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

Adalimumab / administration & dosage Adult Anti-Inflammatory Agents / administration & dosage Azathioprine / administration & dosage Crohn Disease / diagnosis Disease Progression Drug Therapy, Combination / adverse effects Female Follow-Up Studies Hospitalization / statistics & numerical data Humans Male Prednisone / administration & dosage Remission Induction / methods Retrospective Studies Severity of Illness Index Time Factors Treatment Outcome Tumor Necrosis Factor-alpha / antagonists & inhibitors Young Adult

Adalimumab CDEIS IBD Inflammatory Bowel Diseases

Journal

Gastroenterology

ISSN: 1528-0012

Titre abrégé: Gastroenterology

Pays: United States

ID NLM: 0374630

Informations de publication

Date de publication:
07 2020

Historique:

received: 07 06 2019

revised: 06 03 2020

accepted: 13 03 2020

pubmed: 1 4 2020

medline: 1 4 2021

entrez: 1 4 2020

Statut: ppublish

Résumé

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

Sections du résumé

BACKGROUND & AIMS

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

METHODS

We 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.

RESULTS

Major 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.

CONCLUSIONS

In 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.

Identifiants

DOI: 10.1053/j.gastro.2020.03.039 PMID: 32224129 PMC: PMC7751802

pubmed: 32224129

pii: S0016-5085(20)30390-5

doi: 10.1053/j.gastro.2020.03.039

pmc: PMC7751802

mid: NIHMS1646199

pii:

doi:

Substances chimiques

Anti-Inflammatory Agents 0

TNF protein, human 0

Tumor Necrosis Factor-alpha 0

Adalimumab FYS6T7F842

Azathioprine MRK240IY2L

Prednisone VB0R961HZT

Banques de données

ClinicalTrials.gov

['NCT01235689']

Types de publication

Journal Article Multicenter Study Randomized Controlled Trial Research Support, N.I.H., Extramural Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

Pagination

139-147

Subventions

Organisme : NIDDK NIH HHS

ID : K23 DK111995

Pays : United States

Informations de copyright

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