Long-term Efficacy of Vedolizumab for Crohn's Disease.
OBJECTIVE
Vedolizumab is a gut-selective α4β7 integrin antagonist therapy for ulcerative colitis and Crohn's disease. The GEMINI long-term safety [LTS] trial is an ongoing open-label study investigating the safety of vedolizumab. We present interim exploratory analyses of efficacy in patients with Crohn's disease.


METHODS
Patients from the C13004, GEMINI 2 and GEMINI 3 studies and vedolizumab-naïve patients could enrol in GEMINI LTS and received vedolizumab every 4 weeks. Data were collected from May 22, 2009 to June 27, 2013. Outcomes of clinical response and remission, defined by the Harvey-Bradshaw Index, and health-related quality of life [HRQL] were assessed for up to 152 weeks of treatment in the efficacy population.


RESULTS
Among patients with response at week 6 in GEMINI 2 who received vedolizumab continuously, 83% [n=100/120] and 89% [n=62/70] of patients with available data were in remission after 104 and 152 weeks, respectively. Increased dosing frequency from every 8 weeks [GEMINI 2] to every 4 weeks [GEMINI LTS] improved outcomes in patients who had withdrawn early from GEMINI 2, with 47% [n=27/57] experiencing clinical response and 32% [n=18/57] in remission at week 52 of GEMINI LTS [up from 39% and 4% before the dose increase]. Similar improvements were observed regardless of prior tumour necrosis factor [TNF] antagonist exposure. Long-term benefits of HRQL were also observed.


CONCLUSIONS
The clinical benefits of vedolizumab continued with long-term treatment regardless of prior TNF antagonist exposure. Increased dosing frequency might improve outcomes in patients who lose response to conventional 8-weekly dosing.
University Hospitals Leuven, Belgium.
Severine
S
Vermeire
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 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*; D003424:Crohn Disease / Q000188:drug therapy*; D004311:Double-Blind Method; 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
Crohn’s disease; long-term efficacy; vedolizumab