Z Gastroenterol 2016; 54 - P07
DOI: 10.1055/s-0036-1583985

Adalimumab therapy may exhibit a positive influence on anxiety in patients suffering from Crohn's Disease

G Novacek 1, W Petritsch 2, T Feichtenschlager 3, H Gröchenig 4, T Haas 5, H Fuchssteiner 6, A Mayer 7, R Koch 8, W Miehsler 9, N Walder 10, G Moser 1
  • 1Universitätsklinik für innere Medizin III/Abteilung für Gastroenterologie und Hepatologie, Wien, Austria
  • 2Medizinische Universität Graz/Klinische Abteilung für Gastroenterologie und Hepatologie, Graz, Austria
  • 3Krankenhaus Rudolfstifung/Abteilung für innere Medizin IV, Wien, Austria
  • 4Krankenhaus der Barmherzigen Brüder Sankt Veit an der Glan/Abteilung für innere Medizin, St. Veit an der Glan, Austria
  • 5Paracelsus medizinische Privatunivesität/Abteilung für innere Medizin 1, Salzburg, Austria
  • 6Krankenhaus der Elisabethinen/Abteilung für innere Medizin IV, Linz, Austria
  • 7Universitätsklinikum Sankt Pölten/Karl Landsteiner Privatuniversität für Gesundheitswissenschaften/Abteilung für innere Medizin II, St. Pölten, Austria
  • 8Universitätsklinik Innsbruck/Abteilung für Innere Medizin I, Innsbruck, Austria
  • 9Krankenhaus der Barmherzigen Brüder Salzburg, Salzburg, Austria
  • 10Norgine GmbH, Wien, Austria

Introduction: Crohn's disease (CD) is frequently accompanied by mental disorders including anxiety or depression. This study explores if adalimumab (ADA) is not only effective for CD but shows positive effects on anxiety as well.

Method: In this non-interventional study, ADA was prescribed to 83 adult CD patients according to clinical practice at Austrian hospitals. At three visits (V0 at baseline, V1 after 12 and V2 after 24 weeks), clinical activity was assessed using the Harvey-Bradshaw Index (HBI), anxiety was estimated by the State-Trait Anxiety Inventory for Adults (STAI) and the Hospital Anxiety and Depression Scale (HADS), and health related quality of life was assessed by the Short Quality of Life in Inflammatory Bowel Disease Questionnaire (sIBDQ). Primary objective was to evaluate changes in anxiety over 6 months of ADA treatment. Changes were analysed by paired t test and Wilcoxon matched pairs test. For correlations between scores Spearman's rank correlation coefficient was used.

Results: After starting treatment with ADA the mean HBI improved from 6.9 (± 4.1) at V0 to 3.6 (± 4.0) at V1 (p < 0.001) and remained at 3.6 (± 3.7) at V2 (p < 0.001 vs. V0). Mean state anxiety scores for anxiety about an event improved from 40.4 (± 10.7) at V0 to 38.1 (± 10.5) at V1 (p = 0.017) but showed no further change at V2 with 38.0 (± 10.5; p = 0.179 vs. V0). However, this improvement was only observed in females with scores decreasing from 42.6 (± 11.7) at V0 to 37.5 (± 8.2) at V1 (p < 0.001) and yielding 38.9 (± 9.1) at V2 (p = 0.086 vs. V0), while no change was seen in men. Trait anxiety scores describing anxiety level as a personal characteristic did not change between any of the visits. Total HADS anxiety scores only improved in females from 7.4 (± 3.7) at V0 to 5.8 (± 3.5) at V1 (p = 0.010), yielding 6.1 (± 2.9) at V2 (p = 0.119 for V0-V2). Mean sIBDQ improved from 45.8 (± 12.1) at V0 to 51.9 (± 10.1) at V1 (p = 0.001) but showed no further change at V2 with 52.2 (± 10.6; p < 0.001 vs. V0). However, this improvement was only observed in females with sIBDQ scores improving from 43.5 (± 12.5) at V0 to 51.8 (± 9.1) at V1 (p = 0.006) and yielding 52.5 (± 10.3) at V2 (p < 0.001 vs. V0), while no change was seen in men. STAI state and trait scores correlated with HBI at V2 (R2≥0.39; p < 0.5) and negatively correlated with sIBDQ at all visits (R2≤-0.37; p ≤0.001).

Conclusions: State anxiety and quality of life improved during the first 6 months of ADA treatment in patients with CD. However, this effect was only observed in females. These results confirm previously described positive mental effects of CD therapies for ADA.