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Introduction <p>Botulinum toxin injections into the salivary glands inhibit saliva production by reducing the release of acetylcholine at the parasympathetic nerve terminals within the salivary gland. The phase 3 study reported here assessed the safety, tolerability, and effectiveness of repeated cycles of rimabotulinumtoxinB (RIMA) injections in adults with troublesome sialorrhea.</p> Methods <p>In this phase 3, open-label multicenter study, 187 adult participants with troublesome sialorrhea due to Parkinson disease (65.8%), amyotrophic lateral sclerosis (13.9%), and other etiologies (20.3%) received up to 4 cycles of RIMA treatment (3500 U every 11–15 weeks).</p> Results <p>Participants (69% male, 31% female; mean age 64.1 years) had sialorrhea for a mean of&#xa0;3.2 years at baseline with a mean Unstimulated Salivary&#xa0;Flow Rate (USFR) of 0.63 ± 0.49 g/min. During the first treatment cycle, RIMA significantly reduced the mean±standard deviation (SD) USFR from baseline to week 4 by –&#xa0;0.34 ± 0.37 g/min (<i>p</i> &lt; 0.0001), and efficacy was maintained through week 13 (–&#xa0;0.14 ± 0.29 g/min; <i>p</i> &lt; 0.0001). Reductions were maintained at subsequent injection cycles 2–4, with mean absolute USFRs at weeks 4 and 13 of each cycle similar to those of cycle 1. Most adverse events (AEs) were mild, and the most commonly reported AEs in each cycle that were considered to be treatment-related were dry mouth (≤ 15.5% participants/cycle) and dental caries (≤ 6.0% participants/cycle).</p> Conclusion <p>This study demonstrates that RIMA 3500 U safely reduces saliva production over repeated treatment cycles through 1&#xa0;year, thereby supporting its utility in the management of troublesome sialorrhea in adults.</p> ClinicalTrials.gov identifier <p>NCT02610868.</p>

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Long-Term Safety and Efficacy of Repeated Cycles of RimabotulinumtoxinB in the Treatment of Chronic Sialorrhea: Results of the OPTIMYST Trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年6月11日

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  • Rajesh Pahwa,
  • Eric Molho,
  • Mark Lew,
  • Khashayar Dashtipour,
  • Ramon A. Gil,
  • Fredy J. Revilla,
  • Thomas Clinch,
  • Peibing Qin,
  • Stuart H. Isaacson,
  • Pinky Agarwal,
  • Jason Aldred,
  • Susan Criswell,
  • Virgilio Gerald Evidente,
  • Alan Freeman,
  • Stephen Grill,
  • Philip Hanna,
  • Patrick Hogan,
  • Jennifer S. Hui,
  • Olga Klepitskaya,
  • Kevin Klos,
  • Eric Dale Kramer,
  • Mark LeDoux,
  • Jonathan McKinnon,
  • Guillermo D. Moguel-Cobos,
  • Atul T. Patel,
  • Joseph Savitt,
  • Yaryna Brozhyk,
  • Nataliya Buchakchyiska,
  • Lyudmyla Dzyak,
  • Viktoriia Gryb,
  • Iryna Khubetova,
  • Yanosh Sanotskyy,
  • Volodymyr Smolanka,
  • Nataliya Voloshyna,
  • Yuri Alekseenko,
  • Andriy Dubenko,
  • Zigmund Gedrevich,
  • Sergei Likhachev,
  • Siarhei Lialikau,
  • Tatsyana Mikhailava,
  • Natalya Mitkovskaya,
  • Volha Moguchaya,
  • Konstantin Shelepen

摘要

Introduction

Botulinum toxin injections into the salivary glands inhibit saliva production by reducing the release of acetylcholine at the parasympathetic nerve terminals within the salivary gland. The phase 3 study reported here assessed the safety, tolerability, and effectiveness of repeated cycles of rimabotulinumtoxinB (RIMA) injections in adults with troublesome sialorrhea.

Methods

In this phase 3, open-label multicenter study, 187 adult participants with troublesome sialorrhea due to Parkinson disease (65.8%), amyotrophic lateral sclerosis (13.9%), and other etiologies (20.3%) received up to 4 cycles of RIMA treatment (3500 U every 11–15 weeks).

Results

Participants (69% male, 31% female; mean age 64.1 years) had sialorrhea for a mean of 3.2 years at baseline with a mean Unstimulated Salivary Flow Rate (USFR) of 0.63 ± 0.49 g/min. During the first treatment cycle, RIMA significantly reduced the mean±standard deviation (SD) USFR from baseline to week 4 by – 0.34 ± 0.37 g/min (p < 0.0001), and efficacy was maintained through week 13 (– 0.14 ± 0.29 g/min; p < 0.0001). Reductions were maintained at subsequent injection cycles 2–4, with mean absolute USFRs at weeks 4 and 13 of each cycle similar to those of cycle 1. Most adverse events (AEs) were mild, and the most commonly reported AEs in each cycle that were considered to be treatment-related were dry mouth (≤ 15.5% participants/cycle) and dental caries (≤ 6.0% participants/cycle).

Conclusion

This study demonstrates that RIMA 3500 U safely reduces saliva production over repeated treatment cycles through 1 year, thereby supporting its utility in the management of troublesome sialorrhea in adults.

ClinicalTrials.gov identifier

NCT02610868.