Objective: We evaluate the long-term efficacy and safety of incobotulinumtoxinA injections in advanced Parkinson’s disease (PD) patients suffering from sialorrhea.

Background: Sialorrhea is frequently a bothersome problem in patients with advanced Parkinson’s disease.

Method: Patients with idiopathic Parkinson’s disease suffering from sialorrhea were injected with a total of 100 U incobotulinumtoxinA (3:2 ratio parotid vs. submandibular gland bilaterally) based on anatomical landmarks every 3 months, unless prolonged effect allowed for a longer interinjection interval (up to 6 months).

Efficacy was determined using the 7-point Likert Global Impression of Change Scale (GICS) 6 weeks after each injection, and the Drooling Severity and Frequency Scale (DSFS) at baseline and 6 weeks after every injection.

Results: Four years into the study now we have included 32 advanced PD patients (average age of 79 +/- 6 years). 

GICS consistently scored improvement (value below 4 (=no improvement) on a 7-point Likert scale) with a mean score of 2.9+/-1.2 at 6 weeks after injection 1 and 2.8+/-1.1 at 6 weeks after injection 2. 

The total DSFS decreased from 7.5+/-1.1 at baseline to 6.0+/-1.3 at 6 weeks after the second injection. 

Three patients showed efficacy up to 6 months and two patient stopped injections after respectively 2 and 7 cycles because of a sustained benefit and minimal residual sialorrhea. All other patients continued with their 3-monthly intervals.

Dry mouth, swallowing difficulties and taste disturbances were the only treatment-related adverse events observed. Overall in 16/154 treatment cycles (10.3 % of overall cycles) did side-effects occur. Swallowing difficulties only occurred in 5 cycles (3.2%) in 4 patients. These side-effects spontaneously resolved. In two patients a dose reduction to 75 U incobotulinum toxin was warranted because of moderate swallowing difficulties. Treatment interruption was never warranted.

Conclusion: Our interim results confirm the efficacy and safety of repeated incobotulinumtoxinA injections for sialorrhea in PD patients in a real-world setting. Patients continue to receive the planned 3-monthly injection intervals.

An increased duration of effect (up to 6 months or longer) is being observed in 5 patients.

References: SIAXI Wolfgang H. Jost, Andrzej Friedman, Olaf Michel, Christian Oehlwein, Jaroslaw Slawek, Andrzej Bogucki,Stanislaw Ochudlo, Marta Banach, Fernando Pagan, Birgit Flatau-Baqué, János Csikós, Claire J. Cairney, Andrew Blitzer
Neurology Apr 2019, 92 (17) e1982-e1991; DOI: 10.1212/WNL.0000000000007368

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MDS Abstracts - https://www.mdsabstracts.org/abstract/incobotulinumtoxina-to-treat-sialorrhea-in-parkinsons-disease-a-real-life-study-4-year-interim-results/