Subcutaneous immunoglobulin for maintenance treatment in chronic inflammatory demyelinating polyneuropathy – A multicenter, randomized, double-blind, placebo-controlled trial: The PATH Study

Department of Neurology, Academic Medical Centre, University of Amsterdam, Meibergdreef 9, 1105, AZ, Amsterdam, the Netherlands. Department of Medicine (Neurology), University Health Network, University of Toronto, Toronto, Canada. Department of Biostatistics and Bioinformatics, Leiden University Medical Center, Leiden, the Netherlands. Department of Neurology, Heinrich Heine University, Dusseldorf, Germany. Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, CA, USA. Department of Neurology, Nagoya University Graduate School of Medicine, Nagoya, Japan. CSL Behring, Marburg, Germany and King of Prussia, PA, USA. CSL Behring, Marburg, Germany and King of Prussia, PA, USA. CSL Behring, Marburg, Germany and King of Prussia, PA, USA. Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Department of Neurology, Maastricht University Medical Center, Maastricht, the Netherlands. University of Kansas Medical Center, Kansas City, KS, USA.

Muscle & Nerve. 2017;56 Suppl 1:S1-S16

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INTRODUCTION Patients with chronic inflammatory demyelinating polyneuropathy (CIDP) often require long-term intravenous immunoglobulin (IVIG) maintenance therapy. Subcutaneous immunoglobulin (SCIG) offers an alternative administration option with anticipated improvements in patient quality of life, convenience, and flexibility. OBJECTIVES To evaluate IgPro20 (SCIG) as a maintenance treatment in CIDP. METHODS A randomized, double-blind trial in CIDP patients (n=172) investigated 0.2 and 0.4 g/kg weekly doses of IgPro20 versus placebo. The primary outcome was percentage of patients with CIDP relapse/withdrawal during 24-weeks of treatment determined by Inflammatory Neuropathy Cause and Treatment score. Secondary endpoints included grip strength and patient satisfaction. RESULTS Both IgPro20 doses significantly reduced rate of CIDP relapse/withdrawal versus placebo. Grip strength remained stable with Hizentra(R), but deteriorated with placebo. Most subjects preferred SCIG over IVIG. Local reactions, reported in 33% of IgPro20-treated patients, were mild or moderate in intensity. CONCLUSION IgPro20 is efficacious and well-tolerated as maintenance treatment in CIDP. This article is protected by copyright. All rights reserved.
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Language : English
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