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P241. Long-term (5 years) efficacy and safety of infliximab in Crohn's disease patients

R. Ferreiro1, E. Fernandez-Salgado2, V. Ollero3, A. Lorenzo Gonzalez4, D. Carpio2, A. Echarri3, A. Fernandez5, L. De Castro6, J.R. Pineda Marino7, V. Hernandez8, L. Sanromán6, J. Martinez Cadilla9, M.A. Pato10, E. Santos11, S. Pereira12, J. Castro3, M. Barreiro-de Acosta4

1University Hospital, Spain; 2CHOP, Spain; 3Arquitecto Marcide Hospital, Ferrol, Spain; 4University Hospital, Santiago De Compostela, Spain; 5Povisa Hospital, Vigo, Spain; 6Complexo Hospitalario Universitario De Vigo, Vigo, Spain; 7Hospital Meixoeiro, Vigo, Spain; 8Complexo Hospitalario Universitario De Vigo, Digestive Diseases, Vigo, Spain; 9CHUVI, Spain; 10CHOU, Spain; 11Lucus Augusti, Spain; 12Vigo Hospital, Vigo, Spain

Background: Long-term efficacy of infliximab (IFX) for maintenance of remission in Crohn's disease (CD) has not been clearly demonstrated; there are little studies, and most of them are short (<3 years) or included episodic treatment. For this reason, the aim of our study was to evaluate the efficacy and safety of IFX in CD patients five years after their first infusion.

Methods: A multicenter, retrospective and observational study in CD patients treated with IFX (induction and maintenance doses) and followed for at least five years after the first dose was performed. There were included patients from tertiary hospitals of Galicia. All of them had receiving the induction regimen and started maintenance therapy; therefore, they all had started treatment before 30th September 2005. We excluded patients who only received induction therapy and those who received episodic treatment. All patients were evaluated at 5 years of initial treatment about efficacy, treatment withdrawal, adverse events and malignancy. We analyzed the possible influence of sex, smoking, extraintestinal manifestations and concomitant immunosuppressive therapy on the efficacy of IFX. Results are expressed in percentages and it was used chi-square analysis or Fisher's exact test if it was necessary.

Results: We included 86 CD patients with a mean age of 39 years, 55.8% male, 49.4% non-smokers, 31.8% smokers and 18.8% ex-smokers. There were no family history in 88.1% of patients and 81.4% of them received concomitant azathioprine. At 5 years, 18 patients (20.9%) had completed treatment and obtained clinical remission. In 16 (18.6%) patients, therapy was discontinued after remission within 5 years because physician's decision. If we excluded this subgroup, the percentage of patients in remission at 5 years was 25.7%. The mortality was 0% over 5 years and 4 patients (4.6%) developed malignancy. There was no influence of any of the studied factors in response to IFX.

Conclusions: This study confirms that the long-term IFX in patients with CD is safe, but efficacy decreases over time and the number of patients who reach 5 years of treatment is limited.