Efficacy
Crohn’s disease, teduglutidePatients

Short-term treatment with teduglutideThe first 24 weeks of treatment with teduglutide were considered short-term use.Change in PS requirementsA reduction in weekly PS volume of ≥ 20% from baseline at both weeks 20 and 24 was achieved by 9 of 18 patients (50%) (5 of 11 patients [45.5%] in TED-C14-004 and 4 of 7 patients [57.1%] in SHP633-306). At 24 weeks, the PS volume decreased from baseline by 4.9 ± 4.8 L/week (−30.1% ± 25.9%; Change in plasma citrulline levelAt 24 weeks, the level of plasma citrulline increased from baseline by 15.0 ± 17.4 µM (86.9% ± 112.3%, Urine outputAt 24 weeks, the 48 h urine output increased from a baseline of 2933.0 ± 563.0 mL/day (Long-term treatment with teduglutidePatients who participated in TED-C14-004 received up to 30 months of treatment. By the interim cut-off point of the extension study (SHP633-307), patients from SHP633-306 and TED-C14-004 received a maximum of 14 and 57 months of treatment, respectively.Change in PS requirementsAll patients who participated in the extension study following SHP633-306 maintained  ≥ 20% reduction from baseline at each scheduled visit to the last visit before the data cut-off. After 30 months of treatment, 6 of 7 patients (85.7%) in TED-C14-004 achieved  ≥ 20% reduction in weekly PS volume from baseline. By the end of TED-C14-004, all patients had achieved  ≥ 20% reduction in weekly PS volume, which was maintained to the last visit before the data cut-off in the extension study.Reductions in PS volume continued with long-term treatment with teduglutide. Patients from SHP633-306 had notable and progressive reductions in PS from baseline; at 12 months, the PS volume had decreased by 7.3 ± 6.5 L/week (−51.6% ± 28.5%; In TED-C14-004, 2 of 8 patients (25%) achieved enteral autonomy by 30 months of treatment. Both had Crohn’s disease recorded as the reason for small bowel resection, an ileostomy, no remaining colon, and a remaining small intestinal length of 100 cm in one and 120 cm in the other. Furthermore, both remained off PS throughout SHP633-307 until its interim data cut-off. During SHP633-307, 1 patient from SHP633-306 almost achieved enteral autonomy at the interim data cut-off point, which occurred 14 months after this patient had begun treatment. Based on diary data, this individual received 0.5 L/day of PS for 2 days/week during the 2 weeks prior to their visit at month 14, but did not receive PS during the 7 days following this visit.Change in plasma citrulline levelThe levels of plasma citrulline continued to increase with long-term treatment, showing an increase of 13.0 ± 5.6 µM (79.1% ± 33.5%) from baseline for patients from SHP633-306 at the interim cut-off of the extension study (Online Resource 2). For patients in TED-C14-004, the plasma citrulline level continued to increase through 24 months of treatment and plateaued thereafter. After 30 months of treatment, the increase from baseline was 28.3 ± 24.1 µM (135.0% ± 84.2%; Urine outputMean percent change in the PS volume from baseline up to 24 weeks (For patients who advanced to SHP633-307 from SHP633-306, further increases from baseline (1242.5 ± 374.1 mL/day; 