Head-to-Head Trials and Dual Biologics
Sunday, November 15, 2020
8:45 am - 9:15 am
Prof. Laurent Peyrin-Biroulet, MD, PhD
Full Professor of MedicineDepartment of Gastroenterology
Nancy University Hospital, France
Department of Hepato Gastroenterology,
University Hospital of Nancy
Dr. Laurent Peyrin-Biroulet (PH: PERIN BEE-ROO-LAY) is professor of medicine and head of the inflammatory bowel disease (IBD) unit (Inserm U1256 NGERE) at the Nancy University Hospital in France. Upon receiving his medical degree and PhD, he undertook a postdoctoral fellowship at the IBD Centre in Lille in 2007, before taking a research position at the Mayo Clinic in Rochester, USA (2008–2009).
He is President of the GETAID and Past-President of the SciCom of the French association of IBD patients (AFA). He is the current President elect of the European Crohn’s & Colitis Organization (ECCO) and current scientific secretary of IOIBD. He was the coordinator for the development of the first Disability Index for IBD and of the treat to target (STRIDE) recommendations. He proposed the first definitions of early Crohn’s disease and of disease severity for IBD. He is co-founder of the Spectrum consortium and President of the ICARE project. Author of more than 700 peer-reviewed articles and more than 200 non peer-reviewed articles, Professor Peyrin-Biroulet was an associate editor of Digestive Liver Diseases (2013-17), and is a member of the editorial board of Alimentary Pharmacology & Therapeutics, Journal of Crohn’s and colitis, Expert Review of Clinical Immunology, and Gut. He is Associate Editor of Clinical Gastroenterology Hepatology since 2017. He is a staff contributor of the Selected Summary section of Gastroenterology.
With the increase in the number of novel drugs for inflammatory bowel disease (IBD), comparing therapeutic options or strategies has become a key challenge in IBD trials. Head-to-head trials designed and powered to enable formal comparisons are the gold standard in comparative research. Indeed, these trials are requested by some health authorities for evaluating the positioning of new treatments in IBD, as well as helping prescribing physicians to select the most appropriate treatment options for their patients. Despite head-to-head trials including aminosalicylate therapy in IBD having been performed decades ago, the first results of a randomized controlled trial called VARSITY and directly comparing biologic agents with different modes of action have only now been published. I will provide an overview of the past, current and future concepts in IBD trial design, with a detailed focus on the role of comparative research and the challenges and pitfalls in undertaking and interpreting the results from such studies.