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Efficacy and Safety of IncobotulinumtoxinA in the Treatment of Lower Limb Spasticity in Japanese Subjects

OBJECTIVE: To confirm the efficacy and safety of incobotulinumtoxinA (Xeomin®, Merz Pharmaceuticals GmbH; total dose 400 U) in Japanese subjects with lower limb (LL) poststroke spasticity using the Modified Ashworth Scale spasticity score for the plantar flexors (MAS-PF). METHODS: This phase III stu...

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Autores principales: Masakado, Yoshihisa, Kagaya, Hitoshi, Kondo, Kunitsugu, Otaka, Yohei, Dekundy, Andrzej, Hanschmann, Angelika, Geister, Thorin L., Kaji, Ryuji
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8970182/
https://www.ncbi.nlm.nih.gov/pubmed/35370917
http://dx.doi.org/10.3389/fneur.2022.832937
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author Masakado, Yoshihisa
Kagaya, Hitoshi
Kondo, Kunitsugu
Otaka, Yohei
Dekundy, Andrzej
Hanschmann, Angelika
Geister, Thorin L.
Kaji, Ryuji
author_facet Masakado, Yoshihisa
Kagaya, Hitoshi
Kondo, Kunitsugu
Otaka, Yohei
Dekundy, Andrzej
Hanschmann, Angelika
Geister, Thorin L.
Kaji, Ryuji
author_sort Masakado, Yoshihisa
collection PubMed
description OBJECTIVE: To confirm the efficacy and safety of incobotulinumtoxinA (Xeomin®, Merz Pharmaceuticals GmbH; total dose 400 U) in Japanese subjects with lower limb (LL) poststroke spasticity using the Modified Ashworth Scale spasticity score for the plantar flexors (MAS-PF). METHODS: This phase III study (Japic clinical study database No. CTI-153030, 7 October 2015) included a double-blind, 12-week main period (MP) in which 208 subjects were randomized to receive one injection cycle of incobotulinumtoxinA 400 U (n = 104) or placebo (n = 104) in the pes equinus muscles, and an open-label extension (OLEX) that enrolled 202 subjects who received three injection cycles, 10–14 weeks in duration (the last cycle was fixed at 12 weeks). Changes in MAS-PF for incobotulinumtoxinA vs. placebo from baseline to Week 4 of the MP and to the end-of-cycle visits in the OLEX were evaluated. RESULTS: The area under the curve for the change in MAS-PF was statistically significantly greater with incobotulinumtoxinA vs. placebo in the MP (mean: −7.74 vs. −4.76; least squares mean: −8.40 vs. −5.81 [p = 0.0041]). In the OLEX, mean changes in MAS-PF from baseline to end-of-study showed continued improvement with repeated injections. No new safety concerns were observed with the incobotulinumtoxinA treatment. Its efficacy and safety were consistent regardless of the length of the injection cycle interval in the OLEX. CONCLUSION: This study demonstrated that incobotulinumtoxinA (total dose 400 U) is an effective and a well-tolerated treatment for LL spasticity in Japanese subjects using flexible injection intervals of 10–14 weeks.
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spelling pubmed-89701822022-04-01 Efficacy and Safety of IncobotulinumtoxinA in the Treatment of Lower Limb Spasticity in Japanese Subjects Masakado, Yoshihisa Kagaya, Hitoshi Kondo, Kunitsugu Otaka, Yohei Dekundy, Andrzej Hanschmann, Angelika Geister, Thorin L. Kaji, Ryuji Front Neurol Neurology OBJECTIVE: To confirm the efficacy and safety of incobotulinumtoxinA (Xeomin®, Merz Pharmaceuticals GmbH; total dose 400 U) in Japanese subjects with lower limb (LL) poststroke spasticity using the Modified Ashworth Scale spasticity score for the plantar flexors (MAS-PF). METHODS: This phase III study (Japic clinical study database No. CTI-153030, 7 October 2015) included a double-blind, 12-week main period (MP) in which 208 subjects were randomized to receive one injection cycle of incobotulinumtoxinA 400 U (n = 104) or placebo (n = 104) in the pes equinus muscles, and an open-label extension (OLEX) that enrolled 202 subjects who received three injection cycles, 10–14 weeks in duration (the last cycle was fixed at 12 weeks). Changes in MAS-PF for incobotulinumtoxinA vs. placebo from baseline to Week 4 of the MP and to the end-of-cycle visits in the OLEX were evaluated. RESULTS: The area under the curve for the change in MAS-PF was statistically significantly greater with incobotulinumtoxinA vs. placebo in the MP (mean: −7.74 vs. −4.76; least squares mean: −8.40 vs. −5.81 [p = 0.0041]). In the OLEX, mean changes in MAS-PF from baseline to end-of-study showed continued improvement with repeated injections. No new safety concerns were observed with the incobotulinumtoxinA treatment. Its efficacy and safety were consistent regardless of the length of the injection cycle interval in the OLEX. CONCLUSION: This study demonstrated that incobotulinumtoxinA (total dose 400 U) is an effective and a well-tolerated treatment for LL spasticity in Japanese subjects using flexible injection intervals of 10–14 weeks. Frontiers Media S.A. 2022-03-17 /pmc/articles/PMC8970182/ /pubmed/35370917 http://dx.doi.org/10.3389/fneur.2022.832937 Text en Copyright © 2022 Masakado, Kagaya, Kondo, Otaka, Dekundy, Hanschmann, Geister and Kaji. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Neurology
Masakado, Yoshihisa
Kagaya, Hitoshi
Kondo, Kunitsugu
Otaka, Yohei
Dekundy, Andrzej
Hanschmann, Angelika
Geister, Thorin L.
Kaji, Ryuji
Efficacy and Safety of IncobotulinumtoxinA in the Treatment of Lower Limb Spasticity in Japanese Subjects
title Efficacy and Safety of IncobotulinumtoxinA in the Treatment of Lower Limb Spasticity in Japanese Subjects
title_full Efficacy and Safety of IncobotulinumtoxinA in the Treatment of Lower Limb Spasticity in Japanese Subjects
title_fullStr Efficacy and Safety of IncobotulinumtoxinA in the Treatment of Lower Limb Spasticity in Japanese Subjects
title_full_unstemmed Efficacy and Safety of IncobotulinumtoxinA in the Treatment of Lower Limb Spasticity in Japanese Subjects
title_short Efficacy and Safety of IncobotulinumtoxinA in the Treatment of Lower Limb Spasticity in Japanese Subjects
title_sort efficacy and safety of incobotulinumtoxina in the treatment of lower limb spasticity in japanese subjects
topic Neurology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8970182/
https://www.ncbi.nlm.nih.gov/pubmed/35370917
http://dx.doi.org/10.3389/fneur.2022.832937
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