Teduglutide Treatment and Associated Parenteral Support (PS) Reductions in Adult Short Bowel Syndrome (SBS) Patients With Ultra-Short Remnant Bowel and/or No Colon in Continuity

Introduction: Prior to the availability of teduglutide, functional bowel length was recognized as an important prognostic factor in patients with SBS.1 In general, patients with shorter residual small bowel following intestinal resection are more likely to remain chronically dependent on PS to meet their fluid and nutritional needs.1 Phase III clinical trials have demonstrated that teduglutide, a recombinant analog of human glucagon-like peptide 2, enhances absorption and reduces the volume of PS needed to maintain clinical status in a wide range of patients with varying etiologies and durations of SBS. In the randomized, double-blind, placebo-controlled phase III STEPS (CL0600-020) registration study, 27/43 (63%) teduglutide-treated vs 13/43 (30%) placebo-treated patients achieved responder criteria (primary endpoint of ≥20% reduction in weekly PS volume from baseline at weeks 20 and 24)2. There was a mean reduction in PS volume of 4.4 L/week at week 24 from the baseline mean volume of 12.9 L/week.2 Methods: This subanalysis was undertaken to determine the impact of teduglutide in patients with ultra-short (≤40 cm) remnant bowel and/or no colon-in-continuity. Data from all patients who received teduglutide 0.05 mg/kg/day for 24 weeks in STEPS (n=40) were assessed by descriptive statistics; no between-group comparisons were done, owing to the small sample size. Results: The responder criteria were met by similar percentages of patients regardless of bowel length, including 7/11 (64%) patients with remnant bowel length ≤40 cm and 3/5 (60%) patients with remnant bowel length ≤25 cm (Table). At week 24, patients in each of these 2 groups with ultra-short bowel experienced mean decreases in weekly PS volume of 3.9 L and 3.6 L, respectively. Analysis of data from all patients who were randomized to teduglutide treatment in STEPS, regardless of bowel length (n=43), found that 13/17 (77%) patients without colon-in-continuity and 14/26 (54%) patients with colon-incontinuity met the responder criteria. Conclusion: These findings reinforce the benefits of treatment with teduglutide 0.05 mg/kg/day to enhance absorptive capacity in SBS regardless of remnant anatomy. Disclosure - Dr. JeeJeebhoy -- Other (study investigator) for NPS Pharmaceuticals, Inc. Dr. Schneider -- Advisory committee/board member and Other (study investigator) for NPS Pharmaceuticals, Inc. Dr. Gabe -- Advisory committee/board member for NPS Pharmaceuticals, Inc. Dr. Pape -- Advisory committee/board member and Other (study investigator) for NPS Pharmaceuticals, Inc. Dr. Fujioka -- Consultant and Other (study investigator) for NPS Pharmaceuticals, Inc. Dr. Youssef -- Employee of NPS Pharmaceuticals, Inc. Dr. Seidner -- Grant/research support, Consultant, Advisory committee/board member, and Other (study investigator) for NPS Pharmaceuticals, Inc. This research was funded by NPS Pharmaceuticals, Inc., Bedminster, NJ.Table 1

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