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P259. Infliximab as maintenance therapy in IBD. Multicentric retrospective data from five referral centers from Serbia

V.B. Gligorijevic1, D. Bojic1, M. Protic Nedeljkovic1, B. Bojic1, D. Tarabar2, N. Mijalkovic3, A. Nagorni4, L. Hadnadjev5, N. Jojic1

1Zvezdara University Clinical Center, Dept of Gastroenterology and Hepatology, Belgrade, Serbia; 2Military Medical Academy, Belgrade, Serbia; 3Clinical Center Serbia, Belgrade, Serbia; 4Clinical Center Nis, Nis, Serbia; 5Clinical Center Novi Sad, Novi Sad, Serbia

Background: Infliximab is established, effective therapy for active adult and pediatric Crohn's disease (CD) and ulcerative colitis (UC). Since 2002, in Serbia, the only approved indication was fistulizing Crohn's disease. In the last two years is approved for all indications as in the Europe.

Methods: This is retrospective, multicentric study. Retrospective data of patients with inflammatory bowel disease (IBD) treated by Infliximab as maintenance therapy were analyzed The average period of follow up was 2 years.

Results: The outcome of IBD patients treated with infliximab (0, 2, 6 and then every 8 weeks during 12±4 month) was analyzed. This group was composed of 114 IBD patients (75 with CD and 39 with UC). F/M ratio was 1:1. Mean age at diagnosis was 26.3 yrs. Mean age at starting of infliximab was 36.4 yrs. Mean duration of disease was 6.42 yrs. All patients received infliximab as a step up therapy. 101 (89%) were treated with immunosuppressant previously. 37 (33%) patients were steroid refractory or steroid dependence. Clinical remission after one year had 66 (58%) patients. Clinical response had 102 (89%) of patients. Intolerance to infliximab was demonstrated in 10 (8.7%) patients. Loss of response was observed in 9 (7.8%) patients. 3 (2.6%) were primary nonresponders The safety profile was also evaluated. 48 (42%) patients had at least one adverse event. The most frequently reported adverse events were infections, in 28 (24%) patients. Skin manifestation had 17 (15%) patients. Pulmonary TB was diagnosed in 2 IBD patients (1.7%). Two deaths occurred during the study follow up (one thromboembolism and one colon carcinoma).

Conclusions: In the group of patients treated with maintenance IFX protocol 80.9% of patients had clinical response and 58% clinical remission after one year. 48 (42%) of patients had et least one adverse events.