Introduction
autoimmune neuromuscular diseases, primary immunodeficiency diseases, PIDs
MULTIFOCAL MOTOR NEUROPATHY, CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY, ADVERSE REACTIONS, SECONDARY
Immunoglobulin therapies are used to treat various medical conditions, including primary immunodeficiency diseases (PIDs) and autoimmune neuromuscular diseases such as chronic inflammatory demyelinating polyradiculoneuropathy or multifocal motor neuropathy [Compared with IVIG, SCIG is associated with fewer systemic adverse reactions and can be self-administered at home instead of at a clinic or hospital by a healthcare professional [Various strategies have been adopted to mitigate the limitations associated with conventional SCIG treatment. Hyaluronidase-facilitated subcutaneous immunoglobulin 10% (fSCIG 10%; HyQvia/HYQVIA; Baxalta US, Inc., a member of the Takeda group of companies, Lexington, MA, USA) is an infusion of human immunoglobulin G (IgG) 10% and recombinant human hyaluronidase (rHuPH20) [Given that many patients with PIDs require lifelong treatment, the development of new therapies that allow for greater treatment individualization and increased convenience is anticipated to offer meaningful patient benefit (such as through potentially decreased infusion times) and improve the overall patient treatment experience [This phase 1, open-label study investigated the tolerability, safety, and immunogenicity of warmed and unwarmed fSCIG 20% at various infusion rates in healthy adults. The primary objective was to assess the tolerability of fSCIG 20%; assessing the safety and immunogenicity of fSCIG 20% were secondary objectives.