RimabotulinumtoxinB reduces sialorrhea associated with neurologic, other disorders

  • Isaacson SH & al.
  • JAMA Neurol
  • 13/01/2020

  • Susan London
  • Clinical Essentials
L'accesso ai contenuti di questo sito è riservato agli operatori del settore sanitario italiano L'accesso ai contenuti di questo sito è riservato agli operatori del settore sanitario italiano

Takeaway

  • RimabotulinumtoxinB (RIMA) was safe and efficacious for alleviating sialorrhea associated with Parkinson’s disease, stroke, amyotrophic lateral sclerosis, and other disorders.

Why this matters

  • Sialorrhea is associated with substantial morbidity, impaired QoL, social stigma.

Key results

  • At 4 weeks, vs placebo, RIMA 2500 and 3500 U:
    • Reduced unstimulated salivary flow rate (–0.30 g/minute; P<.001 and g p>
    • Improved Clinical Global Impression of Change score (–1.21; P<.001 and p>
  • Treatment benefits emerged within 1 week, durable out to ~13 weeks.
  • Most common adverse events (largely mild/moderate, self-limited) RIMA vs placebo:
    • Dry mouth (38.1%-45.3% vs 8.3%),
    • Dysphagia (4.7%-11.1% vs 1.7%), and
    • Dental caries (4.7%-7.9% vs 3.3%).
  • Efficacy, safety similar regardless of injection technique, sialorrhea cause (Parkinson’s disease vs other), illness severity, sex, age.

Study design

  • A US, Ukrainian, Russian phase 3 randomized controlled trial among 187 adults with troublesome sialorrhea due to any disorder, cause (MYSTICOL trial):
    • Unstimulated salivary flow rate ≥0.2 g/minute and
    • Drooling Frequency and Severity Scale score ≥4.
  • Randomization: double-blind RIMA 2500 U vs RIMA 3500 U vs placebo.
  • Main outcomes: unstimulated salivary flow rate, Clinical Global Impression of Change.
  • Funding: WorldMeds LLC.

Limitations

  • Fixed-dose design.
  • Predominantly white study population.
  • No active comparator.
  • Long-term efficacy, safety, immunogenicity unknown.