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 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 advanced Parkinson’s disease. The SIAXI trial demonstrated the short-term efficacy and safety of the injection of incobotulinum toxin into the parotid and submandibular glands to treat these patients.

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.
We actively explored and recorded (if any) the treatment-related adverse events.

Results: During the first year of the study we have included 16 advanced PD patients (average age of 81 +/- 6 years; average disease duration of 11 +/- 8 years). 69% had already received botulinum toxin injections for sialorrhea before.
GICS consistently scored improvement (value below 4 (4=no improvement) on a 7-point Likert scale) with a mean score of 2.4+/-0.8 at 6 weeks after injection 1 and 2.5+/-1.3 at 6 weeks after injection 2.
The total DSFS decreased from 14+/-5 at baseline to 9+/-6 at 6 weeks after the second injection.
One patient showed efficacy up to 6 months, while the majority of patients was kept on the 3-months schedule.
Dry mouth was the only treatment-related adverse event observed. 2 patients had dry mouth in 3 cycles (7 % of overall cycles). None of the recorded cases were resolved in later cycles so far. However, this symptom was so mild that interrupting the treatment 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) is being observed in 1 patient.

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/