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About Primary Immunodeficiency (PI) Disease

Patients with PI are at risk of infections and further complications

Primary immunodeficiency (PI), often referred to as inborn errors of immunity (IEIs), is a class of inherited genetic disorders that causes an individual to have a deficient or absent immune system due to either a lack of necessary antibodies or a failure of these antibodies to function properly.

PI patients are more vulnerable to infections and more likely to suffer complications from these infections. As patients suffering from PI lack a properly functioning immune system, they typically receive monthly, outpatient infusions of intravenous immunoglobulin (IVIG) therapy. Without this exogenous antibody immune support, these patients would be susceptible to a wide variety of infectious diseases.

PI has an estimated prevalence of 1:1200 in the United States, or approximately 250,000 people. There are over 550 different presentations of PI.

The 10 warning signs of primary immunodeficiency1

1
Four or more new ear infections within 1 year
2
Two or more serious sinus infections within 1 year
3
Two or more months on antibiotics with little effect
4
Two or more pneumonias within 1 year
5
Failure of an infant to gain weight or grow normally
6
Recurrent, deep skin or organ abscesses
7
Persistent thrush in mouth or fungal infection on skin
8
Need for intravenous antibiotics to clear infections
9
Two or more deep-seated infections, including septicemia
10
A family history of PI

Despite Decades of IG use, Improved Therapies Still Needed

In a 40-year study of 473 patients with PI on standard IVIG ² ³

90%
Experiences recurrent respiratory tract infection
11%
Developed bronchiectasis
29%
Developed chronic lung disease

Significant unmet need exists in PI patients refractory to standard IG that continue to experience recurrent respiratory infection and chronic lung disease

Risk factors for infection in PI

Leading the way with innovative immune globulin products

ADMA Biologics is an end-to-end commercial biopharmaceutical company leading a new age of manufacturing, marketing, and commercializing specialty plasma-derived products for the prevention and treatment of infectious diseases in the immune compromised and other patients at risk for certain infections. Our devotion to these underserved populations fuels us, and our hands-on approach to production and development sets us apart.

With three FDA-licensed approved products, including ASCENIV™ (Immune Globulin Intravenous, Human – slra), BIVIGAM® (Immune Globulin Intravenous, Human), and NABI-HB® (Hepatitis B Immune Globulin, Human), ADMA’s mission is to continue to successfully develop and commercialize plasma-derived, human immune globulins targeted to specific patient populations for the treatment and prevention of certain infectious diseases and management of immune compromised patient populations.

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Recurrent pulmonary infections
Excessive use of antibiotics
History of infection
Asthma/COPD
Chronic sinusitis
Bronchiectasis
Age
Environmental factors

ADMA is a champion for the PI patient

Through tailored plasma pool compositions, we pledge to continue developing therapies that make a difference to PI patients. We remain committed to doing everything we can to meet their treatment needs. 

COPD=chronic obstructive pulmonary disease.


Reference:
  1. McCusker C, Upton J, Warrington R. Primary immunodeficiency. Allergy Asthma Clin Immunol. 2018;14(suppl 2):61. doi:10.1186/s13223-018-029.
  2. Resnick ES, Moshier EL, Godbold JH, Cunningham-Rundles C. Morbidity and mortality in common variable immune deficiency over 4 decades. Blood. 2012;119(7):1650-1657. doi:10.1182/blood-2011-09-377945
  3. Jolles S. Subclinical infection and dosing in primary immunodeficiencies. Clin Exp Immunol. 2014;178 Suppl 1(Suppl 1):67-69. doi:10.1111/cei.12516
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