision of Gastroenterology, Department of Medicine, Northwell Health-North Shore University Hospital, Zucker School of Medicine, Manhasset, New York.
Dana J LukinDivision of Gastroenterology, Department of Medicine, Weill Cornell Medicine, New York, New York.
David M FaleckGastroenterology, Hepatology and Nutrition Service, Memorial Sloan Kettering Cancer Center, New York, New York.
Ellen ScherlDivision of Gastroenterology, Department of Medicine, Weill Cornell Medicine, New York, New York.
Shannon ChangDivision of Gastroenterology, Department of Medicine, New York University Grossman School of Medicine, New York, New York.
LeaAnn ChenDivision of Gastroenterology, Department of Medicine, Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey.
Seymour KatzDivision of Gastroenterology, Department of Medicine, New York University Grossman School of Medicine, New York, New York.
Joann KwahDivision of Gastroenterology, Department of Medicine, New York University Grossman School of Medicine, New York, New York.
Arun SwaminathDivision of Gastroenterology, Department of Medicine, Northwell Health-Lenox Hill Hospital, Zucker School of Medicine, New York, New York.
Francesca PetraliaDepartment of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York, New York.
Virginia SharplessCollaborative Studies Coordinating Center, University of North Carolina, Chapel Hill, North Carolina.
David SacharDivision of Gastroenterology, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York.
Lina JandorfDivision of Gastroenterology, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York; Department of Population Health, Icahn School of Medicine at Mount Sinai, New York, New York.
Jordan E AxelradDivision of Gastroenterology, Department of Medicine, New York University Grossman School of Medicine, New York, New York.
New York Crohn’s and Colitis Organization

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
The Role of Enteric Infection in Flares of Inflammatory Bowel DiseaseK23DK124570 · NIDDK · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI AXELRAD, JORDAN ERIC · 2021 to 2025
$998k
NCI NIH HHS P30 CA008748NIDDK NIH HHS K23 DK124570
6 · The paper itself

Abstract

BACKGROUND &

aimsIn patients with inflammatory bowel disease (IBD) and a history of cancer, retrospective studies have suggested that exposure to immunosuppressive agents does not increase the risk of incident (recurrent or new) cancer compared with unexposed patients. Safety of Immunosuppression in a Prospective Cohort of Inflammatory Bowel Disease Patients and a HIstoRy of CancEr (SAPPHIRE) is a prospective registry aimed at addressing this issue.

methodsSince 2016, patients with IBD and confirmed index cancer before enrollment were followed up annually. Patients receiving chemotherapy or radiation at enrollment, or recurrent cancer within 5 years, were excluded. The primary outcome was development of incident cancer related to exposure to immunosuppressive medications.

resultsAmong 305 patients (47% male, 88% white), the median age at IBD diagnosis and cancer were 32 and 52 years, respectively. Index cancers were solid organ (46%), dermatologic (32%), gastrointestinal (13%), and hematologic (9%). During a median follow-up period of 4.8 years, 210 patients (69%) were exposed to immunosuppressive therapy and 46 patients (15%) developed incident cancers (25 new, 21 recurrent). In unadjusted analysis, the crude rate of incident cancer in unexposed patients was 2.58 per 100 person-years vs 4.78 per 100 person-years (relative risk, 1.85; 95% CI, 0.92-3.73) for immunosuppression-exposed patients. In a time-varying proportional hazards model adjusting for sex, smoking history, age and stage at index malignancy, and nonmelanoma skin cancer, no significant association was found between receipt of immunosuppression and incident cancer (adjusted hazard ratio, 1.41; 95% CI, 0.69-2.90), or with any major drug class.

conclusionsIn this interim analysis of patients with IBD and a history of cancer, despite numerically increased adjusted hazard ratios, we did not find a statistically significant association between subsequent exposure to immunosuppressive therapies and development of incident cancers.

Indexed as

Immunosuppression TherapyImmunosuppressive AgentsInflammatory Bowel DiseasesNeoplasmsAdultAgedFemaleHumansIncidenceMaleMiddle AgedProspective StudiesRegistriesYoung AdultImmunosuppressive AgentsCrohn’s DiseaseImmunosuppressionIncident CancerUlcerative Colitis

Identifiers

PMID38768673
PMCPMC12593226

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Registered trials

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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.