Clin Gastroenterol Hepatol. 2024 Apr;22(4):896-898.e13. doi: 10.1016/j.cgh.2023.09.011.Epub 2023 Sep 22.

Pauline Wils ¹, Vipul Jairath ², Bruce E Sands ³, Walter Reinisch ⁴, Silvio Danese ⁵, Laurent Peyrin-Biroulet ⁶

Author information

¹Department of Gastroenterology, Claude Huriez Hospital, University of Lille 2, Lille, France; Inserm, CHU Lille, U1286-INFINITE-Institute for Translational Research in Inflammation, University of Lille, Lille, France.

²Division of Gastroenterology, Department of Medicine, Western University, London, Ontario, Canada.

³The Dr Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York.

⁴Medical University of Vienna, Department of Internal Medicine III, Division Gastroenterology and Hepatology, Vienna, Austria.

⁵Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and, Vita-Salute San Raffaele University, Milan, Italy.

⁶University of Lorraine, CHRU-Nancy, Department of Gastroenterology, Nancy, France; University of Lorraine, Inserm, NGERE, Nancy, France; Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal, Quebec, Canada. Electronic address: peyrinbiroulet@gmail.com.

Abstract

Inflammatory bowel diseases (IBD), encompassing ulcerative colitis (UC) and Crohn's disease (CD), impose a substantial burden. Despite many effective molecules, significant numbers of patients do not achieve clinical remission at 1 year¹ and undergo surgery during their lives, revealing an important unmet need and therapeutic gap. Multiple randomized controlled trials (RCTs) are ongoing or planned to develop more effective and tolerable therapies. In parallel, a dramatic decline in recruitment rates has been observed. A multitude of factors have contributed to poor recruitment rates, including a long washout period between the investigational drug and prior advanced therapies (ie, biologic or small molecule drug).^2,3 This study aims to review the different washout periods with prior advanced therapies or immunosuppressants in phase 3 RCTs for UC and CD and to propose potential solutions to ultimately improve the design of clinical studies and patient enrollment in future trials.