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P369. Side effects in inflammatory bowel disease patients treated with biological therapy: our experience

M.J. Carrillo1, R. Beltrán1, B. Maldonado1, C. Duarte1, L. Castro1, F. Argüelles1, A. Benitez1, A. Caunedo1, F. Pellicer1, J.M. Herrerias1, 1Hospital Virgen Macarena, Sevilla, Spain

Background

Both Infliximab and Adalimumab are anti TNF inhibitors monoclonal antibodies that have demonstrated efficacy in the treatment of inflammatory bowel disease (IBD). The aim of this study was to analyze the side effects in patients with Crohn's disease (CD) and ulcerative colitis (UC) treated with infliximab and adalimumab in our hospital.

Methods

345 IBD patients were included. From February 2000 to March 2012, 255 patients, 182 with CD and 73 with UC were treated with infliximab (5 mg/kg) while 90 patients, 86 with CD and 4 UC, were treated with adalimumab (40 mg/2 weeks) from January 2006 to April 2012.

Results

From the 255 IBD patients treated with infliximab, 121 (47.5%) abandoned treatment; 27 (10.6%) due to side effects, it consist of 18 patients with CD and 9 UC, with 5.9 years average duration of the disease, with mesalazine and azathioprine as previous treatment and with an average dose of 325.92 mg per 8 weeks of infliximab. They were treated during 17.5 months in average.

Additionally, the most frequent type of side effects were minor (12 patients, 44.4%): headache, arthralgia, vomiting and malaise; 6 patients (22.2%) with urticarial reaction; 5 patients (18.5%) with infections (2 meningitis, 2 tuberculosis, 1 pneumonia); 1 hepatotoxicity (3.7%); 1 lupus-like (3.7%); 1 psoriasis (3.7%), 1 B cell lymphoma (3.7%).

From the 90 IBD patients treated with adalimumab, 34 (37.7%) abandoned treatment; 12 (13.3%) due to side, all patients were CD with 5.1 years average duration, with mesalazine and azathioprine as previous treatment and with an average dose 40 mg/ 15 days, They were treated during 14.3 months in average. Additionally, the most frequent type of side effects were minor (5 patients, 41.7%): headache, malaise; 2 injection site cellulitis (16.7%); 1 plantar psoriasis (8.3%); 1 tuberculous meningitis (8.3%); 1 neuropathy (8.3%); 1 fever (8.3%); 1 intraductal breast papilloma (8.3%).

Conclusion

Anti TNF therapy in IBD patients is secure, with 10–13% of side effects accordingly to our study, where the most frequent type were minor side effects, although there still exist serious complications. It is fundamental a strictly follow up of patient with Anti TNF therapy.