Introduction
intestinal failure, malignancy, Short bowel syndrome, Crohn’s disease, mesenteric ischemia, SBS, SBS-IF
INTESTINAL FAILURE, INTESTINAL OBSTRUCTION, SHORT BOWEL SYNDROME, MESENTERIC ISCHEMIA, PATHOLOGY
Short bowel syndrome (SBS) is a rare condition resulting from significant physical or functional loss of portions of the bowel and is the most common cause of intestinal failure (IF) [Patients with SBS-IF comprise a heterogeneous population differing in underlying pathology, the function of the remnant bowel, and demographic characteristics [SBS in adults is commonly caused by extensive intestinal resection for recurrent Crohn’s disease, mesenteric ischemia, intestinal obstruction, or malignancy, and may involve partial or complete colonic resection [Severe reductions in the intestinal absorptive capacity may render patients with chronic SBS-IF dependent on life-sustaining parenteral support (PS; parenteral nutrition and/or intravenous fluids) [Teduglutide is a GLP-2 analogue approved in several countries and continents, including the United States and Europe (2012), for the treatment of patients ≥ 1 year old with SBS-IF (0.05 mg/kg subcutaneously [SC] once daily) who are dependent on PS [The benefits and risks associated with teduglutide in Japanese patients with SBS-IF have not been previously reported. We therefore report herein the efficacy, safety, and pharmacokinetic (PK) findings for teduglutide from two multicenter phase III clinical trials and their extension study in adult Japanese patients with SBS-IF: the up to 30-month TED-C14-004 study; the 24-week SHP633-306 pivotal study; and the SHP633-307 long-term extension study (involving ≥ 12 months’ and 24 weeks’ participation in studies TED-C14-004 and SHP633-306, respectively). These three studies were conducted with the goal of achieving marketing approval for teduglutide in Japan.