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P473 Clinical and biochemical factors that influence response in inflammatory disease patients receiving tacrolimus

I. Rodríguez - Lago*1, 2, O. Merino2, 3, O. Nantes2, 4, C. Muñoz2, 5, U. Aguirre6, J. L. Cabriada1, 2

1Galdakao Hospital, Gastroenterology, Galdakao, Spain, 2IBD Study Group of the Basque – Navarre Society of Gastrointestinal Diseases, Pais Vasco - Navarra, Spain, 3Cruces University Hospital, Gastroenterology, Bilbao, Spain, 4Complejo Hospitalario de Navarra, Gastroenterology Department, Pamplona, Spain, 5Basurto University Hospital, Gastroenterology, Bilbao, Spain, 6Galdakao Hospital, Research Unit, Galdakao, Spain

Background

Ulcerative colitis (UC) and Crohn’s disease (CD) are 2 chronic diseases of the gastrointestinal tract, included in the term inflammatory bowel disease (IBD). Its treatment usually involves the use of immunosuppressive therapy to control the inflammatory changes in the gut. Tacrolimus is a calcineurin inhibitor drug that acts by inhibiting IL-2 production and T-cell activation and is commonly used for prophylaxis of rejection in solid organ transplantation. Some studies have demonstrated the short and medium-term efficacy of tacrolimus in both UC and CD.

Methods

We performed a retrospective, observational, multicentric study in 4 IBD units in Spain. The primary aim of our study was to evaluate the characteristics of the patients treated with tacrolimus, along with their clinical, endoscopic and analytical follow-up in routine practice. Inclusion criteria included an established diagnosis of IBD and indication of tacrolimus for this condition. The local ethics committee approved the final study protocol.

Results

Twenty patients were included. Treatment was prescribed between February 2005 and February 2015. The 2 most common indications were steroid dependency and fistulising CD, accounting for 75% of cases. Fifteen patients have previously received biologics (10 ≥ 2 biologics). Blood drug levels were maintained mostly between 5–10 ng/mL (75%), and between 10–15 ng/ml. In 9 patients (45%) tacrolimus was used as monotherapy. The drug was maintained for 11 months (IQR 5–22). Ten patients were taking the drug for at least 12 months. A complete clinical remission was achieved in 25% and 40% obtained a partial response. Clinical remission was seen in 16% and 37% in CD and UC, respectively. Partial clinical response was observed in 58% and 12%, respectively. Those patients naïve to biologics demonstrated a significantly better remission rate as compared with those previously exposed (80% vs 6.7%, p = 0.0038). This sub-group also maintained tacrolimus for a significantly shorter period of time (6 vs 21 months, p = 0.031). Those patients who achieved remission were more likely to have a significant reduction in CRP values during the first month (p = 0.015). Twelve patients stopped the drug, mainly because absence or loss of response. Further, 7 patients suffered adverse events, leading to discontinuation in 3. The overall clinical follow-up was 35.5 months (IQR 14–66). Seven patients required surgery.

Conclusion

Tacrolimus demonstrated a relatively high efficacy in IBD, especially in those anti-TNF naïve patients. Some biological markers as CRP can be used as early predictors of response to this treatment. Our data suggest that tacrolimus may be considered earlier as an alternative treatment in the natural history of the disease.