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Randomized trial of facilitated subcutaneous immunoglobulin in multifocal motor neuropathy

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@article{e6b940b7bbfc4f4d9a76d1b6ec45cc57,
title = "Randomized trial of facilitated subcutaneous immunoglobulin in multifocal motor neuropathy",
abstract = "BACKGROUND AND PURPOSE: To optimize subcutaneous therapy with immunoglobulins, large volume infusion of immunoglobulin G facilitated by pretreatment with hyaluronidase (fSCIG) was compared to conventional infusion of multiple small dosages (cSCIG) in 20 patients with multifocal motor neuropathy.METHODS: A randomized, non-inferiority and observer-blinded cross-over design was applied with a treatment period of 24 weeks for each therapy.RESULTS: In 18 patients fSCIG was feasible, two patients leaving the study due to side-effects. The primary study variable, isometric strength, was unchanged, being 100.8{\%} [95{\%} confidence interval (CI) 94.8{\%}-107.1{\%}) in fSCIG and 105.9{\%} (95{\%} CI 99.8{\%}-112.0{\%}) in cSCIG. Secondary end-points of disability, functions, impairments and quality of life showed no differences between the two treatments. Mild and short-lasting generalized side-effects were similar in the two groups, whereas the relative frequency of localized side-effects at the injection site was increased after fSCIG [0.63 (95{\%} CI 0.23-1.00) vs. 0.09 (95{\%} CI 0.00-0.22), P = 0.005]. The preference of the patients favoured fSCIG for two out of five visual analogue scale scores as well as the total mean score of all preferences (P = 0.03).CONCLUSIONS: Facilitated SCIG seems effective, feasible and safe. In addition, it is preferred by patients but is accompanied by a higher frequency of short-lasting localized side-effects.",
keywords = "clinical trials randomized controlled, immunoglobulin, multifocal motor neuropathy, peripheral neuropathy, treatment",
author = "A Al-Zuhairy and Johannes Jakobsen and H Andersen and Sindrup, {S H} and Markvardsen, {L K}",
note = "{\circledC} 2019 EAN.",
year = "2019",
month = "10",
doi = "10.1111/ene.13978",
language = "English",
volume = "26",
pages = "1289--e82",
journal = "European Journal of Neurology",
issn = "1351-5101",
publisher = "Wiley-Blackwell Publishing Ltd",
number = "10",

}

RIS

TY - JOUR

T1 - Randomized trial of facilitated subcutaneous immunoglobulin in multifocal motor neuropathy

AU - Al-Zuhairy, A

AU - Jakobsen, Johannes

AU - Andersen, H

AU - Sindrup, S H

AU - Markvardsen, L K

N1 - © 2019 EAN.

PY - 2019/10

Y1 - 2019/10

N2 - BACKGROUND AND PURPOSE: To optimize subcutaneous therapy with immunoglobulins, large volume infusion of immunoglobulin G facilitated by pretreatment with hyaluronidase (fSCIG) was compared to conventional infusion of multiple small dosages (cSCIG) in 20 patients with multifocal motor neuropathy.METHODS: A randomized, non-inferiority and observer-blinded cross-over design was applied with a treatment period of 24 weeks for each therapy.RESULTS: In 18 patients fSCIG was feasible, two patients leaving the study due to side-effects. The primary study variable, isometric strength, was unchanged, being 100.8% [95% confidence interval (CI) 94.8%-107.1%) in fSCIG and 105.9% (95% CI 99.8%-112.0%) in cSCIG. Secondary end-points of disability, functions, impairments and quality of life showed no differences between the two treatments. Mild and short-lasting generalized side-effects were similar in the two groups, whereas the relative frequency of localized side-effects at the injection site was increased after fSCIG [0.63 (95% CI 0.23-1.00) vs. 0.09 (95% CI 0.00-0.22), P = 0.005]. The preference of the patients favoured fSCIG for two out of five visual analogue scale scores as well as the total mean score of all preferences (P = 0.03).CONCLUSIONS: Facilitated SCIG seems effective, feasible and safe. In addition, it is preferred by patients but is accompanied by a higher frequency of short-lasting localized side-effects.

AB - BACKGROUND AND PURPOSE: To optimize subcutaneous therapy with immunoglobulins, large volume infusion of immunoglobulin G facilitated by pretreatment with hyaluronidase (fSCIG) was compared to conventional infusion of multiple small dosages (cSCIG) in 20 patients with multifocal motor neuropathy.METHODS: A randomized, non-inferiority and observer-blinded cross-over design was applied with a treatment period of 24 weeks for each therapy.RESULTS: In 18 patients fSCIG was feasible, two patients leaving the study due to side-effects. The primary study variable, isometric strength, was unchanged, being 100.8% [95% confidence interval (CI) 94.8%-107.1%) in fSCIG and 105.9% (95% CI 99.8%-112.0%) in cSCIG. Secondary end-points of disability, functions, impairments and quality of life showed no differences between the two treatments. Mild and short-lasting generalized side-effects were similar in the two groups, whereas the relative frequency of localized side-effects at the injection site was increased after fSCIG [0.63 (95% CI 0.23-1.00) vs. 0.09 (95% CI 0.00-0.22), P = 0.005]. The preference of the patients favoured fSCIG for two out of five visual analogue scale scores as well as the total mean score of all preferences (P = 0.03).CONCLUSIONS: Facilitated SCIG seems effective, feasible and safe. In addition, it is preferred by patients but is accompanied by a higher frequency of short-lasting localized side-effects.

KW - clinical trials randomized controlled

KW - immunoglobulin

KW - multifocal motor neuropathy

KW - peripheral neuropathy

KW - treatment

UR - http://www.scopus.com/inward/record.url?scp=85066507293&partnerID=8YFLogxK

U2 - 10.1111/ene.13978

DO - 10.1111/ene.13978

M3 - Journal article

VL - 26

SP - 1289-e82

JO - European Journal of Neurology

JF - European Journal of Neurology

SN - 1351-5101

IS - 10

ER -

ID: 58450856