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P383. Predictive factors of early infliximab infusion reactions in inflammatory bowel disease

C. Duron1, A. Buisson1, B. Pereira2, G. Bommelaer1, 1University Hospital Estaing, Gastroenterology department, Clermont-Ferrand, France, 2DRCI, Biostatistics Unit, Clermont-Ferrand, France

Background

Anti-TNF agents including infliximab (IFX), a chimeric antibody, are the most potent therapies in inflammatory bowel diseases (IBD). Early IFX Infusion Reaction (EIIR) is rare, but is a serious complication in IBD patients, and could lead to drug withdrawal and consequently could impact the therapeutic strategy. The role of premedication remains uncertain. We aimed to establish predictors of EIIR in IBD patients and to assess the impact of premedication.

Methods

Patients, disease and perfusions characteristics, collected for all IFX infusions performed in our IBD Unit, were retrieved from electronic charts from 2008 to 2013. The EIIR were defined as events related to IFX infusions occurring within the two hours of the infusion. Univariate and multivariate analysis were performed taking into account the inter-patients and intra-patients variability.

Results

Among the 80 CD patients included, 23 (28.8%) experienced EIIR. Age, prior history of intestinal resection, atopy or allergy, familial history of IBD, type of IBD, disease location, disease extent or disease duration were not predictive of EIIR. In univariate analysis, non-structuring non fistulising CD was predictive of EIIR (26.4% vs 52.2%, p = 0.03). This result was not confirmed by multivariate analysis.

Of 1107 infusions, we observed 38 EIIR (3.4%). In univariate analysis, the first four infusions (26.4% vs 52.6%, p = 0.002) and the reintroduction of IFX after drug discontinuation (17.2% vs 29.0%, p = 0.001) were predictive of EIIR. Multivariate analysis confirms that the reintroduction of IFX after drug discontinuation is a major risk factor of EIIR but not the first four infusions. A premedication (anti-histaminic or hydrocortisone) or concomitant therapies (5-ASA, steroids, thiopurines or methotrexate) did not decrease the risk of EIIR.

Overall, 16 of the 23 patients experiencing EIIR (69.5%) had to discontinue IFX therapy.

Conclusion

EIIR is a major event in the history of IBD patients treated by IFX as it leads to drug discontinuation and thus limits considerably the therapeutic armamentarium available. The reintroduction of IFX after drug discontinuation is the major risk of EIIR. The efficacy of premedication remains uncertain and might be limited only to this high risk situation. The measurement of anti-drug antibodies could be an interesting topic to predict the occurrence of EIIR in IBD patients for whom IFX was reintroduced after drug discontinuation.