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P244. Factors associated with the improvement of quality of life among Crohn's disease patients treated with adalimumab


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

11st Department of Medicine, University of Erlangen-Nuremberg, 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 was to identify patient and disease characteristics with an impact on health-related quality of life (HRQoL) values in Crohn's Disease (CD) patients at the onset and during treatment with the TNF antagonist adalimumab (ADA) in routine gastroenterological care in Germany.

Methods: CD patients receiving ADA were evaluated in a multi-center prospective NIS for 2 years. Patients received ADA according to label. HRQoL was measured by the SIBDQ. At month 0, 3 and 6, forward stepwise and backward elimination regression had been performed to identify parameters showing a statistically significant partial correlation with SIBDQ values at the respective visit.

Results: 184 patients were evaluable after the first 12 months of treatment (mean age 39.2 years, 65.8% female, mean BMI 23.4, mean disease duration 11.2 years). At baseline, patients showed moderate to severe disease activity (DA) (HBI: 10.1) and poor HRQoL (SIBDQ: 36.0). Baseline regression analysis showed that HBI values were the only parameter with a relevant – albeit low – association with SIBDQ levels at the start of ADA therapy (p < 0.0001), that is, high DA levels were associated with low HRQoL levels. Further parameters of borderline significance were sex (p = 0.0347) and age at initial CD diagnosis (p = 0.0428) (male sex and older age were slightly positively associated with better HRQoL). At months 3 and 6, however, there was no association between baseline DA and SIBDQ values. Baseline HRQoL had the strongest impact on HRQoL levels during ADA treatment (p < 0.0001). Patients who started therapy with poor HRQoL levels were shown to experience a greater gain in terms of quality of life. Additionally, older patients showed a slightly lower increase in HRQoL levels at month 3 (p = 0.0024). At month 6, pre-treatment with biologic agents was slightly associated with lower gains in HRQoL (p = 0.0469).

Conclusions: Baseline DA was shown to be the only patient and disease parameter with any relevant impact on quality of life in CD patients prior to ADA therapy start. From 3 months of therapy onwards, however, no impact of DA on therapeutic gain in terms of HRQoL could be seen. At months 3 and 6, baseline HRQoL levels were the only parameter that influenced the degree HRQoL improvement (poor HRQoL at baseline was associated with greater HRQoL gains during ADA therapy).