δείτε την πρωτότυπη σελίδα τεκμηρίου στον ιστότοπο του αποθετηρίου του φορέα για περισσότερες πληροφορίες και για να δείτε όλα τα ψηφιακά αρχεία του τεκμηρίου*
Duration and onset of effect of incobotulinumtoxinA for the treatment of
blepharospasm in botulinum toxin-naive subjects
Mitsikostas, Dimos D.
Dekundy, Andrzej
Hanschmann, Angelika and
Althaus, Michael
Scheschonka, Astrid
Pagan, Fernando and
Jankovic, Joseph
PLAIN LANGUAGE SUMMARY Blepharospasm is a condition in which involuntary
contractions of the eyelid muscles cause the eye to close. The condition
can be treated with botulinum neurotoxin type A (BoNT-A) injections.
This study assessed the duration of effect and time to onset of effect
for the BoNT-A formulation incobotulinumtoxinA (Xeomin, Merz
Pharmaceuticals GmbH) in adults with blepharospasm. Subjects received a
single injection of one of two doses of incobotulinumtoxinA (total dose
25 or 50 U) or placebo and received a second injection of
incobotulinumtoxinA only (total dose <= 70 U; the second injection was
not compared with placebo) if needed 6-20 weeks after the first
injection. After the first injection, the median (mid-point of values
from all subjects) duration of treatment effect was longer with the
higher incobotulinumtoxinA dose (20 weeks) than with the lower dose (11
weeks) and was longer with both incobotulinumtoxinA doses than with
placebo (6 weeks). After the second incobotulinumtoxinA injection, the
median duration of treatment effect was 20 weeks. The time to onset of
effect was quicker with both incobotulinumtoxinA doses (5 and 7 days for
the higher and lower doses, respectively) than with placebo (14 days)
and the difference was statistically significant for the higher
incobotulinumtoxinA dose compared with placebo. The time to waning of
treatment effect was similar for the two incobotulinumtoxinA doses and
placebo. This study shows that incobotulinumtoxinA is an effective
treatment for blepharospasm, with a fast onset of action. In addition,
the effects of one injection can last for up to 20 weeks.
Objective Blepharospasm is a focal dystonia whereby excessive eyelid
muscle contractions cause involuntary eye closure. Botulinum neurotoxin
type A (BoNT-A) injections are an approved treatment. This randomized
placebo-controlled trial (NCT01896895; EudraCT number 2012-004821-26)
assessed the efficacy, safety, and treatment effect duration of
incobotulinumtoxinA (Xeomin, Merz Pharmaceuticals GmbH), a BoNT-A
formulation without complexing proteins, in BoNT-A-naive adults with
blepharospasm. Methods Subjects received incobotulinumtoxinA 50 U, 25 U
(total dose) or placebo during a main study period (MP; 6-20 weeks).
Patients needing a second injection received incobotulinumtoxinA <= 70 U
in an open-label extension period (EP; 6-20 weeks). Treatment effect
durations were time from first injection to EP injection or final MP
visit and from EP injection to end-of-study visit. Times to effect onset
and to waning of effect (MP) were time from injection to first
subject-assessed onset effect and time from injection to
subject-reported waning of effect, respectively. Results Of 61 subjects,
39 entered the EP. During the MP, median duration of treatment effect
was longer with incobotulinumtoxinA 50 U (20 weeks) versus
incobotulinumtoxinA 25 U (11 weeks) or placebo (6 weeks). Median
duration of treatment effect was 20 weeks during the EP. Median time to
effect onset was 5, 7, and 14 days with 50 U, 25 U, and placebo,
respectively (p = .022 for 50 U versus placebo). Median time to waning
of treatment effect was comparable between groups. Conclusion Subjects
reported an effect onset from 5 days after injection lasting up to 20
weeks (maximum observation period). Data indicate that
incobotulinumtoxinA re-treatment of blepharospasm may not be required at
fixed 12-week intervals and provide evidence for a patient-tailored
approach.
(EN)
*Η εύρυθμη και αδιάλειπτη λειτουργία των διαδικτυακών διευθύνσεων των συλλογών (ψηφιακό αρχείο, καρτέλα τεκμηρίου στο αποθετήριο) είναι αποκλειστική ευθύνη των αντίστοιχων Φορέων περιεχομένου.
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