A Direct Comparison of OnabotulinumtoxinA (Botox) and IncobotulinumtoxinA (Xeomin) in the Treatment of Benign Essential Blepharospasm

Saad, Julien; Gourdeau, Alain

doi:10.1097/wno.0000000000000110

Cited by 35 publications

(23 citation statements)

References 10 publications

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“…No differences were found with multiple measures over 5 treatment sessions. 10 Commonly reported adverse events (AEs) with BoNT injections included periorbital hematoma (25%), ptosis (range of risk differences [RDs] 13%-54%), dry eyes (range of RDs 7.1%-13%), and blurred vision (RD 42%).…”

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confidence: 99%

Practice guideline update summary: Botulinum neurotoxin for the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache

et al. 2016

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Objective: To update the 2008 American Academy of Neurology (AAN) guidelines regarding botulinum neurotoxin for blepharospasm, cervical dystonia (CD), headache, and adult spasticity. Methods:We searched the literature for relevant articles and classified them using 2004 AAN criteria.Results and recommendations: Blepharospasm: OnabotulinumtoxinA (onaBoNT-A) and incobotulinumtoxinA (incoBoNT-A) are probably effective and should be considered (Level B). AbobotulinumtoxinA (aboBoNT-A) is possibly effective and may be considered (Level C). CD: AboBoNT-A and rimabotulinumtoxinB (rimaBoNT-B) are established as effective and should be offered (Level A), and onaBoNT-A and incoBoNT-A are probably effective and should be considered (Level B). Adult spasticity: AboBoNT-A, incoBoNT-A, and onaBoNT-A are established as effective and should be offered (Level A), and rimaBoNT-B is probably effective and should be considered (Level B), for upper limb spasticity. AboBoNT-A and onaBoNT-A are established as effective and should be offered (Level A) for lower-limb spasticity. Headache: OnaBoNT-A is established as effective and should be offered to increase headache-free days (Level A) and is probably effective and should be considered to improve health-related quality of life (Level B) in chronic migraine. OnaBoNT-A is established as ineffective and should not be offered for episodic migraine (Level A) and is probably ineffective for chronic tension-type headaches (Level B). Neurology ® 2016;86:1818-1826 GLOSSARY AAN 5 American Academy of Neurology; aboBoNT-A 5 abobotulinumtoxinA; AE 5 adverse event; BDI 5 Blepharospasm Disability Index; BoNT 5 botulinum neurotoxin; CD 5 cervical dystonia; CI 5 confidence interval; CM 5 chronic migraine; DAS 5 Disability Assessment Scale; EM 5 episodic migraine; incoBoNT-A 5 incobotulinumtoxinA; onaBoNT-A 5 onabotulinumtoxinA; QOL 5 quality of life; RD 5 risk difference; rimaBoNT-B 5 rimabotulinumtoxinB; RMT 5 randomized, masked trials; TWSTRS 5 Toronto Western Spasmodic Torticollis Rating Scale; TZD 5 tizanidine.

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confidence: 99%

Practice guideline update summary: Botulinum neurotoxin for the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache

et al. 2016

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“…Another direct comparison of incobotulinumtoxinA and onabotulinumtoxinA was made in a prospective, randomized, double-blind, split-face trial in 48 patients who had previously received onabotulinumtoxinA treatment for blepharospasm ( Table 1 ). 32 Patients received four injections of each formulation to either side of the face, using the same number of dose units for incobotulinumtoxinA and onabotulinumtoxinA. No significant difference was found between incobotulinumtoxinA and onabotulinumtoxinA in the changes from baseline in BSDI scores ( P =0.8161) or JRS scores ( P =0.2314).…”

Section: Clinical Efficacy and Safetymentioning

confidence: 93%

Clinical and pharmacological properties of incobotulinumtoxinA and its use in neurological disorders

Jost¹,

Benecke²,

Hauschke³

et al. 2015

DDDT

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BackgroundIncobotulinumtoxinA (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.SummaryIncobotulinumtoxinA 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.ConclusionIncobotulinumtoxinA 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.

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“…All these data are summarized in the recent AAN guidelines . A direct comparison of onabotulinumtoxinA and incobotulinumtoxinA in the treatment of benign essential blepharospasm, performed using a split-face technique, showed no differences between the two products in either subjective or objective measures (Saad and Gourdeau, 2014). More recently, results of a TRUDOSE pilot study suggested that onabotulinumtoxinA and incobotulinumtoxinA for cervical dystonia and blepharospasm are not equivalent and do not support the 1:1 dose ratio.…”

Section: Pharmacological Safetymentioning

confidence: 99%

Pharmacological differences and clinical implications of various botulinum toxin preparations: a critical appraisal

Ferrari¹,

Manca²,

Tugnoli³

et al. 2018

Functional Neurology

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SummaryThree different type A botulinum neurotoxins (BoNTAs) -onabotulinumtoxinA, abobotulinumtoxinA and incobotulinumtoxinA) -are currently marketed in Europe to treat several conditions. Differences between BoNTA preparations, which depend on their specific biotypes and manufacturing processes, lead to clinically relevant pharmacotherapeutic dissimilarities. All three available products are separately recognized and reviewed in American Academy of Neurology guidelines. The neurotoxin load/100U is likewise different among the different BoNTAs, with the result that the specific potency of the 150kD BoNTA neurotoxin is calculated as 137 units/ng for onabotulinumtoxinA, 154 units/ng for abobotulinumtoxinA, and 227 units/ng for incobotulinumtoxinA. It is important for clinicians to have all three BoNTAs available in order to choose the most suitable preparation for the specific indication in the single patient. Commercially available BoNTAs must be recognized as different from one another, and therefore as non-interchangeable. The essential experience of the clinician is of the utmost importance in choosing the most appropriate treatment.

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A Direct Comparison of OnabotulinumtoxinA (Botox) and IncobotulinumtoxinA (Xeomin) in the Treatment of Benign Essential Blepharospasm

Abstract: No difference between Xeomin and Botox was detected in either subjective or objective measures for the treatment of BEB.

Cited by 35 publications

References 10 publications

Practice guideline update summary: Botulinum neurotoxin for the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache

Practice guideline update summary: Botulinum neurotoxin for the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache

Clinical and pharmacological properties of incobotulinumtoxinA and its use in neurological disorders

Pharmacological differences and clinical implications of various botulinum toxin preparations: a critical appraisal

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