Evidence map›Paper›PMID 32224129›Full record

Trial reportGastroenterology2020

Deep Remission at 1 Year Prevents Progression of Early Crohn's Disease.

Ryan C Ungaro, Clara Yzet, Peter Bossuyt, Filip J Baert, Thomas Vanasek, Geert R D'Haens, Vincent Wilhelmus Joustra, Remo Panaccione, Gottfried Novacek, Walter Reinisch and 29 more

Open access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Gastroenterology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 116 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
116citing papers in PubMed, 4 pooled it
23.4field-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.

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

116 citing papers in PubMed, 4 syntheses or guidelines pooled it, 229 citations in OpenAlex.

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56 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

39 authors at 20 institutions in 18 countries.

Ryan C UngaroIcahn School of Medicine at Mount Sinai, Division of Gastroenterology, New York, New York.
Clara YzetAmiens University Hospital, Department of Gastroenterology, Amiens, France.
Peter BossuytImelda Gastroenterology Clinical Research Center, Department of Gastroenterology, Imelda General Hospital, Bonheiden, Belgium.
Filip J BaertAZ Delta Roeselare, Roeselare, Belgium.
Thomas VanasekSecond Department of Internal Medicine, University Hospital Hradec Králové, Hradec Králové, Czech Republic.
Geert R D'HaensDepartment of Gastroenterology and Hepatology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
Vincent Wilhelmus JoustraDepartment of Gastroenterology and Hepatology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
Remo PanaccioneInflammatory Bowel Disease Unit, University of Calgary, Calgary, Canada.
Gottfried NovacekDivision of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria.
Walter ReinischDivision of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria.
Alessandro ArmuzziInflammatory Bowel Disease Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS-Università Cattolica del Sacro Cuore, Rome, Italy.
Oleksandr GolovchenkoMedical Clinical Investigational Center of Medical Center Health Clinic LLC, Vinnytsia, Ukraine.
Olga PrymakMedical Clinical Investigational Center of Medical Center Health Clinic LLC, Vinnytsia, Ukraine.
Adrian GoldisUniversitatea de Medicina si Farmacie, Timisoara, Romania.
Simon P TravisTranslational Gastroenterology Unit, Nuffield Department of Experimental Medicine, University of Oxford, Oxford, United Kingdom.
Xavier HébuterneGastroenterology and Clinical Nutrition Department, Centre Hospitalier Universitaire of Nice, University of Nice Sophia-Antipolis, Nice, France.
Marc FerranteUniversity Hospitals Leuven, Leuven, Belgium.
Gerhard RoglerDepartment of Gastroenterology and Hepatology, University Hospital Zurich, Zurich, Switzerland.
Mathurin FumeryAmiens University Hospital, Department of Gastroenterology, Amiens, France.
Silvio DaneseHumanitas University, Istituto Clinico Humanitas, Milan, Italy.
Grazyna RydzewskaCentral Clinical Hospital of Ministry of Interior and Administration in Warsaw, Warsaw, Poland.
Benjamin ParienteClaude Huriez Hospital, Lille University, Lille, France.
Erik HertervigSkane University Hospital, Lund, Sweden.
Carol StanciuGrigore T. Popa University of Medicine and Pharmacy, Iasi, Romania.
Melanie SerreroHepato-Gastroenterology Department, North Hospital, University of Mediterranean, Marseille, France.
Mircea DiculescuUniversity of Medicine and Pharmacy "Carol Davila," Bucharest, Romania.
Laurent Peyrin-BirouletHépato Gastro-Entérologie, Hôpital de Brabois, Nancy, France.
David LaharieService d'Hépato-gastroentérologie et Oncologie Digestive, Hôpital Haut-Lévêque, Bordeaux, France.
John P WrightKingsbury Hospital, Cape Town, South Africa.
Fernando GomollónHospital Clínico de Zaragoza, IIS Aragón, Zaragoza, Spain.
Irina GuboninaMilitary Medical Academy named after S.M. Kirov, Saint Petersburg, Russian Federation.
Stefan SchreiberDepartment of Internal Medicine I, Kiel University, Kiel, Germany.
Satoshi MotoyaInflammatory Bowel Disease Center, Sapporo Kosei General Hospital, Sapporo, Japan.
Per M HellströmUppsala University Hospital, Uppsala, Sweden.
Jonas HalfvarsonDepartment of Gastroenterology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
James W ButlerAbbVie, Inc, North Chicago, Illinois.
Joel PeterssonAbbVie, Inc, North Chicago, Illinois.
Francesca PetraliaDepartment of Genetics and Genomic Sciences and Icahn Institute for Data Science and Genomic Technology, Icahn School of Medicine at Mount Sinai, New York, New York.
Jean-Frederic ColombelIcahn School of Medicine at Mount Sinai, Division of Gastroenterology, New York, New York. Electronic address: jean-frederic.colombel@mssm.edu.
Icahn School of Medicine at Mount Sinai · USAbbVie (United States) · USAmsterdam UMC Location University of Amsterdam · NLCentre Hospitalier Universitaire Amiens-Picardie · FRKyiv City Clinical Oncology Center · UAMedical University of Vienna · ATAZ Delta · BECarol Davila University of Medicine and Pharmacy · ROCentre Hospitalier Régional et Universitaire de Nancy · FRCentre Hospitalier Universitaire de Nice · FRChristian-Albrechts-Universität zu Kiel · DEGrigore T. Popa University of Medicine and Pharmacy · ROHôpital Cardiologique du Haut-Lévêque · FRHôpital Claude Huriez · FRHumanitas University · ITImelda Hospital · BEInstituto de Investigación Sanitaria Aragón · ESMinistry of Interior and Administration · PLÖrebro University · SESapporo Kosei General Hospital · JP

Funding

Assessing Predictors of Response to Anti-Tumor Necrosis Alpha Therapy in Early Crohns DiseaseK23DK111995 · NIDDK · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI UNGARO, RYAN · 2019 to 2023
$948k
NIDDK NIH HHS K23 DK111995
6 · The paper itself

Abstract

BACKGROUND &

aimsWe investigated the effects of inducing deep remission in patients with early Crohn's disease (CD).

methodsWe collected follow-up data from 122 patients (mean age, 31.2 ± 11.3 y) with early, moderate to severe CD (median duration, 0.2 years; interquartile range, 0.1-0.5) who participated in the Effect of Tight Control Management on CD (CALM) study, at 31 sites, representing 50% of the original CALM patient population. Fifty percent of patients (n = 61) were randomly assigned to a tight control strategy (increased therapy based on fecal level of calprotectin, serum level of C-reactive protein, and symptoms), and 50% were assigned to conventional management. We categorized patients as those who were vs were not in deep remission (CD endoscopic index of severity scores below 4, with no deep ulcerations or steroid treatment, for 8 or more weeks) at the end of the follow-up period (median, 3.02 years; range, 0.05-6.26 years). The primary outcome was a composite of major adverse outcomes that indicate CD progression during the follow-up period: new internal fistulas or abscesses, strictures, perianal fistulas or abscesses, or hospitalization or surgery for CD. Kaplan-Meier and penalized Cox regression with bootstrapping were used to compare composite rates between patients who achieved or did not achieve remission at the end of the follow-up period.

resultsMajor adverse outcomes were reported for 34 patients (27.9%) during the follow-up period. Significantly fewer patients in deep remission at the end of the CALM study had major adverse outcomes during the follow-up period (P = .01). When we adjusted for potential confounders, deep remission (adjusted hazard ratio, 0.19; 95% confidence interval, 0.07-0.31) was significantly associated with a lower risk of major adverse outcome.

conclusionsIn an analysis of follow-up data from the CALM study, we associated induction of deep remission in early, moderate to severe CD with decreased risk of disease progression over a median time of 3 years, regardless of tight control or conventional management strategy.

Indexed as

AdalimumabAdultAnti-Inflammatory AgentsAzathioprineCrohn DiseaseDisease ProgressionDrug Therapy, CombinationFemaleFollow-Up StudiesHospitalizationHumansMalePrednisoneRemission InductionRetrospective StudiesSeverity of Illness IndexAdalimumabAnti-Inflammatory AgentsAzathioprinePrednisoneTNF protein, humanTumor Necrosis Factor-alphaAdalimumabCDEISIBDInflammatory Bowel Diseases

Identifiers

PMID32224129
PMCPMC7751802
OpenAlexW3013062810

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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.