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High-dose Ig VENA is well tolerated and efficacious in patients with multifocal motor neuropathy

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Abstract

Multifocal motor neuropathy (MMN) is a rare, chronic, motor neuropathy that progressively impairs physical functioning and quality of life. Randomised controlled trials have shown that high-dose intravenous immunoglobulin (IVIg) is superior to placebo in improving muscle strength and disability, but many patients require periodic infusions to maintain long-term improvement. This observational, multicentre, retrospective study investigated the efficacy and tolerability of human normal immunoglobulin (Ig VENA) at high intravenous infusion rates in 20 MMN patients (14 male, 6 female). Thirty days after the first infusion, there was an improvement of at least 1 point in two muscles compared to baseline on the Medical Research Council (MRC) scale and of 1 point in the ONLS (Overall Neuropathy Limitation Scale) scale in 15 patients (75%) and 10 patients (50%), respectively; 45% improved on both scales. At 6 months, 100% of 12 patients had improved on the MRC and 79% of 14 patients had improved on the ONLS scale; 83% improved on both scales. All reported adverse drug reactions (ADR) were mild, transient and possibly related to the study drug. Four patients (20%) reported ADRs, three reported headache and one fever. There were no serious or unexpected ADRs. By confirming that high-dose Ig VENA is efficacious and well tolerated, this study adds to the evidence base for IVIg in MMN and potentially increases clinicians’ and patients’ choice of therapy.

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Acknowledgements

This research was conducted with the financial support of Kedrion Biopharma, Castelvecchio Pascoli—Lucca, Italy. We thank Sue Lyon for preparing an initial English-language draft of this article. Collaborators: (2) Ilaria Paolasso—Turin, Italy. (3) Marta Campagnolo—Padua, Italy. (4) Francesca Pastorelli—Bologna, Italy. (5) Martina Garnero, Marina Grandis & Giulia Ursino—Genoa, Italy.

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Correspondence to Eduardo Nobile-Orazio.

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Eduardo Nobile-Orazio reports personal compensation for serving on the Steering Committee or Advisory Board of: Baxter, Italy; CSL Behring, Italy; Kedrion, Italy; LFB, France; and Novartis, Switzerland. He has received honoraria for lecturing from Baxter, CSL Behring, and Kedrion and travel supports for Scientific Meetings from CSL Behring and Kedrion. All compensations and supports are outside the submitted work. Dario Cocito received honoraria for lecturing CSL Behring, and Kedrion and travel supports for Scientific Meetings from CSL Behring and Kedrion. All compensations and supports are outside the submitted work. Chiara Briani, Rosaria Plasmati, Angelo Schenone received travel support for scientific meetings from Kedrion. Francesca Gallia received travel support for scientific meetings from CSL Behring and Kedrion. Ivan Marjanovic and Anna Lotti Suffredini are employees of Kedrion Biopharma, Castelvecchio Pascoli—Lucca, Italy.

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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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Nobile-Orazio, E., Cocito, D., Briani, C. et al. High-dose Ig VENA is well tolerated and efficacious in patients with multifocal motor neuropathy. Neurol Sci 38, 899–902 (2017). https://doi.org/10.1007/s10072-017-2826-8

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  • DOI: https://doi.org/10.1007/s10072-017-2826-8

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