title: Long-Term Teduglutide for the Treatment of Patients With Intestinal Failure Associated With Short Bowel Syndrome.
abstract: OBJECTIVE
  In the pivotal 24-week, phase III, placebo-controlled trial, teduglutide significantly reduced parenteral support (PS) requirements in patients with short bowel syndrome (SBS). STEPS-2 was a 2-year, open-label extension of that study designed to evaluate long-term safety and efficacy of teduglutide.
  
  
  METHODS
  Enrolled patients had completed 24 weeks of either teduglutide (TED/TED) or placebo (PBO/TED) in the initial placebo-controlled study or qualified for that study, but were not treated (NT/TED) because of full enrollment. Patients received subcutaneous teduglutide 0.05 mg/kg/day for up to 24 months (NT/TED and PBO/TED) or up to 30 months (TED/TED). Clinical response was defined as 20-100% reduction from baseline in weekly PS volume; baseline was considered the beginning of teduglutide treatment in the initial placebo-controlled study (TED/TED) or STEPS-2 (NT/TED and PBO/TED). Descriptive statistics summarized changes in efficacy and safety variables.
  
  
  RESULTS
  Of 88 enrolled patients, 65 (74%) completed STEPS-2. The most common treatment-emergent adverse events were abdominal pain (34%), catheter sepsis (28%), and decreased weight (25%). Mean weight, body mass index, and serum albumin remained stable. In patients who completed the study, clinical response was achieved in 28/30 (93%) TED/TED, 16/29 (55%) PBO/TED, and 4/6 (67%) NT/TED patients. Mean PS volume reductions from baseline were 7.6 (66%), 3.1 (28%), and 4.0 (39%) l/week in the TED/TED, PBO/TED, and NT/TED groups, respectively. Thirteen patients achieved full enteral autonomy.
  
  
  CONCLUSIONS
  In patients with SBS, long-term teduglutide treatment resulted in sustained, continued reductions in PS requirements. Overall health and nutritional status was maintained despite PS reductions.
authors: Division of Gastroenterology, Mount Sinai School of Medicine, New York, New York, USA.
authors: Lauren K
authors: LK
authors: Schwartz
authors: Division of Gastroenterology, Hepatology & Nutrition, University of Pittsburgh Medical School, Pittsburgh, Pennsylvania, USA.
authors: Stephen J D
authors: SJ
authors: O'Keefe
authors: Department of Endocrinology, Scripps Clinic, La Jolla, California, USA.
authors: Ken
authors: K
authors: Fujioka
authors: Lennard Jones Intestinal Failure Unit, St Mark's Hospital, Northwick Park, London, UK.
authors: Simon M
authors: SM
authors: Gabe
authors: Department of Medicine II, Division of Gastroenterology and Endocrinology, University Medical Center Rostock, Rostock, Germany.
authors: Georg
authors: G
authors: Lamprecht
authors: Department of Hepatology and Gastroenterology, Charité University Medicine, Berlin, Germany.
authors: Ulrich-Frank
authors: UF
authors: Pape
authors: NPS Pharmaceuticals, Bedminster, New Jersey, USA.
authors: Benjamin
authors: B
authors: Li
authors: NPS Pharmaceuticals, Bedminster, New Jersey, USA.
authors: Nader N
authors: NN
authors: Youssef
authors: Department of Medical Gastroenterology, Rigshospitalet, Copenhagen, Denmark.
authors: Palle B
authors: PB
authors: Jeppesen