The highly concentrated immunoglobulin (IG) formulation—immune globulin subcutaneous (human) 20% solution (Ig20Gly/Cuvitru)—was designed to allow for subcutaneous (SC) infusion of IG in small infusion volumes and to reduce infusion times compared with less-concentrated products. The CORE study will collect representative real-world information about the utilisation, safety, tolerability, and patient experience of Ig20Gly.
CORE is a noninterventional, prospective, longitudinal study being conducted in Germany and Switzerland (DRKS00014562). Patients of all ages are eligible for participation if they provide written informed consent, have primary humoral immunodeficiency disease requiring gamma globulin replacement, received any SCIG therapy (for at least 3 months at a stable dose) prior to Ig20Gly, received Ig20Gly according to drug-label specifications, and are expected to continue treatment with Ig20Gly. Planned enrolment size is 150 patients at 30 sites who will be followed for 1 year (3 visits). Patient and usage data including maximum infusion rate and volume, number of infusion sites, infusion duration, dose and dosing schedule, number and reason for discontinued, slowed, or interrupted infusions, patient experience including satisfaction, and healthcare utilization will be collected during respective visits. Adverse drug reactions will be recorded according to regulatory requirements.
13 patients have started the study to date, and enrolment is ongoing. The first patient was enrolled on 26 November 2018 and study completion is expected in March 2021.
The CORE study is expected to provide a detailed and complete description of Ig20Gly usage under real-life conditions and to describe the patient experience after switching from other SCIG therapies.