Safety, Pharmacodynamic Response, and Treatment Satisfaction With OnabotulinumtoxinA 40 U, 60 U, and 80 U in Subjects With Moderate to Severe Dynamic Glabellar Lines

OnabotulinumtoxinA 20 U reduces glabellar line (GL) severity at maximum frown for ≈3-4 months. Small studies have suggested that >20 U doses may increase efficacy and duration of response for GLs. Evaluate safety, pharmacodynamic response, and treatment satisfaction with onabotulinumtoxinA doses...

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Published in:Aesthetic surgery journal 2022-10, Vol.42 (11), p.1318-1327
Main Authors: Joseph, John H, Maas, Corey, Palm, Melanie D, Lain, Edward, Glaser, Dee Anna, Bruce, Suzanne, Yoelin, Steven, Cox, Sue Ellen, Fagien, Steven, Sangha, Sara, Maltman, John, Lei, Xiaofang, Brin, Mitchell F
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container_issue 11
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container_title Aesthetic surgery journal
container_volume 42
creator Joseph, John H
Maas, Corey
Palm, Melanie D
Lain, Edward
Glaser, Dee Anna
Bruce, Suzanne
Yoelin, Steven
Cox, Sue Ellen
Fagien, Steven
Sangha, Sara
Maltman, John
Lei, Xiaofang
Brin, Mitchell F
description OnabotulinumtoxinA 20 U reduces glabellar line (GL) severity at maximum frown for ≈3-4 months. Small studies have suggested that >20 U doses may increase efficacy and duration of response for GLs. Evaluate safety, pharmacodynamic response, and treatment satisfaction with onabotulinumtoxinA doses ≥20 U for GLs. This 48-week, double-blind study compared 40, 60, and 80 U onabotulinumtoxinA vs 20 U and placebo in women with moderate or severe dynamic GLs on the Allergan Facial Wrinkle Scale (FWS). Percentage of subjects with investigator-assessed ≥1-grade FWS improvement from baseline at maximum frown (responders) at week 24; estimated median duration of response; proportion of mostly/very satisfied responders on the Facial Line Satisfaction Questionnaire (FLSQ) follow-up Items 1-5; and treatment-emergent adverse events (TEAEs) were evaluated. The modified intent-to-treat population (N=226) had a mean age of 48.0 years, with similar baseline GL severity between treatment groups. Week 24 responder rates were 0% for placebo and 16.0%, 32.0%, 30.6%, and 38.5% for onabotulinumtoxinA 20, 40, 60, and 80 U, with significant (P
doi_str_mv 10.1093/asj/sjac157
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Small studies have suggested that &gt;20 U doses may increase efficacy and duration of response for GLs. Evaluate safety, pharmacodynamic response, and treatment satisfaction with onabotulinumtoxinA doses ≥20 U for GLs. This 48-week, double-blind study compared 40, 60, and 80 U onabotulinumtoxinA vs 20 U and placebo in women with moderate or severe dynamic GLs on the Allergan Facial Wrinkle Scale (FWS). Percentage of subjects with investigator-assessed ≥1-grade FWS improvement from baseline at maximum frown (responders) at week 24; estimated median duration of response; proportion of mostly/very satisfied responders on the Facial Line Satisfaction Questionnaire (FLSQ) follow-up Items 1-5; and treatment-emergent adverse events (TEAEs) were evaluated. The modified intent-to-treat population (N=226) had a mean age of 48.0 years, with similar baseline GL severity between treatment groups. Week 24 responder rates were 0% for placebo and 16.0%, 32.0%, 30.6%, and 38.5% for onabotulinumtoxinA 20, 40, 60, and 80 U, with significant (P&lt;0.05) differences for 40 and 80 U vs 20 U. Median duration of response was longer with all higher doses vs 20 U (≥24.0 vs 19.7 weeks; P&lt;0.05 vs 20 U at week 24). FLSQ results indicated high subject satisfaction. TEAE incidence and severity did not exhibit a dose-response effect. 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Small studies have suggested that &gt;20 U doses may increase efficacy and duration of response for GLs. Evaluate safety, pharmacodynamic response, and treatment satisfaction with onabotulinumtoxinA doses ≥20 U for GLs. This 48-week, double-blind study compared 40, 60, and 80 U onabotulinumtoxinA vs 20 U and placebo in women with moderate or severe dynamic GLs on the Allergan Facial Wrinkle Scale (FWS). Percentage of subjects with investigator-assessed ≥1-grade FWS improvement from baseline at maximum frown (responders) at week 24; estimated median duration of response; proportion of mostly/very satisfied responders on the Facial Line Satisfaction Questionnaire (FLSQ) follow-up Items 1-5; and treatment-emergent adverse events (TEAEs) were evaluated. The modified intent-to-treat population (N=226) had a mean age of 48.0 years, with similar baseline GL severity between treatment groups. Week 24 responder rates were 0% for placebo and 16.0%, 32.0%, 30.6%, and 38.5% for onabotulinumtoxinA 20, 40, 60, and 80 U, with significant (P&lt;0.05) differences for 40 and 80 U vs 20 U. Median duration of response was longer with all higher doses vs 20 U (≥24.0 vs 19.7 weeks; P&lt;0.05 vs 20 U at week 24). FLSQ results indicated high subject satisfaction. TEAE incidence and severity did not exhibit a dose-response effect. 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title Safety, Pharmacodynamic Response, and Treatment Satisfaction With OnabotulinumtoxinA 40 U, 60 U, and 80 U in Subjects With Moderate to Severe Dynamic Glabellar Lines
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