Severine Vermeire1, Edward V Loftus2, Jean-Frédéric Colombel3, Brian G Feagan4, William J Sandborn5, Bruce E Sands3, Silvio Danese6, Geert R D'Haens7, Arthur Kaser8, Remo Panaccione9, David T Rubin10, Ira Shafran11, Megan McAuliffe12, Arpeat Kaviya13, Serap Sankoh12, Reema Mody14, Brihad Abhyankar13, Michael Smyth13. 1. University Hospitals Leuven, Belgium. 2. Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA. 3. Icahn School of Medicine at Mount Sinai, Mount Sinai Hospital, New York, New York, USA. 4. Robarts Clinical Trials, Robarts Research Institute, University of Western Ontario, London, Ontario, Canada. 5. University of California San Diego and UC San Diego Health System, La Jolla, California, USA. 6. Istituto Clinico Humanitas, Milan, Italy. 7. Academic Medical Center, Amsterdam, The Netherlands. 8. Department of Medicine, University of Cambridge, Addenbrooke's Hospital, Cambridge, UK. 9. Inflammatory Bowel Disease Clinic, University of Calgary, Calgary, Alberta, Canada. 10. University of Chicago Inflammatory Bowel Disease Center, Chicago, Illinois, USA. 11. Shafran Gastroenterology Center, Winter Park, Florida, USA. 12. Takeda Pharmaceuticals International Co., Cambridge, Massachusetts, USA. 13. Takeda Development Centre Europe Ltd, London, UK. 14. Takeda Pharmaceuticals International, Inc., Deerfield, Illinois, USA.
Abstract
BACKGROUND AND AIMS: 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dosing frequency from every 8 weeks [GEMINI 2] to every 4 weeks [GEMINI LTS] improved outcomes in patients who had withdrawn early from GEMINI 2, with 47% [n=27/57] experiencing clinical response and 32% [n=18/57] in remission at week 52 of GEMINI LTS [up from 39% and 4% before the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.
BACKGROUND AND AIMS: 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.
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