ArticleInternational journal of clinical pharmacology and therapeutics2026
Novel intravenous human IVIG in patients with secondary immunodeficiency: Interim analysis of a multicenter, prospective, non-interventional study.
Article in International journal of clinical pharmacology and therapeutics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
objectiveTo 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
methodsThis 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.
resultsA 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.
conclusionThis interim analysis shows that the risks are minor compared to the benefits of this novel IVIG preparation in the management of SID.
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