RT Journal Article
T1 Long-term safety and efficacy of subcutaneous immunoglobulin IgPro20 in CIDP: PATH extension study.
A1 van Schaik, Ivo N
A1 Mielke, Orell
A1 Bril, Vera
A1 van Geloven, Nan
A1 Hartung, Hans-Peter
A1 Lewis, Richard A
A1 Sobue, Gen
A1 Lawo, John-Philip
A1 Praus, Michaela
A1 Durn, Billie L
A1 Cornblath, David R
A1 Merkies, Ingemar S J
A1 PATH study group, 
AB To investigate the long-term safety and efficacy of weekly subcutaneous IgPro20 (Hizentra, CSL Behring) in chronic inflammatory demyelinating polyneuropathy (CIDP). 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. 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. 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. This study provides Class IV evidence that for patients with CIDP, long-term treatment with SCIG beyond 24 weeks is safe and efficacious.
YR 2019
FD 2019-07-03
LK https://hdl.handle.net/10668/27338
UL https://hdl.handle.net/10668/27338
LA en
DS RISalud
RD Apr 17, 2025