DOP44 Efficacy and safety of tacrolimus in ulcerative colitis: a nationwide, multi-centre study from GETECCU. (25th January 2019)

• Record Type: Journal Article
• Authors: Rodriguez-Lago, I; Castro-Poceiro, J; Fernández-Clotet, A; Mesonero, F; López-Sanromán, A; López-García, A; Márquez, L; Clos-Parals, A; Cañete, F; Vicuña, M; Nantes, Ó; Merino, O; Matallana Royo, V; Gordillo, J; Elorza, A; Vicente, R; Casanova, M J; Ferreiro-Iglesias, R; Pérez-Galindo, P; Benítez, J M; Taxonera, C; García García, M J; Martín Arranz, E; Calafat, M; Martín-Cardona, A; Muñoz Núñez, F; Miquel-Cusachs, J O; Sáinz Arnau, E; Gisbert, J P
• Is Part Of: Journal of Crohn's and colitis. Volume 13(2019)Supplement 1
• Page Start: S052
• Page End: S053
• Publication Date: 2019-01-25
• Subjects: Inflammatory bowel diseases -- Periodicals; 616.344005
• DOI: 10.1093/ecco-jcc/jjy222.078
• Languages: English
• ISSNs: 1873-9946

Abstract

Abstract: Background: Ulcerative colitis (UC) is a chronic disorder of the gut. Tacrolimus (TCR) is a calcineurin inhibitor drug commonly used for prophylaxis of rejection in renal and liver transplantation. There is some evidence supporting the short- and medium-term efficacy and safety of tacrolimus in UC but data are still limited. The primary aim of our study was to evaluate the efficacy and safety of tacrolimus in UC in clinical practice in Spain. Methods: We performed a retrospective, multi-centre study in 22 inflammatory bowel disease units in Spain. We included all adult patients with a previous established diagnosis of UC in whom oral TCR was prescribed for this underlying condition. Clinical response was assessed by means of partial Mayo score and physician global assessment after 3 months. Follow-up period was considered until the last visit during therapy or 12 months after stopping the drug. Descriptive statistics and non-parametric test were used in the statistical analysis. Results: A total of 58 patients received TCR between January 1999 and June 2018 (mean age 40 years; 40% female; median CRP 8.8 mg/l). The most common indications for TCR were steroid-dependency (55%) and steroid-refractory disease (29%). Previous exposure to anti-TNF agents was observed in 71%, and 22% to vedolizumab, while 43% had been exposed to ≥2 anti-TNF. At the time of starting TCR, 9% were receiving it concomitantly with an anti-TNF agent or vedolizumab (10%). Blood drug levels during induction were 5–10 ng/ml in 35% and 10–15 ng/ml in 33%. During maintenance, blood drug levels were between 5 and 10 ng/ml in most cases (59%). The median clinical follow-up was 25 months (21–67). Partial Mayo score showed a statistically significant decrease after 3 months (mean 1.6 [SD 1.3], p = 0.0001). At this moment, clinical remission was achieved in 24%, while 36% were in partial response. CRP levels showed statistically significant differences after 1, 3, and 6 months when compared with baseline ( p < 0.03). One third of patients (35%) suffered adverse events related to the drug (40% tremor, 20% asthenia), leading in 35% to discontinuation of the drug. The drug was stopped in 81% of patients after a median of 14 months (10–24), with 47% of patients requiring a new immunomodulator, 28% hospitalisation and 33% requiring colectomy during follow-up. Conclusions: Tacrolimus offers a clinical benefit in medically refractory UC cases in the short-term, but its long-term effectiveness and safety represent important limitations.