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* = Presenting author

P579 Combined therapy of tacrolimus and vedolizumab in severe refractory ulcerative colitis

N.-A. Dietrich*1, F. Baer1, A. Dignass2, B. Bokemeyer3, K. Fellermann1, J. Buening1

1University Hospital of Schleswig-Holstein, Luebeck, Internal Medicine, Luebeck, Germany, 2Hospital Agaplesion Markus, Frankfurt am Main, Department of Medicine I, Frankfurt am Main, Germany, 3Gastroenterology Practice Minden, Gastroenterology, Minden, Germany

Background

Tacrolimus is an option for induction of remission in severe refractory ulcerative colitis (UC). Tacrolimus is often used in combination with thiopurines as rescue and bridging therapy. In patients with thiopurine failure vedolizumab might serve as therapeutic alternative, but no data exist so far. The aim of this study was to evaluate the efficacy and safety of vedolizumab in combination with tacrolimus in patients with severe UC.

Methods

Patients with refractory UC undergoing therapy with tacrolimus and vedolizumab were collected retrospectively in 3 IBD centres. Data were recorded for at least 14 weeks after start of vedolizumab. We identified 8 patients (5 male, median age 28 years, and all E3) for analysis. All patients had thiopurine failure, and 5 had tumour necrosis factor (TNF)-antibody failure. A steroid-refractory course was documented in 4 patients, whereas the remaining 4 were intolerable steroid dependent. Ongoing steroid treatment was found in 50 % of the patients (n = 4) at the beginning of tacrolimus therapy. Efficacy was analysed by the colectomy rate, Lichtiger score, steroid reduction, and the C-reactive protein (CRP).

Results

Tacrolimus was initiated with a mean dose of 7.9 mg per day (0.10 mg/kg). Vedolizumab was introduced not later than 2 weeks after tacrolimus. Further, 300 mg vedolizumab were given intravenously at week 0, 2, 6, 10, and 14. No colectomy was necessary up to week 14. Under combination therapy clinical activity decreased (mean Lichtiger Score before treatment 11.2 vs 3.0 at week 14) and 62.5 % of the patients achieved remission (Lichtiger Score ≤ 3). Systemic steroids were terminated in 3 of 4 patients. Tacrolimus was reduced to a mean dose of 4.7 mg per day (0.05 mg/kg) and stopped in 1 patient. The mean CRP decreased from 17.4 mg/L to 2.3 mg/L at week 14. Side effects were recorded in 2 patients (25 %, tremor and kreatinin increase). No infections were observed in this treatment period. Treatment was not terminated because of side effects. None of the patients died.

Conclusion

Our data indicate the efficacy and safety of tacrolimus in combination with vedolizumab in severe refractory UC patients and including previous anti-TNF failure. Induction of remission using tacrolimus might serve as bridging therapy for maintenance of remission with vedolizumab as long-term treatment. Future studies should address this therapeutic concept.