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Comparison of botulinum toxins


Summary and key features

  • Botox® (onabotulinumtoxinA), Dysport® (abobotulinumtoxinA), Xeomin® (incobotulinumtoxinA), and Jeuveau® (prabotulinumtoxinA) are the four currently commercially available formulations of botulinum toxin type A in the United States.

  • Although all four formulations are approved by the United Stated Food and Drug Administration for the treatment of glabellar lines, many off-label cosmetic indications exist, including the treatment of dynamic rhytides on other areas of the face and neck.

  • The botulinum neurotoxin molecule is a natural, single-chain polypeptide that can be assembled into a larger multi-protein complex. While Botox®, Dysport®, and Jeuveau® contain varying amounts of complexing proteins, Xeomin® does not contain any.

  • The exact dosing ratio between the formulations remains controversial and often depends on physician preference and clinical application. A commonly utilized ratio between Botox®, Dysport®, Xeomin®, and Jeuveau® is approximately 1:2.5:1:1.

  • The duration of clinical action appears to be clinically similar between the various formulations of botulinum toxin type A.

  • The degree of diffusion may vary between the formulations of botulinum toxin type A, but these differences are believed to be subtle. Diffusion capacity is also dependent upon the dilution of the reconstituted botulinum toxin.

  • Prior to reconstitution, Botox®, Dysport®, and Jeuveau® must be kept refrigerated, while Xeomin® may be stored at room temperature for up to 36 months.

  • The safety of botulinum toxin type A has been well established over the years, and the various formulations appear to have similar safety profiles. However, Jeuveau® is the newest to the market, so long-term safety profile has not yet been established.

  • Botulinum toxin type A may still possess clinical effects following the 24-hour mark after reconstitution.

Pearls

  • Botulinum toxin type A can be readily combined with other treatments, including soft-tissue fillers, lasers, and other energy-based devices. Patient safety is a key consideration.

  • The “prejuvenation” trend has led botulinum toxin type A to be commonly used in smaller doses for a younger patient population.

  • A commonly utilized clinical dosing ratio between Botox®, Dysport®, Xeomin®, and Jeuveau® is approximately 1:2.5:1:1.

  • Dilution of botulinum toxin plays an important role in the diffusion of the product. For the same number of units, larger injection volumes have greater diffusion capacity. For large injection volumes, care must be taken to reduce any undesirable side effects.

  • Following reconstitution, botulinum toxin type A may still be effective past the 24-hour mark if the product is adequately stored and remains refrigerated.

Introduction

Over the years, treatment with botulinum neurotoxin (BoNT) has become one of the most commonly performed aesthetic procedures. Its clinical effects have consistently been demonstrated to be predictable, repeatable, effective, and safe when appropriately administered by an experienced physician. Dating back to the 1980s, BoNT was originally used to treat hemifacial spasm, strabismus, and benign essential blepharospasm. It was not too long before Drs. Jean and Alastair Carruthers discovered that one of their patients treated with BoNT for blepharospasm had a marked reduction in their glabellar furrows. Dr. Jean Carruthers is an ophthalmologist and oculoplastic surgeon, and Dr. Alastair Carruthers is a dermatologist and aesthetic medicine specialist. Soon after, they began investigating the clinical benefits of BoNT on their staff and patients. Later in 1992, their seminal paper on the efficacy of BoNT for improving the appearance of glabellar frown lines was published. Since this landmark publication, BoNT has been studied for a variety of aesthetic and medical indications across the globe, and its use continues to impact the practice of medicine.

Background

BoNT is a naturally occurring protein that is produced by the anaerobic bacterium Clostridium botulinum . This protein works by blocking the release of acetylcholine at the neuromuscular junction of striated muscle, which subsequently prevents neuromuscular motor transmission and decreases muscular function. This novel mechanism has led to its use across the medical field and especially in cosmetic medicine.

Although seven serologic types of botulinum toxin have been identified, botulinum toxin types A (BoNT-A) and B have generally been clinically used. Serotype A has been considered the most potent, which includes Botox® (onabotulinumtoxinA), Dysport® (abobotulinumtoxinA), Xeomin® (incobotulinumtoxinA), and Jeuveau® (prabotulinumtoxinA) ( Figs. 11.1-11.4 ). Myobloc® (rimabotulinumtoxinB) is a commercially available product that is type B, but its use in cosmetic medicine has been traditionally limited, which is partially due to its systemic anticholinergic adverse effects and high antigenicity. Because of this, this chapter will focus on currently available type A products.

Types of botulinum toxin A

Several formulations of BoNT-A are currently commercially available in the United States. As mentioned, these include Botox® (onabotulinumtoxinA), Dysport® (abobotulinumtoxinA), Xeomin® (incobotulinumtoxinA), and Jeuveau® (prabotulinumtoxinA) ( Table 11.1 ). Botox® is from Allergan, Inc., an AbbVie company; Dysport® from Galderma Laboratories, L.P./Ipsen Biopharmaceuticals, Inc.; Xeomin® from Merz North America, Inc.; and Jeuveau® from Evolus, Inc. These products are not exactly similar, and important differences in their formulation, composition, clinical effects, and safety profile exist. Therefore, physicians should understand that these products are not fully interchangeable. The remainder of this chapter will briefly discuss BoNT-A’s mechanism, composition, dosing, efficacy, duration, diffusion, safety, limited treatment response, and storage.

TABLE 11.1
Comparison of Botulinum Toxin Type A Products That Are Currently Approved by the United States Food and Drug Administration
OnabotulinumtoxinA AbobotulinumtoxinA IncobotulinumtoxinA PrabotulinumtoxinA
Trade name Botox® Dysport® Xeomin® Jeuveau®
Company Allergan, Inc., an AbbVie company Galderma Laboratories, L.P./Ipsen Biopharmaceuticals, Inc. Merz North America, Inc. Evolus, Inc.
Active substance BoNT-A complex BoNT-A complex BoNT-A without complexing proteins BoNT-A complex
Molecular weight (kDa) 900 500–900 150 900
Target protein SNAP-25 SNAP-25 SNAP-25 SNAP-25
Pharmaceutical form Powder Powder Powder Powder
FDA-approved indications Glabellar lines, lateral canthal lines, forehead lines, cervical dystonia, upper limb spasticity, lower limb spasticity, blepharospasm, overactive bladder, urinary incontinence, chronic migraine, axillary hyperhidrosis, strabismus Glabellar lines, cervical dystonia, upper limb spasticity, lower limb spasticity Glabellar lines, cervical dystonia, upper limb spasticity, blepharospasm, chronic sialorrhea Glabellar lines
Storage temperature before/after reconstitution 2–8°C/2–8°C 2–8°C/2–8°C <25°C/2–8°C 2–8°C/2–8°C
BoNT-A, Botulinum toxin type A; FDA, United States Food and Drug Administration; SNAP-25, synaptosomal-associated protein, 25 kDa.

In 2002, Botox® was first granted approved by the United States Food and Drug Administration (FDA) for the temporary improvement in appearance of moderate to severe glabellar lines associated with corrugator and procerus muscle activity. Its effects on wrinkles are mediated by its action on motor neurons as previously discussed. Later in 2004, Botox® was approved for the treatment of primary axillary hyperhidrosis that is inadequately managed by topical agents. It is believed that BoNT can disrupt neurotransmitter release at autonomic endings and reduce the responsiveness of sweat glands. In 2013, Botox® was FDA-approved to temporarily improve the appearance of moderate to severe lateral canthal lines, and it later received approval for moderate to severe forehead lines in 2017. Other formulations were also approved to treat glabellar lines, including Dysport® in 2009, Xeomin® in 2011, and Jeuveau® in 2019. Outside of these indications, there have been numerous off-label uses for both medical and cosmetic reasons, which have been shown to be highly effective over the years.

Looking into the near future, daxibotulinumtoxinA for injection from Revance Therapeutics, Inc. is currently working to receive FDA approval to treat glabellar lines following completion of their phase 3 clinical trials. This product contains a novel stabilizing peptide excipient that does not contain human- or animal-based components, and it may have a longer clinical duration of 6 months. Additionally, Allergan, Inc., an AbbVie company, is looking to bring the MT10109L compound from Medytox Inc. in Korea to the United States market. This product is a liquid formulation of BoNT-A, so no reconstitution is required. Finally, Galderma Laboratories, L.P. is also currently investigating a novel liquid formulation of BoNT-A, relabotulinumtoxinA (QM1114), for the treatment of glabellar and lateral canthal lines.

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