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) into the parotid and submandibular glands). Furthermore, we evaluate the evolution of the interinjection intervals in terms of duration of effect.

Background: Sialorrhea is frequently a bothersome problem in patients with PD. The SIAXI trial demonstrated the efficacy and safety up to 4 IC of the injection of incobotulinum toxin to treat these patients.

Method: Patients with PD 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.
We actively explored and recorded (if any) the treatment-related adverse events.

Results: Three years into the study now we have included 20 advanced PD patients (average age of 80 +/- 5 years). Inclusion almost completely stalled since the start of the pandemic. 
GICS consistently scored improvement (value below 4 (=no improvement) on a 7-point Likert scale) with a mean score of 2.8+/-0.8 at 6 weeks after injection 1 and 2.6+/-1.2 at 6 weeks after injection 2.
The total DSFS decreased from 14+/-4 at baseline to 9+/-5 at 6 weeks after the second injection (p<0.01).
Dry mouth and swallowing difficulties were the only treatment-related adverse events observed. Overall in only 5/102 treatment cycles (5 % of overall cycles) did side-effects occur. These side-effect spontaneously resolved. In only one patient a dose reduction to 75 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 2 patients.
The increased dropout rate since the start of the COVID pandemic underscores the difficulties in performing clinical trials during the COVID pandemic.

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-2/