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    Original Investigation
    January 13, 2020

    Safety and Efficacy of RimabotulinumtoxinB for Treatment of Sialorrhea in Adults: A Randomized Clinical Trial

    Author Affiliations
    • 1Parkinson’s Disease and Movement Disorder Center of Boca Raton, Boca Raton, Florida
    • 2Houston Methodist Neurological Institute, Houston, Texas
    • 3Weill Cornell Medicine, Houston, Texas
    • 4The University of Texas Health Science Center, San Antonio
    • 5Franklin Neurology, Farmington Hills, Michigan
    • 6Parkinson’s Disease and Movement Disorder Center, Albany Medical Center, Albany, New York
    • 7Georgetown University Medical Center, Washington, DC
    • 8Keck School of Medicine of University of Southern California, Los Angeles
    • 9Loma Linda University Schools of Medicine and Pharmacy, Loma Linda, California
    • 10US WorldMeds LLC, Louisville, Kentucky
    • 11James J. and Joan A. Gardner Family Center for Parkinson’s Disease and Movement Disorders, University of Cincinnati, Cincinnati, Ohio
    JAMA Neurol. Published online January 13, 2020. doi:10.1001/jamaneurol.2019.4565
    Key Points

    Question  Are rimabotulinumtoxinB injections safe and effective for management of sialorrhea in adults?

    Findings  In this randomized clinical trial of 187 adults with sialorrhea, rimabotulinumtoxinB injections (2500 U and 3500 U) appeared to statistically significantly reduce sialorrhea vs placebo (treatment effect, −0.30 for both doses vs placebo, P < .001). Therapeutic benefits were seen as early as 1 week after injection and persisted for 11 to 15 weeks.

    Meaning  RimabotulinumtoxinB is a safe, effective, and well-tolerated treatment for sialorrhea in adults.

    Abstract

    Importance  RimabotulinumtoxinB (RIMA) may be preferable as an anti-sialorrhea treatment compared with current oral anticholinergic drugs in people with neurological disorders.

    Objective  To assess the safety, efficacy, and tolerability of RIMA injections for the treatment of sialorrhea in adults.

    Design, Setting, and Participants  This randomized, parallel, double-blind, placebo-controlled clinical trial of RIMA 2500 U and 3500 U was conducted from November 14, 2013, to January 23, 2017. A total of 249 adult patients with troublesome sialorrhea secondary to any disorder or cause were screened. Of them, 13 refused further participation in the study or were lost to follow-up and 49 did not fulfill the criteria for participation; 187 were ultimately enrolled. Patients had to have a minimum unstimulated salivary flow rate (USFR) of 0.2 g/min and a minimum Drooling Frequency and Severity Scale score of 4.

    Exposures  Patients were randomized 1:1:1 to RIMA, 2500 U (n = 63); RIMA, 3500 U (n = 64); or placebo (n = 60).

    Main Outcomes and Measures  Primary outcomes were the change in USFR from baseline to week 4 and the Clinical Global Impression of Change (CGI-C) at week 4. The CGI-C scores were recorded on a 7-point scale ranging from very much improved to very much worse. Adverse events were recorded throughout the trial period.

    Results  Of 187 patients enrolled (147 men [78.6%]; mean [SD] age, 63.9 [13.3] years), 122 patients had Parkinson disease (65.2%), 13 (7.0%) were stroke survivors, 12 had amyotrophic lateral sclerosis (6.4%), 6 had medication-induced sialorrhea (3.2%), 4 had adult cerebral palsy (2.1%), and 30 had sialorrhea owing to other causes (16.0%). A total of 176 completed the study. Treatment with both doses of RIMA significantly reduced USFR at week 4 vs placebo (mean treatment difference, −0.30 g/min [95% CI, −0.39 to −0.21] for both doses vs placebo, P < .001). The CGI-C scores were statistically significantly improved at week 4 for both treatment groups vs placebo (−1.21 [95% CI, −1.56 to −0.87] for 2500 U, −1.14 [95% CI, −1.49 to −0.80] for 3500 U, both P < .001). Treatment benefits were seen as early as 1 week after injection and were maintained over the treatment cycle of approximately 13 weeks. The RIMA injections were well tolerated compared with placebo. The most common adverse events were self-limited mild to moderate dry mouth, dysphagia, and dental caries.

    Conclusions and Relevance  Treatment with RIMA (2500 U and 3500 U) in adults was well tolerated and reduced sialorrhea, with the onset of the effect at 1 week after the injection. These data support the clinical use of RIMA in the management of sialorrhea in adults.

    Trial Registration  ClinicalTrials.gov identifier: NCT01994109

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