Duration of Treatment Effect Using IncobotulinumtoxinA for Upper-limb Spasticity: A Post-hoc Analysis
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F61989592%3A15110%2F21%3A73604900" target="_blank" >RIV/61989592:15110/21:73604900 - isvavai.cz</a>
Result on the web
<a href="https://www.frontiersin.org/articles/10.3389/fneur.2020.615706/full" target="_blank" >https://www.frontiersin.org/articles/10.3389/fneur.2020.615706/full</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.3389/fneur.2020.615706" target="_blank" >10.3389/fneur.2020.615706</a>
Alternative languages
Result language
angličtina
Original language name
Duration of Treatment Effect Using IncobotulinumtoxinA for Upper-limb Spasticity: A Post-hoc Analysis
Original language description
The efficacy and safety of incobotulinumtoxinA ≤400U 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 ≤400U 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 spasticitymay not be required at 12-week intervals and provides evidence for flexible treatment intervals beyond this time frame.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30210 - Clinical neurology
Result continuities
Project
—
Continuities
N - Vyzkumna aktivita podporovana z neverejnych zdroju
Others
Publication year
2021
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
Frontiers in Neurology
ISSN
1664-2295
e-ISSN
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Volume of the periodical
11
Issue of the periodical within the volume
January 2021
Country of publishing house
CH - SWITZERLAND
Number of pages
8
Pages from-to
"nestránkováno"
UT code for WoS article
000614741100001
EID of the result in the Scopus database
2-s2.0-85100527416