Conclusions
PIDs
fSCIG 20%, both warmed and unwarmed, was well-tolerated and had a favorable safety profile at doses of up to 1 g/kg/infusion and infusion rates of up to 300 mL/h/site. There were no substantial differences between treatment arms in tolerability, TEAEs, or immunogenicity, suggesting minimal impact of in-line warming of IgG 20% on the tolerability and safety profile of fSCIG 20%. The pharmacokinetics, safety, tolerability, and immunogenicity of unwarmed fSCIG 20% will be further investigated in patients with PIDs.