Edward V Loftus1, Jean-Frédéric Colombel2, Brian G Feagan3, Severine Vermeire4, William J Sandborn5, Bruce E Sands2, 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. Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA. 2. Icahn School of Medicine at Mount Sinai, Mount Sinai Hospital, New York, New York, USA. 3. Robarts Clinical Trials, Robarts Research Institute, University of Western Ontario, London, Ontario, Canada. 4. University Hospitals, Leuven, Belgium. 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: 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.
BACKGROUND AND AIMS: 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.
Authors: Sarah Fischer; Timo Rath; Carol-Immanuel Geppert; Bernhard Manger; Georg Schett; Markus F Neurath; Raja Atreya Journal: Am J Gastroenterol Date: 2017-10 Impact factor: 10.864
Authors: Luisa Guidi; Daniela Pugliese; Tommaso Panici Tonucci; Lorenzo Bertani; Francesco Costa; Giuseppe Privitera; Barbara Tolusso; Clara Di Mario; Eleonora Albano; Gherardo Tapete; Elisa Gremese; Alfredo Papa; Antonio Gasbarrini; Gian Ludovico Rapaccini; Alessandro Armuzzi Journal: United European Gastroenterol J Date: 2019-09-03 Impact factor: 4.623