Safety, pharmacodynamic response, and treatment satisfaction with onabotulinumtoxinA 40 U, 60 U, and 80 U in subjects with moderate-to-severe dynamic glabellar lines

Cox, Sue Ellen; Joseph, John; Fagien, Steven; Glaser, Dee Anna; Bruce, Suzanne; Lain, Edward; Yoelin, Steven G; Palm, Melanie D.; Maas, Corey S.; Lei, Xiaofang; Maltman, John; Sangha, Sara; Brin, Mitchell F.

doi:10.1016/j.toxicon.2020.11.368

Cited by 5 publications

(16 citation statements)

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“…For ONA, Cox et al reported that subject satisfaction with the effect of treatment on the facial lines at Week 24 increased from 20 U (24% satisfied subjects) to 40 U (60%) but thereafter decreased with further escalated doses (60 U, 51% and 80 U, 39%). Similar results were obtained for satisfaction with natural look [ 19 ].…”

Section: Resultssupporting

confidence: 86%

“…One study of high-dose ONA treatment of glabellar lines met the inclusion criteria, with results recently presented at the virtual ASDS 2020 Annual Meeting [ 19 ] ( Table 2 ). In this randomized, placebo-controlled, dose-ranging study in 226 women, the highest doses tested (40–80 U, up to 4-fold the on-label dose) of ONA demonstrated longer duration of response.…”

Section: Resultsmentioning

confidence: 99%

“…In this randomized, placebo-controlled, dose-ranging study in 226 women, the highest doses tested (40–80 U, up to 4-fold the on-label dose) of ONA demonstrated longer duration of response. The median time until return to baseline severity score at maximum frown among responders was approximately 24.0 weeks for 40–80 U, compared with a median of 19.7 weeks for the on-label 20 U dose ( p ≤ 0.03 for each comparison of 20 U with a higher dose) [ 19 ] ( Table 2 ). Notably, there was a plateau in terms of duration of response among the 40, 60 and 80 U groups (range: 24.0 to 24.1 weeks).…”

Section: Resultsmentioning

confidence: 99%

“…A 2–2.5-fold increase above the 50 U ABO on-label dose (to 100 or 125 U) extended the median duration of effect to approximately 9 months [ 18 ]. For ONA, increasing the dose by 2–4 times was associated with greater responder rates and longer duration of response than the standard 20 U dose [ 19 ]. A 4-fold increase in the ONA on-label dose (from 20 to 80 U) increased the median duration to around 6 months [ 19 ], although the same duration of response was observed at 40 and 80 U. Dose-ranging studies of INCO also suggest a trend toward increased duration of response with escalating doses; increasing the on-label dose by 3.75-fold (from 20 to 75 U) increased the median duration of response to 7 months [ 20 ] and a 5-fold increase of the on-label dose (to 100 U) increased the median duration to 9 months [ 21 ].…”

Section: Discussionmentioning

confidence: 99%

“…For ONA, increasing the dose by 2–4 times was associated with greater responder rates and longer duration of response than the standard 20 U dose [ 19 ]. A 4-fold increase in the ONA on-label dose (from 20 to 80 U) increased the median duration to around 6 months [ 19 ], although the same duration of response was observed at 40 and 80 U. Dose-ranging studies of INCO also suggest a trend toward increased duration of response with escalating doses; increasing the on-label dose by 3.75-fold (from 20 to 75 U) increased the median duration of response to 7 months [ 20 ] and a 5-fold increase of the on-label dose (to 100 U) increased the median duration to 9 months [ 21 ]. Another BoNT-A product, daxibotulinumtoxinA, under development for the treatment of glabellar lines, has been shown in Phase 3 studies using a dose of 40 U (planned registration dose) to achieve a median duration of response (time to return to baseline from a none or mild response) of 26.0–27.7 weeks (6.1–6.5 months) [ 33 ], which is in the same range as shown for 2.5-fold the on-label dose of INCO [ 21 ] and the on-label dose of ABO reported in Joseph et al [ 18 ] ( Table 2 ).…”

Section: Discussionmentioning

confidence: 99%

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Botulinum Toxin Type A for Glabellar Frown Lines: What Impact of Higher Doses on Outcomes?

Kaufman‐Janette

Cox²,

Dayan

et al. 2021

Toxins

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Botulinum toxin serotype-A (BoNT-A) preparations are widely used to improve the appearance of wrinkles. While effective and well tolerated, patients require retreatment over time to re-establish the effects. There is growing interest from patients as to whether higher doses can prolong response without significantly increasing side effects. We reviewed the efficacy and safety evidence for high-dose BoNT-A treatment of glabellar lines, by evaluating high-dose studies published since 2015. Toxins approved for glabellar line treatment in the US or Europe were considered. “High-dose” indicated doses above the licensed dose for each BoNT-A preparation. Five studies met the inclusion criteria and most were randomized, double-blind trials; designs and population sizes varied. Findings suggested that higher-dose BoNT-A treatment is feasible and may improve response duration without increased safety issues. Around 9 months’ median duration was achieved with a 2–2.5-fold increase of the abobotulinumtoxinA on-label dose, or with a 5-fold increase in incobotulinumtoxinA dose. A 2–4-fold increase of the onabotulinumtoxinA on-label dose yielded a median duration of around 6 months. Importantly, patient satisfaction and natural look remained with increasing abobotulinumtoxinA doses. While more data are needed, these findings may lead to more effective, individually tailored treatment plans to meet patient expectations.

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Section: Resultssupporting

confidence: 86%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Botulinum Toxin Type A for Glabellar Frown Lines: What Impact of Higher Doses on Outcomes?

Kaufman‐Janette

Cox²,

Dayan

et al. 2021

Toxins

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High-Dose Neuromodulators: A Roundtable on Making Sense of the Data in Real-World Clinical Practice

Fabi¹,

Carruthers

Joseph³

et al. 2021

Aesthetic Surgery Journal Open Forum

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Background For aesthetic treatment with botulinum toxin type A (BoNTA), interest in maximizing treatment duration and efficacy has prompted study of doses higher than those used in registration studies. As data emerge, it is important that physicians understand how to apply study findings to their own practice so that patient demand is satisfied in a meaningful way. Objectives To bring together leading experts in neuromodulators for a roundtable discussion on the implications of high-dose BoNTA studies for patient care. Methods The authors reviewed recent data from high-dose BoNTA studies for abobotulinum toxin A, incobotulinum toxin A, and Oonobotulinumtoxin A. Following this review, a moderated group discussion took place. Results Discussion focused on the challenges of data interpretation and extrapolation of study findings for real-world patient care. The authors participated in a candid discussion of whether the observed improvements in duration of treatment effect and patient satisfaction warrant treatment with high-dose regimens delivered as high-concentration injections. Safety was also discussed, as well as economic considerations for both practices and patients. Of note, for BoNTA products, the registration dose, when administered in a smaller total volume, appears to give rise to more durable results than those observed in pivotal trials, implicating product concentration as an important consideration. Importantly, at higher doses, extended duration of effect does not appear to be at the expense of natural-looking results. Conclusions While the authors provide considerations for the development of individual clinical practice, there is no one-size-fits all recommendation. It may be that “high-dose” BoNTA is in reality the optimal dose; however, important economic considerations may prevent rapid uptake in clinical practice for all patients.

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Important Considerations in the High-Dose Toxins Discussion

Brown¹,

Herrmann²,

Gallagher³

2022

Aesthetic Surgery Journal Open Forum

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Safety, pharmacodynamic response, and treatment satisfaction with onabotulinumtoxinA 40 U, 60 U, and 80 U in subjects with moderate-to-severe dynamic glabellar lines

Cited by 5 publications

References 0 publications

Botulinum Toxin Type A for Glabellar Frown Lines: What Impact of Higher Doses on Outcomes?

Botulinum Toxin Type A for Glabellar Frown Lines: What Impact of Higher Doses on Outcomes?

High-Dose Neuromodulators: A Roundtable on Making Sense of the Data in Real-World Clinical Practice

Important Considerations in the High-Dose Toxins Discussion

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