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P463. Infliximab use in ulcerative colitis from 2003 to 2013: Clinical practice, safety and efficacy

L. Fernández-Salazar1, J. Barrio2, C. Muñoz3, J. Legido4, G. González1, R. S-Ocaña2, F. Santos2, B. Velayos1, J.M. González1, 1Hospital Clínico Universitario, Gastroenterology, Valladolid. ACAD, Spain, 2Hospital Universitario Río Hortega, Gastroenterology, Valladolid, Spain, 3Hospital Virgen de la Salud, Gastroenterology, Toledo. ACAD, Spain, 4Complejo Asistencial de Segovia, Gastroenterology, Segovia. ACAD, Spain

Background

Infliximab (IFX) was approved in 2006 for the treatment of ulcerative colitis (UC) unresponsive to other therapies. We want to describe our current practice in treating UC with IFX with special attention to some topics as cotreatment with immunosuppressant agents, intensification, IFX response, and colectomy rates.

Methods

This is a multicentric and retrospective study which collects clinical data from UC patients teated with IFX in four Spanish hospitals from June 2003 to September 2013.

Results

88 UC patients (age 35 years (SD 14.8), 42% females, E1 12%, E2 27%, E3 60%) were treated with IFX during 25 (SD 22) months. 83% received intravenous steroids at least once and 80% were treated with thiopurines before IFX. Thiopurines were stoped because of intolerance in 45% and because of resistance in 50%. 7% received methotrexate, 18% cyclosporine or tacrolimus and 21% were treated with leukocyto-apheresis. Time from UC diagnosis to infliximab was 8.8 (SD 6.9) years. IFX was decided because: steroid resistance 27%, intolerance/resistance to steroids or immunosuppressant agents 38%, steroid dependence 30%, pouchitis 2%, extraintestinal manifestations 1%. 5 mg/kg (0–2 and 6 weeks) induction dose was programmed for 98% of patients but the third dose was finally 10 mg/kg in 7%. Steroids were used with infliximab induction in 78%. Mantainment (5 mg/kg every 8 weeks) was scheduled in 92% of patients (42% with clinical remission after induction, 39% with clinical response after induction and 10% with no response to induction). 75% of patients received thiopurines (63% since more than 6 months before IFX induction, 14% since less than 6 months before induction, 14% since induction, 6% after induction) but they were stopped in 42%, 13 (0–48) months after IFX induction. IFX treatment was intensificated in 40% (10% doubling dose, 60% shortening intervales, 30% both). 43% of intensificated patients were deintensificated, but 23% of them were reintensificated. Steroids were reintroduced in 38%. 44% of patients had IFX stopped (20% because of no response, 39% because of loss of response after 11 (3–65) months, 31% because of AE and 10% because of prolonged remission). AEs were infusional reactions in 28% and severe infections in 28%. From IFX induction to end of follow up [42 (1–122) months] 20% of patients had a colectomy.

Conclusion

56% of patients mantain response to IFX after 42 (SD 27) months from IFX induction. In 44% of patients IFX treatment is stopped because of loss or no response and adverse events mainly. Cotreatment with immunosuppressants and intensification seems to be useful strategies in the management of these patients and are regularly used.