Vivaglobin therapy effective for patients with primary immunodeficiency

Oct 7 2010

Vivaglobin® (subcutaneous immunoglobulin [IgG]) (SCIg) is an effective and safe initial therapy for treatment-naive patients with primary immunodeficiency (PI) and may offer an attractive alternative to intravenous IgG (IVIg) therapy in the newly diagnosed, according to data presented today at the XIVth Meeting of the European Society for Immunodeficiencies. The study found that IgG replacement therapy initiated with Vivaglobin in patients with PI provided adequate serum IgG levels, protected the patients from infections, and improved health-related quality of life, without raising safety concerns.

SCIg treatment, which is delivered directly under the skin, is an important treatment option for patients who do not easily tolerate administration by intravenous infusion because they have poor venous access or experience serious side effects. SCIg is self-administered, offering users convenience and reducing some of the need for healthcare resources associated with IVIg therapy. Additionally, because SCIg is infused weekly, it provides sustained serum IgG levels.

"Though SCIg treatment sustains IgG levels better than IVIg does, for the newly diagnosed patient, IVIg therapy has usually been the recommended first course of treatment," said Bruce Ritchie, MD, FRCPC, Associate Professor, Division of Hematology, Department of Medicine, University of Alberta, and study investigator. "Our findings challenge the practice of initiating replacement therapy using IVIg in people newly diagnosed with primary immunodeficiency disease. The findings also confirm the therapeutic benefits of administering SCIg as first-line treatment in this patient population."

Vivaglobin is approved in the European Union and Switzerland for treating PI as well as secondary immunodeficiency (SI) patients. In Canada and the United States, Vivaglobin is approved for treating PI.

Study Design

In this study, 18 treatment-naïve patients were administered Vivaglobin 100 mg/kg for 5 consecutive days, followed by weekly infusion of 100 mg/kg (as 1-2 infusions per week) for 24 weeks. The primary endpoint was the proportion of patients achieving IgG trough levels of at least 5 g/L on day 12. Secondary endpoints included IgG increase from baseline to day 12, total Ig levels, rate of any infections, antibiotic use and health-related quality of life assessment (HRQoL).

Findings demonstrate that the proportion of patients achieving serum IgG levels of at least 5 g/L was 94.4 percent by day 12. The mean baseline IgG level of 3.56+/-1.28 g/L increased by 3.94+/-0.75 g/L on day 12, and remained stable throughout the study. Due to irregular attendance, one patient achieved only 3.39 g/L at day 12 and later withdrew informed consent. Thirty-four infection episodes were reported by 10 patients (annualized rate: 3.95/patient). Antibiotic use to treat infections totaled 267 days in 8 patients (annualized rate: 31 days/patient). HRQoL significantly improved from screening to completion visit (43.5 percent vs. 62.0 percent in general health). Nine patients experienced 58 adverse events (AE) at least possibly related to treatment (rate: 0.105/infusion), most frequently injection site swelling (4 patients), injection site erythema (3 patients), and headache (3 patients), all of mild intensity. Two patients had 7 serious AEs (rate: 0.013/infusion) which were considered not related to treatment. No AE led to withdrawal.

SOURCE CSL Behring