P439 Deep remission as a predictor of clinical outcomes in vedolizumab-treated patients with ulcerative colitis
W. Sandborn*1, J.-F. Colombel2, R. Panaccione3, K. Lasch4, R. Mody5, A. Green6, B. Abhyankar7
1University of California San Diego and UC San Diego Health System, Gastroenterology, San Diego, California, United States, 2Icahn School of Medicine at Mount Sinai Hospital, Gastroenterology, New York, NY, United States, 3University of Calgary, Medicine, Alberta, Canada, 4Takeda Pharmaceuticals International Inc., Medical Affairs, Deerfield, IL, United States, 5Takeda Pharmaceuticals International Inc., Global Outcomes and Epidemiology Research, Deerfield, IL, United States, 6Takeda Global Research & Development Centre (Europe) Ltd., Statistics, London, United Kingdom, 7Takeda Global Research and Development Centre (Europe) Ltd., Clinical Science, London, United Kingdom
Deep remission (a combination of endoscopic and patient-reported outcomes) is an emerging treatment goal for patients with ulcerative colitis (UC). Vedolizumab (VDZ), a monoclonal antibody to α4β7 integrin, has demonstrated efficacy in achieving clinical remission and mucosal healing in patients with UC (GEMINI 1, NCT00783718). In post hoc analyses of data from GEMINI 1, we investigated whether deep remission is a predictor of clinical outcomes and health-related quality of life (HRQoL) in patients with UC.
Responders to VDZ induction therapy at week (wk) 6 were re-randomised to placebo (PBO) or VDZ every 8 or 4 wks (Q8W or Q4W) for 46 wks (maintenance intent-to-treat [ITT] population). Clinical outcomes and HRQoL were evaluated at wk 52 in the maintenance ITT population who were in deep remission at wks 6 and 52. We selected 2 definitions of deep remission to represent a range of stringency: (1) Mayo endoscopic subscore=0, rectal bleeding subscore=0, and decrease or no change from baseline in stool frequency subscore or (2) Mayo endoscopic subscore=0 or 1, rectal bleeding subscore=0, and stool frequency subscore=0 or 1.
All patients in the maintenance ITT population received VDZ during induction, and rates of deep remission at wk 6 (maintenance baseline) were comparable across treatment groups (Table 1). At wk 52, almost 3 times as many VDZ-treated patients were in deep remission as were PBO-treated patients (Table 1). Compared with patients not in deep remission, patients in deep remission at wk 6 had better wk 52 outcomes (Table 2). Further, deep remission at wk 52 was aligned with better outcomes at wk 52 compared with no deep remission. Similar trends were observed with both definitions of deep remission.
Deep remission at wk 6 was a consistent predictor of positive outcomes at wk 52. More VDZ-treated patients were in deep remission at wk 52 compared with PBO-treated patients. Patients in deep remission at wk 6 or 52 had better clinical and HRQoL outcomes at wk 52 than those who were not in deep remission.
Table 1 Percentage of patients in deep remission at wks 6 and 52 (maintenance ITT population)
Table 2 . Clinical and HRQoL outcomes at wk 52 in patients with or without deep remission (definition 2) at wk 6 (maintenance ITT population)
The clinical study was funded by Millennium Pharmaceuticals, Inc. (d/b/a Takeda Pharmaceuticals International Co.). Medical writing assistance was provided by inVentiv Medical Communications and supported by Takeda Pharmaceuticals International, Inc.
 Feagan BG, (2013), Vedolizumab as induction and maintenance therapy for ulcerative colitis, N Engl J Med, 699-710