Tacrolimus, beclomethasone effective treatments for ulcerative proctitis 5-ASA refractory
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New data showed similar clinical and endoscopic responses between tacrolimus and beclomethasone suppositories in patients with ulcerative proctitis refractory to 5-aminosalicylic acid, according to a study published in Clinical Gastroenterology and Hepatology.
“There were no significant differences in adverse events rates,” Mitchell R.K.L. Lie, MD, from the department of Gastroenterology and Hepatology at Erasmus MC University Medical Center Rotterdam, in the Netherlands, said. “Tacrolimus and beclomethasone suppositories are therefore each safe and effective treatment options for 5-ASA refractory disease.”
Lie added, “Both tacrolimus and beclomethasone suppositories are viable treatment options for 5-ASA refractory ulcerative proctitis and should be considered before step-up to systemic therapies.”
Researchers performed a randomized controlled, double-blind study comprising 85 patients with refractory ulcerative proctitis from 8 hospitals between 2014 and 2017. They assigned 43 patients to receive once daily tacrolimus suppositories 2 mg, and 42 patients to receive beclomethasone 3 mg, for 4 weeks. The clinical response of a decrease in the Mayo score of 3 or more served as the primary outcome. Other outcomes included clinical remission, endoscopic response and remission, adverse events and quality of life. Investigators used the Fisher’s exact test and Mann-Whitney U test to compare outcomes.
Results showed 63% patients in the tacrolimus group and 59% in the beclomethasone group achieved clinical responses. Researchers saw clinical remission 46% of patients in the tacrolimus group and 38% in the beclomethasone group. They reported that 68% of patients in the tacrolimus group and 60% in the beclomethasone group saw an endoscopic response. Proportion rates in endoscopic remission were 30% in the tacrolimus group and 13% in the beclomethasone group.
According to researchers, median increases in inflammatory bowel disease questionnaire score in the tacrolimus group and in the beclomethasone group were 18 and 20.5, respectively. Groups were not significantly different regarding the rate of adverse events.
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