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.

Glycopyrrolate Improves Disability From Sialorrhea in Parkinson's Disease: A 12‐Week Controlled Trial

“…The use of an outcome that measures the impact of treatment on activities of daily living related to sialorrhea in patients with PD will strengthen the approval decision of a new indication because novel patient-reported outcomes are prioritized by regulatory agencies to better assess the impact of novel interventions in the life of patients. 9 This option is in contrast with recent double-blind, placebocontrolled trials conducted with incobotulinumtoxinA 10 and rimabotulinumtoxinA 11 using an unstimulated salivary flow rate as a primary outcome in an adult population with sialorrhea associated with various etiologies. These 2 studies have expanded the evidence efficacy of incobotulinumtoxinA 10 and rimabotulinumtoxinA 11 for a period of 12 weeks using a placebo-controlled design.…”

“…9 This option is in contrast with recent double-blind, placebocontrolled trials conducted with incobotulinumtoxinA 10 and rimabotulinumtoxinA 11 using an unstimulated salivary flow rate as a primary outcome in an adult population with sialorrhea associated with various etiologies. These 2 studies have expanded the evidence efficacy of incobotulinumtoxinA 10 and rimabotulinumtoxinA 11 for a period of 12 weeks using a placebo-controlled design. Compared with BonT, glycopyrrolate is associated with greater ease of administration in elderly populations with frequent mobility problems that may limit the accessibility to a BonT center.…”

Impacto do uso da Toxina Botulínica em pacientes com Doença de Parkinson: uma revisão Sistemática

“…Houve uma melhora na severidade e frequência da saliva, além disso, as pontuações dos sintomas de fala permaneceram estáveis ao longo do estudo. Efeitos adversos foram relatados, sendo em sua grande maioria leve ou moderado, o mais frequente foi boca seca por 3 (4,4%) e 9 (12,5), outros efeitos foram disfagia relatado por 1 (1,5%), e 3 (4,2%), e distúrbio da fala relatado por 2 (2,9%) e zero pacientes após o uso da TB-A 75U e 100U respectivamente 14 .…”

“…Jost 202014 realizaram um estudo no qual foram selecionados adultos com idade média entre 18-80 anos com DP, Parkinsonismo atípico, acidente vascular cerebral (AVC) ou lesão cerebral traumática. O estudo investigou a eficácia a longo prazo e a segurança de Toxina botulínica tipo A (TxB-A) 75 e 100U para o tratamento da sialorreia crônica durante 64 semanas.…”

Autonomic Dysfunction in Parkinson's Disease

“…Sublingual administration of 1% atropine eye drops, one drop once or twice daily, may reduce saliva production while avoiding systemic anticholinergic effects [54]. However, intraparotid injection of botulinum toxin, either type A or type B, has now become the primary treatment approach to treating troublesome drooling in persons with PD by reducing saliva production, typically producing benefit that persists for 3 months or more [55][56][57][58].…”