Duration of Treatment Effect Using IncobotulinumtoxinA for Upper-limb Spasticity: A Post-hoc Analysis

Petr Kaňovský; Elie P. Elovic; Angelika Hanschmann; Irena Pulte; Michael Althaus; Reinhard Hiersemenzel; Christina Marciniak

doi:10.3389/fneur.2020.615706

Duration of Treatment Effect Using IncobotulinumtoxinA for Upper-limb Spasticity: A Post-hoc Analysis

Petr Kaňovský^*, Elie P. Elovic, Angelika Hanschmann, Irena Pulte, Michael Althaus, Reinhard Hiersemenzel, Christina Marciniak

^*Corresponding author for this work

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Abstract

The efficacy and safety of incobotulinumtoxinA ≤400 U was demonstrated in subjects with post-stroke upper-limb spasticity in a randomized, double-blind Phase 3 study with an open-label extension (OLEX; EudraCT number 2005-003951-11, NCT00432666). We report a post-hoc analysis of the duration of the treatment effect. Subjects completing the placebo-controlled main period (single injection cycle with 12–20-week observation) entered the OLEX and received a maximum of five further treatments (maximum duration 69 weeks) with incobotulinumtoxinA ≤400 U at flexible intervals with a minimum duration of 12 weeks, based on clinical need. Intervals between two consecutive incobotulinumtoxinA injections, excluding treatment intervals prior to the end-of-study visit, were evaluated. Of 437 incobotulinumtoxinA treatment intervals, 415 received by 136 subjects were included in the post-hoc analysis. More than half (52.3%; 217/415) of all incobotulinumtoxinA reinjections were administered at Week ≥14, 31.1% (129/415) at Week ≥16, 19.0% (79/415) at Week ≥18, and 11.6% (48/415) at Week ≥20. The duration of effect may vary and can exceed 20 weeks or more, which was observed in at least one injection cycle in 29.4% (40/136) subjects over the course of their treatment. Data show that incobotulinumtoxinA retreatment for upper-limb spasticity may not be required at 12-week intervals and provides evidence for flexible treatment intervals beyond this time frame.

Original language	English (US)
Article number	615706
Journal	Frontiers in Neurology
Volume	11
DOIs	https://doi.org/10.3389/fneur.2020.615706
State	Published - Jan 22 2021

Funding

The authors wish to thank the subjects and study investigators. Medical writing support, under the direction of the authors, was provided by Claire Cairney, Ph.D., CMC Connect, McCann Health Medical Communications, funded by Merz Pharmaceuticals GmbH, in accordance with Good Publication Practice (GPP3) guidelines. Funding. This study was supported by Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany. This clinical trial was registered in the European Union Clinical Trials Register (EudraCT number 2005-003951-11) and the United States National Library of Medicine (clinicaltrials.gov study ID NCT00432666).

Keywords

duration of effect
incobotulinumtoxinA
post-stroke
treatment interval
upper-limb spasticity

ASJC Scopus subject areas

Clinical Neurology
Neurology

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.3389/fneur.2020.615706

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title = "Duration of Treatment Effect Using IncobotulinumtoxinA for Upper-limb Spasticity: A Post-hoc Analysis",

abstract = "The efficacy and safety of incobotulinumtoxinA ≤400 U was demonstrated in subjects with post-stroke upper-limb spasticity in a randomized, double-blind Phase 3 study with an open-label extension (OLEX; EudraCT number 2005-003951-11, NCT00432666). We report a post-hoc analysis of the duration of the treatment effect. Subjects completing the placebo-controlled main period (single injection cycle with 12–20-week observation) entered the OLEX and received a maximum of five further treatments (maximum duration 69 weeks) with incobotulinumtoxinA ≤400 U at flexible intervals with a minimum duration of 12 weeks, based on clinical need. Intervals between two consecutive incobotulinumtoxinA injections, excluding treatment intervals prior to the end-of-study visit, were evaluated. Of 437 incobotulinumtoxinA treatment intervals, 415 received by 136 subjects were included in the post-hoc analysis. More than half (52.3%; 217/415) of all incobotulinumtoxinA reinjections were administered at Week ≥14, 31.1% (129/415) at Week ≥16, 19.0% (79/415) at Week ≥18, and 11.6% (48/415) at Week ≥20. The duration of effect may vary and can exceed 20 weeks or more, which was observed in at least one injection cycle in 29.4% (40/136) subjects over the course of their treatment. Data show that incobotulinumtoxinA retreatment for upper-limb spasticity may not be required at 12-week intervals and provides evidence for flexible treatment intervals beyond this time frame.",

keywords = "duration of effect, incobotulinumtoxinA, post-stroke, treatment interval, upper-limb spasticity",

author = "Petr Ka{\v n}ovsk{\'y} and Elovic, {Elie P.} and Angelika Hanschmann and Irena Pulte and Michael Althaus and Reinhard Hiersemenzel and Christina Marciniak",

note = "Publisher Copyright: {\textcopyright} Copyright {\textcopyright} 2021 Ka{\v n}ovsk{\'y}, Elovic, Hanschmann, Pulte, Althaus, Hiersemenzel and Marciniak.",

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AU - Kaňovský, Petr

AU - Elovic, Elie P.

AU - Hanschmann, Angelika

AU - Pulte, Irena

AU - Althaus, Michael

AU - Hiersemenzel, Reinhard

AU - Marciniak, Christina

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AB - The efficacy and safety of incobotulinumtoxinA ≤400 U was demonstrated in subjects with post-stroke upper-limb spasticity in a randomized, double-blind Phase 3 study with an open-label extension (OLEX; EudraCT number 2005-003951-11, NCT00432666). We report a post-hoc analysis of the duration of the treatment effect. Subjects completing the placebo-controlled main period (single injection cycle with 12–20-week observation) entered the OLEX and received a maximum of five further treatments (maximum duration 69 weeks) with incobotulinumtoxinA ≤400 U at flexible intervals with a minimum duration of 12 weeks, based on clinical need. Intervals between two consecutive incobotulinumtoxinA injections, excluding treatment intervals prior to the end-of-study visit, were evaluated. Of 437 incobotulinumtoxinA treatment intervals, 415 received by 136 subjects were included in the post-hoc analysis. More than half (52.3%; 217/415) of all incobotulinumtoxinA reinjections were administered at Week ≥14, 31.1% (129/415) at Week ≥16, 19.0% (79/415) at Week ≥18, and 11.6% (48/415) at Week ≥20. The duration of effect may vary and can exceed 20 weeks or more, which was observed in at least one injection cycle in 29.4% (40/136) subjects over the course of their treatment. Data show that incobotulinumtoxinA retreatment for upper-limb spasticity may not be required at 12-week intervals and provides evidence for flexible treatment intervals beyond this time frame.

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Duration of Treatment Effect Using IncobotulinumtoxinA for Upper-limb Spasticity: A Post-hoc Analysis

Abstract

Funding

Keywords

ASJC Scopus subject areas

UN SDGs

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