(204) A Real-World Study of Incidence Rates of Safety Outcomes of Interest in Infants Aged 1 Month to < 1 Year and Patients Aged 1 to < 2 Years Treated with Intravenous Pantoprazole Sodium Using an Electronic Health Records Database from the US

Publication Number: 1249

Background: Protonix [pantoprazole sodium (PPS)] intravenous (IV) for Injection is indicated for short-term treatment of adult patients with gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) and is not indicated for use in pediatric patients. Due to an inability of enrolling infants aged 1 month to < 1 year and insufficient number of patients aged 1 to < 2 years enrolled in an ongoing clinical trial, a real-world non-interventional study was conducted to collect safety data in these two patient cohorts who were treated with IV PPS using Optum’s longitudinal electronic health records database from the United States.

Objectives: To estimate incidence rates of outcomes of interest in infants aged 1 month to < 1 year (Cohort 1) and patients aged 1 to < 2 years (Cohort 2) who were treated with IV PPS identified using Optum’s database during a study period of 01 January 2007 to 31 December 2020.

Methods: This retrospective cohort study identified Cohort 1 and 2 who received at least 1 administration of IV PPS identified using inpatient procedure and drug codes during the study period from the database. In each cohort, 3 subgroups were identified as follows: (1) GERD and EE, (2) GERD without EE, and (3) no diagnosis of GERD/EE. The following outcomes were identified using International Classification of Diseases codes in an inpatient or outpatient setting (but not limited to): agranulocytosis, thrombocytopenia, hypersensitivity, and hepatobiliary injury. Patients were followed from the date of first administration of IV PPS until the occurrence of an outcome, 90 days post-discontinuation of IV PPS, initiation of a separate infusion within 90 days post-discontinuation of IV PPS, death, end of enrollment or study period, whichever occurred first. Incidence rates (IRs) per 1,000 person-years (PY) and 95% confidence intervals (CI) of outcomes were estimated in each cohort/subgroup.

Results: There were 6,581 infants in Cohort 1 with 0, 781, and 5,800 infants in subgroups 1 to 3 and 1,429 patients in Cohort 2 with 0, 510, and 919 patients in subgroups 1 to 3, respectively. The IRs per 1,000 PY (95% CI) of agranulocytosis, thrombocytopenia, hypersensitivity and hepatobiliary injury were 3.48 (1.96, 5.01), 17.26 (13.71, 20.80), 18.73 (15.08, 22.39), 16.08 (12.62, 19.53) in Cohort 1 and 6.90 (3.95, 9.85), 20.40 (15.06, 25.74), 12.49 (8.47, 16.51), 17.64 (12.70, 22.58) in Cohort 2, respectively. Results on all outcomes of interest in each subgroup will be presented in the poster.

Conclusions: Although the use of IV PPS is rare in the cohorts of interest, this study highlights the feasibility of using real-world data from pediatric populations and provided safety data following IV PPS administration.