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P232. Adalimumab in steroid-dependent Crohn's disease patients: Analysis of efficacy, prognostic factors for clinical benefit and safety

A. Orlando1, S. Renna1, F. Mocciaro1, M. Cappello2, R. Di Mitri3, C. Randazzo2, M. Cottone1

1DiBiMis, Division of Internal Medicine “Villa Sofia-V. Cervello” Hospital, Palermo University, Palermo, Italy; 2DiBiMis, Department of Gastroenterology and Hepatology, Palermo University, Palermo, Italy; 3Gastroenterology Unit, Civico-A.R.N.A.S Hospital, Palermo, Italy

Aim: Corticosteroids (CS) have been proved effective in the treatment of active Crohn's disease (CD) but some patients relapse during CS tapering or early after CS discontinuation. The aim of our study is to report data on efficacy, prognostic factors of response and safety of adalimumab (ADA) treatment in a cohort of steroid-dependent CD patients

Materials and Methods: 110 patients were enrolled from 3 centres from January 2007 to May 2010. Steroid-dependency was defined as the inability to stop systemic steroids within 3 months or budesonide within 6–9 months, without clinical relapse or relapse within 3 months after steroid weaning. All patients were treated with ADA subcutaneously with 2 different induction regimens: 80/40 mg (64 patients, 58.2%) eow or 160/80 mg (46 patients, 41.8%) eow. Initially we chose the lower induction dosage because of costs and supply of the drug. In responders ADA was maintained (40 mg eow). Clinical remission was defined as complete steroid sparing without symptomatic recurrence, and clinical response as a significant clinical improvement reducing steroid dosage (at least 50% of the initial dosage).

Results: We evaluated 60 male and 50 female with a mean age of 41±13.2 years. At week 6, 91% of patients had a clinical benefit: 45.5% were in clinical remission, and 45.5% achieved a clinical response. At the end of the follow-up, mean time 14.6±10 months, 80.9% of responders maintained the clinical benefit (clinical response 16.4%, complete remission 64.5%). At univariable analysis 4 variables were found to be associated with clinical remission at week 6: age of patients <30 years at the baseline (p = 0.03, OR = 2.67, 95% CI, 1.132–6.724), no history of surgery (p < 0.001, OR = 4.92, 95% CI, 2.162–11.180), inflammatory pattern (p < 0.001, OR = 5.55, 95% CI, 2.437–12.634), higher (160/80 mg) induction regimen (p < 0.05, OR = 2.17, 95% CI, 1.1–4.689). At multivariable analysis only higher induction regimen was related with clinical remission at week 6 (p < 0.05, OR = 2.78, 95% CI, 1.208–6.968). The higher induction regimen was related also with low risk of reinduction (p = 0.05, OR = 0.14). Concerning the univariable analysis at the end of the follow-up none of the tested variables were found to be associated with clinical remission. None of the tested variables were related, also, with clinical response both at 6 weeks and the end of the follow-up. Only 4.5% of severe side effects were observed.

Conclusion: Our study shows that ADA is a powerful and safe weapon for early steroid discontinuation in patients with steroid-dependent CD. Higher induction regimen dosage is the better therapeutic choice for achieving clinical remission with low risk of clinical relapse.