Limited long-term effectiveness and safety of tacrolimus in ulcerative colitis

Tacrolimus is a calcineurin inhibitor commonly used for prophylaxis of rejection in renal and liver transplantation. Efficacy and safety of tacrolimus in ulcerative colitis were evaluated in a retrospective, multicentre study performed in Spain, in which 58 patients received tacrolimus between 1999 and 2018 [1]. The most common indications for tacrolimus were steroid-dependency (55%) and steroid-refractory disease (29%). The median clinical follow-up was 25 months.

Tacrolimus offered a clinical benefit in medically refractory ulcerative colitis in the short-term, but its long-term effectiveness and safety was found to have important limitations. After 3 months, partial Mayo score had decreased significantly (mean 1.6, P=0.0001), with 36% of patients having partial response and 24% being in clinical remission. One third of patients (35%) suffered adverse events related to the drug (40% tremor, 20% asthenia), leading to discontinuation in 35%. The drug was stopped in 81% of patients after a median of 14 months, with 47% requiring a new immunomodulator, 28% hospitalisation, and 33% colectomy thereafter.

1. Rodriguez-Lago I, et al. ECCO 2019, DOP44.



Posted on 9 May, 20199 April, 2024