Jost Wolfgang H, Benecke Reiner, Hauschke Dieter, Jankovic Joseph, Kaňovský Petr, Roggenkämper Peter, Simpson David M, Comella Cynthia L
Department of Neurology, University of Freiburg, Freiburg, Germany.
Clinic and Policlinic for Neurology, University of Rostock, Rostock, Germany.
Drug Des Devel Ther. 2015 Apr 1;9:1913-26. doi: 10.2147/DDDT.S79193. eCollection 2015.
IncobotulinumtoxinA (Xeomin(®)) is a purified botulinum neurotoxin type A formulation, free from complexing proteins, with proven efficacy and good tolerability for the treatment of neurological conditions such as blepharospasm, cervical dystonia (CD), and post-stroke spasticity of the upper limb. This article provides a comprehensive overview of incobotulinumtoxinA based on randomized controlled trials and prospective clinical studies.
IncobotulinumtoxinA provides clinical efficacy in treating blepharospasm, CD, and upper-limb post-stroke spasticity based on randomized, double-blind, placebo-controlled trials with open-label extension periods (total study duration up to 89 weeks). Adverse events were generally mild or moderate. The most frequent adverse events, probably related to the injections, included eyelid ptosis and dry eye in the treatment of blepharospasm, dysphagia, neck pain, and muscular weakness in patients with CD, and injection site pain and muscular weakness when used for treating spasticity. In blepharospasm and CD, incobotulinumtoxinA was investigated in clinical trials permitting flexible intertreatment intervals based on the individual patient's clinical need; the safety profile of intervals shorter than 12 weeks was comparable to intervals of 12 weeks and longer. There were no cases of newly formed neutralizing antibodies during the Phase III and IV incobotulinumtoxinA trials. Phase III head-to-head trials of incobotulinumtoxinA versus onabotulinumtoxinA for the treatment of blepharospasm and CD have demonstrated therapeutic equivalence of both formulations. Additional Phase III trials of incobotulinumtoxinA in conditions such as lower-limb spasticity, spasticity in children with cerebral palsy, and sialorrhea in various neurological disorders are ongoing.
IncobotulinumtoxinA is an effective, well-tolerated botulinum neurotoxin type A formulation. Data from randomized clinical trials and further observational studies are expected to help physicians to optimize treatment by tailoring the choice of formulation, dose, and treatment intervals to the patient's clinical needs.
因卡波糖毒素A（Xeomin(®)）是一种纯化的A型肉毒杆菌神经毒素制剂，不含复合蛋白，在治疗诸如眼睑痉挛、颈部肌张力障碍（CD）和中风后上肢痉挛等神经疾病方面已证实具有疗效且耐受性良好。本文基于随机对照试验和前瞻性临床研究对因卡波糖毒素A进行了全面概述。
基于随机、双盲、安慰剂对照试验及开放标签延长期（总研究时长长达89周），因卡波糖毒素A在治疗眼睑痉挛、CD和中风后上肢痉挛方面具有临床疗效。不良事件一般为轻度或中度。最常见的不良事件可能与注射有关，包括治疗眼睑痉挛时的上睑下垂和干眼、CD患者的吞咽困难、颈部疼痛和肌肉无力，以及用于治疗痉挛时的注射部位疼痛和肌肉无力。在眼睑痉挛和CD的临床试验中，基于个体患者的临床需求对因卡波糖毒素A进行了灵活的治疗间隔研究；短于12周的治疗间隔的安全性与12周及更长间隔相当。在因卡波糖毒素A的III期和IV期试验中未出现新形成的中和抗体病例。因卡波糖毒素A与A型肉毒毒素用于治疗眼睑痉挛和CD的III期头对头试验已证明两种制剂具有治疗等效性。因卡波糖毒素A在诸如下肢痉挛、脑瘫儿童痉挛以及各种神经疾病中的流涎等病症方面的其他III期试验正在进行中。
因卡波糖毒素A是一种有效且耐受性良好的A型肉毒杆菌神经毒素制剂。随机临床试验和进一步观察性研究的数据有望帮助医生根据患者的临床需求调整制剂选择、剂量和治疗间隔，从而优化治疗方案。
