Summary

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• This summary is based on the review of one randomized controlled trial(s). ^[1]
• The primary efficacy outcome was achieved with an unadjusted serious bacterial infection (SBI) rate of 0.01 per subject-year and an adjusted rate of 0.015 per subject-year, with the upper limit of the one-sided 99% confidence interval at 0.151; only one adult patient experienced an SBI.
• Secondary efficacy outcomes, including infection-related endpoints, supported the effectiveness of BT595 (Yimmugo) in the study population of 67 patients with primary immunodeficiency diseases, aged 2 to <76 years. 4. 8% of infusions were associated with one or more infusional adverse events (AEs) occurring during or within 72 hours post-infusion. Specific AEs included headache (2.4%), fatigue (0.9%), and nausea (0.5%). No AEs were reported at infusion rates greater than 4.0 ml/kg/h.
• The severity, frequency, and patterns of treatment-emergent adverse events were consistent with the established safety profile for intravenous immunoglobulins (IVIgs), with no clinically relevant differences in safety outcomes across age groups.
• The study included 67 patients aged 2 to <76 years, with 49 adults and 18 children; no clinically relevant differences in safety outcomes were observed between age groups, and efficacy outcomes did not indicate significant differences between adult and pediatric populations.