A Multi‑Center, Open‑Label, Single‑Arm Trial to Evaluate the Efficacy ...
A study on 61 subjects with primary immunodeficiency evaluated the efficacy, pharmacokinetics, and safety of IGSC 20% for IgG replacement. The SBI rate was 0.017 per person per year, with a 99% upper confidence limit of 0.036. Mean trough IgG concentrations were comparable to previous regimens. Seven subjects had serious TEAEs, none drug-related. IGSC 20% was well tolerated, with a safety profile similar to IGIV-C 10%.
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A study on 61 subjects with primary immunodeficiency evaluated the efficacy, pharmacokinetics, and safety of IGSC 20% for IgG replacement. The SBI rate was 0.017 per person per year, with a 99% upper confidence limit of 0.036. Mean trough IgG concentrations were comparable to previous regimens. Seven subjects had serious TEAEs, none drug-related. IGSC 20% was well tolerated, with a safety profile similar to IGIV-C 10%.