PHOENIX — Botulinum toxin injections offered relief from sialorrhea, or excessive saliva production, in patients with amyotrophic lateral sclerosis (ALS), according to a small study.
The retrospective review identified 19 veterans at a single ALS center from 2013 to 2023, and their health records were evaluated for frequency and timing of botulinum toxin (BoNT) injections, as well as immediate adverse events (AEs), explained Joshua Wilson, MD, of the University of Washington/Seattle VA Medical Center.
Wilson and colleagues reported in a poster at the American Association of Neuromuscular & Electrodiagnostic Medicine annual meeting that 47.7% received more than one BoNT injection, and that 26.3% stopped injections due to salivary secretion changes. Also in 26%, one or more antisialagogues were stopped after BoNT injections. Before the study intervention, a third of the patients were taking ≥3 of more oral medications at a given time, they said.
Finally, there were no immediate postprocedural complications, according to Wilson’s group.
Following tracheostomy, nearly 88% continued to get BoNT injections. “For most of the patients, [BoTN injection] is a temporary fix, but it is nondurable,” Wilson stated.
Nonetheless, “botulinum toxin injections appear to be a well-tolerated and safe therapy for sialorrhea in patients with ALS compared to the well-known systemic side effects of anticholinergic medications,” Wilson told MedPage Today. While the current study did not do a direct comparison between BoTN injection and oral medications, “we found that with botulinum toxin injections, some of the patients were able to stop some of their systemic therapies,” he noted.
Wilson said that he plans to explore the possibility of making BoNT injections for ALS sialorrhea front-line therapy: “Because we work at the Veterans Affairs facilities, we are fortunate that we don’t have to usually wait for insurance authorization, and I think we may want to see if we can begin botulinum toxin therapy a little sooner.”
People with ALS often have difficulty with swallowing, Wilson said, and ALS-associated excess secretions of saliva in the mouth can lead to aspiration. “It can be risky and can lead to bulbar crises, and frequent trips to the hospital and ICU,” he said. “Sialorrhea is common among patients with ALS, and the patients absolutely hate it. They often have to stop to wipe their mouth and have to suction these secretions from their mouth and throat,” adding that sialorrhea can lead to more social isolation because ALS patients are anxious about leaving home and not having access to suction devices.
The FDA approved incobotulinumtoxinA (Xeomin) in 2018 for chronic sialorrhea in adults, and in 2020 for chronic sialorrhea in patients ages ≥2 years, and for the treatment of upper limb spasticity. But “there has been a paucity of investigations into its use in patient with ALS,” according to Wilson.
Wilson explained that the review of records for patients on antisialagogues included comments such as “These drugs make my mouth dry” and “The atropine gives me dry mouth.”
In terms of BoTN injection timing, Wilson said that “usually we give the treatments every 3 months, and sometimes we can push that to every 6 months because that’s when the effects of the toxin begin to wear off.”
As for AEs, “we had no cellulitis; we had no seromas; we didn’t see any new soft tissue infections in the mouth,” he said. “We checked for pretty much everything we could check, and didn’t find anything harmful with botulinum toxin treatments in the ALS patients with sialorrhea.”
Morgan Heber, MD, of the Cleveland Clinic, told MedPage Today that “This is definitely a promising treatment option for these patients to avoid medications that have side effects, and possibly giving them relief from sialorrhea.”
Heber, who was not involved in the study, explained that “I know this is listed as an option for treatment of our patients at the Cleveland Clinic, but I am not aware of anyone using it very often. After seeing this work, I think that there may be potential for using botulinum toxin injections in these individuals.”
Wilson disclosed no relationships with industry. A co-author is an employee of Merz Therapeutics, the developer of Xeomin.
Heber disclosed no relationships with industry.
American Association of Neuromuscular & Electrodiagnostic Medicine
Source Reference: Wilson J, et al “Longitudinal management of sialorrhea in Veterans with ALS using botulinum toxin” AANEM 2023.