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P233. Adalimumab produces high responder and remission rates and has an independent effect on quality of life in Crohn's disease patients

J. Mudter1, M.F. Neurath1, P. von Arnauld de la Perrière2, N. Teich3, H. Hartmann4, G. Manok5, M. Schwarz6, B.M. Wittig6

1University of Erlangen-Nuremberg, 1st Department of Medicine, Erlangen, Germany; 2Clinic at the Blankeneser Markt, Hamburg, Germany; 3Center for Gastroenterological and Metabolic Diseases, Leipzig, Germany; 4Center For Gastroenterology, Herne, Germany; 5Center for Internal Diseases, Dingolfing, Germany; 6Abbott GmbH & Co. KG, Wiesbaden, Germany

Background: The objective of this study is to evaluate effectiveness and safety of the TNF antagonist adalimumab (ADA) in patients with severe, active Crohn's disease in routine gastroenterological care in Germany.

Methods: Patients with active Crohn's disease receiving ADA are evaluated in a multi-center prospective NIS for 2 years. They received ADA according to label, after failure of corticosteroid and/or immunosuppressive therapy. Disease activity (DA), health-related quality of life (HRQoL), concomitant medication and safety parameters were evaluated routinely at 0, 3, 6, 9, 12, 18 and 24 months. Outcome assessments included CDAI, HBI and SIBDQ.

Results: Data after the first 12 months of treatment (March 2010) are presented here (184 patients evaluable, mean age 39.2 years, 65.8% female, mean BMI 23.4, mean disease duration 11.2 years). 43.2% of patients were pre-treated with biologics. Systemic steroids were taken by 89.9%. At baseline, patients showed moderate to severe DA (mean CDAI: 299.4, mean HBI: 10.1). Patients reported poor HRQoL (mean SIBDQ: 36.0). After 3 months, DA was markedly reduced (HBI: 5.0) and decreased further until month 12 (HBI 4.3). 71.3% of patients showed a response (Δ HBI ≥3) to ADA therapy at month 3, 82.0% after 12 months. 56.1% were in remission (HBI ≤4) at month 3 and 63.9% at month 12. HRQoL values rose to 47.3 at month 3 and reached 52.1 at month 12. The rate of patients with systemic steroids dropped to 19.4% at month 12. Correlation between CDAI and HBI was r = 0.7 at month 0 and changed only slightly to r = 0.8 at the subsequent visits. Correlation between HBI and SIBDQ was low at baseline (r = −0.4) and rose to a moderate level at the subsequent visits (r = −0.7 at month 12). However, extreme group analysis revealed that this mounting correlation might be attributed to a statistical artifact, pointing to a discrete effect of ADA therapy on increasing levels of HRQoL.

Conclusions: ADA therapy effective in daily clinical practice, as can be shown by high responder and remission rates as early as month 3. Overall, DA was reduced by 57% at month 12, HRQoL was strongly increased and the use of systemic steroids was markedly reduced. ADA therapy showed an independent effect on increasing levels of HRQoL that was not moderated by decreasing levels of ADA.