Long-term incobotulinumtoxinA treatment for chronic sialorrhea: Efficacy and safety over 64 weeks.

Abstract

BACKGROUND:

Botulinum neurotoxin (BoNT) is an effective treatment for chronic sialorrhea; however, reliable and robust evidence supporting long-term efficacy and safety is lacking. This study investigated the efficacy and safety of repeated incobotulinumtoxinA injections for chronic sialorrhea over 64 weeks.

METHODS:

Adults with sialorrhea were randomized (2:2:1) to incobotulinumtoxinA 75 U, incobotulinumtoxinA 100 U (n = 74 each), or placebo (n = 36) in the double-blind, placebo-controlled main period (NCT02091739). Eligible subjects entered the extension period and received dose-blinded incobotulinumtoxinA 75 or 100 U in three further 16±2-week injection cycles. Efficacy and safety assessments in subjects who received incobotulinumtoxinA throughout the study included unstimulated salivary flow rate (uSFR), subjects' Global Impression of Change Scale (GICS), Drooling Severity and Frequency Scale (DSFS), modified Radboud Oral Motor Inventory for Parkinson's Disease (mROMP) drooling, speech, and swallowing symptom scores, and incidence of adverse events (AEs).

RESULTS:

In total, 173/184 subjects (94%) completed the main period and entered the extension period; 141 subjects received incobotulinumtoxinA 75 U (n = 69) or 100 U (n = 72) in both periods. Mean uSFR decreased consistently with repeated incobotulinumtoxinA 75 and 100 U treatment and by -0.16 and -0.17, respectively, at the end-of-study visit. Subjects' GICS, DSFS, and mROMP drooling scores also improved at all assessments. mROMP speech and swallowing scores remained stable. The most common treatment-related AEs during the extension period were dry mouth (4.4% and 11.1%) and dysphagia (1.5% and 4.2%).

CONCLUSIONS:

Data support long-term efficacy and safety of repeated incobotulinumtoxinA treatment for sialorrhea, with no additional safety concerns reported over 64 weeks.

• Authors: Wolfgang H Jost, Andrzej Friedman, Olaf Michel, Christian Oehlwein, Jaroslaw Slawek, Andrzej Bogucki, Stanislaw Ochudlo, Marta Banach, Fernando Pagan, Birgit Flatau-Baqué, Ulrike Dorsch, János Csikós, Andrew Blitzer
• Journal: Parkinsonism & related disorders (Parkinsonism Relat Disord) Vol. 70 Pg. 23-30 (01 2020) ISSN: 1873-5126 [Electronic] England
• PMID: 31794936 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2019. Published by Elsevier Ltd.

Chemical References

• Neuromuscular Agents
• Botulinum Toxins, Type A
• incobotulinumtoxinA

Topics

• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Botulinum Toxins, Type A (administration & dosage, adverse effects, pharmacology)
• Brain Diseases (complications)
• Chronic Disease
• Double-Blind Method
• Female
• Humans
• Male
• Middle Aged
• Neuromuscular Agents (administration & dosage, adverse effects, pharmacology)
• Outcome Assessment, Health Care
• Parkinson Disease (complications)
• Prospective Studies
• Sialorrhea (drug therapy, etiology, physiopathology)
• Time Factors
• Young Adult