SUBCUTANEOUS IMMUNOGLOBULIN FORMAINTENANCE TREATMENT IN CHRONICINFLAMMATORY DEMYELINATING POLYNEUROPATHY– A MULTICENTER, RANDOMIZED, DOUBLE-BLIND,PLACEBO-CONTROLLED TRIAL: THE PATH STUDY

I. N. van Schaik; V. Bril; N. van Geloven; H. P. Hartung; R. A. Lewis; G. Sobue; J. P. Lawo; O. Mielke; B. L. Durn; D. R. Cornblath; I. S. J. Merkies; M. M. Dimachkie

doi:https://doi.org/10.1002/mus.25768

SUBCUTANEOUS IMMUNOGLOBULIN FORMAINTENANCE TREATMENT IN CHRONICINFLAMMATORY DEMYELINATING POLYNEUROPATHY– A MULTICENTER, RANDOMIZED, DOUBLE-BLIND,PLACEBO-CONTROLLED TRIAL: THE PATH STUDY

I. N. van Schaik, V. Bril, N. van Geloven, H. P. Hartung, R. A. Lewis, G. Sobue, J. P. Lawo, O. Mielke, B. L. Durn, D. R. Cornblath, I. S. J. Merkies, M. M. Dimachkie

Research output: Contribution to journal › Meeting Abstract › Academic

Abstract

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. To evaluate IgPro20 (SCIG) as a maintenance treatment in CIDP. 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. Both IgPro20 doses significantly reduced rate of CIDP relapse/withdrawal versus placebo. Grip strength remained stable with Hizentra®, 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. IgPro20 is efficacious and well-tolerated as maintenance treatment in CIDP. This article is protected by copyright. All rights reserved

Original language	English
Pages (from-to)	S1
Journal	Muscle & Nerve
Volume	56
Issue number	S1
DOIs	https://doi.org/10.1002/mus.25768
Publication status	Published - 2017

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https://doi.org/10.1002/mus.25768

Cite this

van Schaik, I. N., Bril, V., van Geloven, N., Hartung, H. P., Lewis, R. A., Sobue, G., Lawo, J. P., Mielke, O., Durn, B. L., Cornblath, D. R., Merkies, I. S. J., & Dimachkie, M. M. (2017). SUBCUTANEOUS IMMUNOGLOBULIN FORMAINTENANCE TREATMENT IN CHRONICINFLAMMATORY DEMYELINATING POLYNEUROPATHY– A MULTICENTER, RANDOMIZED, DOUBLE-BLIND,PLACEBO-CONTROLLED TRIAL: THE PATH STUDY. Muscle & Nerve, 56(S1), S1. https://doi.org/10.1002/mus.25768

@article{3eee29262ea644e784c3e754776e494d,

title = "SUBCUTANEOUS IMMUNOGLOBULIN FORMAINTENANCE TREATMENT IN CHRONICINFLAMMATORY DEMYELINATING POLYNEUROPATHY– A MULTICENTER, RANDOMIZED, DOUBLE-BLIND,PLACEBO-CONTROLLED TRIAL: THE PATH STUDY",

abstract = "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. To evaluate IgPro20 (SCIG) as a maintenance treatment in CIDP. 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. Both IgPro20 doses significantly reduced rate of CIDP relapse/withdrawal versus placebo. Grip strength remained stable with Hizentra{\textregistered}, 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. IgPro20 is efficacious and well-tolerated as maintenance treatment in CIDP. This article is protected by copyright. All rights reserved",

author = "{van Schaik}, {I. N.} and V. Bril and {van Geloven}, N. and Hartung, {H. P.} and Lewis, {R. A.} and G. Sobue and Lawo, {J. P.} and O. Mielke and Durn, {B. L.} and Cornblath, {D. R.} and Merkies, {I. S. J.} and Dimachkie, {M. M.}",

year = "2017",

doi = "https://doi.org/10.1002/mus.25768",

language = "English",

volume = "56",

pages = "S1",

journal = "Muscle & Nerve",

issn = "0148-639X",

publisher = "John Wiley & Sons, Inc",

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}

van Schaik, IN, Bril, V, van Geloven, N, Hartung, HP, Lewis, RA, Sobue, G, Lawo, JP, Mielke, O, Durn, BL, Cornblath, DR, Merkies, ISJ & Dimachkie, MM 2017, 'SUBCUTANEOUS IMMUNOGLOBULIN FORMAINTENANCE TREATMENT IN CHRONICINFLAMMATORY DEMYELINATING POLYNEUROPATHY– A MULTICENTER, RANDOMIZED, DOUBLE-BLIND,PLACEBO-CONTROLLED TRIAL: THE PATH STUDY', Muscle & Nerve, vol. 56, no. S1, pp. S1. https://doi.org/10.1002/mus.25768

TY - JOUR

T1 - SUBCUTANEOUS IMMUNOGLOBULIN FORMAINTENANCE TREATMENT IN CHRONICINFLAMMATORY DEMYELINATING POLYNEUROPATHY– A MULTICENTER, RANDOMIZED, DOUBLE-BLIND,PLACEBO-CONTROLLED TRIAL: THE PATH STUDY

AU - van Schaik, I. N.

AU - Bril, V.

AU - van Geloven, N.

AU - Hartung, H. P.

AU - Lewis, R. A.

AU - Sobue, G.

AU - Lawo, J. P.

AU - Mielke, O.

AU - Durn, B. L.

AU - Cornblath, D. R.

AU - Merkies, I. S. J.

AU - Dimachkie, M. M.

PY - 2017

Y1 - 2017

N2 - 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. To evaluate IgPro20 (SCIG) as a maintenance treatment in CIDP. 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. Both IgPro20 doses significantly reduced rate of CIDP relapse/withdrawal versus placebo. Grip strength remained stable with Hizentra®, 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. IgPro20 is efficacious and well-tolerated as maintenance treatment in CIDP. This article is protected by copyright. All rights reserved

AB - 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. To evaluate IgPro20 (SCIG) as a maintenance treatment in CIDP. 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. Both IgPro20 doses significantly reduced rate of CIDP relapse/withdrawal versus placebo. Grip strength remained stable with Hizentra®, 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. IgPro20 is efficacious and well-tolerated as maintenance treatment in CIDP. This article is protected by copyright. All rights reserved

U2 - https://doi.org/10.1002/mus.25768

DO - https://doi.org/10.1002/mus.25768

M3 - Meeting Abstract

C2 - 28967683

SN - 0148-639X

VL - 56

SP - S1

JO - Muscle & Nerve

JF - Muscle & Nerve

IS - S1

ER -