Tacrolimus Suppositories in Therapy-Resistant Ulcerative Proctitis

Inflammatory Intestinal Diseases
Simon U JaegerJan Wehkamp

Abstract

Ulcerative proctitis may often be managed with topical salicylates or steroids alone, but in some patients, symptoms are persistent and severe. We analyzed the efficacy of tacrolimus suppositories in patients who had proven refractory to combined topical and systemic treatment. In this retrospective analysis, ulcerative colitis activity index (CAI), side effects, co-medication and drug levels were assessed in 43 patients with distal ulcerative colitis who received suppositories containing 2 mg of tacrolimus b.i.d. as add-on medication. A total of 23 patients with ulcerative proctitis presented to follow-up within ≤50 days (mean 27.0 days) after suppositories were started. A decrease in CAI (from 8.0 to 5.5 points) was observed and 52.3% reached clinical remission (CAI ≤4). In total, 43 patients were available for analysis, of whom 9 had inflammation of the sigmoid colon as well. For the entire cohort, the median treatment duration was 76 days; 60% were in remission on the last documented visit. Serum measurements revealed a substantial tacrolimus level with a mean of 5.5 ng/mL. We observed one case of mild reversible acute kidney injury. In ulcerative proctitis, adding tacrolimus suppositories can be an effective and safe optio...Continue Reading

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Citations

Aug 13, 2020·JGH Open : an Open Access Journal of Gastroenterology and Hepatology·Sasha R FehilyMichael A Kamm
Jul 8, 2020·United European Gastroenterology Journal·Evelyne DuboisSéverine Vermeire
Nov 6, 2020·Diseases of the Colon and Rectum·Amy L LightnerPaulo Kotze
Feb 25, 2021·Journal of Investigative Medicine : the Official Publication of the American Federation for Clinical Research·George SalemRussell Cohen
Feb 23, 2021·Asian Journal of Pharmaceutical Sciences·Iria Seoane-ViañoAlvaro Goyanes

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