DOP026 Sustained remission with vedolizumab in patients with moderately to severely active ulcerative colitis: a GEMINI 1 post hoc analysis of week 14 remitters

作     者：Stallmach, A. Bokemeyer, B. Axler, J. Curtis, R. Ehehalt, R. Feagan, B. Geransar, P. James, A. Kaviya, A. Khalid, J.M. Wolf, D. Schreiber, S. 

作者机构：University hospital Jena Department of Internal Medicine IV Jena Germany Gastroenterology Practice Private practice Minden Germany TDDA (Toronto Digestive Disease Associates Inc.) Toronto Canada Takeda Development Centre Europe Ltd Global Medical Affairs London United Kingdom Praxis für Gastroenterologie Gastroenterology Heidelberg Germany Robarts Research Institute University of Western Ontario Robarts Clinical Trials London Canada Takeda Pharmaceuticals International AG Global Medical Affairs Zurich Switzerland Takeda Development Centre Europe Ltd Global Statistics and Statistical Programming London United Kingdom Takeda Development Centre Europe Ltd Clinical Development London United Kingdom Takeda Development Centre Europe Ltd Evidence and Value Generation London United Kingdom Atlanta Gastroenterology Associates Emory Saint Joseph's Atlanta United States University Hospital Schleswig-Holstein Institute for Clinical Molecular Biology Kiel Germany 

出 版 物：《Journal of Crohn's and Colitis》 

年 卷 期：2017年第11卷第SUPPL_1期

页      面：S42-S43页

学科分类：1002[医学-临床医学] 100201[医学-内科学(含：心血管病、血液病、呼吸系病、消化系病、内分泌与代谢病、肾病、风湿病、传染病)] 10[医学] 

摘      要：Background:Sustained remission is a key therapeutic goal in ulcerative colitis (UC). Vedolizumab (VDZ) was more effective than placebo as induction and maintenance therapy in patients (pts) with moderately to severely active UC in the GEMINI 1 study (NCT00783718). This post hoc analysis assessed sustained remission during the maintenance phase of GEMINI ***:Analyses included pts enrolled in GEMINI 1, who received 6 weeks (wks) of induction with placebo or VDZ and entered 46 wks of maintenance continuing placebo or VDZ, respectively; eligible pts could then enrol into an open-label extension (OLE) to receive VDZ every 4 wks. The primary aim was to assess sustained remission (remission at Wks 26, 38 and 52) in pts who achieved remission at Wk 14. Remission was defined as 1) clinical remission (partial Mayo Score [PMS] ≤2 points with no individual subscore 1 point) or 2) rectal bleeding subscore =0. For the analyses, pts who received VDZ maintenance, discontinued before Wk 52 and then entered the OLE had missing maintenance data imputed using OLE ***:In total, 620 pts received VDZ (Wk 6 responders and non-responders) and 149 received placebo throughout GEMINI 1. Patient characteristics were broadly similar between treatment groups. From Wk 4 onwards, a significantly higher proportion of pts receiving VDZ were in clinical remission versus placebo in the overall and anti-TNF-naïve populations; significance was achieved at Wk 26 in the anti-TNF failure population. At Wk 14, 203 (33%) pts receiving VDZ and 30 (20%) pts receiving placebo were in clinical remission based on PMS, and 293 (47%) pts receiving VDZ and 43 (29%) pts receiving placebo were in remission based on rectal bleeding subscore. Of pts in remission at Wk 14, the VDZ group had a higher proportion of pts with sustained remission versus placebo according to both PMS and rectal bleeding definitions (Table); significance was reached in both the overall and anti-TNF-naïve populations, and a simila