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)
Octagam® efficacy for PID
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*.6 This is well below the FDA requirement of ≤1 serious infection per patient per year for demonstrating prevention of infection.6
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 (one), bacteraemia (two), and ‘bacteraemia or sepsis’ (two). 6
The most common ADRs from this study are shown below. No serious adverse events were connected to treatment with octagam®5%*.7
Most common ADR | Number of patients, n (%) | Number of ADRs, 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) |
Study 1 ¹¹ | Study 2 ²* | |
|---|---|---|
Number of patients | 117† | 193 |
Number of infusions | 867 | 4,613 |
Percentage of patients with ADRs | Not specified | 8.3% |
Percentage of infusions with ADRs | 1.4% | 0.5% |
Prospective observational studies demonstrate the tolerability of octagam®5%.
*The PID cohort is a subgroup of patients analysed in this study.
†Not all patients received octagam®.11
References
1. Frenzel W, et al. Tolerability and safety of octagam® (IVIG): a post-authorization safety analysis of four non-interventional phase IV trials. Int J Clin Pharmacol Ther. 2016;54(11):847-855.
2. Debes A, et al. Tolerability and safety of the intravenous immunoglobulin octagam®: a 10-year prospective observational study. Pharmacoepidemiol Drug Saf. 2007;16(9):1038-1047.
6. Ochs HD et al. octagam®5%, an intravenous IgG product, is efficacious and well tolerated in subjects with primary immunodeficiency diseases. J Clin Immunol. 2004; 24(3): 309-314.
7. Wietek S et al. Tolerability and safety of the intravenous immunoglobulin octagam®10% in patients with immune thrombocytopenia: a post-authorisation safety analysis of two non-interventional phase IV trials. Hematololgy. 2017; 1-6.
11. Bichuetti-Silva DC, et al. Immediate infusion-related adverse reactions to intravenous immunoglobulin in a prospective cohort of 1765 infusions. Int Immunopharmacol. 2014;23(2):442–446.
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