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Toxins
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Botulinum Neurotoxins: From Toxin to Medicine
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Botulinum Neurotoxins: From Toxin to Medicine

A special issue of Toxins (ISSN 2072-6651). This special issue belongs to the section "Bacterial Toxins".

Deadline for manuscript submissions: closed (31 March 2023) | Viewed by 20134

Special Issue Editor

Prof. Dr. Andrea Santamato

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Guest Editor
Physical Medicine and Rehabilitation, Spasticity and Movement Disorder Unit, Policlinico Riuniti, University of Foggia, Viale Pinto 1, 71122 Foggia, Italy
Interests: spasticity; botulinum neurotoxin; neurological rehabilitation; robotics for neurological rehabilitation
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

I am pleased to invite you to contribute with your valuable work to this Special Issue on “Botulinum Neurotoxins: From Toxin to Medicine”. 

This is an exciting theme that provides us with the possibility of updating our expertise and knowledge on the different implications of and approaches to the treatment of different neurological and non-neurological disorders using Botulinum toxins.

Since its initial reported clinical application more than 30 years ago, BoNT has grown to be a significant therapeutic product in different fields, such as neuromuscular disorders, autonomic conditions, urogenital disorders, pain, and aesthetics. Botulinum toxins have undergone remarkable changes in their uses, and this development is a result of years of intensive study into the structure and function of these toxins, which is a reflection of the toxins’ complex biology.

Various features of BoNTA, such as injection accuracy, dilution, doses, and timing, need to be clarified. Additionally, it is important to have an up-to-date awareness of the proper evaluation both before and after treatment, as well as the potential of modifying functional status by using botulinum toxins.

The aim of this Special Issue is to collect original research articles, reviews, and short communications on the current developments in the evolving theories and uses of BoNTA in medicine.

Prof. Dr. Andrea Santamato
Guest Editor

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a double-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Toxins is an international peer-reviewed open access monthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2700 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • botulinum toxin
  • spasticity
  • non-neurological condition
  • evaluation
  • outcome
  • clinic therapy

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Published Papers (8 papers)

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Editorial

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4 pages, 227 KiB  
Editorial
Botulinum Neurotoxins: From Toxin to Medicine
by Andrea Santamato
Toxins 2023, 15(10), 621; https://doi.org/10.3390/toxins15100621 - 20 Oct 2023
Cited by 1 | Viewed by 1791
Abstract
Ancient scientific manuscripts indicate that Dr [...] Full article
(This article belongs to the Special Issue Botulinum Neurotoxins: From Toxin to Medicine)

Research

Jump to: Editorial

14 pages, 1278 KiB  
Article
Increasing the Passive Range of Joint Motion in Stroke Patients Using Botulinum Toxin: The Role of Pain Relief
by Carlo Trompetto, Lucio Marinelli, Laura Mori, Nicola Bragazzi, Giulia Maggi, Filippo Cotellessa, Luca Puce, Lucilla Vestito, Franco Molteni, Giulio Gasperini, Nico Farina, Luciano Bissolotti, Francesco Sciarrini, Marzia Millevolte, Fabrizio Balestrieri, Domenico Antonio Restivo, Carmelo Chisari, Andrea Santamato, Alessandra Del Felice, Paolo Manganotti, Carlo Serrati and Antonio Curràadd Show full author list remove Hide full author list
Toxins 2023, 15(5), 335; https://doi.org/10.3390/toxins15050335 - 13 May 2023
Cited by 5 | Viewed by 2603
Abstract
By blocking the release of neurotransmitters, botulinum toxin A (BoNT-A) is an effective treatment for muscle over-activity and pain in stroke patients. BoNT-A has also been reported to increase passive range of motion (p-ROM), the decrease of which is mainly due to muscle [...] Read more.
By blocking the release of neurotransmitters, botulinum toxin A (BoNT-A) is an effective treatment for muscle over-activity and pain in stroke patients. BoNT-A has also been reported to increase passive range of motion (p-ROM), the decrease of which is mainly due to muscle shortening (i.e., muscle contracture). Although the mechanism of action of BoNT-A on p-ROM is far from understood, pain relief may be hypothesized to play a role. To test this hypothesis, a retrospective investigation of p-ROM and pain was conducted in post-stroke patients treated with BoNT-A for upper limb hypertonia. Among 70 stroke patients enrolled in the study, muscle tone (Modified Ashworth Scale), pathological postures, p-ROM, and pain during p-ROM assessment (Numeric Rating Scale, NRS) were investigated in elbow flexors (48 patients) and in finger flexors (64 patients), just before and 3–6 weeks after BoNT-A treatment. Before BoNT-A treatment, pathological postures of elbow flexion were found in all patients but one. A decreased elbow p-ROM was found in 18 patients (38%). Patients with decreased p-ROM had higher pain-NRS scores (5.08 ± 1.96, with a pain score ≥8 in 11% of cases) than patients with normal p-ROM (0.57 ± 1.36) (p < 0.001). Similarly, pathological postures of finger flexion were found in all patients but two. A decreased finger p-ROM was found in 14 patients (22%). Pain was more intense in the 14 patients with decreased p-ROM (8.43 ± 1.74, with a pain score ≥ 8 in 86% of cases) than in the 50 patients with normal p-ROM (0.98 ± 1.89) (p < 0.001). After BoNT-A treatment, muscle tone, pathological postures, and pain decreased in both elbow and finger flexors. In contrast, p-ROM increased only in finger flexors. The study discusses that pain plays a pivotal role in the increase in p-ROM observed after BoNT-A treatment. Full article
(This article belongs to the Special Issue Botulinum Neurotoxins: From Toxin to Medicine)
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16 pages, 1807 KiB  
Article
Pain Reduction in Cervical Dystonia Following Treatment with IncobotulinumtoxinA: A Pooled Analysis
by Alberto Albanese, Jörg Wissel, Wolfgang H. Jost, Anna Castagna, Michael Althaus, Georg Comes, Astrid Scheschonka, Matteo Vacchelli and Hyder A. Jinnah
Toxins 2023, 15(5), 333; https://doi.org/10.3390/toxins15050333 - 12 May 2023
Cited by 4 | Viewed by 2645
Abstract
This analysis pooled pain severity data from four phase 3 and 4 studies of incobotulinumtoxinA (incoBoNT-A) for the treatment of cervical dystonia (CD) in adults. CD-related pain severity was assessed at baseline, each injection visit, and 4 weeks after each injection of incoBoNT-A [...] Read more.
This analysis pooled pain severity data from four phase 3 and 4 studies of incobotulinumtoxinA (incoBoNT-A) for the treatment of cervical dystonia (CD) in adults. CD-related pain severity was assessed at baseline, each injection visit, and 4 weeks after each injection of incoBoNT-A using the Toronto Western Spasmodic Torticollis Rating Scale pain severity subscale or a pain visual analog scale. Both were analyzed using a score range of 0–10 and pain was categorized as mild, moderate, or severe. Data for 678 patients with pain at baseline were assessed and sensitivity analyses evaluated pain responses in the subgroup not taking concomitant pain medication (n = 384 at baseline). At Week 4 after the first injection, there was a mean change of −1.25 (standard deviation 2.04) points from baseline pain severity (p < 0.0001), with 48.1% showing ≥ 30% pain reduction from baseline, 34.4% showing ≥50% pain reduction from baseline, and 10.3% becoming pain free. Pain responses were sustained over five injection cycles with a trend to incremental improvements with each successive cycle. Pain responses in the subgroup not taking concomitant pain medication demonstrated the lack of confounding effects of pain medications. These results confirmed the pain relief benefits of long-term treatment with incoBoNT-A. Full article
(This article belongs to the Special Issue Botulinum Neurotoxins: From Toxin to Medicine)
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15 pages, 2011 KiB  
Article
Replacement of the Mouse LD50 Assay for Determination of the Potency of AbobotulinumtoxinA with a Cell-Based Method in Both Powder and Liquid Formulations
by Elena Fonfria, Elizabeth Marks, Lisa-Marie Foulkes, Rebecca Schofield, Daniel Higazi, Sam Coward and Alistair Kippen
Toxins 2023, 15(5), 314; https://doi.org/10.3390/toxins15050314 - 29 Apr 2023
Cited by 3 | Viewed by 3179
Abstract
Botulinum neurotoxins (BoNTs) are important therapeutic agents. The in vivo median lethal dose (LD50) assay has been commonly used to measure the potency of BoNT commercial preparations. As an alternative, we developed cell-based assays for abobotulinumtoxinA in both powder (Dysport® [...] Read more.
Botulinum neurotoxins (BoNTs) are important therapeutic agents. The in vivo median lethal dose (LD50) assay has been commonly used to measure the potency of BoNT commercial preparations. As an alternative, we developed cell-based assays for abobotulinumtoxinA in both powder (Dysport®, Azzalure®) and liquid (Alluzience®) formulations using the in vitro BoCell® system. The assays demonstrated linearity over 50–130% of the expected relative potency, with a correlation coefficient of 0.98. Mean recoveries of 90–108% of the stated potency were observed over this range. The coefficients of variation for powder and liquid formulations, respectively, were 3.6% and 4.0% for repeatability and 8.3% and 5.0% for intermediate precision. A statistically powered comparability assessment of the BoCell® and LD50 assays was performed. Equivalence was demonstrated between the assays for the liquid formulation at release and end of shelf life using a paired equivalence test with predefined equivalence margins. For the powder formulation, the assays were also shown to be equivalent for release samples and when determining loss of potency following thermal degradation. The BoCell® assay was approved for establishing the potency of abobotulinumtoxinA for both powder and liquid formulations in Europe and for the powder formulation only in the USA. Full article
(This article belongs to the Special Issue Botulinum Neurotoxins: From Toxin to Medicine)
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10 pages, 1963 KiB  
Article
Trends in Botulinum Toxin Use among Patients with Multiple Sclerosis: A Population-Based Study
by Djamel Bensmail, Pierre Karam, Anne Forestier, Jean-Yves Loze and Jonathan Lévy
Toxins 2023, 15(4), 280; https://doi.org/10.3390/toxins15040280 - 12 Apr 2023
Cited by 7 | Viewed by 2276
Abstract
There are limited real-world data on the use of botulinum toxin type A (BoNT-A) in patients with multiple sclerosis (MS). Accordingly, this nationwide, population-based, retrospective cohort study aimed to describe BoNT-A treatment trends in patients with MS between 2014 and 2020 in France. [...] Read more.
There are limited real-world data on the use of botulinum toxin type A (BoNT-A) in patients with multiple sclerosis (MS). Accordingly, this nationwide, population-based, retrospective cohort study aimed to describe BoNT-A treatment trends in patients with MS between 2014 and 2020 in France. This study extracted data from the French National Hospital Discharge Database (Programme de Médicalisation des Systèmes d’Information, PMSI) covering the entire French population. Among 105,206 patients coded with MS, we identified those who received ≥1 BoNT-A injection, administered within striated muscle for MS-related spasticity and/or within the detrusor smooth muscle for neurogenic detrusor overactivity (NDO). A total of 8427 patients (8.0%) received BoNT-A injections for spasticity, 52.9% of whom received ≥3 BoNT-A injections with 61.9% of the repeated injections administered every 3 to 6 months. A total of 2912 patients (2.8%) received BoNT-A injections for NDO, with a mean of 4.7 injections per patient. Most repeated BoNT-A injections within the detrusor smooth muscle (60.0%) were administered every 5 to 8 months. There were 585 patients (0.6%) who received both BoNT-A injections within striated muscle and the detrusor smooth muscle. Overall, our study highlights a broad range of BoNT-A treatment practices between 2014 and 2020 in patients with MS. Full article
(This article belongs to the Special Issue Botulinum Neurotoxins: From Toxin to Medicine)
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14 pages, 2454 KiB  
Article
Characterization of Serotype CD Mosaic Botulinum Neurotoxin in Comparison with Serotype C and A
by Shin-Ichiro Miyashita, Shura Karatsu, Mako Fujiishi, I Hsun Huang, Yuki Nagashima, Tamaki Morobishi, Keita Hosoya, Tsuyoshi Hata, Min Dong and Yoshimasa Sagane
Toxins 2023, 15(2), 123; https://doi.org/10.3390/toxins15020123 - 3 Feb 2023
Cited by 5 | Viewed by 2210
Abstract
Botulinum neurotoxin (BoNT), produced by Clostridium botulinum, cleaves proteins involved in neurotransmitter release, thereby triggering flaccid paralyses, which are responsible for botulism. BoNT is classified into seven serotypes (BoNT/A-G); BoNT/A and BoNT/B are used as medical therapeutics and anti-wrinkle reagents. In this [...] Read more.
Botulinum neurotoxin (BoNT), produced by Clostridium botulinum, cleaves proteins involved in neurotransmitter release, thereby triggering flaccid paralyses, which are responsible for botulism. BoNT is classified into seven serotypes (BoNT/A-G); BoNT/A and BoNT/B are used as medical therapeutics and anti-wrinkle reagents. In this study, we investigated the efficacy of BoNT/CD, a mosaic toxin of BoNT/C and BoNT/D, to assess its potential as a therapeutic alternative for BoNT/A. In a cultured neuron assay, BoNT/CD cleaved syntaxin and SNAP-25 with higher efficacy than BoNT/C and BoNT/A. Intramuscularly administrated BoNT/CD induced dose-dependent muscle paralysis, and the paralysis lasted ~21 days in a mouse digit abduction score assay (BoNT/A-induced paralysis lasted ~30 days). BoNT/C failed to induce local paralysis without systemic toxicity. Multiple alignment analyses of the amino acid sequences of the receptor binding domain (HC) of eight BoNT/CDs and two BoNT/Ds showed sequence clustering in five groups. Comparing BoNT/CD strain 003-9 (BoNT/CD003-9) and strain 6813 (BoNT/CD6813) showed that both BoNT/CDs displayed similar efficacies in cultured neurons, but BoNT/CD003-9 displayed higher efficacy in a mouse model than BoNT/CD6813. These findings suggest that BoNT/CD may be a potential alternative for patients who do not respond to existing BoNT-based therapeutics. Full article
(This article belongs to the Special Issue Botulinum Neurotoxins: From Toxin to Medicine)
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12 pages, 946 KiB  
Article
Reasons and Determinants of BoNT-A Treatment Discontinuation in Patients Living with Spasticity: A 10-Year Retrospective Analysis
by Nicoletta Cinone, Luigi Santoro, Stefania Spina, Salvatore Facciorusso, Marco Battaglia, Alessio Baricich, Pasqua Marcogiuseppe and Andrea Santamato
Toxins 2022, 14(10), 675; https://doi.org/10.3390/toxins14100675 - 29 Sep 2022
Cited by 5 | Viewed by 2648
Abstract
Background: The present study aimed to evaluate the reasons and determinants of BoNT-A discontinuation in patients with stroke, multiple sclerosis, spinal cord injury, and traumatic brain injury. Methods: It is a retrospective study of 56 discontinuer patients treated with botulinum toxin between January [...] Read more.
Background: The present study aimed to evaluate the reasons and determinants of BoNT-A discontinuation in patients with stroke, multiple sclerosis, spinal cord injury, and traumatic brain injury. Methods: It is a retrospective study of 56 discontinuer patients treated with botulinum toxin between January 2011 and December 2021. Discontinuation rates and their predictors were estimated using Kaplan–Meier, Log rank test, and Cox’s regression method of analyses. Results: The mean age was 56.54 years, 53.57% were affected by post-stroke spasticity, 17.86% by spinal cord injury, 12.5% and 16.07% by traumatic brain injury and multiple sclerosis, respectively. The median discontinuation time was 5 months. The main reason for discontinuation were logistic problems (37%) and orthopedic surgeries or intrathecal baclofen (27%). Discontinuers were more likely to have severe spasticity (R = 1.785), have no pain (HR = 1.320), no access to rehabilitation services (HR = 1.402), and have cognitive impairment (HR = 1.403). Conclusions: The main reasons for discontinuation are related to logistic issues (due to distance or the absence of an adequate caregiver) and surgical interventions for spasticity, including intrathecal baclofen. It is crucial to identify possible predictors of discontinuation to improve the effectiveness of a multidisciplinary management. The study confirms the crucial role of rehabilitation and caregivers in achieving better long-term outcomes. Full article
(This article belongs to the Special Issue Botulinum Neurotoxins: From Toxin to Medicine)
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10 pages, 1381 KiB  
Article
Does Ultrasound Guidance Improve the Effectiveness of Neurotoxin Injections in Patients with Cervical Dystonia? (A Prospective, Partially-Blinded, Clinical Study)
by Małgorzata Tyślerowicz, Jarosław Dulski, Justyna Gawryluk and Jarosław Sławek
Toxins 2022, 14(10), 674; https://doi.org/10.3390/toxins14100674 - 28 Sep 2022
Cited by 8 | Viewed by 2043
Abstract
Aim: The aim of this study was to evaluate the efficacy of ultrasound guidance (US) in the treatment of cervical dystonia (CD) with botulinum neurotoxin type A (BoNT-A) injections in comparison to anatomical landmarks (AL). To date, US is routinely used in many [...] Read more.
Aim: The aim of this study was to evaluate the efficacy of ultrasound guidance (US) in the treatment of cervical dystonia (CD) with botulinum neurotoxin type A (BoNT-A) injections in comparison to anatomical landmarks (AL). To date, US is routinely used in many centers, but others deny its usefulness. Materials and Methods: Thirty-five patients (12 males, 23 females) with a clinical diagnosis of CD were included in the study. Intramuscular administration of BoNT-A was performed using either US guidance, or with AL, in two separate therapeutic sessions. The efficacy of BoNT-A administration was assessed with the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS), Tsui modified scale, Craniocervical Dystonia Questionnaire (CDQ-24) and Clinical Global Impression—Improvement scale (CGI-I). Additionally, patients at therapeutic sessions were digitally recorded and evaluated by two blinded and independent raters. Results: A significant decrease in total TWSTRS, severity subscale TWSTRS, Tsui score, and CDQ-24 was found in both the AL and US group; however, in the TWSTRS disability and pain subscales, a significant decrease was found only in the US group. Moreover, US guided treatment also resulted in a greater decrease in TWSTRS, Tsui score and CDQ-24 compared to anatomical landmarks use only. Conclusions: US guidance might be helpful in improving the results of BoNT-A injections in cervical dystonia, reducing associated pain and disability; however, more studies are needed to evaluate its clinical efficacy. Full article
(This article belongs to the Special Issue Botulinum Neurotoxins: From Toxin to Medicine)
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