Immunogenicity Associated with Aesthetic Botulinumtoxin A: A Survey of Asia-Pacific Physicians’ Experiences and Recommendations

The efficacy and safety of botulinum toxin injection have made it a popular aesthetic procedure worldwide. A cross-sectional survey was performed in order to determine the pattern of type A botulinum toxin injections in cosmetic practice, for which an 18-item questionnaire was distributed to dermatologists. A total of 469 Korean board-certified dermatologists participated in the survey, with the following results: the main candidates for type A botulinum toxin injection were individuals in their 40–50 years (46.1%), followed by those in their 20–30 years (33.4%), and people over 60 years of age (20.5%). Overall, the upper face (the glabella, forehead, and crow’s line, in decreasing order) was the most favored area of injection (51%). In contrast, body contouring (i.e., shoulder, calf) and treatment for benign masseter hypertrophy were significantly more popular in the 20–30 years age group than their older counterparts. For wrinkle effacement, the most preferred dilution was 100 units/2.5 mL with isotonic sodium chloride injection (51.2%), and the most often used interval was six months (43.6%). About half (46.3%) of the dermatologists reported the experience of clinical cases which were suspicious of botulinum toxin resistance. Despite this, regarding the choice of the product, type A botulinum toxin products with greater cost-effectiveness were favored over products with a lower risk of antibody formation. Other than its cosmetic usage, botulinum toxin is applied for a variety of skin conditions. Further studies are suggested in order to identify the practice pattern of type A botulinum toxin for therapeutic uses in dermatology, such as hyperhidrosis and rosacea.

Section: Discussionsupporting

confidence: 85%

Section: Discussionmentioning

confidence: 99%

An Update on the Cosmetic Use of Botulinum Toxin: The Pattern of Practice among Korean Dermatologists

Rho

Han²,

Kim

2022

“…However, there are studies that emphasize the immunogenicity of BoNTs by selecting highly purified BoNT products early in treatment. This not only improves long-term outcomes and patient satisfaction, but it also reduces the risk of immune system activation and antibody neutralization [ 82 ]. In addition, there is an opportunity to diminish the risk of stimulation of antibody formation by using BoNTs with increased clinical efficacy and lowering the repetitively administered BoNT protein dosage [ 83 ].…”

Section: Future Directionsmentioning

confidence: 99%

Recent Developments in Engineering Non-Paralytic Botulinum Molecules for Therapeutic Applications

Zhantleuova,

Leese,

Andreou

et al. 2024

This review discusses the expanding application of botulinum neurotoxin in treating neurological conditions. The article specifically explores novel approaches to using non-paralytic botulinum molecules. These new molecules, such as BiTox or el-iBoNT, offer an alternative for patients who face limitations in using paralytic forms of botulinum neurotoxin due to concerns about muscle function loss. We highlight the research findings that confirm not only the effectiveness of these molecules but also their reduced paralytic effect. We also discuss a potential cause for the diminished paralytic action of these molecules, specifically changes in the spatial parameters of the new botulinum molecules. In summary, this article reviews the current research that enhances our understanding of the application of new botulinum neurotoxins in the context of common conditions and suggests new avenues for developing more efficient molecules.

“…However, the presence of complexing proteins and other bacterial contaminants have been discussed to affect the immunogenicity of BoNT/A formulations due to their adjuvant properties. This is true for therapeutic applications [ 27 ] and in aesthetic use [ 28 ]. It has been shown that repeated injections of complexing-protein-containing (CPC) BoNT/A formulations may lead to the formation of nAbs to BoNT/A [ 29 ].…”

Section: Immunological Consequences Of Impurities In a Bont/a Formula...mentioning

confidence: 99%

Complexing Protein-Free Botulinum Neurotoxin A Formulations: Implications of Excipients for Immunogenicity

Martin,

Frevert,

Tay

2024

The formation of neutralizing antibodies is a growing concern in the use of botulinum neurotoxin A (BoNT/A) as it may result in secondary treatment failure. Differences in the immunogenicity of BoNT/A formulations have been attributed to the presence of pharmacologically unnecessary bacterial components. Reportedly, the rate of antibody-mediated secondary non-response is lowest in complexing protein-free (CF) IncobotulinumtoxinA (INCO). Here, the published data and literature on the composition and properties of the three commercially available CF-BoNT/A formulations, namely, INCO, Coretox® (CORE), and DaxibotulinumtoxinA (DAXI), are reviewed to elucidate the implications for their potential immunogenicity. While all three BoNT/A formulations are free of complexing proteins and contain the core BoNT/A molecule as the active pharmaceutical ingredient, they differ in their production protocols and excipients, which may affect their immunogenicity. INCO contains only two immunologically inconspicuous excipients, namely, human serum albumin and sucrose, and has demonstrated low immunogenicity in daily practice and clinical studies for more than ten years. DAXI contains four excipients, namely, L-histidine, trehalosedihydrate, polysorbate 20, and the highly charged RTP004 peptide, of which the latter two may increase the immunogenicity of BoNT/A by introducing neo-epitopes. In early clinical studies with DAXI, antibodies against BoNT/A and RTP004 were found at low frequencies; however, the follow-up period was critically short, with a maximum of three injections. CORE contains four excipients: L-methionine, sucrose, NaCl, and polysorbate 20. Presently, no data are available on the immunogenicity of CORE in human beings. It remains to be seen whether all three CF BoNT/A formulations demonstrate the same low immunogenicity in patients over a long period of time.