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P728 Effectiveness and quality of life (QoL) of Ustekinumab (UST) therapy in a Real-world Setting in Germany – First Results of the RUN-CD Study

B. Bokemeyer*1,2, S. Plachta-Danielzik3, N. Teich4, W. Mohl5, M. Hoffstadt6, A. Schweitzer7, M. von der Ohe8, T. Krause9, J. Höchstödter3, P. Hartmann1, B. Wiebe3, S. Schreiber2

1Gastroenterology Practice, Minden, Germany, 2University Medical Center Schleswig-Hostein, Campus Kiel, I. Department Internal Medicine - General Internal Medicine, Kiel, Germany, 3Competence Network IBD, Kiel, Germany, 4Gastroenterology Practice, Leipzig, Germany, 5Gastroenterology Practice, Saarbrücken, Germany, 6Gastroenterology Practice, Iserlohn, Germany, 7Gastroenterology Practice, Münster, Germany, 8Gastroenterology Practice, Herne, Germany, 9Gastroenterology Practice, Kassel, Germany

Background

RUN-CD study is an investigator initiated, ongoing, non-interventional trial on biologics in Crohn′s Disease (CD) patients in Germany with a prospective documentation of effectiveness in induction and maintenance therapy of biologics, especially of UST. Aim of this analysis was to compare steroid-free remission rates and QoL in CD-patients after a 16 week-long induction phase of UST vs. other biologic-therapies.

Methods

From 04/2017- 09/2018 334 CD patients from 42 gastroenterology practices and hospitals with IBD-experience from all over Germany completed induction phase (Week 16) of the RUN-CD study. We compared steroid-free remission rates (i.e. HBI < 4 and no systemic use of steroids or budesonide during the last 8 weeks) in patients with UST vs. other biologics therapies. Anxiety/depression as marker of QoL was assessed by EQ-5D at baseline as well as at Week 16. T-test and χ2-test were used to compare the UST- and other biologic-group. Level of significance was set at p < 0.05 (two-sided).

Results

174 CD-patients received a new UST therapy while 160 patients were newly treated with another biologic (Infliximab: 38.1%; Adalimumab: 46.0%; Vedolizumab: 15.9%). Baseline characteristics were well balanced between both groups (UST/other biologics; p>0.05): males: 42%/48%, mean (SD) age [years]: 41 ± 14/43 ± 15, smokers: 31%/24%, mean (SD) disease duration [years]: 13 ± 10/11 ± 11, extraintestinal manifestations: 41%/39%, stenosis: 30%/33%. Perianal fistula was more frequent in patients with UST therapy (32% vs. 23%; p < 0.05 Steroid-free remission rates after induction phase in patients with UST and other biologic therapies were 45.4% vs. 49.4% (p > 0.05), respectively. Concomitantly, we found a significant reduction of patients who were anxious or depressed with 48.0% at baseline to 36.4% at Week 16 in the UST group and from 48.8% to 34.5% in the group of other biologics (reduction in both groups: p < 0.05; difference between groups: p > 0.05). In the UST group 21 patients were biologic-naïve and 54 were biologic-experienced with one previous biologic treatment; in the group with other biologics, these were 115 and 33 patients. Stratified to biologic-naïve and biologic-experienced with one previous biologic treatment, steroid-free remission rates were 47.6% (UST) vs.. 49.6% and 51.9% (UST) vs. 54.6% (p>0.05).

Conclusion

In this real-world setting remission as assessed by symptom scores rates or QoL, respectively, were similar between patients receiving UST and other biologic therapies. Surprisingly the clinical effectiveness in biologics-naïve patients was not superior to biologics-experienced CD patients.