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Vivaglobin

Clinical Pharmacology
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Clinical Pharmacology

Vivaglobin

A non-IND 6-month clinical study was conducted in Europe and Brazil in 60 subjects with PID. After the subjects had reached steady state with weekly VivaglobinÃ? administration, peak serum IgG levels were observed after a mean of 2.5 days (range 0 to 7 days) in 41 subjects.

In contrast to serum IgG levels observed with monthly IGIV treatment (rapid peaks followed by a slow decline), the serum IgG levels in subjects receiving weekly subcutaneous VivaglobinÃ?therapy were relatively stable in both studies.

CLINICAL STUDIES

The pivotal open-label, prospective, multicenter clinical study conducted in the United States and Canada evaluated the pharmacokinetics, efficacy, safety and tolerability of Immune Globulin Subcutaneous (Human), VivaglobinÃ? in adult and pediatric subjects with primary immune deficiency (PID). In this study, 65 adult and pediatric PID subjects previously treated monthly with IGIV were switched to weekly subcutaneous administrations of VivaglobinÃ? for 12 months. The per-protocol efficacy analysis included 51 subjects. Subjects received a weekly mean VivaglobinÃ? dose of 158 mg/kg body weight (range: 34 to 352 mg/kg), which was 136% (range: 99 to 188%) of their previous weekly-equivalent IGIV dose.

The annual rate of serious bacterial infections (defined as bacterial pneumonia, meningitis, sepsis, osteomyelitis, and visceral abscesses), the primary endpoint, was 0.04 infections per subject per year (one-sided upper 99% confidence interval: 0.14) for the per-protocol set (n = 51). Pneumonia was reported in two subjects. The annual rate of any infections, a secondary endpoint, was 4.4 infections per subject per year.

The IgG subclass levels observed in this study were consistent with a physiologic distribution pattern (mean values) IgG1: 703 mg/dL, IgG2: 278 mg/dL, IgG3: 36 mg/dL, and IgG4: 30 mg/dL.

Table 3 summarizes the dosing and annual rate of infections for the efficacy phase of this study.

Table 3: Dose and Annual Rate of Infections with VivaglobinÃ? Per-protocol Subjects Efficacy Phase of the US and Canada Study
Number of Subjects (Efficacy)
51
VivaglobinÃ? Dose
Mean % Previous IGIV Dose (range):
136% (99 188%)
Mean:
158 mg/kg b.w.
Range:
34 352 mg/kg b.w.
Annual Rate of Serious Bacterial
0.04 infections/subject
Infections:
year
Annual Rate of Any Infections:
4.4 infections /subject year
b.w.: body weight

Table 4 provides a summary of missed school or work and hospitalization due to infection, which were secondary endpoints.

Table 4: Summary of Secondary Efficacy Endpoints Per-protocol Subjects Efficacy Phase of the US and Canada Study
Number of Subjects
51
Total Number of Subject Days
18,949
Total Number of Days Missed School/Work Due to Infection (%)
192 (1.0%)
Annual Rate Missed School/Work Due to Infection (days/subject year)
3.7
Total Number of Days Hospitalized Due to Infection (%)
12 (<0.1%)
Annual Rate of Hospitalization (days/subject year)
0.23
Brand Name: Vivaglobin
Generic Name: Immune Globulin Subcutaneous (Human)

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