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Both tacrolimus and beclomethasone equally effective in refractory ulcerative proctitis

Ulcerative proctitis (UP) is a form of ulcerative colitis (UC) that is limited to the rectum and considered by many to be the initial manifestation of UC.

Satisfactory induction therapy for UP may therefore help to delay disease progression. The usual treatment for UP is 5-aminosalicylic acid (5-ASA) and where this is ineffective, corticosteroids are added but this only induces remission in around 46% of cases and is associated with several side-effects.

In this randomised, double-blind trial by a Dutch and Flemish team, 85 patients (aged 18 years and over) and with endoscopically proven UP, refractory to 5-ASA were given either topical tacrolimus (2mg suppositories) or beclomethasone (3mg suppositories) once daily for 4 weeks.

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A clinical response was defined as a ≥ 3-point change in the Mayo score (which ranges from 0 to 12) with higher scores representing more severe disease. At the study end, there was no significant difference in clinical response between tacrolimus or beclomethasone (63% vs 59%, p = 0.812). In addition, the proportion of patients in remission was also not significantly different (46% vs 38%, p = 0.638).

The authors concluded that either treatment represents a viable treatment option for patients refractory to 5-ASA that should be offered before other therapies.

Lie MRKL et al. No superiority of tacrolimus suppositories vs beclomethasone suppositories in a randomised trial of patients with refractory ulcerative proctitis. Clin Gastroenterol Hepatol 2020;18(9):1777-84.