Safety Recommendations For Treatment With Botulinum Toxin During The Covid-19 Pandemic Prepared By The Italian Botulinum Toxin Network In Collaboration With The Accademia Limpe-Dismov, Sisc, And Anircef Associations

Bono F,Marchese R,Albanese A,De Cesaris F, Altavista M,Eleopra R, Anircef associations

TOXICON(2021)

Cited 1|Views0
No score
Abstract
s Toxicon 190 (2020) GmbH, Frankfurt am Main, Germany; Columbia University Irving Medical Center/New York Presbyterian Hospital, New York, NY, USA E-mail address: sberweck@schoen-klinik.de * Corresponding author: Center for Botulinum Toxin Therapy, Neurology Unit, A.O.U. Mater Domini, Catanzaro, 88100, CZ, Italy. Introduction and Objectives: The SIPEXI study investigated the efficacy and safety of repeated intraglandular incobotulinumtoxinA (incoBoNT/A) injections for sialorrhea associated with neurological disorders, also in young children aged 2-5 years (yrs). Methods: SIPEXI was a prospective, multicenter, phase III study (NCT02270736) enrolling children with chronic sialorrhea associated with neurological disorders and/or intellectual disability. The younger cohort of 2to 5-year-olds (N1⁄435) was recruited after older children had been enrolled and assessed for safety. The 2to 5-year-olds received up to 4 injection cycles (ICs) of incoBoNT/A with body weightedependent doses according to weight classes of around 2 U/kg. The follow-up period was 16 weeks per IC. Efficacy outcomes included Carers’ Global Impression of Change Scale (GICS) ratings (scale from -3 [very much worse] to +3 [very much improved]). Adverse events (AEs) were recorded. AEs of special interest (AESIs, including dysphagia, aspiration, and pneumonia aspiration) were questioned. Results: We present the results for 2to 5-year-old patients (mean age 4 yrs; 57% with cerebral palsy; >94% with intellectual disability). Thirty-five patients were treated with incoBoNT/A, 33 out of 35 completed all 4 ICs. Good treatment effects were seen, although results were descriptive only (small sample size) (Figure). GICS ratings showed consistent improvements at all visits, with mean ratings around +1.1. Other endpoints supported the results. A sustained effect of incoBoNT/A was seen after repeated ICs, with notable improvements over time. The AE rate varied between the ICs (1st: 14.3%; 2nd: 21.2%; 3rd: 15.2%; 4th: 33.3%). Few related AEs and serious AEs (non-related) and no AESIs occurred. Most AEs were respiratory infections. No unexpected safety concerns arose. Conclusions: Treatment of chronic sialorrhea with body weightedependent doses of incoBoNT/A showed clinically relevant improvements and few and minor side effects in children aged 2-5 years. Funding: Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany Fig 1. Carers’ Global Impression of Change Scale (GICS) mean ratings for 2to 5-yearolds. GICS 7-point scale from -3 (very much worse) to +3 (very much improved). S9
More
Translated text
Key words
Botulinum toxin, COVID-19 pandemic, Italian Botulinum Toxin Network, Rete Italiana Tossina Botulinica, Safety Recommendations, SARS-CoV-2 infection
AI Read Science
Must-Reading Tree
Example
Generate MRT to find the research sequence of this paper
Chat Paper
Summary is being generated by the instructions you defined