Infusions with AEs (n=20,642) | Patients with AEs n, (%) | |
|---|---|---|
CLL | 48/8,584 (0.56%) | 45/728 (6.2%) |
MM | 29/2,949 (0.98%) | 27/339 (8.0%) |
Bone marrow transplantation | 23/3,739 (0.62%) | 21/566 (3.7%) |
Other SID | 29/537 (0.54%) | 27/776 (3.5%) |
SID overall | 129/20,642 (0.62%) | 120/2,409 (5.0%) |
Secondary Immunodeficiency (SID)
)
Octagam® helps to prevent infections in patients who are immune compromised following secondary causes.1,2
Secondary immune deficiencies (SID) are caused by varied mechanisms and are common in patients with haematological malignancies such as chronic lymphocytic leukaemia (CLL) and multiple myeloma (MM). In addition, haematopoietic stem cell transplantation (HSCT) may be associated with secondary immunodeficiency.3-5
Both the underlying disease and its treatment, e.g. B-cell targeting therapy, contribute to the development of secondary antibody deficiency. Infections remain a major cause of morbidity and mortality. Patients with severe and long-lasting disease are at greater risk.3-5
As it has been shown for primary immunodeficiencies, studies indicate a clinical benefit of immunoglobulin therapy (IgG) as a treatment for secondary immunodeficiency. Thus, guidelines are in support of considering immunoglobulin replacement therapy in selected patients with secondary antibody deficiency.3-8
Disease distribution of patients enrolled in observational studies of octagam® in SID9
*NOS: not otherwise specified
(n=1,368)
Most patients (78.5–84.5%) had a favourable outcome with octagam® regarding infection frequency, severity and duration, as well as antibiotic use.* 10
*This was a post-authorisation analysis of observational, multicentre, open-label trials studying 2,397 immune compromised patient, of which 1,368 had SID.10 Patients with SID received on average 0.2 g/kg body weight per infusion of either octagam®10%.10 The median dose interval was 4.1 weeks.10
Octagam® is well tolerated in SID patients
A 10-year observational study has demonstrated that octagam® is well tolerated in routine clinical use.11
Frequency of adverse events (AEs) in a 10-year study11
In observational studies including patients with hematological malignancies the tolerability of octagam® was very well demonstrated.10
Number of SID patients | 1,368 |
Number of infusions in SID patients | 11,348 |
Percent of infusions in SID patients with ADRs | 1.0 |
In a multicentre, non-interventional safety study including 3,846 patients with SID who received 69,320 IVIG infusions, AEs were reported in 9.4% of patients and in 0.6% of infusions. The majority of AEs were non-serious, with the most frequent being chills, back pain, and pruritus for IVIG 5%, and chills, nausea, pyrexia, and rash for IVIG 10%.12
Patients with AEs: 362/3,846 (9.4%)12
Infusions with AEs: 419/69,320 (0.60%)12
Visit our website to learn more about SID
References
Octagam®5%. Summary of Product Characteristics. July 2024.
Octagam®10%. Summary of Product Characteristics. July 2024.
Patel, S. et al., S. Frontiers in Immunology 2019; 10: 33
Tadmor, T. et al, Expert Rev Hematol. 2018; 11 (1): 57-70
Perez, E. et al., J Allergy Clin Immunol. 2017; 139:S1
Benbrahim, O. et. al., Hematology 2018; 24(1): 173-182
Vacca, A. et al., Clinical Immunology 2017; 191: 110-115
Guideline EMA/CHMP/BPWP/94038/2007 rev. 6
Svorc D et al. Poster presented at ESID, September 11-17 2017, Edinburgh.
Frenzel W, et al. Int J Clin Pharmacol Ther. 2016;54(11):847-855.
Debes A, et al. Pharmacoepidemiol Drug Saf. 2007;16(9):1038-1047.
Habier A, et al. Hemasphere. 2023;7(Suppl):e2043884
This is an international website for octagam® and is intended for healthcare professionals outside the US. The information on this site is not country-specific and may contain information that is outside the approved indications in the country in which you are located.
IMPORTANT: The information on this website is based on the European Summary of Product Characteristics (EU SmPC).
If you wish to contact Octapharma please use the contact form on our corporate website www.octapharma.com.
