Evidence map›Paper›PMID 38216022›Full record

ArticleClinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association2024

Impact of Treatment Response on Risk of Serious Infections in Patients With Crohn's Disease: Secondary Analysis of the PYRAMID Registry.

Dhruv Ahuja, Jiyu Luo, Yuchen Qi, Gaurav Syal, Brigid S Boland, John Chang, Christopher Ma, Vipul Jairath, Ronghui Xu, Siddharth Singh

Registry-linked trialOpen access · greenAbstract read
In one paragraph

Article in Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00524537 (A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA®), which is not on this map. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 pooled it
7.2field-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.

NCT00524537 completednot on this map

A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Subjects With Moderately to Severely Active Crohn's Disease (CD)

TypeobservationalSponsorAbbVie (prior sponsor, Abbott)Ran2007 to 2015Enrolled5,025ConditionsCrohn's Disease
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 2 syntheses or guidelines pooled it, 13 citations in OpenAlex.

  1. Guideline
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  3. Article
  4. Comparative Safety of Janus Kinase Inhibitors vs Tumor Necrosis Factor Antagonists in Patients With Inflammatory Bowel Diseases.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2026
    Article
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4 · The record

Corrections and comments

  • Commented on by
    2024
5 · Who and what money

Authors and funding

10 authors at 4 institutions in 3 countries.

Dhruv AhujaDepartment of Medicine, Indira Gandhi Hospital, New Delhi, India.
Jiyu LuoBiostatistics and Bioinformatics, Herbert Wertheim School of Public Health, University of California San Diego, La Jolla, California.
Yuchen QiBiostatistics and Bioinformatics, Herbert Wertheim School of Public Health, University of California San Diego, La Jolla, California.
Gaurav SyalDivision of Gastroenterology, Department of Medicine, University of California San Diego, La Jolla, California.
Brigid S BolandDivision of Gastroenterology, Department of Medicine, University of California San Diego, La Jolla, California.
John ChangDivision of Gastroenterology, Department of Medicine, University of California San Diego, La Jolla, California.
Christopher MaDivision of Gastroenterology and Hepatology, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada; Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada.
Vipul JairathDivision of Gastroenterology, Department of Medicine, Western University, London, Ontario, Canada; Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada.
Ronghui XuBiostatistics and Bioinformatics, Herbert Wertheim School of Public Health, University of California San Diego, La Jolla, California.
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.
University of California San Diego · USIndira Gandhi Delhi Technical University for Women · INUniversity of Calgary · CAWestern University · CA

Funding

Comparative effectiveness research in Hispanic patients with inflammatory bowel diseasesR01DK135937 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI Siddharth Singh · 2024 to 2026
$1.9M
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
NIDDK NIH HHS K23 DK117058NIDDK NIH HHS R01 DK135937NIDDK NIH HHS R03 DK129631
6 · The paper itself

Abstract

BACKGROUND &

aimsTraditional risk factors for serious infections with advanced therapies in patients with Crohn's disease (CD) have been assessed at baseline before starting therapy. We evaluated the impact of treatment response on the risk of serious infections in adalimumab-treated patients with CD through secondary analysis of the PYRAMID registry (NCT00524537).

methodsWe included patients with CD who initiated adalimumab and classified them as treatment responders (achieved steroid-free clinical remission based on patient-reported outcomes) vs nonresponders (not in steroid-free clinical remission) at 6 months after treatment initiation (landmark). We compared the risk of serious infections between responders vs nonresponders between 6 and 36 months after treatment initiation through stabilized inverse probability of treatment weighting Cox proportional hazards model.

resultsOf 1515 adalimumab-treated patients, 763 (50.4%) were classified as responders at 6 months (37 ± 13 y; 56% female; disease duration, 9.5 ± 8.5 y). Compared with nonresponders, responders were less likely to have moderate to severe symptoms (55.6% vs 33%), or require steroids (45.5% vs 17.3%) or opiates (6.6% vs 1.3%) at baseline, without any differences in disease location, perianal disease, and prior CD complications. During follow-up evaluation, using stabilized inverse probability of treatment weighting, responders were 34% less likely to experience serious infections compared with nonresponders (hazard ratio, 0.66; 95% CI, 0.46-0.96). Risk of gastrointestinal and extraintestinal infections was lower in responders vs nonresponders.

conclusionsPatients with CD who respond to adalimumab have a lower risk of developing serious infections compared with nonresponders. These findings underscore that initiation of advanced therapy for CD may lower the risk of serious infections through effective disease control and avoidance of corticosteroids.

Indexed as

AdalimumabCrohn DiseaseRegistriesAdultAnti-Inflammatory AgentsFemaleHumansInfectionsMaleMiddle AgedRisk AssessmentRisk FactorsTreatment OutcomeYoung AdultAdalimumabAnti-Inflammatory AgentsBiologicsComparative EffectivenessIBDPositioningSafety

Identifiers

PMID38216022
PMCPMC11260264
OpenAlexW4390742247

What OpenQuestion holds

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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.