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P305. Therapy-related adverse events in Crohn's disease (CD) – A comparison between thiopurines, infliximab and combined therapy

W. Fries1, M. Mastronardi2, M. Cappello3, L. Grossi4, G. Costantino1, F. Furfaro1, A. Belvedere1, A. Lauria5, M. Principi6, N. della Valle7, N. Buccianti8, A. Alibrandi9, A.C. Privitera10

1Dept. of Internal Medicine, University of Messina, Italy; 2UOC Gastroenterologia ed Endoscopia Digestiva, IRCCS, Castellana Grotte (BA), Italy; 3Gastroenterologia ed Epatologia, Policlinico, University of Palermo, Italy; 4Unità di Fisiopatologia Digestiva, Pescara, University of Chieti-Pescara, Italy; 5Gastroenterologia e Endoscopia Digestiva A. O. Bianchi-Melacrino-Morelli, Reggio Calabria, Italy; 6Gastroenterologia ed Endoscopia Digestiva, Policlinico, University of Bari, Italy; 7Gastroenterologia, Policlinico, University of Foggia, Italy; 8U.O.C. di Medicina Interna, A. O. S.Carlo, Potenza, Italy; 9Department of Economical, Financial, Social, Environmental, Statistical and Territorial Sciences, University of Messina, Italy; 10Dip di Scienze Chirurgiche, University of Catania, Italy

Therapy of CD is mainly based on immunesuppression and is commonly administered in a step-up fashion or by combination of 2 or more principles. One of the major concerns are potential side effects e.g. infections, demyelinating disorders, or malignancies. The aim of the present study was to compare 3 therapeutic regimens: thiopurines alone (THIO), inflximab alone (IFX) or combination therapy of both (COMBO).

Methods: Data on THIO were collected retrospectively in our centre (1998–2009), whereas data on IFX, and COMBO came from a multicentre retrospective data collection of patients treated between 2003 and 2009. Adverse events (AE) were identified and classified as mild or severe, the latter defined as conditions leading to hospitalization or discontinuation of therapy, diagnosis of neoplasias or demyelinating disorders during therapy, or death related to therapy; time to AE and outcome were recorded. Data are mean values ± SD. Comparison of groups were performed with the Z-test.

Results: One hundred fifty-seven CD patients (M 85; mean age 30.9 yrs ±14) were identified in THIO with 476 patient years; 137 patients (M 64; 40 yrs ±13) in IFX with 228 patient years, and 130 patients (M 77; 40 yrs ±13) in COMBO with 243 patient years. A total of 68 AE occurred in THIO, 48 in IFX, and 46 in COMBO. Serious AE were 59 in THIO, 14 in IFX, and 9 in COMBO. Five infections were recorded in THIO, 10 in IFX, and 6 in COMBO. Demyelinating disease was diagnosed in 1 patient in IFX and in 1 patient in COMBO and 1 tumour was newly diagnosed in IFX. No therapy-related death occurred in the 3 groups. After normalization for patient years, comparison revealed no statistical significance for total AE, infections, tumours, and demyelinating disease between the 3 study groups, whereas serious AE were statistically more frequent in THIO (p < 0.013) compared with COMBO.

Comments: Compared to monotherapy with thiopurines, monotherapy with infliximab or combined therapy had similar safety profiles. Serious AE were statistically more frequent in patients treated with thiopurines only compared with the combination therapy.