REAL-WORLD UTILIZATION OF IMMUNE GLOBULIN INTRAVENOUS 10% AT PHYSICIAN OFFICE INFUSION CENTERS

Abstract

<h3>Introduction</h3> Immune Globulin Intravenous (human) 10% liquid (IGIV 10%) was FDA-approved in 2012, voluntarily withdrawn in 2016, and reintroduced in 2019 by a new manufacturer with an optimized manufacturing process. Given the manufacturing process changes and utilization of the product in the US, the assessment of post-marketing clinical experience is warranted. The objective of this study is to evaluate post-marketing tolerability of IVIG 10% in a real-world setting. <h3>Methods</h3> We conducted a retrospective observational review of a random sample of patients who received IGIV 10% from 8/2021-5/2022 at physician office infusion centers (OICs) throughout the US. Study data from electronic medical records included demographics, therapy details, and infusion-related adverse events (AEs). <h3>Results</h3> Twenty-three of 96 IGIV 10% patients were randomly-selected from 9 OICs. The mean age was 74±5.3 years with 78% female. Common comorbidities included hypertension (74%) and gastroesophageal reflux disease (61%). One patient was immune globulin (IG) naïve, and 22 patients (96%) were IG-treatment experienced. Most (91%) had primary immunodeficiencies, with one chronic lymphocytic leukemia and one dermatomyositis. The mean IGIV 10% dose was 432±129.2 infused every three or four weeks. IGIV 10% infusions were titrated over an average of 78±28.8 minutes with an average maximum infusion rate of 154±18.8 mL/hr. During the study, patients received a mean of 7±2 infusions. Of 155 infusions, five AEs were reported (fatigue, headache, nausea, dizziness) during 4 infusions (17%) for an overall AE rate per infusion of 3%. <h3>Conclusions</h3> IGIV 10% was successfully administered to patients in OICs and was well-tolerated over multiple infusions.