OP36 Real-world evidence on comparative effectiveness of Ustekinumab vs anti-TNF in Crohn’s disease with propensity score adjustment: two-year maintenance phase results from the prospective observational RUN-CD study
Bokemeyer, B.(1,2,3)*;Plachta-Danielzik, S.(3);Deppe, H.(4);Mohl, W.(5);Teich, N.(6);Hoffstadt, M.(7);Schweitzer, A.(8);von der Ohe, M.(9);Gauss, A.(10);Atreya, R.(11);Krause, T.(12);Blumenstein, I.(13);Fajardo Salmon, S.(3);Hartmann, P.(4);Gilman, E.(3);Schreiber, S.(3,14);
(1)Prof. Dr. Bernd Bokemeyer, Interdisciplinary Crohn Colitis Centre Minden, Minden, Germany;(2)University Hospital Schleswig-Holstein- Campus Kiel, Clinic for General Internal Medicine I, Kiel, Germany;(3)Competence Network IBD, Study Department, Kiel, Germany;(4)Gastroenterology Practice Minden, Gastroenterology, Minden, Germany;(5)Centre for Gastroenterology Saar MVZ, Gastroenterology, Saarbrücken, Germany;(6)Gastroenterology Practice Leipzig, Gastroenterology, Leipzig, Germany;(7)Gastroenterology Practice Iserlohn, Gastroenterology, Iserlohn, Germany;(8)Gastroenterology Practice Münster, Gastroenterology, Münster, Germany;(9)Gastroenterology Practice Herne, Gastroenterology, Herne, Germany;(10)University Hospital Heidelberg, Department Internal Medicine IV - Gastroenterology Clinic, Heidelberg, Germany;(11)Friedrich-Alexander-University Erlangen-Nürnberg, Medical Clinic 1, Erlangen, Germany;(12)Gastroenterology Practice Kassel, Gastroenterology, Kassel, Germany;(13)Johann Wolfgang Goethe University Clinic Frankfurt, Department of Gastroenterology and Clinical Nutrition, Frankfurt, Germany;(14)University Hospital Schleswig-Holstein Campus Kiel, Clinic of General Internal Medicine I, Kiel, Germany;
Background
Methods
Results
308 UST (naïve: 27) and 242 anti-TNF (naïve: 162) CD-patients were included (ADA: 61.2%, IFX: 38.8%). The number of switches within 24 months was significantly lower with UST than with anti-TNF (27.6% vs 37.1%; p=0.038), and especially with IFX, whereby the difference between UST and IFX (27.6% vs 46.7%; p=0.003) proves to be statistically significant (Fig. 1). Clinical remission at two years was not statistically different for the overall UST vs anti-TNF groups (51.2% vs 54.4) (numerically higher in biologic-naïve UST- vs anti-TNF-patients, without statistically significance) (Tab. 1). Remission rates were similar for UST vs ADA, while they were significantly higher for UST vs IFX (54.4% vs 37.9%; p=0.008) (Tab. 2), and also significantly higher for ADA vs. IFX (58.2% vs 37.9%; p=0.003). As a sign of an improved QoL we observed a significant increase in EQ-VAS within both treatment groups. However, a similar increase in EQ-VAS was observed with UST and anti-TNF (+14.2 vs +12.3; p=0.147).