Tolerability and safety of intravenous immunoglobulins (5% and 10%) for the treatment of patients with secondary immunodeficiencies – Final subgroup results of a non-interventional safety study

Hematological diseases and/or its immunosuppressive treatments can cause secondary immunodeficiencies (SID). In case of recurrent infections and hypogammaglobulinemia, replacement therapy with intravenous immunoglobulins (IVIG) may reduce the risk of infections and irreversible complications.
The tolerability and efficacy of a 5% and 10% IVIG preparation was examined by a subgroup analysis focused on SID patients.
From 2014 to 2019 a multicenter, non-interventional safety study was conducted in 229 in- and outpatient centers throughout Germany to evaluate the efficacy and tolerability of two IVIG products (5% and 10%) in routine clinical practice. Results:
In this subgroup analysis a total of 3,846 patients with SID were analyzed who received 69,320 IVIG infusions. The most common diseases included chronic lymphocytic leukemia (CLL, 36.1%), non-hodgkin lymphoma (NHL, 21.9%) and multiple myeloma (MM, 12.8%). Further 20.7% received a stem cell transplantation (BMT) in the past. Of these patients, 1,927 were treated with IVIG 5%, 1,749 with IVIG 10% and 170 with both products. The patients received a median dose of 0.24 g/kg body weight (BW) per treatment cycle every 4.3 weeks. The number of SID patients with infections decreased from 66.9% at baseline to 40.2% at the last follow-up documentation while the mean IgG levels increased from 6.5 g/l at baseline to 7.4 g/l within the first three months.
In total, adverse drug reactions (ADR) were reported in 419 out of 69,320 infusions (0.60%) in 9.4% of the SID patients. 7.5% of the patients treated with IVIG 5% and 11.5% treated with IVIG 10% experienced at least one ADR. Serious ADRs were rare and reported for 0.9% (IVIG 5%) and 1.5% (IVIG 10%) of the patients. Conclusion:
This subgroup analysis shows that both IVIG products (5% and 10%) are well tolerated and effective in patients with hematological malignancies associated with SID.

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