Objective: To assess the duration of rimabotulinumtoxinB action in the management of sialorrhea.

Background: In neurological disorders, sialorrhea (drooling) is both prevalent and problematic. Local injections of botulinum toxin-B (BoNT-B) into the parotid and submandibular glands reduce saliva production, however patients require regular, repeated injections for maintained effectiveness. The standard reinjection schema is set at 12 weeks; however, it is important to understand the duration of action to ensure full symptom coverage over a treatment cycle.

Method: This was a double-blind, placebo-controlled study (NCT01994109). Adult subjects with Parkinson’s disease, amyotrophic lateral sclerosis, medication-induced, stroke and other disorders were randomized (1:1:1) to receive rimabotulinumtoxinB 2500U vs 3500U vs placebo. The last scheduled visit/time of reinjection was flexibly scheduled as 13 ±2 weeks. This post-hoc analysis evaluated the duration of action in those patients who responded (as defined by a 25% reduction in Unstimulated Salivary Flow Rate [USFR]) at peak effect (4 weeks).

Results: Of the 176 patients who completed the double-blind phase, 52/63 (82.5 %) in the 2500U group, 52/64 (81.3%) in the 3500U group and 18/57 (31.6%) in the placebo group were responders at peak effect. The proportion of responding patients (placebo vs. 2500U vs. 3500U) who went on to have their next injection in the open-label phase was 33% vs. 10% vs. 15% at ≤12 weeks; 60% vs. 74% vs. 52% at >12-≤14 weeks; and 7% vs. 16% vs. 33% at >14 weeks.

Conclusion: RimabotulinumtoxinB provided effective treatment for sialorrhea over the duration of the treatment cycle. Most patients had a treatment interval that was longer than the standard 12 weeks (78% had an injection at 13 weeks or later) and a third of patients on the 3500U dose had an interval of more than 14 weeks.

« Back to 2019 International Congress

MDS Abstracts - https://www.mdsabstracts.org/abstract/duration-of-rimabotulinumtoxinb-action-in-the-treatment-of-adult-sialorrhea/