Evidence map›Paper›PMID 36343846›Full record

ArticleClinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association2023

Comparative Safety and Effectiveness of Biologic Therapy for Crohn's Disease: A CA-IBD Cohort Study.

Siddharth Singh, Jihoon Kim, Jiyu Luo, Paulina Paul, Vivek Rudrapatna, Sunhee Park, Kai Zheng, Gaurav Syal, Christina Ha, Phillip Fleshner and 11 more

Open access · bronzeAbstract readMulticenter Study
In one paragraph

Article in Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 2 pooled it
6.2field-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

25 citing papers in PubMed, 2 syntheses or guidelines pooled it, 37 citations in OpenAlex.

  1. Pooled it
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  9. Cost calculation model of introducing Upadacitinib and Risankizumab for adult ulcerative colitis and Crohn's disease in the Kingdom of Saudi Arabia.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association · 2026
    Article
  10. Modern Advanced Therapies for Inflammatory Bowel Diseases: Practical Considerations and Positioning.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2025
    Review
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  19. Impact of Treatment Response on Risk of Serious Infections in Patients With Crohn's Disease: Secondary Analysis of the PYRAMID Registry.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2024
    Article
  20. Histologic Activity in Inflammatory Bowel Disease and Risk of Serious Infections: A Nationwide Study.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2024
    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

21 authors at 7 institutions in 1 country.

Siddharth SinghDivision of Gastroenterology, Department of Medicine, University of California San Diego, La Jolla, California; Division of Biomedical Informatics, Department of Medicine, University of California San Diego, La Jolla, California. Electronic address: sis040@ucsd.edu.
Jihoon KimDivision of Biomedical Informatics, Department of Medicine, University of California San Diego, La Jolla, California.
Jiyu LuoDivision of Biostatistics and Bioinformatics, Department of Family Medicine and Public Health, University of California San Diego, La Jolla, California.
Paulina PaulDivision of Biomedical Informatics, Department of Medicine, University of California San Diego, La Jolla, California.
Vivek RudrapatnaDivision of Gastroenterology, Department of Medicine, University of California San Francisco, California.
Sunhee ParkDivision of Gastroenterology, Department of Medicine, University of California Irvine, Orange, California.
Kai ZhengDepartment of Informatics, Donald Bren School of Information and Computer Sciences, University of California Irvine, Orange, California.
Gaurav SyalKarsh Division of Gastroenterology and Hepatology, Department of Medicine, Cedars-Sinai Medical System, Los Angeles, California.
Christina HaDivision of Gastroenterology, Department of Medicine, Mayo Clinic, Scottsdale, Arizona.
Phillip FleshnerDivision of Colorectal Surgery, Department of Surgery, Cedars-Sinai Medical System, Los Angeles, California.
Dermot McGovernKarsh Division of Gastroenterology and Hepatology, Department of Medicine, Cedars-Sinai Medical System, Los Angeles, California.
Jenny S SaukVatche and Tamar Manoukian Division of Digestive Diseases, Department of Medicine, University of California Los Angeles, Los Angeles, California.
Berkeley LimketkaiVatche and Tamar Manoukian Division of Digestive Diseases, Department of Medicine, University of California Los Angeles, Los Angeles, California.
Parambir S DulaiDivision of Gastroenterology, Department of Medicine, Northwestern University, Chicago, Illinois.
Brigid S BolandDivision of Gastroenterology, Department of Medicine, University of California San Diego, La Jolla, California.
Samuel EisensteinDivision of Colon and Rectal Surgery, Department of Surgery, University of California San Diego, La Jolla, California.
Sonia RamamoorthyDivision of Colon and Rectal Surgery, Department of Surgery, University of California San Diego, La Jolla, California.
Gil MelmedKarsh Division of Gastroenterology and Hepatology, Department of Medicine, Cedars-Sinai Medical System, Los Angeles, California.
Uma MahadevanDivision of Gastroenterology, Department of Medicine, University of California San Francisco, California.
William J SandbornDivision of Gastroenterology, Department of Medicine, University of California San Diego, La Jolla, California.
Lucila Ohno-MachadoDivision of Biomedical Informatics, Department of Medicine, University of California San Diego, La Jolla, California.
University of California San Diego · USCedars-Sinai Medical Center · USUniversity of California, Irvine · USUniversity of California, Los Angeles · USUniversity of California, San Francisco · USMayo Clinic in Arizona · USNorthwestern University · US

Funding

California Precision Medicine Research Program ConsortiumOT2OD026552 · OD · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI ANTON-CULVER, HODA A, OHNO-MACHADO, LUCILA · 2018 to 2023
$73.4M
RADx-Rad Discoveries & Data: Consortium Coordination Center Program OrganizationU24LM013755 · NLM · YALE UNIVERSITY · PI ARONOFF-SPENCER, ELIAH S, OHNO-MACHADO, LUCILA · 2021 to 2023
$23.3M
Protecting Privacy and Facilitating Shared Access of Clinical and Genetic Data of Special PopulationsR01HL136835 · NHLBI · YALE UNIVERSITY · PI OHNO-MACHADO, LUCILA · 2018 to 2022
$6.5M
iAGREE: A Multi-Center, Networked Patient Consent StudyR01HG011066 · NHGRI · YALE UNIVERSITY · PI OHNO-MACHADO, LUCILA · 2020 to 2024
$4.2M
Comparative Risks and Benefits of Pharmacological Therapies for Older Patients with Inflammatory Bowel DiseasesK23DK117058 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI SINGH, SIDDHARTH · 2018 to 2022
$971k
Predicting Short- and Long-term Risk of Serious Infections in Older Patients with Inflammatory Bowel DiseasesR03DK129631 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI SINGH, SIDDHARTH · 2021 to 2022
$203k
NHGRI NIH HHS R01 HG011066NHLBI NIH HHS R01 HL136835NIDDK NIH HHS K23 DK117058NIDDK NIH HHS R03 DK129631NIH HHS OT2 OD026552NLM NIH HHS U24 LM013755
6 · The paper itself

Abstract

BACKGROUND &

aimsWe compared the safety and effectiveness of tumor necrosis factor α (TNF-α) antagonists vs vedolizumab vs ustekinumab in patients with Crohn's disease (CD) in a multicenter cohort (CA-IBD).

methodsWe created an electronic health record-based cohort of adult patients with CD who were initiating a new biologic agent (TNF-α antagonists, ustekinumab, vedolizumab) from 5 health systems in California between 2010 and 2017. We compared the risk of serious infections (safety) and all-cause hospitalization and inflammatory bowel disease-related surgery (effectiveness) between different biologic classes using propensity score (PS) matching.

resultsAs compared with TNF-α antagonists (n = 1030), 2:1 PS-matched, ustekinumab-treated patients with CD (n = 515) experienced a lower risk of serious infections (hazard ratio [HR], 0.36; 95% CI, 0.20-0.64), without any difference in the risk of hospitalization (HR, 0.99; 95% CI, 0.89-1.21) or surgery (HR, 1.08; 95% CI, 0.69-1.70). Compared with vedolizumab (n = 221), 1:1 PS-matched, ustekinumab-treated patients with CD (n = 221) experienced a lower risk of serious infections (HR, 0.20; 95% CI, 0.07-0.60), without significant differences in risk of hospitalization (HR, 0.76; 95% CI, 0.54-1.07) or surgery (HR, 1.42; 95% CI, 0.54-3.72). Compared with TNF-α antagonists (n = 442), 2:1 PS-matched, vedolizumab-treated patients with CD (n = 221) had a similar risk of serious infections (HR, 1.53; 95% CI, 0.84-2.78), hospitalization (HR, 1.32; 95% CI, 0.98-1.77), and surgery (HR, 0.63; 95% CI, 0.27-1.47). High comorbidity burden, concomitant opiate use, and prior hospitalization were associated with serious infections and hospitalization in biologic-treated patients with CD.

conclusionIn a multicenter cohort of biologic-treated patients with CD, ustekinumab was associated with a lower risk of serious infections compared with TNF-α antagonists and vedolizumab, without any differences in risk of hospitalization or surgery. The risk of serious infections was similar for TNF-α antagonists vs vedolizumab.

Indexed as

Biological ProductsCrohn DiseaseInflammatory Bowel DiseasesAdultBiological TherapyCohort StudiesHumansRetrospective StudiesTreatment OutcomeTumor Necrosis Factor-alphaTumor Necrosis Factor InhibitorsUstekinumabBiological ProductsTumor Necrosis Factor-alphaTumor Necrosis Factor InhibitorsUstekinumabBiologicsComparative EffectivenessImmunosuppressivesInflammatory Bowel DiseasesPositioning

Identifiers

PMID36343846
PMCPMC12145724
OpenAlexW4308499172

What OpenQuestion holds

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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.