Clin Gastroenterol Hepatol. 2022 Mar 7:S1542-3565(22)00213-0. doi: 10.1016/j.cgh.2022.02.055. Online ahead of print.
BACKGROUND: Corticosteroids are the mainstay of treatment for hospitalized patients with acute severe ulcerative colitis (ASUC). However, whether the addition/continuation of 5-aminosalicylates (5ASA) with corticosteroids during hospitalization is superior to corticosteroids alone is unknown METHODS: This was a randomized controlled investigator-blinded clinical trial conducted in ten centers in six countries. Patients hospitalized with ASUC (Lichtiger score ≥10) were eligible. Patients received corticosteroids alone or corticosteroid+5ASA (4gr/day mesalamine) by a stratified randomization according to 5ASA use prior to 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: 346 patients were screened and 149 were included (70/149 females, median age 41). Of these, 73 received corticosteriods+5ASA and 76 corticosteroids alone. For the primary outcome, 53/73 (72.6%) of patients receiving corticosteroids with 5ASA responded versus 58/76 (76.3%) of patients on corticosteroids alone (OR 0.82 95%CI 0.39-1.72, P= .60). There was no difference between groups in duration of hospitalization, CRP normalization rate or colectomy rate up to day 90. The need for biologics among patients receiving combination corticosteroids with 5ASA was numerically lower by day 30 (P= .11) and day 90 (P= .07).
CONCLUSION: In this randomized controlled trial, combination 5ASA 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 5ASA group merits further evaluation.
CLINICALTRIALS: gov ID: NCT01941589.