Abstract

Objective: To evaluate the effectiveness, safety, and tolerability of Yimmug, a novel, highly purified, 10% human plasma-based intravenous immunoglobulin (IVIG) preparation, in patients with secondary immunodeficiency (SID) under real-world conditions.
Materials and methods: This interim analysis is based on data from a multicenter, prospective, non-interventional study conducted with out-patients in Germany. Effectiveness was assessed by changes in (i) serum IgG levels, (ii) severe infection rates, (iii) clinical symptoms, and (iv) patient-reported quality of life (QoL) at three treatment intervals (after 3, 12, and 24 IVIG infusions) compared to baseline. Safety was evaluated through documentation of adverse events (AEs), including adverse drug reactions (ADRs), while tolerability was assessed by investigators.
Results: A total of 119 SID patients received 726 IVIG infusions at a median (IQR) dose of 0.3 (0.2 – 0.3) g/kg over a median (IQR) duration of 1.4 (0.4 – 2.9) years, with a median interval of 30.1 days between infusions. Serum IgG trough levels increased, with the proportion of patients achieving IgG ≥ 6 g/L rising from 30.3% at baseline to 66.7% after both 12 and 24 infusions. The mean annual rate of infections requiring antibiotics decreased from 2.3 at baseline to 0.0 after 3 and 12, and to 0.4 after 24 infusions, respectively. The new IVIG was well tolerated, and patients’ clinical symptoms and QoL improved during treatment. AEs were reported in 20 (16.8%) patients, with 41 events in total, while ADRs occurred in 9 (7.6%) patients, with 16 events. Serious AEs (SAEs) occurred in 4 (3.4%) patients, involving 5 events, but no serious ADRs (SADRs) were reported.
Conclusion: This interim analysis shows that the risks are minor compared to the benefits of this novel IVIG preparation in the management of SID.

Author Details

Authors

• Artur Bauhofer¹
• Silke Aigner¹
• Stephan Borte²

Departments

• ¹ Biotest, Dreieich, and
• ² Immune Defect Center, Clinic St. Georg, Leipzig, Germany

Address

Prof. Dr. Artur Bauhofer
Biotest
Landsteinerstr. 5
63303 Dreieich, Germany
Email: [email protected]

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