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Long-term safety and efficacy of subcutaneous immunoglobulin IgPro20 in CIDP: PATH extension study
Ivo N van Schaik1, Orell Mielke1, Vera Bril1
1Department of Neurology (I.N.S.), Amsterdam University Medical Centers, University of Amsterdam, The Netherlands; Spaarne Gasthuis (I.N.S.), Haarlem, The Netherlands; CSL Behring (O.M., M.P., B.L.D.), Marburg, Germany and King of Prussia, PA; Department of Medicine (Neurology) (V.B.), University Health Network, University of Toronto, Canada; Medical Statistics (N.G.), Department of Biomedical Data Sciences, Leiden University Medical Center, The Netherlands; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich Heine University, Düsseldorf, Germany; Department of Neurology (R.A.L.), Cedars-Sinai Medical Center, Los Angeles, CA; Department of Neurology (G.S.), Nagoya University Graduate School of Medicine, Japan; Department of Neurology (D.R.C.), Johns Hopkins University School of Medicine, Baltimore, MD; and Department of Neurology (I.S.J.M.), Maastricht University Medical Center, The Netherlands.
Objective:
To investigate the long-term safety and efficacy of weekly subcutaneous IgPro20 (Hizentra, CSL Behring) in chronic inflammatory demyelinating polyneuropathy (CIDP).
Methods:
In a 48-week open-label prospective extension study to the PATH study, patients were initially started on 0.2 g/kg or on 0.4 g/kg weekly and-if clinically stable-switched to 0.2 g/kg weekly after 24 weeks. Upon CIDP relapse on the 0.2 g/kg dose, 0.4 g/kg was (re)initiated. CIDP relapse was defined as a deterioration by at least 1 point in the total adjusted Inflammatory Neuropathy Cause and Treatment score.
Results:
Eighty-two patients were enrolled. Sixty-two patients initially received 0.4 g/kg, 20 patients 0.2 g/kg weekly. Seventy-two received both doses during the study. Sixty-six patients (81%) completed the 48-week study duration. Overall relapse rates were 10% in 0.4 g/kg-treated patients and 48% in 0.2 g/kg-treated patients. After dose reduction from 0.4 to 0.2 g/kg, 51% (27/53) of patients relapsed, of whom 92% (24 of 26) improved after reinitiation of the 0.4 g/kg dose. Two-thirds of patients (19/28) who completed the PATH study without relapse remained relapse-free on the 0.2 g/kg dose after dose reduction in the extension study. Sixty-two patients had adverse events (AEs) (76%), of which most were mild or moderate with no related serious AEs.
Conclusions:
Subcutaneous treatment with IgPro20 provided long-term benefit at both 0.4 and 0.2 g/kg weekly doses with lower relapse rates on the higher dose. Long-term dosing should be individualized to find the most appropriate dose in a given patient.
Classification Of Evidence:
This study provides Class IV evidence that for patients with CIDP, long-term treatment with SCIG beyond 24 weeks is safe and efficacious.
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