Long-term Efficacy of Vedolizumab for Ulcerative Colitis.
OBJECTIVE
The GEMINI long-term safety [LTS] study is a continuing phase 3 trial investigating the safety and efficacy of vedolizumab, an α4β7 integrin antagonist for ulcerative colitis [UC] and Crohn's disease. We provide an interim analysis of efficacy in patients with UC.


METHODS
Patients from the C13004 and GEMINI 1 studies and a cohort of vedolizumab-naïve patients received open-label vedolizumab every 4 weeks. Interim data were collected from May 22, 2009 to June 27, 2013. Clinical response and remission, evaluated using partial Mayo scores, and health-related quality of life [HRQL] were assessed for up to 152 weeks of cumulative treatment in the efficacy population.


RESULTS
As of June 27, 2013, 63% of the efficacy population [n = 532/845] were continuing treatment. Among patients who responded to vedolizumab induction and had data available, 88% [n = 120/136] were in remission after 104 weeks of exposure (96% [n = 70/73] after 152 weeks). Among patients who withdrew from every-8-week vedolizumab maintenance in GEMINI 1 [n = 32] before week 52, increased dosing to every 4 weeks in GEMINI LTS resulted in response and remission rates of 41% and 28%, respectively, after 52 weeks, an increase from 19% and 6%, respectively, from before the dose increase. Similar benefits were demonstrated regardless of prior tumour necrosis factor-antagonist exposure. Durable benefits on HRQL were also observed.


CONCLUSIONS
Patients with UC experienced clinical and HRQL improvements with continued vedolizumab treatment. Increased dosing frequency to every 4 weeks was beneficial in patients who had loss of response to 8-weekly dosing.
Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.
Edward V
EV
Loftus
Icahn School of Medicine at Mount Sinai, Mount Sinai Hospital, New York, New York, USA.
Jean-Frédéric
JF
Colombel
Robarts Clinical Trials, Robarts Research Institute, University of Western Ontario, London, Ontario, Canada.
Brian G
BG
Feagan
University Hospitals, Leuven, Belgium.
Severine
S
Vermeire
University of California San Diego and UC San Diego Health System, La Jolla, California, USA.
William J
WJ
Sandborn
Icahn School of Medicine at Mount Sinai, Mount Sinai Hospital, New York, New York, USA.
Bruce E
BE
Sands
Istituto Clinico Humanitas, Milan, Italy.
Silvio
S
Danese
Academic Medical Center, Amsterdam, The Netherlands.
Geert R
GR
D'Haens
Department of Medicine, University of Cambridge, Addenbrooke's Hospital, Cambridge, UK.
Arthur
A
Kaser
Inflammatory Bowel Disease Clinic, University of Calgary, Calgary, Alberta, Canada.
Remo
R
Panaccione
University of Chicago Inflammatory Bowel Disease Center, Chicago, Illinois, USA.
David T
DT
Rubin
Shafran Gastroenterology Center, Winter Park, Florida, USA.
Ira
I
Shafran
Takeda Pharmaceuticals International Co., Cambridge, Massachusetts, USA.
Megan
M
McAuliffe
Takeda Development Centre Europe Ltd, London, UK.
Arpeat
A
Kaviya
Takeda Pharmaceuticals International Co., Cambridge, Massachusetts, USA.
Serap
S
Sankoh
Takeda Pharmaceuticals International, Inc., Deerfield, Illinois, USA.
Reema
R
Mody
Takeda Development Centre Europe Ltd, London, UK.
Brihad
B
Abhyankar
Takeda Development Centre Europe Ltd, London, UK.
Michael
M
Smyth
D000328:Adult; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D005260:Female; D005765:Gastrointestinal Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D011788:Quality of Life; D012074:Remission Induction; D016896:Treatment Outcome
D061067:Antibodies, Monoclonal, Humanized; D005765:Gastrointestinal Agents; C543529:vedolizumab
Vedolizumab; long-term efficacy; ulcerative colitis