First and Only 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

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Largest Ig Study in CIDP (n=172)

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

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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.


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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.

View information about Hizentra for:


primary immunodeficiency


chronic inflammatory demyelinating polyneuropathy

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