P326 Efficacy of vedolizumab on patient-reported outcomes in ulcerative colitis patients: results from a prospective German observational study
Schmidt C.*1, Langbein C.1, Atreya R.2, Bruns T.1, Dignass A.3, Ende K.4, Hampe J.5, Hartmann F.3, Neurath M.F.2, Maul J.6,7, Preiss J.C.7, Schmelz R.5, Siegmund B.7, Schulze H.3, Teich N.8, van Arnim U.9, Baumgart D.C.10, Stallmach A.1
1Jena University Hospital, Department of Gastroenterology, Jena, Germany 2Friedrich-Alexander University Erlangen-Nürnberg, Medical Clinic 1, Erlangen, Germany 3Agaplesion Markus Hospital, Department of Medicine I, Frankfurt/Main, Germany 4HELIOS Hospital Erfurt, Department of Internal Medicine, Erfurt, Germany 5University Hospital Dresden, Technical University Dresden, Medical Department 1, Dresden, Germany 6Gastroenterologie am Bayerischen Platz, Berlin, Germany 7Charité Medical School, Department of Medicine (Gastroenterology, Infectious Diseases, Rheumatology), Berlin, Germany 8Group Practice for Digestive and Metabolic Diseases, Leipzig, Germany 9Otto-von-Guericke-University Magdeburg, 9Department of Gastroenterology, Hepatology and Infectious Diseases, Magdeburg, Germany 10Charité Medical School, Humboldt-University of Berlin, 10Department of Gastroenterology and Hepatology, Berlin, Germany
Patient reported-outcomes [PROs] are becoming a major therapeutic goal in IBD, both in clinical trials and in daily clinical care. Moreover, it has recently been shown that in patients with UC the absence of rectal bleeding (Mayo Clinic endoscopic Score (MCSe)=0) shows high sensitivity for detecting mucosal healing.  We therefore investigated the efficacy of vedolizumab, a humanized monoclonal antibody against α4 β7-integrins, in achieving PROs, especially with regard to rectal bleeding (MCSe=0).
A consecutive cohort of 60 adult IBD patients with ulcerative colitis (partial Mayo score >4) receiving vedolizumab was prospectively recruited from 9 German tertiary IBD centers. Primary endpoint was the absence of rectal bleeding (MCSe=0) as determined at week 2, 6, 14, 30 and 54, resp. Secondary endpoints included a combined endpoint (absence of rectal bleeding and stool frequency of 1 or 2, respectively, according to the Mayo Clinic Scoring system (MCSsf)). Quality of life (QoL) was evaluated by use of a visual analogue scale (VAS; 0–100). This data represents a subgroup analysis from a larger prior observational study.  
81.7% of patients had received prior treatment with anti-TNF-antibodies, 40% of patients had been hospitalized within one year prior to vedolizumab treatment initiation. 53.4% of patients received corticosteroids at week 0 (median 20 mg; range 0–60 mg). At week 54 20/60 patients (33.3%) reported absence of rectal bleeding, 17/60 patients (28.3%) achieved steroid-free cessation of rectal bleeding. A combined endpoint of MCSe=0 and normal stool frequency (MCSsf=0) was achieved by 16.7% of patients, while 26.7% of patients experienced absence of rectal bleeding (MCSe=0) and a mild increase in stool frequency (MCSsf=1) (Table 1). Quality of life increased from 47,5 at week 0 to 70 at week 14, 72.5 at week 30 and 70 at week 54, resp.
Week 2 6 14 30 54 MCSe=0 25% 36.7% 43.3% 36.7% 33.3% MCSe=0, steroid-free 10% 23.3% 26.7% 30% 28.3% MCSe=0 and MCSsf=0 5% 10% 21.7% 15% 16.7% MCSe=0 and MCSsf=1 10% 16.7% 28.3% 26.7% 26.7%
In UC patients with a severe disease course vedolizumab treatment results in a rapid and persistent absence of rectal bleeding in one third of patients. Normalization of stool frequency occurs less frequently and may reflects chronic alterations/damages of the bowel that may not be reverted by anti-inflammatory treatment strategies in this severely ill patient population. Absence of rectal bleeding is associated with a substantial improvement in patients quality of life. However, a substantial percentage of patients still required steroid-treatment to achieve these endpoints.
 Colombel-JF et al. (2016), Discrepancies between patient-reported outcomes, and endoscopic and histological appearance in UC.
 Baumgart-DC et al. (2016), Vedolizumab induction therapy for inflammatory bowel disease in clinical practice–a nationwide consecutive German cohort study.
 Stallmach-A et al. (2016), Vedolizumab provides clinical benefit over 1 year in patients with active inflammatory bowel disease - a prospective multicenter observational study.