First FDA-Approved Subcutaneous Ig for CIDP maintenance

CIDP Efficacy and Safety

Proven in the largest Ig clinical trial in CIDP and further evaluated in an extension study

CIDP Path Logo

Largest Ig Study in CIDP (n=172)

See the study design of PATH and the PATH Extension Study1,2

CIDP Pivotal Trial and Open-Label Extension Study Chart CIDP Pivotal Trial and Open-Label Extension Study Chart

The percentage of CIDP patients who relapsed or withdrew for any other reason during SCIg treatment was significantly lower with Hizentra than with placebo.1*

*

PATH Study Design: Data from a randomized, multicenter, double-blind, placebo-controlled, parallel-group, phase III study of 2 doses of weekly Hizentra versus placebo for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP)—the PATH Study. Subjects who relapsed during the post-randomization phase were to receive IVIg as a rescue medication within 1 week. CIDP relapse was defined as a ≥1-point increase in adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) score compared with baseline.

Extension Study Design: 48-week, open-label, prospective extension study to PATH. 82 patients were enrolled: 62 patients were started on 0.4 g/kg weekly infusion of Hizentra, and 20 patients were started on 0.2 g/kg weekly. If clinically stable, patients on 0.4 g/kg were switched to 0.2 g/kg after 24 weeks. Upon CIDP relapse on 0.2 g/kg dose, 0.4 g/kg was either initiated or reinitiated. CIDP relapse defined as a ≥1-point increase in adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) score compared with baseline.

Dosing

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Administration

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Administration guidance
References: 1. van Schaik IN, Bril V, van Geloven N, et al. Subcutaneous immunoglobulin for maintenance treatment in chronic inflammatory demyelinating polyneuropathy (PATH): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Neurol. 2018;17(1):35-46. 2. van Schaik IN, Orell M, Bril V, et al. Long-term safety and efficacy of subcutaneous immunoglobulin IgPro20 in CIDP. Neurol Neuroimmunol Neuroinflamm. 2019;6:e590.
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