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Persistence with Botulinum Toxin Treatment for Spasticity Symptoms in Multiple Sclerosis

Botulinum toxin (BT) is an effective treatment for spasticity symptoms in multiple sclerosis (MS). Despite its wide use in clinical practices, only few studies have explored long-term persistence. We aim to evaluate the rate of discontinuation of BT treatment and the correlation with MS, spasticity,...

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Autores principales: Novarella, Federica, Carotenuto, Antonio, Cipullo, Paolo, Iodice, Rosa, Cassano, Emanuele, Spiezia, Antonio Luca, Capasso, Nicola, Petracca, Maria, Falco, Fabrizia, Iacovazzo, Carmine, Servillo, Giuseppe, Lanzillo, Roberta, Brescia Morra, Vincenzo, Moccia, Marcello
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9693315/
https://www.ncbi.nlm.nih.gov/pubmed/36356024
http://dx.doi.org/10.3390/toxins14110774
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author Novarella, Federica
Carotenuto, Antonio
Cipullo, Paolo
Iodice, Rosa
Cassano, Emanuele
Spiezia, Antonio Luca
Capasso, Nicola
Petracca, Maria
Falco, Fabrizia
Iacovazzo, Carmine
Servillo, Giuseppe
Lanzillo, Roberta
Brescia Morra, Vincenzo
Moccia, Marcello
author_facet Novarella, Federica
Carotenuto, Antonio
Cipullo, Paolo
Iodice, Rosa
Cassano, Emanuele
Spiezia, Antonio Luca
Capasso, Nicola
Petracca, Maria
Falco, Fabrizia
Iacovazzo, Carmine
Servillo, Giuseppe
Lanzillo, Roberta
Brescia Morra, Vincenzo
Moccia, Marcello
author_sort Novarella, Federica
collection PubMed
description Botulinum toxin (BT) is an effective treatment for spasticity symptoms in multiple sclerosis (MS). Despite its wide use in clinical practices, only few studies have explored long-term persistence. We aim to evaluate the rate of discontinuation of BT treatment and the correlation with MS, spasticity, and injection variables. This retrospective study on 3-year prospectively collected data included 122 MS patients receiving BT injections for spasticity. We collected MS clinical variables (disease durations, Expanded Disability Status Scales [EDSSs], disease-modifying treatments [DMT], and Symbol Digit Modalities Tests [SDMTs]), modified Ashworth scales [MASs], concomitant treatments, and injection variables (formulation, dose, number of injections, and intervals between injections). A total of 14 out of the 122 patients discontinued BT after a mean time of 3.0 ± 1.5 years. In the Cox regression model including the MS clinical variables, the probability of BT discontinuations increased in patients with DMT changes during follow-ups (HR = 6.34; 95%Cl = 2.47, 18.08; p < 0.01) and with impaired SDMTs (HR = 1.20; 95%Cl = 1.04, 1.96; p < 0.01). In the model including the spasticity variables, there were no associations between BT discontinuation and MAS or other spasticity treatments. In the model including the injection variables, the probability of discontinuation decreased by 80% for each cumulative injection (HR = 0.16; 95%Cl = 0.05, 0.45; p < 0.01), but increased by 1% for each additional day over the 3-month interval between injections (HR = 1.27; 95%Cl = 1.07, 1.83; p < 0.01). BT discontinuation was associated with concomitant MS-related issues (e.g., treatment failure and DMT change) and the presence of cognitive impairment, which should be accounted for when planning injections. The interval between injections should be kept as short as possible from regulatory and clinical perspectives to maximize the response across all of the spasticity symptoms and to reduce discontinuation in the long term.
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spelling pubmed-96933152022-11-26 Persistence with Botulinum Toxin Treatment for Spasticity Symptoms in Multiple Sclerosis Novarella, Federica Carotenuto, Antonio Cipullo, Paolo Iodice, Rosa Cassano, Emanuele Spiezia, Antonio Luca Capasso, Nicola Petracca, Maria Falco, Fabrizia Iacovazzo, Carmine Servillo, Giuseppe Lanzillo, Roberta Brescia Morra, Vincenzo Moccia, Marcello Toxins (Basel) Article Botulinum toxin (BT) is an effective treatment for spasticity symptoms in multiple sclerosis (MS). Despite its wide use in clinical practices, only few studies have explored long-term persistence. We aim to evaluate the rate of discontinuation of BT treatment and the correlation with MS, spasticity, and injection variables. This retrospective study on 3-year prospectively collected data included 122 MS patients receiving BT injections for spasticity. We collected MS clinical variables (disease durations, Expanded Disability Status Scales [EDSSs], disease-modifying treatments [DMT], and Symbol Digit Modalities Tests [SDMTs]), modified Ashworth scales [MASs], concomitant treatments, and injection variables (formulation, dose, number of injections, and intervals between injections). A total of 14 out of the 122 patients discontinued BT after a mean time of 3.0 ± 1.5 years. In the Cox regression model including the MS clinical variables, the probability of BT discontinuations increased in patients with DMT changes during follow-ups (HR = 6.34; 95%Cl = 2.47, 18.08; p < 0.01) and with impaired SDMTs (HR = 1.20; 95%Cl = 1.04, 1.96; p < 0.01). In the model including the spasticity variables, there were no associations between BT discontinuation and MAS or other spasticity treatments. In the model including the injection variables, the probability of discontinuation decreased by 80% for each cumulative injection (HR = 0.16; 95%Cl = 0.05, 0.45; p < 0.01), but increased by 1% for each additional day over the 3-month interval between injections (HR = 1.27; 95%Cl = 1.07, 1.83; p < 0.01). BT discontinuation was associated with concomitant MS-related issues (e.g., treatment failure and DMT change) and the presence of cognitive impairment, which should be accounted for when planning injections. The interval between injections should be kept as short as possible from regulatory and clinical perspectives to maximize the response across all of the spasticity symptoms and to reduce discontinuation in the long term. MDPI 2022-11-09 /pmc/articles/PMC9693315/ /pubmed/36356024 http://dx.doi.org/10.3390/toxins14110774 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Novarella, Federica
Carotenuto, Antonio
Cipullo, Paolo
Iodice, Rosa
Cassano, Emanuele
Spiezia, Antonio Luca
Capasso, Nicola
Petracca, Maria
Falco, Fabrizia
Iacovazzo, Carmine
Servillo, Giuseppe
Lanzillo, Roberta
Brescia Morra, Vincenzo
Moccia, Marcello
Persistence with Botulinum Toxin Treatment for Spasticity Symptoms in Multiple Sclerosis
title Persistence with Botulinum Toxin Treatment for Spasticity Symptoms in Multiple Sclerosis
title_full Persistence with Botulinum Toxin Treatment for Spasticity Symptoms in Multiple Sclerosis
title_fullStr Persistence with Botulinum Toxin Treatment for Spasticity Symptoms in Multiple Sclerosis
title_full_unstemmed Persistence with Botulinum Toxin Treatment for Spasticity Symptoms in Multiple Sclerosis
title_short Persistence with Botulinum Toxin Treatment for Spasticity Symptoms in Multiple Sclerosis
title_sort persistence with botulinum toxin treatment for spasticity symptoms in multiple sclerosis
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9693315/
https://www.ncbi.nlm.nih.gov/pubmed/36356024
http://dx.doi.org/10.3390/toxins14110774
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