A Quantitative Analysis of OnabotulinumtoxinA, AbobotulinumtoxinA, and IncobotulinumtoxinA: A Randomized, Double-Blind, Prospective Clinical Trial of Comparative Dynamic Strain Reduction

Wilson, Anthony J.; Chang, Brian L.; Taglienti, Anthony J.; Chin, Bianca C.; Chang, Catherine S.; Folsom, Nancy; Percec, Ivona

doi:10.1097/prs.0000000000002076

Cited by 22 publications

(8 citation statements)

References 25 publications

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“…We found that the dose ratio relationship between the two botulinum toxins was much more complex in the real world than was suggested by consensus panels [ 35 ] or meta-analyses of clinical trials [ 36 ], both of which concluded the botulinum toxins were equipotent and could be switched using a 1:1 conversion ratio. In this study, the incobotulinumtoxinA to onabotulinumtoxinA dose ratio was >1 across both conditions; there was considerable variability in the dose ratio and the inter-injection interval at an individual patient level, but mean dose ratios were all >1 and are consistent with the results of Kollowe and colleagues [ 18 ], Wilson [ 28 ], Thomas [ 29 ], and the preclinical studies cited above. Our results support that there is no fixed-dose ratio conversion between incobotulinumtoxinA and onabotulinumtoxinA, and consistent with the product label and recommendations from regulatory agencies, the potency units of onabotulinumtoxinA are not interchangeable with other botulinum toxin type A products [ 37 ].…”

Section: Discussionsupporting

confidence: 89%

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Real-World Dosing of OnabotulinumtoxinA and IncobotulinumtoxinA for Cervical Dystonia and Blepharospasm: Results from TRUDOSE and TRUDOSE II

Kent

Robertson

Aguilar³

et al. 2021

Toxins

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The real-world use of onabotulinumtoxinA and incobotulinumtoxinA for cervical dystonia and blepharospasm treatment was assessed in two separate retrospective studies using identical protocols (TRUDOSE and TRUDOSE II). The studies were conducted in Mexico, Norway, and United Kingdom and designed to evaluate dose utilization of the two botulinum toxins in clinical practice. Eighty-three patients treated with both onabotulinumtoxinA and incobotulinumtoxinA for ≥2 years for each botulinum toxin were included, (52, cervical dystonia; 31, blepharospasm). All patients switched from onabotulinumtoxinA to incobotulinumtoxinA for administrative/financial reasons. A range of dose ratios (incobotulinumtoxinA to onabotulinumtoxinA) was reported; with the majority of dose ratios being >1. The mean dose ratio was >1 regardless of the study site or underlying clinical condition. The inter-injection interval was significantly longer for onabotulinumtoxinA versus incobotulinumtoxinA when assessed for all patients (15.5 vs. 14.3 weeks; p = 0.006), resulting in fewer onabotulinumtoxinA treatments over the study time period. Consistent with product labeling, no single fixed-dose ratio exists between incobotulinumtoxinA and onabotulinumtoxinA. The dosage of each should be individualized based on patient needs and used as per product labeling. These real-world utilization data may have pharmacoeconomic implications.

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Section: Discussionsupporting

confidence: 89%

“…With respect to its potential to treat blepharospasm, studies suggest that onabotulinumtoxinA (20 U) and abobotulinumtoxinA (60 U) significantly outperform incobotulinumtoxinA (20 U) based on dynamic strain reduction after injection into the glabella [ 28 ], and sustained improvements in facial synkinesias at week 4 [ 29 ].…”

Section: Discussionmentioning

confidence: 99%

Real-World Dosing of OnabotulinumtoxinA and IncobotulinumtoxinA for Cervical Dystonia and Blepharospasm: Results from TRUDOSE and TRUDOSE II

Kent

Robertson

Aguilar³

et al. 2021

Toxins

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“…Since the introduction of incobotA (Merz Pharmaceuticals received FDA approval in 2010), there has been on-going debate within the literature as to the interchangeability of incobotA and onabotA at a uniform clinical dose conversion (1:1) ratio across a variety of indications (reviewed in [ 19 , 20 , 26 , 37 , 38 ]). Many studies refute the interchangeability of these products [ 24 , 25 , 39 , 40 , 41 , 42 ] and highlight that differences in injection volumes, patterns, and techniques, as well as distribution/diffusion patterns and other factors, vary between BoNT/A products [ 26 ]. For example, Moers-Carpi et al found that 20 U of onabotA was as effective as 30 U of incobotA at treating glabellar lines in a randomized, double-blind study [ 24 ], demonstrating the non-interchangeability of units of onabotA and incobotA in this indication.…”

Section: Discussionmentioning

confidence: 99%

OnabotulinumtoxinA Displays Greater Biological Activity Compared to IncobotulinumtoxinA, Demonstrating Non-Interchangeability in Both In Vitro and In Vivo Assays

Rupp

Nicholson

Canty

et al. 2020

Toxins

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Differences in botulinum neurotoxin manufacturing, formulation, and potency evaluation can impact dose and biological activity, which ultimately affect duration of action. The potency of different labeled vials of incobotulinumtoxinA (Xeomin®; 50 U, 100 U, or 200 U vials; incobotA) versus onabotulinumtoxinA (BOTOX®; 100 U vial; onabotA) were compared on a unit-to-unit basis to assess biological activity using in vitro (light-chain activity high-performance liquid chromatography (LCA-HPLC) and cell-based potency assay (CBPA)) and in vivo (rat compound muscle action potential (CMAP) and mouse digit abduction score (DAS)) assays. Using LCA-HPLC, incobotA units displayed approximately 54% of the protease activity of label-stated equivalent onabotA units. Lower potency, reflected by higher EC50, ID50, and ED50 values (pooled mean ± SEM), was displayed by incobotA compared to onabotA in the CBPA (EC50: incobotA 7.6 ± 0.7 U/mL; onabotA 5.9 ± 0.5 U/mL), CMAP (ID50: incobotA 0.078 ± 0.005 U/rat; onabotA 0.053 ± 0.004 U/rat), and DAS (ED50: incobotA 14.2 ± 0.5 U/kg; onabotA 8.7 ± 0.3 U/kg) assays. Lastly, in the DAS assay, onabotA had a longer duration of action compared to incobotA when dosed at label-stated equivalent units. In summary, onabotA consistently displayed greater biological activity than incobotA in two in vitro and two in vivo assays. Differences in the assay results do not support dose interchangeability between the two products.

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“… 3 Each of these neurotoxins is formulated differently, has a different manufacturing process, and demonstrates unique characteristics, and subsequently, these products are not interchangeable ( Table 2 ). 15 For safe clinical practice and achieving optimal results for a given indication, the practitioners need to understand the clinical issues of potency, conversion ratio, and safety (toxin spread and immunogenicity). A correct and optimal treatment plan and procedure requires an in-depth knowledge of the product(s) used, anatomy, and injection technique.…”

Section: Bont-a Formulationsmentioning

confidence: 99%

Botulinum neurotoxin formulations: overcoming the confusion

Samizadeh¹,

Boulle²

2018

CCID

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Botulinum toxin A is produced by anaerobic spore-forming bacteria and is used for various therapeutic and cosmetic purposes. Botulinum toxin A injections are the most popular nonsurgical procedure worldwide. Despite an increased demand for botulinum toxin A injections, the clinical pharmacology and differences in formulation of commonly available products are poorly understood. The various products available in the market are unique and vary in terms of units, chemical properties, biological activities, and weight, and are therefore not interchangeable. For safe clinical practice and to achieve optimal results, the practitioners need to understand the clinical issues of potency, conversion ratio, and safety issues (toxin spread and immunogenicity). In this paper, the basic clinical pharmacology of botulinum toxin A and differences between onabotulinum toxin A, abobotulinum toxin A, and incobotulinum toxin A are discussed.

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A Quantitative Analysis of OnabotulinumtoxinA, AbobotulinumtoxinA, and IncobotulinumtoxinA: A Randomized, Double-Blind, Prospective Clinical Trial of Comparative Dynamic Strain Reduction

Abstract: Therapeutic, II.

Cited by 22 publications

References 25 publications

Real-World Dosing of OnabotulinumtoxinA and IncobotulinumtoxinA for Cervical Dystonia and Blepharospasm: Results from TRUDOSE and TRUDOSE II

Real-World Dosing of OnabotulinumtoxinA and IncobotulinumtoxinA for Cervical Dystonia and Blepharospasm: Results from TRUDOSE and TRUDOSE II

OnabotulinumtoxinA Displays Greater Biological Activity Compared to IncobotulinumtoxinA, Demonstrating Non-Interchangeability in Both In Vitro and In Vivo Assays

Botulinum neurotoxin formulations: overcoming the confusion

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