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Maintaining Steady-state IgG Levels

Avoid the high peaks and low troughs associated with IV therapy1

Multicenter, open-label, prospective clinical studies in North America and Europe have compared serum immunoglobulin (Ig) levels in patients receiving subcutaneous (Sub-Q) Vivaglobin® therapy or intravenous immunoglobulin (IVIg) therapy.

Vivaglobin® avoids the high peaks and low troughs associated with serum IgG levels in patients receiving intravenous (IV) therapy. With IVIg therapy, serum IgG levels rise sharply during administration and drop off until the next infusion, which typically occurs 3 to 4 weeks later. By contrast, Sub-Q Ig administration results in stable, steady-state serum IgG levels. Consequently, it may eliminate the “wear off” effects experienced by some patients.

Summary of additional pharmacokinetic parameters

  • Serum IgG levels observed in monthly IVIg infusions show rapid peaks followed by slow declines
  • Serum IgG levels observed in subjects receiving Sub-Q Vivaglobin® infusions were relatively stable
* In clinical trials, the weekly Vivaglobin® dose was adjusted as 137% of the average weekly IVIg dose to achieve equivalent effect.

Weekly administration of Vivaglobin® leads to steady-state serum Ig levels

Vivaglobin® administration achieves consistent, stable, steady-state serum IgG levels and consistent protection against infection when administered on a weekly basis. This serum IgG profile is more similar to that found in the healthy population.

In addition, Sub-Q Ig therapy sustains higher serum IgG trough levels than IVIg. In other words, studies have shown that the nadir of serum IgG levels in Sub-Q Ig therapy is greater (ie, at a higher level) than that with IV administration.

Mean serum IgG levels

  • Weekly administration leads to stable, steady-state serum IgG levels and consistent protection against infection1,3
  • Sub-Q Ig therapy sustains higher trough levels than IVIg4
  • Sub-Q administration maintains steady-state IgG levels without “wear off” effects1,4

References:

  1. Ochs HD, Gupta S, Kiessling P, et al. Safety and efficacy of self-administered subcutaneous immunoglobulin in patients with primary immunodeficiency diseases.J Clin Immunol. 2006;26:265-273.
  2. Waniewski I, Gardulf A, Hammarström L. Bioavailability of gamma-globulin after subcutaneous infusions in patients with common variable immunodeficiency. J Clin Immunol. 1994;14(2):90-7.
  3. Berger M, Ochs H, and CE1200 Investigators. Conversion from intravenous to subcutaneous immunoglobulin therapy: relationship between dose, serum trough IgG concentration and infection rate in patients with primary immune deficiency diseases. J Allergy Clin Immunol. 2006;117(suppl):S109.
  4. Gardulf A, Nicolay U, Asensio O, et al. Rapid subcutaneous IgG replacement therapy is effective and safe in children and adults with primary immunodeficiencies—a prospective, multi-national study. J Clin Immunol. 2006;26:177-185

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