Privigen IVIg therapy effective for primary, secondary immunodeficiencies: Study

CSL BehringOct 7 2010

Privigen®, the first and only 10% liquid intravenous immunoglobulin (IVIg) therapy stabilized with proline, is effective and well tolerated in patients with several primary and secondary immunodeficiencies, according to data presented today at the XIVth Meeting of the European Society for Immunodeficiencies. Results also demonstrate that Privigen offers significant protection against infection.

In a separate observational study, patients reported higher overall satisfaction with Privigen compared to previous treatments, along with fewer adverse events and improvements in quality of life. Even at higher rates of infusion, Privigen tolerability appeared superior to Sandoglobulin.

"Some patients have difficulty tolerating infusions at high rates, experiencing side effects such as general tiredness and long-lasting headaches," said Bodo Grimbacher, MD, Professor, Division of Immunology, Royal Free Hospital NHS Trust, London, and study investigator. "Our observation suggests that Privigen allows for higher infusion rates, substantially reducing the time needed for infusions."

Privigen is approved in the European Union, Switzerland, Canada and the United States for treating patients diagnosed with primary immune deficiency (PID) and immune thrombocytopenic purpura (ITP). In Europe, Privigen is also approved for treating Guillain-Barre Syndrome and Kawasaki-Syndrome.

Study Design

In an interim analysis of an ongoing, multicenter, observational study to evaluate the efficacy and tolerability of Privigen, 76 patients received a total of 371 Privigen infusions. Overall, infection incidence decreased following initiation of treatment with Privigen compared with 6 months prior to the study (37 infections versus 160 infections). Patients who had not received any IVIg treatment for 6 months prior to study entry, and who received Privigen for at least 3 months, experienced significantly fewer infections during the study period than before study entry. Efficacy and tolerability were judged as very good or good in 91 percent and 88 percent of patients, respectively. Adverse events were reported for 17 of the 371 infusions.

Findings from a second observational study examined 35 patients receiving intravenous replacement therapy who were switched from Sandoglobulin® NF liquid (12% IgG) to Privigen without dose adjustment. Results indicate that a large proportion of patients could not tolerate infusion at rates higher than 0.5 mL/kg/h with Sandoglobulin, due to side effects. In contrast, some patients were also able to infuse Privigen safely at an infusion rate of 7.2 mL/kg/h for more than 30 minutes, without compromising tolerability. Approximately 70 percent of patients were able to infuse higher rates with Privigen, substantially reducing the time for infusion. Anecdotal feedback also indicated that patients experienced fewer adverse events, reported improvements in their quality of life and reported higher overall satisfaction following a switch to Privigen.