P603 Response and remission rates with up to 3 years of vedolizumab treatment in patients with Crohn’s disease
S. Vermeire*1, B.G. Feagan2, R. Mody3, A. Previtali4, B. Abhyankar4
1University Hospital Gasthuisberg, Gastroenterology, Leuven, Belgium, 2Robarts Research Institute, University of Western Ontario, Clinical Trials, London, ON, Canada, 3Takeda Development Centre Americas, Inc, Deerfield, Illinois, United States, 4Takeda Development Centre Europe Ltd, London, United Kingdom
Vedolizumab (VDZ), a gut-selective alpha4beta7 integrin antagonist, was demonstrated to be effective in treating moderately to severely active Crohn’s disease (CD) in the GEMINI 2 study (NCT00783692). We report interim efficacy analyses from the ongoing GEMINI long-term safety (LTS) study (NCT00790933).
Interim data were collected from May 22, 2009 to June 27, 2013 for patients (pts) who responded to VDZ induction at week (wk) 6, completed the 52-wk GEMINI 2 study and enrolled in the open-label extension study, GEMINI LTS. These pts received VDZ maintenance every 8 wk (Q8W) or every 4 wk (Q4W) during GEMNI 2 before receiving VDZ Q4W during GEMINI LTS. Outcomes of clinical response and remission, defined by the Harvey–Bradshaw Index (HBI), and the mean change from baseline in HBI score, C-reactive protein (CRP) concentration and health-related quality of life (HRQL) were analysed up to wk 100 of GEMINI LTS. For the evaluation of response and remission, pts with missing data were counted as failures. Adverse events of anal fistula were collected for all enrolled pts.
Of the 1 349 CD pts enrolled in GEMINI LTS, 145 had wk-6 response and completed 52 wk of VDZ treatment in GEMINI 2; of those, 70 had completed an additional 100 wk of open-label VDZ in GEMINI LTS (152 wk cumulative), and 10 had discontinued because of lack of efficacy at the time of this data cut. At 152 wk, 39% and 46% of pts from the Q8W/Q4W and Q4W/Q4W populations, respectively, were in remission (HBI score ≤ 4), with a mean change from baseline CRP of -12.8 and -7.7 mg/L, respectively. When evaluated by tumour necrosis factor alpha antagonist (anti-TNF) treatment history, 62% and 45% of pts with prior failure (Q8W/Q4W and Q4W/Q4W, respectively) and 23% and 48% who were anti-TNF naive were in remission. HRQL improvements were observed amongst all pts. Of all CD pts enrolled, 329 (25%) had history of anal fistula; at interim analysis, 82 (6%) experienced anal fistula as an adverse event.
Table 1 Clinical efficacy with long-term VDZ treatment during GEMINI LTS among patients who completed the 52-week GEMINI 2 study
Clinical benefits were observed with up to 3 years of VDZ treatment during GEMINI 2 and GEMINI LTS in pts with moderately to severely active CD. The clinical studies were funded by Millennium Pharmaceuticals, Inc (d/b/a Takeda Development Centre Americas, Inc). Medical writing assistance was provided by inVentiv Medical Communications and supported by Takeda Development Centre Americas, Inc.
 Sandborn WJ. Vedolizumab as induction and maintenance therapy for Crohn’s disease, N Engl J Med 2013;2(10):7117–21.