Subcutaneous immunoglobulin for maintenance treatment in chronic inflammatory demyelinating polyneuropathy - A multicenter, randomized, double-blind, placebo-controlled trial: The PATH Study
Muscle & Nerve Aug 25, 2017
van Schaik IN, et al. – This multicenter, randomized, double–blind, placebo–controlled trial was performed to assess IgPro20 subcutaneous immunoglobulin (SCIG) as a maintenance treatment in chronic inflammatory demyelinating polyneuropathy (CIDP). As maintenance treatment, IgPro20 was efficacious and well–tolerated in CIDP.
Methods- The physicians conducted a randomized, double-blind trial in CIDP patients (n=172) investigated 0.2 and 0.4 g/kg weekly doses of IgPro20 vs. placebo.
- Percentage of patients with CIDP relapse/withdrawal during 24-weeks of treatment determined by Inflammatory Neuropathy Cause and Treatment score was the primary outcome.
- Grip strength and patient satisfaction were included as secondary endpoints.
- The physicians found that both IgPro20 doses significantly reduced rate of CIDP relapse/withdrawal vs. placebo.
- With Hizentra, grip strength remained stable, but deteriorated with placebo.
- Over IVIG, most subjects preferred SCIG.
- In intensity, local reactions were mild or moderate, reported in 33% of IgPro20-treated patients.
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