RESULTS OF A PHASE 4 STUDY OF IMMUNOGLOBULIN [HUMAN] SUBCUTANEOUS FOR PATIENTS REQUIRING IMMUNOGLOBULIN

Abstract

<h3>Introduction</h3> Immunoglobulin (Ig) therapy has transformed into the preferred treatment for patients diagnosed with various conditions that attack and disable the immune system. Originally, immunoglobulin therapy could only be administered intravenously, but subcutaneous IgG (SCIg) has become a standard of care. This study compares immunoglobulin [human] subcutaneous 16.5% to other currently marketed SCIg products. <h3>Methods</h3> The study was designed to enroll 150 male or female patients with immune dysfunction in one of 3 study arms. Arm 1 enrolled patients naïve to Ig therapy; arm 2 enrolled patients currently receiving IVIG therapy; and arm 3 enrolled participants receiving other SCIg products. Participants receiving SCIg continued on their current product for Visit 1 and Visit 2, with the option of switching to the test product for Visit 3 – Visit 7. After screening, the length of study participation is approximately 6 months. Data regarding number of infusions, laboratory measurements, rate of infection, and quality of life (using 4 mental health questionnaires) were collected every 4 weeks (±3 days). <h3>Results</h3> The study currently has 45 actively enrolled patients. Patients had an average IgG serum quantitative value of 960.55 in arm 1, 1084.27 in arm 2, and 1231.34 in arm 3. Patients in arm 3 had been on therapy longer, which might explain their higher trough levels, although efficacy was seen in all 3 arms. Additionally, patients reported greater quality of life during the study. <h3>Conclusion</h3> Preliminary results suggest a link between higher IgG levels and greater reported quality of life. Further data is forthcoming.