Data collection
BLOOD
For TED-C14-004 and SHP633-306, patient demographic and clinical characteristics were captured at baseline, defined as the last visit before initiation of treatment with teduglutide. The baseline for the analysis of the efficacy and PK assessments for each patient was the baseline from core studies TED-C14-004 or SHP633-306. Data collected at each clinic visit included the daily PS volume, safety parameters, clinical laboratory test results, vital signs, body weight, and body mass index (BMI).Concentrations of plasma citrulline, a biomarker of intestinal epithelial mass, were measured at baseline; weeks 4, 8, 16, and 24; and then every 2 months thereafter up to 30 months of treatment. Patients who continued into SHP633-307 from SHP633-306 had measurements taken at month 12, while those continuing from TED-C14-004 had measurements taken every 3 months.In TED-C14-004 and SHP633-306, blood samples for PK evaluations were taken pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 h post-dose during the first 12 weeks of treatment with teduglutide. In SHP633-307, patients continuing from study TED-C14-004 had blood samples for PK evaluations taken pre-dose and at 0.25 and 0.5 min, and 1, 2, 3, 4, 6, 8, 10, and 12 h post-dose at the first extension study visit. Patients continuing from SHP633-306 had blood samples taken pre-dose and 1 and 2 h post-dose at the first extension study visit. Blood samples to test for the presence of antibodies to teduglutide were taken at baseline and weeks 12 and 24 in SHP633-306; ≥ 14 h after dosing at baseline and weeks 12 and 24, and then every 6 months thereafter in TED-C14-004; and every 3 months in SHP633-307.