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

Abstract

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.

PrabotulinumtoxinA vs OnabotulinumtoxinA for the Treatment of Adult Males With Moderate to Severe Glabellar Lines: Post-hoc Analyses of the Phase III Clinical Study Data

“…It may simply be that, due to the greater glabellar muscle mass typical of males, 28 males tend to exhibit more dynamic and severe glabellar lines than females and accordingly require higher doses of botulinum toxin to achieve a satisfactory response. 7 , 9 , 28 , 29 …”

SAMCEP Society consensus on the treatment of upper facial lines with botulinum neurotoxin type A: A tailored approach

“…Several international consensus recommendations and guidelines have been published in the last few years. 8,10,[13][14][15][16] The aim of the current consensus was to provide detailed and tailored injection protocols for the three upper facial indications approved in France, combining the experts' significant injection experience with the latest anatomical knowledge and injection techniques. This information is intended to assist injectors with less experience to develop the skills for optimal and safe patient outcomes.…”

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

“…Rather unusually, the paper reads as a summary of a roundtable discussion between experts on the use of botulinum toxin for aesthetic facial rejuvenation, with a specific focus on whether changes to the existing dose-concentration standards might deliver more durable effects given that the current manufacturer guidelines are based on commercial and regulatory factors rather than optimized clinical standards (Video). 1 The first important point raised by the paper is evidence in the literature to suggest that, when aliquots are administered at a higher concentration, the median time to return to baseline seems to be prolonged. In other words, the typical formulae for administration have not been optimized.…”