Background & Aims: 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. 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.
|Journal||Clinical Gastroenterology and Hepatology|
|Publication status||Published - 2022 Dec|
Bibliographical noteFunding Information:
Funding Supported by the Talpiot Medical Leadership grant of Sheba Medical Center (to SBH).
Conflicts of interest These authors disclose the following: SBH has received consultancy and/or advisory board fees from Schering-Plough, AbbVie, Celltrion, Pfizer, Ferring, Janssen, Takeda; Galmed, BMS, and Novartis and has received research support from Celltrion, AbbVie, Janssen, Galmed, and Takeda. OHN received non-restricted educational grant from Ferring. XR has received consultancy and/or advisory board fees from MSD, AbbVie, Celltrion, Ferring, Janssen, Takeda, Gilead, and Amgen. DC has received fees for consulting/speaking from Janssen, MSD, Takeda, Pfizer, Ferring, and Galenica. KK has received speaker fees from AbbVie, Aenorasis, Janssen, MSD, Pfizer, and Takeda and consultancy or advisory board member fees from AbbVie, Amgen, Ferring, Galenica, Genesis, Janssen, MSD, Pfizer, and Takeda. MP was previously an employee of Tillotts Pharma. DS received speaker fees from Janssen, Takeda, AbbVie, Ferring, and Neopharm and consultancy/advisory fees from Rafa, Takeda, and AbbVie. The remaining authors disclose no conflicts.
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