Rectal Therapy with Prograf Helped Patients with Resistant UC, Study Shows

Rectal Therapy with Prograf Helped Patients with Resistant UC, Study Shows
Patients with resistant ulcerative proctitis, a mild form of ulcerative colitis (UC), respond to therapy with rectal Prograf (tacrolimus) ointment, achieving clinical remission and mucosal healing, according to the results of a small clinical trial. The study “Efficacy of Rectal Tacrolimus for Induction Therapy in Patients With Resistant Ulcerative Proctitis” was published in the journal Clinical Gastroenterology and Hepatology. Approximately 25 percent of patients with UC have ulcerative proctitis, in which the inflammation is usually confined to the final segment of the large intestine, the rectum. Despite available therapies, patients can develop resistant ulcerative proctitis, meaning they do not respond to available therapies. Prograf (tacrolimus) is a calcineurin inhibitor widely used as a topical immunosuppressive therapy with success in UC. Previous studies suggested that Prograf is a potential effective therapy for difficult-to-treat proctitis. To expand and further confirm the results of these earlier studies, researchers performed a small Phase 4 clinical trial (NCT01418131) with a group of patients with active UC who failed to respond to previous therapies. Patients were then assigned randomly to receive either a 0.5 mg/mL dose of a rectal Prograf ointment, twice a day, or a placebo (control) for 8 weeks. In total, 11 patients were assigned to the Prograf and 10 patients to the placebo arm of the study. The study's main outcome was
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