Treatment and Dosing
autoimmune neuromuscular diseases, PIDs
MULTIFOCAL MOTOR NEUROPATHY, CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY
After admission to the clinic on day − 1 of the study, participants received a single dose of fSCIG 20% on day 1 of the study treatment period, comprising 80 U/g of rHuPH20 and IgG 20%. Different doses of fSCIG 20% were administered in the different treatment arms: in treatment arm 1, IgG 20% was administered at a dose of 0.4 g/kg with in-line warming; in treatment arm 2, IgG 20% was administered at a dose of 1.0 g/kg with in-line warming; and in treatment arm 3, IgG 20% was administered at a dose of 1.0 g/kg with no warming. In all participants, fSCIG 20% was administered using a gradual ramp-up of infusion rates at 10-min intervals. The doses selected aimed to cover the potential dose range for multiple indications for fSCIG 20%. The lower dose of 0.4 g/kg was a representative dose for PIDs, and the higher dose of 1.0 g/kg was representative of dosing levels required for autoimmune neuromuscular diseases (such as chronic inflammatory demyelinating polyradiculoneuropathy or multifocal motor neuropathy, for the treatment of which a fSCIG 10% therapy is under investigation) [A sequential and sentinel dosing design was used as a precaution to ensure optimal tolerability and safety (Fig. 