Pahwa Rajesh, Molho Eric, Lew Mark, Dashtipour Khashayar, Gil Ramon A, Revilla Fredy J, Clinch Thomas, Qin Peibing, Isaacson Stuart H
University of Kansas Medical Center, 3599 Rainbow Blvd, Kansas City, KS, 66103, USA.
Parkinson's Disease and Movement Disorders Center, Albany Medical Center, Albany, NY, USA.
Neurol Ther. 2025 Jun 11. doi: 10.1007/s40120-025-00777-z.
Botulinum toxin injections into the salivary glands inhibit saliva production by reducing the release of acetylcholine at the parasympathetic nerve terminals within the salivary gland. The phase 3 study reported here assessed the safety, tolerability, and effectiveness of repeated cycles of rimabotulinumtoxinB (RIMA) injections in adults with troublesome sialorrhea.
In this phase 3, open-label multicenter study, 187 adult participants with troublesome sialorrhea due to Parkinson disease (65.8%), amyotrophic lateral sclerosis (13.9%), and other etiologies (20.3%) received up to 4 cycles of RIMA treatment (3500 U every 11-15 weeks).
Participants (69% male, 31% female; mean age 64.1 years) had sialorrhea for a mean of 3.2 years at baseline with a mean Unstimulated Salivary Flow Rate (USFR) of 0.63 ± 0.49 g/min. During the first treatment cycle, RIMA significantly reduced the mean±standard deviation (SD) USFR from baseline to week 4 by - 0.34 ± 0.37 g/min (p < 0.0001), and efficacy was maintained through week 13 (- 0.14 ± 0.29 g/min; p < 0.0001). Reductions were maintained at subsequent injection cycles 2-4, with mean absolute USFRs at weeks 4 and 13 of each cycle similar to those of cycle 1. Most adverse events (AEs) were mild, and the most commonly reported AEs in each cycle that were considered to be treatment-related were dry mouth (≤ 15.5% participants/cycle) and dental caries (≤ 6.0% participants/cycle).
This study demonstrates that RIMA 3500 U safely reduces saliva production over repeated treatment cycles through 1 year, thereby supporting its utility in the management of troublesome sialorrhea in adults.
NCT02610868.
向唾液腺注射肉毒杆菌毒素可通过减少唾液腺内副交感神经末梢乙酰胆碱的释放来抑制唾液分泌。本文报道的3期研究评估了重复注射利美布托毒素B（RIMA）对患有严重流涎症的成年人的安全性、耐受性和有效性。
在这项3期开放标签多中心研究中，187名因帕金森病（65.8%）、肌萎缩侧索硬化症（13.9%）和其他病因（20.3%）导致严重流涎症的成年参与者接受了多达4个周期的RIMA治疗（每11 - 15周注射3500单位）。
参与者（69%为男性，31%为女性；平均年龄64.1岁）在基线时流涎症平均持续3.2年，平均非刺激性唾液流速（USFR）为0.63±0.49克/分钟。在第一个治疗周期中，RIMA使平均±标准差（SD）USFR从基线到第4周显著降低了 - 0.34±0.37克/分钟（p < 0.0001），并且在第13周时疗效得以维持（ - 0.14±0.29克/分钟；p < 0.0001）。在随后的第2 - 4个注射周期中，降低效果得以维持，每个周期第4周和第13周的平均绝对USFR与第1周期相似。大多数不良事件（AE）为轻度，每个周期中最常报告的被认为与治疗相关的AE是口干（≤15.5%参与者/周期）和龋齿（≤6.0%参与者/周期）。
本研究表明，3500单位的RIMA在长达1年的重复治疗周期中能安全地减少唾液分泌，从而支持其在治疗成年人严重流涎症中的应用。
NCT0
