Induction response was higher in ulcerative colitis than in Crohn disease, but maintenance of remission in both was around 40% at 1 year.
Phase II studies suggest that vedolizumab, a monoclonal antibody, might be effective in inflammatory bowel disease (IBD). It could also present an alternative to natalizumab, which is associated with progressive multifocal leukoencephalopathy, a devastating brain infection.
In two separate but similarly designed industry-supported, phase III trials, investigators randomized patients with ulcerative colitis (UC) and Crohn disease (CD) to receive 300 mg of intravenous vedolizumab or placebo at weeks 0 and 2. A separate large group of patients was treated with open-label vedolizumab, and those who responded were randomized to maintenance therapy with vedolizumab at 4-week or 8-week intervals or placebo.
Results of the UC trial included:
Reviewing Author
DisclosuresConsultant/Advisory BoardOlympus Corporation America; Boston Scientific
Speaker’s BureauOlympus
Grant/Research SupportMedtronic; Boston Scientific; Colonary Solutions; Paion Medical; Medivators; Braintree Laboratories
Editorial BoardsWorld Journal of Gastroenterology; The Journal of Clinical Gastroenterology; Techniques in Gastrointestinal Endoscopy; Gastroenterology & Hepatology; Expert Review of Gastroenterology & Hepatology; Medscape Gastroenterology; World Journal of Gastrointestinal Pharmacology and Therapeutics; Annals of Gastroenterology & Hepatology; World Journal of Gastrointestinal Oncology; Comparative Effectiveness Research; Journal of Anesthesia & Clinical Research; Gastroenterology; World Journal of Gastrointestinal Pathophysiology; Gastroenterology Research and Practice; GI & Hepatology News; Gastroenterology Report; Clinical Epidemiology Reviews; JSM Gastroenterology and Hepatology; GI Journal Watch; Austin Journal of Gastroenterology; World Journal of Gastrointestinal Pharmacology & Therapeutics
Leadership Positions in Professional SocietiesAmerican Society for Gastrointestinal Endoscopy (Treasurer); US Multi-Society Task Force (AGA, ACG, ASGE) (Chair)
DisclosuresConsultant/Advisory BoardOlympus Corporation America; Boston Scientific
Speaker’s BureauOlympus
Grant/Research SupportMedtronic; Boston Scientific; Colonary Solutions; Paion Medical; Medivators; Braintree Laboratories
Editorial BoardsWorld Journal of Gastroenterology; The Journal of Clinical Gastroenterology; Techniques in Gastrointestinal Endoscopy; Gastroenterology & Hepatology; Expert Review of Gastroenterology & Hepatology; Medscape Gastroenterology; World Journal of Gastrointestinal Pharmacology and Therapeutics; Annals of Gastroenterology & Hepatology; World Journal of Gastrointestinal Oncology; Comparative Effectiveness Research; Journal of Anesthesia & Clinical Research; Gastroenterology; World Journal of Gastrointestinal Pathophysiology; Gastroenterology Research and Practice; GI & Hepatology News; Gastroenterology Report; Clinical Epidemiology Reviews; JSM Gastroenterology and Hepatology; GI Journal Watch; Austin Journal of Gastroenterology; World Journal of Gastrointestinal Pharmacology & Therapeutics
Leadership Positions in Professional SocietiesAmerican Society for Gastrointestinal Endoscopy (Treasurer); US Multi-Society Task Force (AGA, ACG, ASGE) (Chair)