Category: Parkinson’s Disease: Clinical Trials
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
To cite this abstract in AMA style:
B. Bergmans, N. Winter, V. Schotte, N. Sys, E. van Massenhove, G. Pollet, H. Couckuyt, L. Delameilleure, M. van Zandijcke. Incobotulinumtoxin A to Treat Sialorrhea in Parkinson’s Disease: a Real-life Study: 5-year Interim Results [abstract]. Mov Disord. 2024; 39 (suppl 1). https://www.mdsabstracts.org/abstract/incobotulinumtoxin-a-to-treat-sialorrhea-in-parkinsons-disease-a-real-life-study-5-year-interim-results/. Accessed October 6, 2024.« Back to 2024 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/incobotulinumtoxin-a-to-treat-sialorrhea-in-parkinsons-disease-a-real-life-study-5-year-interim-results/