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More than 70% of both groups met the primary efficacy outcomes.
While corticosteroids are effective in treating severe acute ulcerative colitis, it is unknown whether adding additional medications could be effective treating this patient population.
An international team of investigators, led by Shomron Ben-Horin, MD, Sheba Medical Center, examined outcomes for hospitalized patients with acute severe ulcerative colitis treated with corticosteroids compared to patients treated with corticosteroids with an additional treatment of 5-aminosalicylates (5ASA).
The data was presented during the Crohn’s and Colitis Congress 2022 Annual Meeting.
Corticosteroids are a common treatment for hospitalized patients with acute severe ulcerative colitis. While corticosteroids are effective, it is not known whether the additional or continuation of 5ASA with corticosteroids during hospitalization are superior to corticosteroids alone.
In the randomized controlled investigator-blinded clinical trial, the investigators examined patients in 10 centers in 6 countries. Patients included in the final analysis were hospitalized with acute severe ulcerative colitis, defined as a Lichtiger score of at least 10.
Each participant received either corticosteroids alone or corticosteroids with 5ASA (4gr/day mesalamine). The patients were selected by a stratified randomization according to 5ASA use prior to admission.
The investigators sought primary outcomes of the percentage of patients who responded to treatment by day 7, which was defined as a drop of at least 3 points in the Lichtiger score and an absolute score less than 10 without the need of rescue medications or colectomy.
There was a total of 346 patients screened, 149 of which were included in the final analysis. Of this group, 70 were female and the median age was 41 years. Also within this group 73 participants received corticosteroids with 5ASA, while 76 individuals were treated with corticosteroids alone.
The investigators found 72.6% (n = 53) of participants in the combination group met the primary outcome, compared to 76.3% (n = 58) in the corticosteroids alone group (OR, 0.82; 95% CI, 0.39-1.72; P = 0.60).
There was also no difference between the groups in hospital length of stay or CRP normalization rate, while the colectomy rate up to 90 days was also similar. However, the need for biologics in the combination group was numerically lower by day 30 (P = 0.11) and day 90 (P = 0.07).
“In this randomized controlled trial, combination 5ASA with corticosteroids did not benefit hospitalized patients with ASUC more than corticosteroids alone,” the authors wrote. “An exploratory finding of a reduced need for biologics at 90 days in the combination group merits further evaluation.”
The study, “CORTICOSTEROIDS AND 5ASA VERSUS CORTICOSTEROIDS ALONE FOR ACUTE SEVERE ULCERATIVE COLITIS: A RANDOMIZED CONTROLLED TRIAL,” was published online by the Crohn’s and Colitis Congress.