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

StudyImmunotherapy· Aug 2026

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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Allergy & ImmunologyStudyTreatmentQ3IF 2.1

Under half of patients had a drug-related adverse event, most mild or moderate.

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

Roberto Crea … Chaim M Roifman

Immunotherapy · Aug 2026 · Q3 in Immunology & Allergy

Purpose

This report presents safety and tolerability data from a phase III study.

Methods

This was an open-label, prospective, single-arm, historically controlled, multicenter study in adults with confirmed primary immunodeficiency receiving commercially available IVIg products.

n = 30 participants

Results

nearly half had a side effect from the drug, mostly mild or moderate

Any TEAE

97.9%

Drug-related TEAE

46.8%

More results

Forty-seven participants received KIg10 every 21 days ( n = 8) or every 28 days ( n = 39).

Across 80 infusions, 122 infusional AEs occurred in 30 participants (63.8%); infusional AEs decreased with later versus initial infusions.

A drug-related hypersensitivity event (skin reaction) occurred in 1 participant.

More results

Forty-four (93.6%) participants reached the maximum dose rate (8 mg/kg/min).

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Conclusion

KIg10 was well tolerated in adults with primary immunodeficiency, supporting its use as a replacement therapy option in this population.

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

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

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