Corticosteroids and Mesalamine Versus Corticosteroids for Acute Severe Ulcerative Colitis: A Randomized Controlled Trial.

Humans Female Adult Mesalamine / therapeutic use Colitis, Ulcerative / drug therapy Anti-Inflammatory Agents, Non-Steroidal / therapeutic use Treatment Outcome Adrenal Cortex Hormones / therapeutic use Biological Products / therapeutic use

5-Aminosalycilates Corticosteroids Inflammatory Bowel Disease Ulcerative Colitis

Journal

Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association

ISSN: 1542-7714

Titre abrégé: Clin Gastroenterol Hepatol

Pays: United States

ID NLM: 101160775

Informations de publication

Date de publication:
12 2022

Historique:

received: 11 10 2021

revised: 14 02 2022

accepted: 21 02 2022

pubmed: 11 3 2022

medline: 29 11 2022

entrez: 10 3 2022

Statut: ppublish

Résumé

Corticosteroids are the mainstay of treatment for hospitalized patients with acute severe ulcerative colitis (ASUC). However, whether the addition/continuation of mesalamine with corticosteroids during hospitalization is superior to corticosteroids alone is unknown. This was a randomized controlled, investigator-blinded, clinical trial conducted in 10 centers in 7 countries. Patients hospitalized with ASUC (Lichtiger score ≥10) were eligible. Patients received corticosteroids alone or corticosteroid + mesalamine (4 g/day mesalamine) by a stratified randomization according to mesalamine use before admission. The primary outcome was the percentage of patients who responded to treatment by day 7, defined by a drop >3 points in the Lichtiger score and an absolute score <10 without the need for rescue medications or colectomy. Three hundred forty-six patients were screened, and 149 were included (70/149 female; median age, 41 years). Of these, 73 received corticosteroids + mesalamine, and 76 received corticosteroids alone. For the primary outcome, 53 of 73 patients (72.6%) receiving corticosteroids with mesalamine responded versus 58 of 76 patients (76.3%) on corticosteroids alone (odds ratio, 0.82; 95% confidence interval, 0.39-1.72; P = .60). There was no difference between groups in duration of hospitalization, C-reactive protein normalization rate, or colectomy rate up to day 90. The need for biologics among patients receiving combination of corticosteroids with mesalamine was numerically lower by day 30 (P = .11) and day 90 (P = .07). In this randomized controlled trial, combination of mesalamine with corticosteroids did not benefit hospitalized patients with ASUC more than corticosteroids alone. An exploratory signal for a reduced need for biologics at 90 days in the mesalamine group merits further evaluation. gov ID: NCT01941589.

Sections du résumé

BACKGROUND & AIMS

METHODS

This was a randomized controlled, investigator-blinded, clinical trial conducted in 10 centers in 7 countries. Patients hospitalized with ASUC (Lichtiger score ≥10) were eligible. Patients received corticosteroids alone or corticosteroid + mesalamine (4 g/day mesalamine) by a stratified randomization according to mesalamine use before admission. The primary outcome was the percentage of patients who responded to treatment by day 7, defined by a drop >3 points in the Lichtiger score and an absolute score <10 without the need for rescue medications or colectomy.

RESULTS

Three hundred forty-six patients were screened, and 149 were included (70/149 female; median age, 41 years). Of these, 73 received corticosteroids + mesalamine, and 76 received corticosteroids alone. For the primary outcome, 53 of 73 patients (72.6%) receiving corticosteroids with mesalamine responded versus 58 of 76 patients (76.3%) on corticosteroids alone (odds ratio, 0.82; 95% confidence interval, 0.39-1.72; P = .60). There was no difference between groups in duration of hospitalization, C-reactive protein normalization rate, or colectomy rate up to day 90. The need for biologics among patients receiving combination of corticosteroids with mesalamine was numerically lower by day 30 (P = .11) and day 90 (P = .07).

CONCLUSIONS

In this randomized controlled trial, combination of mesalamine with corticosteroids did not benefit hospitalized patients with ASUC more than corticosteroids alone. An exploratory signal for a reduced need for biologics at 90 days in the mesalamine group merits further evaluation.

CLINICALTRIALS

gov ID: NCT01941589.

Identifiants

DOI: 10.1016/j.cgh.2022.02.055 PMID: 35272029

pubmed: 35272029

pii: S1542-3565(22)00213-0

doi: 10.1016/j.cgh.2022.02.055

pii:

doi:

Substances chimiques

Mesalamine 4Q81I59GXC

Anti-Inflammatory Agents, Non-Steroidal 0

Adrenal Cortex Hormones 0

Biological Products 0

Banques de données

ClinicalTrials.gov

['NCT01941589']

Types de publication

Randomized Controlled Trial Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

Pagination

2868-2875.e1