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P276. Efficacy and effectiveness of biological therapy in inflammatory bowel disease (IBD): Comparative study between clinical practice and pivotal studies

D. Ginard, S. Khorrami, M. Vanrell

IBD Unit. Gastroenterology Department. Hospital Universitario Son Dureta, Palma de Mallorca, Spain

Introduction: Randomised placebo-controlled clinical trials (RCT) are used to asses the efficacy of a drug. However, their results do not always correlate with the probability of response in current clinical practice (CCP). Observational studies provide the probability of response to biological drugs in CCP, in which optimization and adjuvant treatments are applied to achieve the “best possible management” of the disease.

Aims and Methods: The aim of this study was to evaluate the theoretical efficacy (under RCT conditions) and the effectiveness (in CCP) of biological treatment in IBD. Patients under biological therapy between June 2002 and November 2008 with at least one year follow-up, were included retrospectively. Demographic, disease and concomitant treatment data were collected. Effectiveness of biological therapy in CCP was determined as well as the hypothetical results if the patient had been included in a RTC, by the usual definitions of remission, response and failure.

Results: 74 patients (52.7% females, mean age: 33.6±12.9) for a total of 83 biological treatments were included in the study. 59 (79.9%) patients had Crohn's disease (CD) (41 luminal and 18 perianal) and 15 were ulcerative colitis (UC). Remission and response were achieved in 56.6% and 71.1%, respectively. 92% of evaluated patients were included in a hypothetical trial cohort, with remission and response – using the criteria of these studies – of 36.4% and 41.6% (both p < 0.0001 in comparison with CCP results). Remission and response were achieved in 55.9% and 73.3% of patients in CCP cohort versus 36.8% and 44.1% in RTC cohort (p = 0.0001 for both), for luminal CD. In perianal CD, 60.7% versus 50.0% (p = 0.018) obtained remission and 85.7% versus 57.1% (p = 0.024) response, in CCP and RTC cohorts respectively. For UC, remission was achieved in 60% in CCP cohort versus 33.3% in RCT cohort (p = 0.001).

Conclusions: Effectiveness of biological drugs in clinical practice exceeds its efficacy. Should we use the effectiveness of the biological therapy when we asses de probability of response in clinical practice?