Hizentra An Alternative Therapy to IVIG for IVF-ET Patients

IVF - Hizentra

Recently, many patients have seen their IVIG claim denied by their insurance companies. Out of a permanent concern to help you getting the best care, we are trying to find new therapies with similar efficacy but with a higher cost effectiveness than IVIG.
In this blog, we will introduce you to Hizentra 20% (CSL Behring).
What is Hizentra?
Hizentra is a subcutaneous immunoglobulin therapy (SCIg) that patients can self-infuse after receiving proper training. The infusion can be provided at home with flexible dosing options, improving the quality of life and reducing global costs.
Is it safe?
Because Hizentra is delivered under your skin, there is no need to venous access. This brings a very good tolerability with limited side effects such as rash at the injection sites or fatigue and headaches.
A recent study in the USA and in the EU aiming to assess the long-term efficacy and tolerability of Hizentra in patients aged 4 to 69 years old, and suffering from primary immunodeficiency disease (genetic disorders in which patients are predisposed to recurrent infections, autoimmune disease, and malignancy) showed a favorable tolerability and efficacy (1).
Another retrospective study in lung-transplant patients showed that Hizentra is as efficient and as well tolerated as IVIG with a significant lower dose used (2).
Is it as effective as IVIG?
Recent in vitro studies showed comparable suppressive effects of Hizentra and IVIG on T cell proliferation with a significant decrease in key inflammatory cytokines such as TNFα, IFNΥ, IL17, IL1b or IL2 (3).
What are the advantages in comparison with IVIG?
Dosage
IVIG is usually administrated to a dose of 1g/kg every 3 weeks in pregnant women or women trying to conceive. Unfortunately, there is no data available on Hizentra use in pregnant women.
Nevertheless, literature in the organ transplant field provides us with some relevant information.
In a lung transplant study (2), the monthly effective dose of Hizentra 20% was 0.4gr/kg.
The Atlantic guidelines for the use of IVIG in solid organs transplant recommends the use of a monthly IVIG dose ranging from 0.5-2g/kg.
If we consider the median of 1g/kg/month based on the guidelines above, Hizentra is used at a dose 2.5 times lower than IVIG in this study.
Because Hizentra 20% is a concentrate solution in comparison with IVIG such as Gammagard 10%, it should be use at least at half the dosage of IVIG.
More stable IgG levels
As SCIG administration is more frequent (weekly or biweekly compared to every month for IVIG), it results in a more stable serum IgG levels compared with the characteristic peak of IVIG administration (4-5). The maintenance of a steady state IgG level may reduce the wear off effect reported toward the end of an IVIG dosing. Interestingly IgG levels were 18% higher with Hizentra compared to IVIG in primary immunodeficiency patients (6).
An every-2-week dose has been approved for CSL Behring’s Hizentra 20% and a recent study showed that a biweekly injection (volume 2X) gives the same result than a weekly injection (volume X) without changing the IgG peak and concentration (7).
Limited Nursing costs:
After a few training sessions (generally 1 or 2) with a healthcare provider, Hizentra can be self-administrated at home.
References:
1- Jolles S, Borte M, Nelson RP Jr, Rojavin M, Bexon M, Lawo JP, Wasserman RL. Long-term efficacy, safety, and tolerability of Hizentra® for treatment of primary immunodeficiency disease. Clin Immunol. 2014 Feb; 150(2):161-9.
2- Shankar T, Gribowicz J, Crespo M, Silveira FP, Pilewski J, Petrov AA. Subcutaneous IgG replacement therapy is safe and well tolerated in lung transplant recipients. Int Immunopharmacol. 2013 Apr; 15(4):752-5.
3- Issekutz AC, Rowter D, Miescher S, Käsermann F. Intravenous IgG (IVIG) and subcutaneous IgG (SCIG) preparations have comparable inhibitory effect on T cell activation, which is not dependent on IgG sialylation, monocytes or B cells. Clin Immunol. 2015 May 14; 160(2):123-132.
4- Jolles S, Sleasman JW. Subcutaneous immunoglobulin replacement therapy with Hizentra, the first 20% SCIG preparation: a practical approach. Adv Ther. 2011 Jul;28(7):521-33.
5- Hagan JB, Fasano MB, Spector S, Wasserman RL, Melamed I, Rojavin MA, Zenker O,Orange JS. Efficacy and safety of a new 20% immunoglobulin preparation for subcutaneous administration, IgPro20, in patients with primary immunodeficiency. J Clin Immunol. 2010 Sep; 30(5):734-45.
6- Jolles S, Bernatowska E, de Gracia J, Borte M, Cristea V, Peter HH, Belohradsky BH, Wahn V, Neufang-Hüber J, Zenker O, Grimbacher B. Efficacy and safety of Hizentra(®) in patients with primary immunodeficiency after a dose-equivalent switch from intravenous or subcutaneous replacement therapy. Clin Immunol. 2011 Oct; 141(1):90-102.
7- Landersdorfer CB, Bexon M, Edelman J, Rojavin M, Kirkpatrick CM, Lu J, Pfister M, Sidhu J. Pharmacokinetic modeling and simulation of biweekly subcutaneous immunoglobulin dosing in primary immunodeficiency. Postgrad Med. 2013 Nov; 125(6):53-61.
Source:  Dr. Braverman (RI)
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