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Review
. 2023 Dec 13:14:1275807.
doi: 10.3389/fneur.2023.1275807. eCollection 2023.

Botulinum neurotoxin type A in the interdisciplinary treatment of sialorrhea in adults and children-update and practice recommendations

Wolfgang H Jost  1 , Tobias Bäumer  2 , Andrea Bevot  3 , Ulrich Birkmann  4 , Carsten Buhmann  5 , Maria Grosheva  6 , Orlando Guntinas-Lichius  7 , Rainer Laskawi  8 , Sebastian Paus  9 , Christina Pflug  10 , A Sebastian Schroeder  11 , Björn Spittau  12 , Armin Steffen  13 , Bernd Wilken  14 , Martin Winterholler  15 , Steffen Berweck  16
Affiliations
Review

Botulinum neurotoxin type A in the interdisciplinary treatment of sialorrhea in adults and children-update and practice recommendations

Wolfgang H Jost et al. Front Neurol. .

Abstract

Sialorrhea is defined as a chronic excessive flow of saliva from the mouth, often with adverse consequences for health and quality of life of patients. In addition to currently used non-drug treatment and systemic drugs, intraglandular Botulinum Neurotoxin A (BoNT/A) injections have been examined in case studies, controlled trials and clinical practice. Two pivotal Phase III trials recently led to market approval in the USA and EU for IncobotulinumtoxinA [Xeomin®, IncoBoNT/A, Clostridium botulinum neurotoxin type A (150 kD), free from complexing proteins, Merz Pharmaceuticals GmbH] for treatment of chronic sialorrhea in adults and pediatric patients. This review provides a multidisciplinary approach to discuss the current state of sialorrhea therapy as well as benefits and current limitations of BoNT/A injections. A consensus regarding treatment recommendations made available to physicians in Germany in 2022 has now been updated here for presentation to an international audience. This review provides a framework including a flow chart for patient selection, recommendations for dosing and the injection process, as well as a discussion of therapeutic goals, long-term benefits and safety aspects. This review is aimed at supporting physicians in developing multidisciplinary and individualized treatment approaches to achieve optimal benefits for patients.

Keywords: BoNT/A; IncobotulinumtoxinA; botulinum neurotoxin type A; botulinum toxin; hypersalivation; practice recommendations; quality of life; sialorrhea.

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Conflict of interest statement

The content of this review was created based on interdisciplinary consultations and cooperation with all authors and the consensus recommendations were developed during three working meetings. Merz Therapeutics GmbH supported these meetings financially but had no further influence on the recommendations and the content of this review. WJ is or was a consultant and speaker for AbbVie, Bial, Desitin, Kyowa Kirin, Stada, UCB, Zambon, Pharm Allergan, Ipsen Pharma, and Merz Therapeutics and was principal investigator of the SIAXI study. TB is a consultant for Merz Therapeutics and Pharm Allergan and a speaker for Merz Therapeutics, Pharm Allergan, and Ipsen. He received speaker and consultant fees from the Pelzerhaken Children’s Center, AbbVie/Allergan, Ipsen Pharma, and Merz Therapeutics. He received research grants from Deutsche Forschungsgemeinschaft (FG2698-2) and Ipsen Pharma. AB received consultant and speaker fees from Allergan/AbbVie, Merz Therapeutics, and Novartis. UB received consultant fees from Merz Therapeutics. CB received speaker and/or consultant fees from AbbVie, Bial, Desitin, Kyowa Kirin, Merz Therapeutics, STADA Pharm, TAD Pharma, UCB, and Zambon. MG received speaker and consultant fees from Merz Therapeutics, MSD, and Bayer Vital. OG-L received speaker and consultant fees from Merz Therapeutics, MEDICE, MEDEL, and Novartis. RL is a speaker for Merz Therapeutics. SP is or was a consultant for Bial, Idorsia, Ipsen, Merz Therapeutics, and TEVA and a speaker from AbbVie, Bayer, Bial, Ipsen, Merz Therapeutics, and Novartis. Furthermore, SP is or was involved in clinical studies (phase II and III) for Bayer, Ipsen, and Syneos Health. CP received honoraria as a speaker and/or consultant from AbbVie, Merz Therapeutics, InfectoPharm, and Olympus. ASc was a consultant and speaker for Allergan/AbbVie, Ipsen, Merz Therapeutics, Proveca, and Medice. ASt is a consultant and speaker for Merz Therapeutics, Inspire Medical, and ZOLL Respicardia. He received speaking honoraria and travel support from Intersect Medical and Clinigen. BW received speaker fees from AbbVie/Allergan, Takeda, Novartis, and Eisai. MW received honoraria as a speaker and/or consultant from AbbVie. SB received speaker fees from Merz Therapeutics, Ipsen Pharma, and Pharm Allergan and consultant fees from Merz Therapeutics and Ipsen Pharma. He was principal investigator of the SIPEXI study. The remaining author declares that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The author(s) declared that they were an editorial board member of Frontiers, at the time of submission. This had no impact on the peer review process and the final decision.

Figures

Figure 1
Figure 1
Schematic illustration of the location of the salivary glands. Actual position and size of the salivary glands show patient individual variability. Therefore, ultrasound-guided injection is recommended. (Modified according to Jost W., Atlas der Botulinumtoxin-Injektion © KVM—Der Medizinverlag, Berlin).
Figure 2
Figure 2
Flow chart for selection of patients for BoNT/A treatment. DSFS, Drooling Severity and Frequency Scale; ENT, Ear nose throat physician; FEES, flexible endoscopic evaluation of swallowing; VFSS, videofluoroscopic swallowing study.
Figure 3
Figure 3
Demonstration of ultrasound-guided injection in subject 1 and 2 on the left side, respectively. (A) Submandibular gland, (B) Parotid gland. (Copyright Tobias Bäumer, Institute of Systemic Motor Science, CBBM, University of Lübeck).
See this image and copyright information in PMC

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