Abstract
Intravenous immunoglobulin (IVIg) is well-established in the treatment of patients with chronic inflammatory demyelinating polyneuropathy (CIDP). Immune globulin subcutaneous (human) 20% liquid (Hizentra®; referred to as IgPro20 hereafter) has recently been approved in a number of countries, including the USA and those of the EU, as maintenance therapy in patients with CIDP. In the pivotal phase III PATH trial in adults with CIDP who were first stabilized on IVIg therapy, maintenance therapy with IgPro20 for 24 weeks significantly reduced CIDP relapse or study withdrawal rates versus placebo. Efficacy was sustained during ≤ 48 weeks of additional treatment with IgPro20 in the open-label PATH extension study. IgPro20 was generally well tolerated, with low rates of systemic adverse events (AEs); the most common AEs were local reactions (e.g. infusion-site erythema, infusion-site swelling). In PATH, more than one-half of IgPro20 recipients preferred this therapy to their previous IVIg therapy. IgPro20 offers a convenient alternative to IVIg with a better systemic AEs profile and thus extends the options for maintenance therapy in CIDP.
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During the peer review process, the manufacturer of IgPro20 was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.
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The preparation of this review was not supported by any external funding.
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Yvette Lamb, Yahiya Syed and Sohita Dhillon are salaried employees of Adis International Ltd/Springer Nature, are responsible for the article content and declare no relevant conflicts of interest.
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The manuscript was reviewed by:I. Beuchat, Neurologie, Centre Hospitalier Universitaire Vaudois, Switzerland; M. Jakaria, Applied Life Science, Konkuk University, Chungju, South Korea; M. G. Şenol, Department of Neurology, School of Medicine, Health Sciences University, Uskudar, Istanbul, Turkey.
Additional information for this Adis Drug Evaluation can be found at https://doi.org/10.6084/m9.figshare.8940242.
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Lamb, Y.N., Syed, Y.Y. & Dhillon, S. Immune Globulin Subcutaneous (Human) 20% (Hizentra®): A Review in Chronic Inflammatory Demyelinating Polyneuropathy. CNS Drugs 33, 831–838 (2019). https://doi.org/10.1007/s40263-019-00655-x
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DOI: https://doi.org/10.1007/s40263-019-00655-x