Efficacy and Safety of IncobotulinumtoxinA in the Treatment of Lower Limb Spasticity in Japanese Subjects
ObjectiveTo 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).MethodsThis phase III study (J...
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| Format: | Article |
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Frontiers Media S.A.
2022-03-01
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| Series: | Frontiers in Neurology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fneur.2022.832937/full |
| _version_ | 1818312845525254144 |
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| author | Yoshihisa Masakado Hitoshi Kagaya Kunitsugu Kondo Yohei Otaka Andrzej Dekundy Angelika Hanschmann Thorin L. Geister Ryuji Kaji |
| author_facet | Yoshihisa Masakado Hitoshi Kagaya Kunitsugu Kondo Yohei Otaka Andrzej Dekundy Angelika Hanschmann Thorin L. Geister Ryuji Kaji |
| author_sort | Yoshihisa Masakado |
| collection | DOAJ |
| description | ObjectiveTo 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).MethodsThis 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.ResultsThe 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.ConclusionThis 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. |
| first_indexed | 2024-12-13T08:24:19Z |
| format | Article |
| id | doaj.art-a750a1977be94d578372c8d629953610 |
| institution | Directory Open Access Journal |
| issn | 1664-2295 |
| language | English |
| last_indexed | 2024-12-13T08:24:19Z |
| publishDate | 2022-03-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Neurology |
| spelling | doaj.art-a750a1977be94d578372c8d6299536102022-12-21T23:53:55ZengFrontiers Media S.A.Frontiers in Neurology1664-22952022-03-011310.3389/fneur.2022.832937832937Efficacy and Safety of IncobotulinumtoxinA in the Treatment of Lower Limb Spasticity in Japanese SubjectsYoshihisa Masakado0Hitoshi Kagaya1Kunitsugu Kondo2Yohei Otaka3Andrzej Dekundy4Angelika Hanschmann5Thorin L. Geister6Ryuji Kaji7Department of Rehabilitation Medicine, Tokai University School of Medicine, Kanagawa, JapanDepartment of Rehabilitation Medicine I, School of Medicine, Fujita Health University, Toyoake, JapanDepartment of Rehabilitation Medicine, Tokyo Bay Rehabilitation Hospital, Chiba, JapanDepartment of Rehabilitation Medicine I, School of Medicine, Fujita Health University, Toyoake, JapanMerz Pharmaceuticals GmbH, Frankfurt am Main, GermanyMerz Pharmaceuticals GmbH, Frankfurt am Main, GermanyMerz Pharmaceuticals GmbH, Frankfurt am Main, GermanyDepartment of Clinical Neuroscience, Tokushima University, Tokushima, JapanObjectiveTo 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).MethodsThis 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.ResultsThe 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.ConclusionThis 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.https://www.frontiersin.org/articles/10.3389/fneur.2022.832937/fullbotulinum neurotoxin type AincobotulinumtoxinAtreatmentspasticitylower limbJapan |
| spellingShingle | Yoshihisa Masakado Hitoshi Kagaya Kunitsugu Kondo Yohei Otaka Andrzej Dekundy Angelika Hanschmann Thorin L. Geister Ryuji Kaji Efficacy and Safety of IncobotulinumtoxinA in the Treatment of Lower Limb Spasticity in Japanese Subjects Frontiers in Neurology botulinum neurotoxin type A incobotulinumtoxinA treatment spasticity lower limb Japan |
| 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 | botulinum neurotoxin type A incobotulinumtoxinA treatment spasticity lower limb Japan |
| url | https://www.frontiersin.org/articles/10.3389/fneur.2022.832937/full |
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