Secondary endpoints | Events per patient, mean (range) |
|---|---|
Number of days absent from work or school | 5 (0–22) |
Number of days hospitalised | 0.3 (0–6) |
Number of physician or emergency room visits | 2 (0–11) |
Primary Immunodeficiency (PID)
)
PID refers to a large heterogeneous group of disorders that result from mostly inherited defects in the development and/or function of the immune system.1
Almost 500 different PIDs have been described so far, with more than 6 million people affected around the world.2
Around 60% of all PID cases are associated with hypogammaglobulinemia due to impaired antibody production.3
IVIg replacement therapy can help address the key needs of patients with PIDs, such as:
↓ number of severe infections4,5
↓ days of antibiotic use4
↓ rate and duration of hospitalisation4,5
↑ quality of life5,6
Proven efficacy in preventing serious infections
In a multicentre, open-label clinical trial, octagam®5% helped to prevent serious infections for patients with PID. An incidence of only 0.1 serious infections per patient per year was observed*.7 This is well below the FDA requirement of ≤1 serious infection per patient per year for demonstrating prevention of infection.7
Only 0.1 serious infections per patient per year
Study details | |
|---|---|
Number of patients | 46 |
Days in the study/patient, mean (range) | 345 (170–393) |
Number of infusions | 654 |
Dosing of octagam®5% received | 400–600 mg/kg every 28 days or 300–450 mg/kg every 21 days |
*There were five serious infections in three patients: pneumonia (1), bacteraemia (2), and ‘bacteraemia or sepsis’ (2).7
:quality(80))
Proven tolerability7
Most adverse events were not related to the study medication, and were mild to moderate in severity.7
:quality(80))
Most common related adverse events (AEs) ⁷ | Number of patients, n (%) | Number of related AEs, n (%) |
|---|---|---|
Headache | 7 (15) | 18 (25) |
Nausea | 3 (6) | 4 (6) |
Chills | 2 (4) | 5 (7) |
Back pain | 2 (4) | 2 (3) |
Chest pain | 2 (4) | 2 (3) |
Injection site reactions | 2 (4) | 2 (3) |
References
McCusker C, et al. Allergy Asthma Clin Immunol 2018;14:61;
Tangye SG, et al. J Clin Immunol 2022;42:1473–1507;
Krivan G, et al. Am J Clin Exp Immunol 2017;6:76–83; I
Modell V, et al. Immunol Res 2011;51:61–70;
Wood P. Ther Clin Risk Manag 2012;
Espanol T, et al. Patient Prefer Adherence 2014;
Ochs HD and Pinciaro PJ. J Clin Immunol 2004;24:309–14.
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IMPORTANT: The information on this website is based on the European Summary of Product Characteristics (EU SmPC).
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