Long-term safety and efficacy of subcutaneous immunoglobulin IgPro20 in CIDP: PATH extension study

Ivo N. Van Schaik, Orell Mielke, Vera Bril, Nan Van Geloven, Hans Peter Hartung, Richard A. Lewis, Gen Sobue, John Philip Lawo, Michaela Praus, Billie L. Durn, David R. Cornblath, Ingemar S.J. Merkies, Angelo Schenone, Marina Grandis

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Abstract

ObjectiveTo investigate the long-term safety and efficacy of weekly subcutaneous IgPro20 (Hizentra, CSL Behring) in chronic inflammatory demyelinating polyneuropathy (CIDP).MethodsIn 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.ResultsEighty-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.ConclusionsSubcutaneous 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 evidenceThis study provides Class IV evidence that for patients with CIDP, long-term treatment with SCIG beyond 24 weeks is safe and efficacious.

Original languageEnglish
JournalNeurology: Neuroimmunology and NeuroInflammation
Volume6
Issue number5
DOIs
Publication statusPublished - Sep 1 2019

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ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology

Cite this

Van Schaik, I. N., Mielke, O., Bril, V., Van Geloven, N., Hartung, H. P., Lewis, R. A., Sobue, G., Lawo, J. P., Praus, M., Durn, B. L., Cornblath, D. R., Merkies, I. S. J., Schenone, A., & Grandis, M. (2019). Long-term safety and efficacy of subcutaneous immunoglobulin IgPro20 in CIDP: PATH extension study. Neurology: Neuroimmunology and NeuroInflammation, 6(5). https://doi.org/10.1212/NXI.0000000000000590