Objective: We evaluate the long-term efficacy and safety of incobotulinumtoxinA injections in advanced Parkinson’s disease (PD) patients suffering from sialorrhea (10 injection cycles (IC)).

Background: Sialorrhea is frequently a bothersome problem in patients with advanced PD. The SIAXI trial demonstrated the efficacy and safety up to 4 IC over 64 weeks of the injection of incobotulinum toxin into the parotid and submandibular glands.

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.

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: Five years into the study now we have included 36 advanced PD patients (average age of 78 +/- 6 years). 61% had already received botulinum toxin injections for sialorrhea before.

GICS consistently scored improvement (value below 4) with a mean score of 3.0+/-1.1 at 6 weeks after injection 1. Also over the longer term this benefit is preserved with a GICS mean score of 3.0+/-1.1 at 6 weeks after injection 6.

The total DSFS decreased from 7.5+/-1.3 at baseline to 6.4+/-1.3 at 6 weeks after the second injection. Also over the longer term this benefit is preserved with a DSFS mean score of 6.4+/-1.6 at 6 weeks after injection 6.

Five patients (13,9%) showed efficacy up to 6 months and six patients (16,7%) stopped injections because of a sustained benefit. 

Overall in 29/184 treatment cycles (15.8 % of overall cycles) did side-effects occur. Swallowing difficulties occurred in 18 cycles (9.8%) in 11 patients. These side-effects spontaneously resolved. In five patients a dose reduction to 75 U or 60 U incobotulinum toxin was warranted because of moderate swallowing difficulties.

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 11 patients (30,6%).

We recommend starting with 75 U incobotulinum toxin in patients with pre-existing swallowing difficulties.

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/incobotulinumtoxin-a-to-treat-sialorrhea-in-parkinsons-disease-a-real-life-study-5-year-interim-results/