P118 - Adalimumab's effect on extraintestinal manifestations of Crohn's disease: results of the CARE trial

Abstract

s of the 4th Congress of ECCO the European Crohn’s and Colitis Organisation S57 endoscopic remission in 3/3 patients at 24 months. Bowel thickness as assessed by US was slower to decrease, but improved in all patients and disappeared in 4/6 patients. Complete perianal fistulas closure was observed in 3/4 patients. No deaths or life-threatening infections occurred. Unexpected adverse events included a perianal abscess after mobilisation in one patient, pleural and pericardial effusions in another, BK virus-related macrohaematuria in one case, and acute pielonephritis in another patient, all rapidly resolved with conservative treatment. Conclusion: Unselected CD34+ cells transplantation can induce and maintain both clinical and endoscopic remission in refractory CD patients. P117 Global safety of adalimumab in trials of patients with Crohn’s disease J.F. Colombel1 *, R. Panaccione2, W.J. Sandborn3, P. Rutgeerts4, S.B. Hanauer5, W. Reinisch6, P.F. Pollack7, J.D. Kent7, A.T. Cardoso7, W. Lau8. 1Centre Hospitalier Universitaire de Lille, Lille, France, 2University of Calgary, Calgary, AB, Canada, 3Mayo Clinic, Rochester, MN, USA, 4University Hospital of Gasthuisberg, Leuven, Belgium, 5University of Chicago, Chicago, IL, USA, 6Medical University of Vienna, Vienna, Austria, 7Abbott Laboratories, Abbott Park, IL, USA, 8Abbott Laboratories, Parsippany, NJ, USA Introduction: Adalimumab, a fully human anti-tumor necrosis factor (anti-TNF) monoclonal antibody, is approved for treating patients with severely active Crohn’s disease (CD) who have had an inadequate response to conventional therapy. Methods: All patients with CD participating in the pivotal randomized controlled clinical trials, open label extensions, and Phase IIIb studies were evaluated for safety at regular intervals. Rates of adverse events (AEs) of interest to physicians prescribing anti-TNF therapy were assessed per 100-patientyears (E/100-PYs) of adalimumab exposure. Standardized mortality ratios were calculated using the World Health Organization 2003 age-and sex-matched US mortality data. These analyses are based on data available as of 15 April 2008. Rates of AEs of interest AE of interest E (E/100-PYs)