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August 7, 2026Immunotherapy

Safety and tolerability of a new intravenous immunoglobulin 10% in patients with primary immunodeficiency

Roberto Crea Elena Perez Chaim M. Roifman

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Key Points

The aim is to assess the safety and tolerability of a new intravenous immunoglobulin treatment in adults with primary immunodeficiency.
Open-label, prospective, single-arm, historically controlled multicenter study
Participants received KIg10 at 200-800 mg/kg every 21 or 28 days
Total of 17 or 13 infusions were administered
30 participants experienced 122 infusion-related adverse events (63.8%), mostly mild or moderate
No serious or life-threatening drug-related adverse events were reported
93.6% of participants reached maximum infusion rate of 8 mg/kg/min

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Implication

Shows good tolerability of Kedrion IVIg 10% in adults with primary immunodeficiency, implying its potential as a therapy.

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Cite This Study

Crea et al. (2026) studied this question.

synapsesocial.com/papers/6a782d4e2e1896536c840435 https://doi.org/10.1080/1750743x.2026.2706964

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Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

1Clinical Evaluation of Pharmacokinetics, Efficacy, and Safety of a 10% Immunoglobulin in Primary Immunodeficiency Disease (CARES10 Study)Human Clinical Trial · 2026 · 1 citations
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3Intravenous Immunoglobulin 10% in Children with Primary Immunodeficiency DiseasesCohort Study · 2018 · 11 citations
4Novel intravenous human IVIG in patients with secondary immunodeficiency: Interim analysis of a multicenter, prospective, non-interventional studyHuman Clinical Trial · 2026
5A Multicentre Study on the Efficacy, Safety and Pharmacokinetics of IqYmune®, a Highly Purified 10% Liquid Intravenous Immunoglobulin, in Patients with Primary Immune DeficiencyCohort Study · 2017 · 13 citations