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Keywords = abobotulinumtoxin

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12 pages, 655 KB  
Article
Two Toxins, One Disorder: Neurophysiological and Clinical Effects in Caput-Type of Cervical Dystonia at Waning and Peak Response Phases of BoNT-A Therapy
by Artur Drużdż, Małgorzata Dudzic, Igor Bednarski, Anna Sowińska, Natalie Górna and Agnieszka Przystańska
Toxins 2026, 18(7), 277; https://doi.org/10.3390/toxins18070277 - 24 Jun 2026
Viewed by 316
Abstract
Botulinum toxin type A (BoNT-A) is an established treatment for cervical dystonia (CD), but objective neurophysiological markers across the injection cycle and between preparations are not well defined. We assessed afferent conduction (captured by CSP parameters), efferent conduction (captured by F-wave parameters) and [...] Read more.
Botulinum toxin type A (BoNT-A) is an established treatment for cervical dystonia (CD), but objective neurophysiological markers across the injection cycle and between preparations are not well defined. We assessed afferent conduction (captured by CSP parameters), efferent conduction (captured by F-wave parameters) and clinical severity (TWSTRS) in 28 patients with caput-type cervical dystonia during waning (>14 weeks post-injection) and peak (4–6 weeks) phases, comparing onabotulinumtoxinA (ONA) and abobotulinumtoxinA (ABO). F-wave measures changed only modestly: F–M latency increased with ONA, while F-wave persistence decreased with ABO. In contrast, CSP measures consistently increased at peak in both groups (CSP end latency and CSP duration; both p ≤ 0.001). Overall, BoNT-A treatment phase is better reflected by CSP-derived inhibitory measures than by F-wave indices. TWSTRS improved at peak for both toxins, with no difference between ONA and ABO in clinical change (ΔTWSTRS p = 0.5514). Full article
(This article belongs to the Special Issue Botulinum Toxins: Past Successes and New Goals)
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8 pages, 3098 KB  
Case Report
Pattern Changes and Recurrent Remissions in Cervical Dystonia: Insights from a Long-Term Treated Case
by Simone Aloisio, Massimiliano Passaretti, Luca Angelini, Martina De Riggi, Francesca Santachiara, Anna Sofia Grandolfo, Daniele Birreci and Matteo Bologna
Toxins 2026, 18(6), 243; https://doi.org/10.3390/toxins18060243 - 25 May 2026
Viewed by 560
Abstract
Cervical dystonia (CD) is increasingly recognized as a disorder with a dynamic clinical course rather than a fixed phenomenological profile. This report describes the long-term observation of a man with isolated CD followed for nearly 12 years from symptom onset. The course was [...] Read more.
Cervical dystonia (CD) is increasingly recognized as a disorder with a dynamic clinical course rather than a fixed phenomenological profile. This report describes the long-term observation of a man with isolated CD followed for nearly 12 years from symptom onset. The course was characterized by multiple pattern changes, including a clear shift from left- to right-sided torticollis in 2019, followed by alternating and mixed dystonic patterns. Three remission phases were documented during follow-up: two prolonged periods in 2017–2018 and 2020–2021, and a further phase from March to November 2022. Over time, treatment requirements decreased from higher initial doses (500–700 U abobotulinumtoxinA and up to 130 U onabotulinumtoxinA) to lower maintenance doses of 30–50 U incobotulinumtoxinA/onabotulinumtoxinA, with longer injection intervals and no obvious documented need for dose adjustment to maintain clinical responsiveness. This case highlights the coexistence of pattern changes and recurrent remissions within a single continuously followed patient over an unusually long period. Although a treatment-related mechanism remains speculative and alternative explanations cannot be excluded, the observation underscores the value of prolonged follow-up and individualized treatment strategies in CD. Full article
(This article belongs to the Section Bacterial Toxins)
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10 pages, 826 KB  
Review
Botulinum Toxin Treatment of Stiff Person Syndrome—A Critical Review and Update
by Ava Grace Tohidian, Samira Marie Comtesse, Shahroo Etemadmoghadam and Bahman Jabbari
Toxins 2026, 18(3), 130; https://doi.org/10.3390/toxins18030130 - 5 Mar 2026
Viewed by 1540
Abstract
Stiff person syndrome (SPS) is an autoimmune disorder with muscle stiffness and spasms, for which current therapies provide incomplete relief. Botulinum neurotoxin (BoNT) has been explored as an adjunctive symptomatic treatment. The aim of this review was to critically evaluate the clinical evidence [...] Read more.
Stiff person syndrome (SPS) is an autoimmune disorder with muscle stiffness and spasms, for which current therapies provide incomplete relief. Botulinum neurotoxin (BoNT) has been explored as an adjunctive symptomatic treatment. The aim of this review was to critically evaluate the clinical evidence for BoNT therapy in SPS. Using Medline, Scopus and Google Scholar, we identified nine reports that were published up to 1 January 2026. English articles and articles with information on study type, type/dose of BoNT and treatment results were included. One study was double-blind and placebo-controlled, one was retrospective and seven were single-case reports, comprising 46 patients. Open-label trials used botulinumtoxin-A (Botox, Dysport or Xeomin), while the blind study applied abobotulinumA (Dysport). All but one study (a case report) demonstrated motor improvement and a reduction in painful spasms associated with patient satisfaction. Reported doses ranged from 300 to 800 units for onabotulinumtoxinA and incobotulinumtoxinA and from 700 to 1000 units for abobotulinumtoxinA. The literature highlights the need for randomized clinical trials in larger cohorts, with careful selection of dose, injection sites, and adjunct physiotherapy, as well as an evaluation of early BoNT therapy in SPS. The novelty of this review lies in its critical synthesis of reported data and inclusion of most recent reports. Full article
(This article belongs to the Special Issue Botulinum Toxin: Advancing Treatments for Spasticity)
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9 pages, 403 KB  
Communication
Cross-Induction of Anti-Complexing Antibodies in Patients Treated with Botulinum Toxin Formulations Containing Complexing Proteins
by Yuttana Srinoulprasert, Surachet Sirisuthivoranunt, Chattip Sripatumtong, Tunsuda Tansit, Pornsuk Yamlexnoi, Onjira Meethong and Rungsima Wanitphakdeedecha
Toxins 2026, 18(2), 99; https://doi.org/10.3390/toxins18020099 - 14 Feb 2026
Viewed by 1467
Abstract
Botulinum toxin type A (BoNT/A) formulations differ in their content of non-toxic accessory proteins, also known as complexing proteins (CPs), which may influence immunogenicity. Some BoNT/A products share structurally similar CPs, potentially leading to antibody cross-reactivity among formulations. This prospective study investigated whether [...] Read more.
Botulinum toxin type A (BoNT/A) formulations differ in their content of non-toxic accessory proteins, also known as complexing proteins (CPs), which may influence immunogenicity. Some BoNT/A products share structurally similar CPs, potentially leading to antibody cross-reactivity among formulations. This prospective study investigated whether patients treated with different BoNT/A products develop cross-reactive anti-CP antibody responses. One hundred participants were allocated into five treatment groups, each receiving a single BoNT/A formulation: incobotulinumtoxinA (IncoA), onabotulinumtoxinA (OnaA), abobotulinumtoxinA (AboA), letibotulinumtoxinA (LetiA), or prabotulinumtoxinA (PraboA). Each participant received 50 units or equivalent dosing. Serum samples were collected 180 days post-injection, and anti-CP antibodies were quantified using an absorption ELISA and compared with a toxin-naïve control group. IncoA did not induce significant anti-CP antibody responses. In contrast, higher antibody levels were observed in the OnaA, LetiA, and PraboA groups against multiple CPs, suggesting structural similarity and cross-reactivity. AboA primarily induced antibodies directed against its own CPs and those of PraboA. These findings demonstrate that CP-containing formulations can induce cross-reactive antibody responses, whereas CP-free incobotulinumtoxinA exhibits minimal immunogenicity. This study highlights the importance of CP composition in guiding clinical product selection, particularly in patients requiring repeated BoNT/A administration. Full article
(This article belongs to the Special Issue Antibodies for Innovative Studies of Bacterial Toxins)
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11 pages, 266 KB  
Review
Botulinum Toxin Treatment in Hereditary Spastic Paraplegia—A Comprehensive Review and Update
by Bahman Jabbari, Samira Comtesse and Fattaneh Tavassoli
Toxins 2025, 17(10), 503; https://doi.org/10.3390/toxins17100503 - 13 Oct 2025
Cited by 1 | Viewed by 2712
Abstract
Using Medline and Scopus as search engines, we identified reports of 10 clinical studies (published up to 1 September 2025) on botulinum neurotoxin therapy for hereditary spastic paraplegia (HSP). Nine studies were conducted in adults and one in children. Only one of the [...] Read more.
Using Medline and Scopus as search engines, we identified reports of 10 clinical studies (published up to 1 September 2025) on botulinum neurotoxin therapy for hereditary spastic paraplegia (HSP). Nine studies were conducted in adults and one in children. Only one of the ten studies was double-blind and placebo-controlled. The search strategy included only articles published in English and articles providing basic information such as the type of the study, type and dose of the toxin and results of the treatment. Articles not in English, case reports and review articles were excluded. A total of 258 patients were included across all studies. The injected toxin in the open-label studies was botulinumtoxin-A (Botox or Dysport or Xeomin), whereas in the blinded study, the investigators used Prosigne. All open-label studies, which used FDA approved botulinumtoxin-A neurotoxins, demonstrated a degree of motor and non-motor improvement, whereas treatment with Prosigne did not improve patients’ function. The possible reasons for this discrepancy between the blinded study and the open-label studies are discussed. We found no studies on the effect of BoNTs on bladder dysfunction in HSP. There is a need for double-blind, placebo-controlled studies assessing the efficacy of FDA-approved botulinum neurotoxins in children and adults affected by hereditary spastic paraparesis. Such studies should also investigate the effect(s) of early botulinum neurotoxin therapy in this disorder. The novelty of this review is that it represents a comprehensive and critical literature review on this subject, with no other studies of this kind published previously. It also includes data not present in previous reviews of this subject. Full article
12 pages, 538 KB  
Review
Comparing Injection Methods of Botulinum Toxin A for Cervical Dystonia: A Systematic Review
by Hristo Shipkov, Petar Uchikov, Abdulrahman Imran, Zain Ul Hassan, Ivan Grozdev, Krasimir Kraev, Maria Kraeva, Nina Koleva, Maria Bozhkova and Stanislav Karamitev
Life 2025, 15(6), 920; https://doi.org/10.3390/life15060920 - 6 Jun 2025
Cited by 5 | Viewed by 5645
Abstract
Background: Cervical dystonia (CD) is a chronic neurological disorder characterized by involuntary neck muscle contractions, leading to abnormal head postures, pain, and functional impairment. Botulinum toxin type A (BoNT-A) remains the treatment of choice, but its efficacy is highly dependent on injection accuracy. [...] Read more.
Background: Cervical dystonia (CD) is a chronic neurological disorder characterized by involuntary neck muscle contractions, leading to abnormal head postures, pain, and functional impairment. Botulinum toxin type A (BoNT-A) remains the treatment of choice, but its efficacy is highly dependent on injection accuracy. Various techniques, including palpation-guided, ultrasound-guided, and electromyography-guided (EMG), have been developed to optimize delivery, each with distinct advantages and limitations. Methods: A systematic search of PubMed and Scopus was conducted up until 30 December 2024, using defined keywords related to BoNT-A, CD, and injection techniques. Studies were included if they reported clinical outcomes of BoNT-A injection methods in adult CD patients. Data on efficacy, safety, accuracy, and muscle targeting were extracted and synthesized. Results: Seven studies comprising 239 patients were included: two randomized controlled trials, one retrospective study, one cohort study, one systematic review, one literature review, and one cadaveric study. The most common CD subtype was torticollis/torticaput (49.79%). Frequently targeted muscles included the trapezius (56.9%), levator scapulae (51.7%), and splenius capitis (48.3%). Ultrasound guidance consistently demonstrated superior injection accuracy and reduced adverse effects due to real-time anatomical visualization. EMG-guided techniques showed advantages in identifying dystonic muscles, especially when anatomy was unclear. In contrast, palpation-guided injections were less accurate and suitable only for superficial muscles. Dosing varied by product, with mean doses of 117–118 units for onabotulinumtoxinA and incobotulinumtoxinA, and 405 units for abobotulinumtoxinA. Adverse events were generally mild, including local discomfort, dysphagia, and transient muscle weakness. Conclusions: Ultrasound- and EMG-guided injections enhance the precision, safety, and efficacy of BoNT-A therapy for CD compared to anatomy-guided techniques. While ultrasound guidance improves anatomical accuracy, EMG remains valuable for functionally identifying dystonic muscles. Integration of both may offer optimal outcomes. However, further high-quality, standardized trials are needed to definitively establish best practices. Full article
(This article belongs to the Special Issue Feature Paper in Physiology and Pathology: 2nd Edition)
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18 pages, 630 KB  
Study Protocol
Protocol and Demographics of the RELY-CD Study: Assessing Long-Term Clinical Response to Botulinum Neurotoxin in Cervical Dystonia
by Benjamin Waeschle, John-Ih Lee, Tristan Kölsche, Robin Jansen, Marta Banach, Stanislaw Ochudlo, Małgorzata Tyślerowicz, Piotr Sobolewski, Sara Sánchez Valiente, Eva López-Valdés, Pablo Mir, Silvia Jesús, Elena Ojeda-Lepe, Ewa Papuć, Pilar Sánchez Alonso, Gabriel Salazar, Georg Comes, Holger Stark and Philipp Albrecht
Toxins 2025, 17(4), 180; https://doi.org/10.3390/toxins17040180 - 5 Apr 2025
Cited by 1 | Viewed by 2452
Abstract
The RELY-CD study investigated the long-term clinical response to botulinum neurotoxin type A in cervical dystonia within a multicenter, real-world setting. This retrospective study focused on patients treated with complex-free (incobotulinumtoxinA) and complex-containing (onabotulinumtoxinA and abobotulinumtoxinA) BoNT/A formulations over an up to 10-year [...] Read more.
The RELY-CD study investigated the long-term clinical response to botulinum neurotoxin type A in cervical dystonia within a multicenter, real-world setting. This retrospective study focused on patients treated with complex-free (incobotulinumtoxinA) and complex-containing (onabotulinumtoxinA and abobotulinumtoxinA) BoNT/A formulations over an up to 10-year period. The novel dose–effect parameter “DEff” was introduced to quantify the relationship between dose adjustments and clinical outcomes, enabling the identification of partial treatment failures. The primary endpoint was a comparison of a clinically meaningful worsening in DEff in treatment year 7 compared to year 2 between complex-free and complex-containing botulinum neurotoxin type A. The RELY-CD study provides unique insights into long-term treatment patterns, clinical resistance phenomena, and the implications of formulation differences on treatment outcomes, addressing a critical gap in the literature on real-world botulinum neurotoxin type A application. The study methodology, including the definition and calculation of the novel DEff, as well as clinical baseline characteristics, are presented. Full article
(This article belongs to the Special Issue Immunogenicity of Botulinum Toxin)
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19 pages, 1146 KB  
Systematic Review
Botulinum Toxin in the Treatment of Hair and Scalp Disorders: Current Evidence and Clinical Applications
by Sofia M. Perez, Sarah A. AlSalman, Betty Nguyen and Antonella Tosti
Toxins 2025, 17(4), 163; https://doi.org/10.3390/toxins17040163 - 25 Mar 2025
Cited by 11 | Viewed by 12137
Abstract
Botulinum toxin (BoNT) is well-recognized throughout dermatology for its cosmetic indications and growing therapeutic value. Recent studies have trialed BoNT in the treatment of hair and scalp disorders, many of which lack long-term effective treatments and significantly impact quality of life. In this [...] Read more.
Botulinum toxin (BoNT) is well-recognized throughout dermatology for its cosmetic indications and growing therapeutic value. Recent studies have trialed BoNT in the treatment of hair and scalp disorders, many of which lack long-term effective treatments and significantly impact quality of life. In this review, we summarize the current clinical literature on this topic to comprehensively evaluate the efficacy, safety, and clinical value of BoNT in treating hair and scalp conditions. A literature search on PubMed/MEDLINE and Scopus identified 40 articles reporting the use of 25–200 units of BoNT-A or B in 689 patients with hair loss (79.5%), scalp seborrheic dermatitis/hyperseborrhea (10%), craniofacial hyperhidrosis (9%), folliculitis decalvans/dissecting folliculitis (0.86%), scalp pain (0.43%), or linear scleroderma (0.29%). Most studies on BoNT therapy for androgenetic alopecia (AGA) reported mild or non-significant hair growth; however, considerable variability in outcome measures complicates the ability to draw definitive conclusions or justify the use of BoNT over established AGA therapies. BoNT-A and B showed consistent efficacy in treating craniofacial hyperhidrosis with minimal side effects. Additional scalp conditions may benefit from BoNT therapy, but the evidence is limited, and larger, controlled studies are needed to better understand BoNT’s clinical value in these conditions. Full article
(This article belongs to the Special Issue Botulinum Toxins: New Uses in the Treatment of Diseases (2nd Edition))
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20 pages, 2771 KB  
Article
Delphi Consensus on the Management of Spanish Patients with Post-Stroke Hemiplegic Shoulder Pain Treated with Botulinum Toxin A: Result Study
by Carlos Cordero-García, Irene de Torres, Jacobo Formigo-Couceiro, Lluis Guirao, Mª Dolores Romero-Torres, Sergio Otero-Villaverde, Alberto Herrera, Cristina Santa and Antonio Mena-Rodriguez
Toxins 2025, 17(1), 40; https://doi.org/10.3390/toxins17010040 - 16 Jan 2025
Cited by 1 | Viewed by 4119
Abstract
The study aimed to identify expert opinions and obtain recommendations on the management of post-stroke hemiplegic shoulder pain (HSP) and treatment with botulinum toxin A (BoNT-A). A multicenter Delphi study was conducted using an online survey designed by a committee of experts with [...] Read more.
The study aimed to identify expert opinions and obtain recommendations on the management of post-stroke hemiplegic shoulder pain (HSP) and treatment with botulinum toxin A (BoNT-A). A multicenter Delphi study was conducted using an online survey designed by a committee of experts with at least 10 years of experience in post-stroke HSP management with BoNT-A in Spain. Forty-seven panelists (specialists with at least 5 years of experience in post-stroke HSP management with BoNT-A) rated their level of agreement in two rounds based on acceptance by ≥66.7% of them. In round 1, 245 statements on three dimensions were evaluated (diagnosis, treatment, and follow-up of the HSP patients treated with BoNT-A). A total of 159 statements (70.9%) were finally accepted after round 2. Experts recommended BoNT-A as soon as spasticity affects daily activities. They considered ultrasound as the preferred guided technique. Experts recommended regular assessments using validated scales and patient-reported outcomes to evaluate treatment goals and safety. In case of lack of response, experts suggested increasing the dose or number of treated muscles or considering alternative treatments. These consensus-based recommendations offer clinicians an approach to the management of post-stroke HSP with BoNT-A, supporting informed decision making. Full article
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9 pages, 235 KB  
Opinion
Are We Missing Something About the Maximum Dosing of Botulinum Toxin Type A1 in Adult and Pediatric Patients with Spasticity?
by Alessandro Picelli, Rita Di Censo, Stefano Tamburin, Nicola Smania and Mirko Filippetti
Toxins 2024, 16(12), 513; https://doi.org/10.3390/toxins16120513 - 27 Nov 2024
Cited by 2 | Viewed by 4381
Abstract
Botulinum toxin type A1 is a first-line treatment for adult and pediatric spasticity. However, when considering the quantity of 150 kDa neurotoxin protein in relation to patient weight and the maximum recommended dose for treating adult and pediatric patients with spasticity, several concerns [...] Read more.
Botulinum toxin type A1 is a first-line treatment for adult and pediatric spasticity. However, when considering the quantity of 150 kDa neurotoxin protein in relation to patient weight and the maximum recommended dose for treating adult and pediatric patients with spasticity, several concerns arise. First, the therapeutic margin (the ratio of the actual maximum quantity of toxin recommended for treating adult spasticity to its median lethal dose) appears to be relevant. Second, there is no consistency between adult and pediatric dosing of botulinum toxin type A1 for spasticity. The third point concerns the suitability of the recommended doses for treating spasticity in pediatric patients. Based on the average body weight of American children and adolescents, the maximum weight-based doses for abobotulinumtoxinA and onabotulinumtoxinA could be administered to children as young as 9 years old. Additionally, the maximum weight-based dose for incobotulinumtoxinA could be administered to children as young as 6 years old. The final point concerns managing the maximum dose of BoNT/A1 in pediatric patients with spasticity who weigh more than 25 kg for incobotulinumtoxinA, or more than 34 kg for abobotulinumtoxinA and onabotulinumtoxinA. No labeled recommendations are given on the weight cut-off for transitioning to adult dosing in pediatric patients. Full article
(This article belongs to the Section Bacterial Toxins)
20 pages, 9763 KB  
Article
Stable Convergent Polyneuronal Innervation and Altered Synapse Elimination in Orbicularis oculi Muscles from Patients with Blepharospasm Responding Poorly to Recurrent Botulinum Type-A Neurotoxin Injections
by Brigitte Girard, Aurélie Couesnon, Emmanuelle Girard and Jordi Molgó
Toxins 2024, 16(12), 506; https://doi.org/10.3390/toxins16120506 - 24 Nov 2024
Cited by 2 | Viewed by 2629
Abstract
Botulinum neurotoxin type-A (BoNT/A), which blocks quantal acetylcholine (ACh) release at the neuromuscular junction (NMJ), has demonstrated its efficacy in the symptomatic treatment of blepharospasm. In 3.89% of patients treated for blepharospasm at Tenon Hospital, BoNT/A was no longer effective in relieving the [...] Read more.
Botulinum neurotoxin type-A (BoNT/A), which blocks quantal acetylcholine (ACh) release at the neuromuscular junction (NMJ), has demonstrated its efficacy in the symptomatic treatment of blepharospasm. In 3.89% of patients treated for blepharospasm at Tenon Hospital, BoNT/A was no longer effective in relieving the patient’s symptoms, and a partial upper myectomy of the Orbicularis oculi muscle was performed. We used surgical waste samples from 14 patients treated with repeated injections of either abobotulinumtoxinA (Dysport®) or incobotulinumtoxinA (Xeomin®). These muscle fragments were compared to others from 4 normal subjects, naïve of BoNT/A. The morphological study was performed blinded to the BoNT/A treatment and between treated and control samples. Neuromuscular specimens analyzed by confocal laser scanning microscopy, using fluorescent staining and immune-labeling of presynaptic proteins, revealed that the pattern of innervation (e.g., polyneuronal and convergent innervation), the muscle nicotinic ACh receptors (nAChRs), and the NMJs exhibited marked differences in BoNT/A-treated muscles (regardless of the toxin clinically used), with respect to controls. BoNT/A-treated junctions exhibited profuse polyneuronal innervation in which 2–6 axons innervated 74.84% of single muscle fibers, while 99.47% of control junctions were mono-innervated. Another new finding was the stable convergent innervation, in which several motor axons end onto the same endplate. Morphological signs of synapse elimination included the presence of retraction bulbs in axons and nerve terminals and a reduced extension of postsynaptic nAChRs. These outcomes suggest that synapse elimination is altered and raise questions on the origin and factors contributing to the plasticity changes observed and the functioning of NMJs. Full article
(This article belongs to the Special Issue Toxins: From the Wild to the Lab)
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11 pages, 1767 KB  
Review
Botulinum Toxin Treatment of Psoriasis—A Comprehensive Review
by Ali Ghaseminejad-Bandpey, Shahroo Etemadmoghadam and Bahman Jabbari
Toxins 2024, 16(10), 449; https://doi.org/10.3390/toxins16100449 - 18 Oct 2024
Cited by 6 | Viewed by 4821
Abstract
A literature search on the subject of botulinum toxin treatment in psoriasis found 15 relevant articles, 11 on human subjects and 4 on animal studies. Of the human data, eight were clinical trials and three were single case reports. Seven out of eight [...] Read more.
A literature search on the subject of botulinum toxin treatment in psoriasis found 15 relevant articles, 11 on human subjects and 4 on animal studies. Of the human data, eight were clinical trials and three were single case reports. Seven out of eight clinical trials, all open-label, reported improvement in psoriasis following intradermal or subcutaneous botulinum toxin injections. One double-blind, placebo-controlled study, which used a smaller dose than the open-label studies, did not note a healing effect. Animal studies have shown that injection of botulinum toxins in the skin heals psoriatic skin lesions and can reduce the level of interleukins (ILs) and cytokines as well as inflammatory cells in psoriatic plaques. There is a need for controlled, blinded studies conducted in larger numbers of patients with doses that have shown promise in open-label studies. Full article
(This article belongs to the Special Issue Botulinum Toxins: New Uses in the Treatment of Diseases (2nd Edition))
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8 pages, 236 KB  
Review
Onabotulinumtoxin A for the Treatment of Post-Traumatic Headache: Is It Better than Anti-CGRP Antibodies?
by Lanfranco Pellesi, Dilara Onan and Paolo Martelletti
Toxins 2024, 16(10), 427; https://doi.org/10.3390/toxins16100427 - 2 Oct 2024
Cited by 8 | Viewed by 4386
Abstract
Post-traumatic headache (PTH) is a common and debilitating consequence of traumatic brain injury (TBI), often resembling migraine and tension-type headaches. Despite its prevalence, the optimal treatment for PTH remains unclear, with current strategies largely extrapolated from other headache disorders. This review evaluates the [...] Read more.
Post-traumatic headache (PTH) is a common and debilitating consequence of traumatic brain injury (TBI), often resembling migraine and tension-type headaches. Despite its prevalence, the optimal treatment for PTH remains unclear, with current strategies largely extrapolated from other headache disorders. This review evaluates the use of onabotulinumtoxin A (ONA) and anti-calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAbs) in the treatment of PTH. A comprehensive literature search was conducted on PubMed, including studies published up to September 2024, focusing on the efficacy, safety, and mechanisms of onabotulinumtoxin A and anti-CGRP mAbs in PTH. Both clinical trials and observational studies were reviewed. ONA, widely recognized for its efficacy in chronic migraine, has shown limited benefits in PTH with only one trial involving abobotulinumtoxin A in a cohort of 40 subjects. A phase 2 trial with fremanezumab, an anti-CGRP monoclonal antibody, failed to demonstrate significant efficacy in PTH, raising questions about the utility of targeting CGRP in this condition. ONA may offer advantages over anti-CGRP mAbs, not only in terms of its broader mechanism of action but also in cost-effectiveness and higher patient adherence. Both ONA and anti-CGRP mAbs are potential options for the management of PTH, but the current evidence is insufficient to establish clear guidelines. The negative results from the fremanezumab trial suggest that CGRP inhibition may not be sufficient for treating PTH, whereas onabotulinumtoxin A’s ability to target multiple pain pathways may make it a more promising candidate. Full article
(This article belongs to the Special Issue Immunogenicity of Botulinum Toxin)
14 pages, 1389 KB  
Article
A Cost-Effectiveness and Budget Impact Analysis of AbobotulinumtoxinA in Greece
by Nikolaos Nomikos, Christos Eleftheriou and Kostas Athanasakis
Toxins 2023, 15(9), 561; https://doi.org/10.3390/toxins15090561 - 8 Sep 2023
Cited by 1 | Viewed by 2689
Abstract
This study aimed to assess the cost-effectiveness of abobotulinumtoxinA (aboBoNT-A) plus Best Supportive Care (BSC) compared with BSC alone for managing limb spasticity in adult patients in Greece, as well as to conduct a budget impact analysis of the introduction of aboBoNT-A in [...] Read more.
This study aimed to assess the cost-effectiveness of abobotulinumtoxinA (aboBoNT-A) plus Best Supportive Care (BSC) compared with BSC alone for managing limb spasticity in adult patients in Greece, as well as to conduct a budget impact analysis of the introduction of aboBoNT-A in the Greek healthcare system compared to onabotulinumtoxinA (onaBoNT-A). Clinical studies were utilized to extract data on drug efficacy and patients’ utility, while cost data were collected from Greek sources. The results of the study showed that aboBoNT-A plus BSC was a cost-effective treatment option for both upper and lower limb spasticity in adult patients compared to BSC. Additionally, introducing aboBoNT-A into the Greek healthcare system resulted in cost savings in pharmaceutical spending over a 5-year period. The findings suggest that incorporating aboBoNT-A into the Greek healthcare system could improve patient access to treatment and healthcare resource efficiency, as it is a more economical option compared to onaBoNT-A. Full article
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16 pages, 958 KB  
Article
A UK Single-Center, Retrospective, Noninterventional Study of Clinical Outcomes and Costs of Two BotulinumtoxinA Treatments for Limb Spasticity
by Clive Bezzina, Vadim Degtiar, Natalya Danchenko, Pascal Maisonobe, Benjamin Davis, Emanuel Engmann, Elodie Guyon, Sophie Lecanuet and John Whalen
Toxins 2023, 15(9), 532; https://doi.org/10.3390/toxins15090532 - 30 Aug 2023
Cited by 1 | Viewed by 2192
Abstract
Service model changes at the North Staffordshire Rehabilitation Centre (UK) included switching spasticity treatment from onabotulinumtoxinA (onaBoNT-A) to abobotulinumtoxinA (aboBoNT-A). This noninterventional, retrospective, longitudinal study (NCT04396704) describes the clinical and economic outcomes in toxin-naive adults with spasticity who received onaBoNT-A (Cohort 1; 2015–2017) [...] Read more.
Service model changes at the North Staffordshire Rehabilitation Centre (UK) included switching spasticity treatment from onabotulinumtoxinA (onaBoNT-A) to abobotulinumtoxinA (aboBoNT-A). This noninterventional, retrospective, longitudinal study (NCT04396704) describes the clinical and economic outcomes in toxin-naive adults with spasticity who received onaBoNT-A (Cohort 1; 2015–2017) or aboBoNT-A (Cohort 2; 2017–2019). Outcomes included Goal Attainment Scale T (GAS-T) score, treatment satisfaction, quality of life (QoL; EQ-5D visual analog scale [VAS] score), and treatment costs. Adverse events were recorded for Cohort 2. Cohort 1 included 60 patients (mean [standard deviation] dose, 206.0 [98.8] U); Cohort 2 included 54 patients (753.7 [457.3] U). Mean (95% confidence interval) GAS-T scores for Cohorts 1 and 2 were 43.1 (39.3–46.9) and 47.8 (43.7–51.9) at Week 6, and 43.2 and 44.3 at Week 12, respectively. In both cohorts most patients were satisfied with treatment. At Week 12, QoL had not changed in Cohort 1 but had improved in Cohort 2 (EQ-5D VAS, −5). Mean estimated per-patient costs (in 2021) for Cohorts 1 and 2 were £315.56 and £249.25, respectively, at Week 6, and £343.20 and £273.21, respectively, at Week 12. Fifteen non–treatment-related serious adverse events and two deaths were recorded. These data may warrant a larger prospective study powered to compare outcomes of aboBoNT-A and onaBoNT-A. Full article
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