P542 Topical tacrolimus versus systemic biological therapy for refractory ulcerative proctitis: a retrospective cohort study

Crispino, F.(1);Michielan, A.(2);Tieppo, C.(2);Mazza, M.(2);Rogger, T.M.(2);Brinch, D.(1);Cappello, M.(1);Armelao, F.(2);

(1)University of Palermo, Gastroenterology & Hepatology Section- PROMISE, Palermo, Italy;(2)Santa Chiara Hospital, Gastroenterology and Digestive Endoscopy Unit, Trento, Italy;


Refractory ulcerative proctitis significantly affects patients’ quality of life, because of disabling symptoms such as tenesmus, fecal urgency and rectal bleeding. Immunosuppressive drugs, such as thiopurines and biologics, are recommended by clinical guidelines. Recently, a few studies have suggested that topical tacrolimus can be an effective and safe therapy in inducing clinical remission in these patients. However, there are no comparative data with biologics. The aim of our study was to compare the efficacy and safety of topical tacrolimus versus biological therapy in a retrospective cohort of refractory ulcerative proctitis patients’ followed up in two tertiary IBD clinics.


Consecutive patients with refractory ulcerative proctitis who started rectal tacrolimus 2 mg o.d. or biologics were enrolled between 2018 and 2020. Ulcerative refractory proctitis was defined as active disease up to 20 cm beyond the anal verge and endoscopic Mayo score ≥2 failure to both topical and oral mesalamine and corticosteroids. Primary endpoints were clinical response and remission after 8 and 54 weeks of treatment. Secondary endpoints were endoscopic remission after 54 weeks and the rate of adverse events. Clinical response was defined as a decrease in partial Mayo score of ≥3 points, plus either a decrease in rectal bleeding subscore of ≥1 or an absolute rectal bleeding score of ≤1. Clinical remission was defined as a partial Mayo score ≤2, while endoscopic remission as a Mayo endoscopic subscore ≤1.


25 patients were enrolled (17 males, mean age 52.0±17.2 years, mean disease duration 11.6±9.0 years, mean partial Mayo score 6.7±1.3; mean endoscopic Mayo score 2.6±0.2). 10 patients were treated with rectal tacrolimus, 15 with biologics (antiTNFs=12; vedolizumab=3). There were no differences at baseline between the two groups. At week 8, 64.0% of patients had a clinical response, while 32.0% obtained clinical remission. At week 54, 80.0% were on clinical response and almost half of the patients were on clinical and endoscopic remission. No significant difference in clinical and endoscopic response and remission rates was observed in the two groups except for a trend toward significance in favour of biologics in the rate of concomitant topical corticosteroid use at 8 weeks (p = 0.06). Two patients experienced biologics related-side effects, while no one had tacrolimus related-ones.


In this real-world two centers experience, both rectal tacrolimus and systemic biological therapy seem to have comparable efficacy in inducing and maintaining remission in refractory ulcerative proctitis patients. Topical tacrolimus can be a safer and cheaper therapeutic option. Our results need confirmation in prospective and larger studies.