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IncobotulinumtoxinA: A Review in Upper Limb Spasticity

机译:IncobotulinumtoxinA:上肢痉挛的回顾

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摘要

Intramuscular incobotulinumtoxinA (Xeomin (R)) is indicated for the treatment or improvement of adult patients with upper limb spasticity (featured indication), cervical dystonia, blepharospasm and glabellar lines. It is a highly purified formulation of botulinum toxin type A that inhibits acetylcholine signalling at neuromuscular junctions, reducing muscle hypertonia. This narrative review discusses the clinical use of incobotulinumtoxinA in adults with upper limb spasticity and summarizes its pharmacological properties. In single-treatment phase 3 trials, compared with placebo, incobotulinumtoxinA treatment improved muscle tone, global spasticity, functional spasticity-related disability and some aspects of carer burden in adults with upper limb spasticity. These beneficial effects of incobotulinumtoxinA on muscle tone were generally maintained in extension studies, in which up to five additional incobotulinumtoxinA treatments were administered. Functional spasticity-related disability and carer burden were also reduced during longer-term incobotulinumtoxinA treatment. IncobotulinumtoxinA was generally well tolerated in clinical trials, with relatively few patients experiencing treatment-related adverse events, most of which were of mild to moderate intensity. No neutralizing antibodies that would potentially cause secondary nonresponse against incobotulinumtoxinA were detected after single and multiple treatments in these trials or in phase 3 and 4 trials of incobotulinumtoxinA in other indications, which may be an advantage of this purified formulation. Further research would help to more fully determine the impact of neurotoxin purification in terms of reducing the potential risk of immunogenic responses during long-term treatment. Hence, incobotulinumtoxinA is a useful treatment option for upper limb spasticity in adult patients.
机译:肌内注射incobotulinumumxinA(Xeomin(R))用于治疗或改善患有上肢痉挛(特征性适应症),颈肌张力障碍,睑裂和睑板肌线的成年患者。这是一种高度纯化的A型肉毒杆菌毒素制剂,可抑制神经肌肉接头处的乙酰胆碱信号传导,减少肌肉高渗。这篇叙述性评论讨论了incobotulinumtoxinA在上肢痉挛的成人中的临床使用,并总结了其药理特性。在单项治疗的3期试验中,与安慰剂相比,incobotulinumtoxinA治疗可改善成年人上肢痉挛的肌肉张力,整体痉挛,与功能性痉挛相关的残疾以及某些方面的照顾者负担。在扩展研究中,incobotulinumtoxinA对肌张力的这些有益作用通常得以维持,在该研究中,最多进行了五次额外的incobotulinumtoxinA治疗。在长期incobotulinumtoxinA治疗期间,也减少了与功能性痉挛相关的残疾和照顾者负担。在临床试验中,IncobotulinumtoxinA通常被很好地耐受,相对较少的患者经历了与治疗相关的不良事件,其中大多数为轻度至中度强度。在这些试验的单次或多次治疗后,或在其他适应症的3和4期临床试验中,未检测到可能会引起针对incobotulinumtoxinA的继发性无应答的中和抗体,这可能是该纯化制剂的优势。进一步的研究将有助于从减少长期治疗过程中免疫原性反应的潜在风险方面更充分地确定神经毒素纯化的影响。因此,incobotulinumtoxinA是成年患者上肢痉挛的有用治疗选择。

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