Significant Long-Lasting Improvement after Switch to Incobotulinum Toxin in Cervical Dystonia Patients with Secondary Treatment Failure

Hefter, Harald; Ürer, Beyza; Brauns, Raphaela; Rosenthal, Dietmar; Meuth, Sven G.; Lee, John-Ih; Albrecht, Philipp; Samadzadeh, Sara

doi:10.3390/toxins14010044

Cited by 9 publications

(11 citation statements)

References 50 publications

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“…Additional strengths include that most of the incorporated studies were placebo-controlled for the first injection cycle, data were obtained over multiple incobotulinumtoxinA injection cycles and the analyses were performed on a background of stable antispastic medications (centrally acting muscle relaxants, benzodiazepine) and physical/occupational therapy. Using a multipattern treatment approach, incobotulinumtoxinA produced effective improvements in QoL-related outcomes, a finding that should be considered along with the well-established safety profile and low immunogenicity profile of incobotulinumtoxinA [ 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 , 61 , 62 , 63 , 64 , 65 , 66 , 67 , 68 , 69 , 70 , 71 , 72 , 73 , 74 , 75 , 76 , 77 , 78 ]. Furthermore, the mixed etiology of spasticity evident in this study may make the findings applicable to a wider range of patients, although most patients had poststroke spasticity.…”

Section: Discussionmentioning

confidence: 99%

Improvement in Quality-of-Life-Related Outcomes Following Treatment with IncobotulinumtoxinA in Adults with Limb Spasticity: A Pooled Analysis

Molteni,

Wissel,

Fheodoroff

et al. 2023

Toxins

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A strong correlation has been reported between patient-reported quality of life (QoL) and the investigator-rated Disability Assessment Scale (DAS) in patients with spasticity. The current analysis evaluates the effect of incobotulinumtoxinA on QoL-related outcomes (limb position abnormality, as well as dressing- and hygiene-related disability, measured with the DAS) in adults with upper limb spasticity, using pooled data from six studies. Separate analyses for each DAS domain were performed using data from patients with disabilities for that domain (DAS score ≥1). Results showed that a significantly greater proportion of incobotulinumtoxinA-treated compared with placebo-treated patients achieved a ≥1-point reduction from baseline in each of the DAS domains (improvement) 4 weeks after the first injection. The benefits of incobotulinumtoxinA were observed regardless of the baseline severity of DAS impairment and of the time elapsed since stroke. The effects of incobotulinumtoxinA 4 weeks after injection were maintained or enhanced over multiple injection cycles for all three DAS domains, supporting the use of repeated injection cycles to provide sustained QoL benefit. IncobotulinumtoxinA represents an important treatment option to achieve better QoL-related outcomes for patients with upper limb spasticity, irrespective of the duration of their condition.

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Section: Discussionmentioning

confidence: 99%

Improvement in Quality-of-Life-Related Outcomes Following Treatment with IncobotulinumtoxinA in Adults with Limb Spasticity: A Pooled Analysis

Molteni,

Wissel,

Fheodoroff

et al. 2023

Toxins

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“… 18 Moreover, a recent study found significant long‐lasting improvement after switch to A/Inco for cervical dystonia patients with secondary treatment failure. 19 In addtion to the CPs, the excipients in different BTX‐As might be the reason for the enhancement of paralytic efficacy, and studies had reported that the stabilizer such as human serum albumin could result in enhanced BTX‐A activity in the mLD50 assay. 12 , 20 , 21 …”

Section: Discussionmentioning

confidence: 99%

“…16 Except from this, CPs played a vital role in the antibody-induced failure of the BTX therapy, probably via increasing the BTX-A antigenicity. 17 19 In addtion to the CPs, the excipients in different BTX-As might be the reason for the enhancement of paralytic efficacy, and studies had reported that the stabilizer such as human serum albumin could result in enhanced BTX-A activity in the mLD50 assay. 12,20,21 There are some limations in this study.…”

Section: Gastrocnemius Muscle Strength Meanmentioning

confidence: 99%

Dynamic muscle paralytic effects of a novel botulinum toxin A free of neurotoxin‐associated proteins

Liu

Feng

et al. 2022

Pharmacology Res & Perspec

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Structurally, botulinum toxin type A (BTX‐A) is composed of neurotoxin and nontoxic complexing proteins (CPs), and the neurotoxin has the function of blocking acetylcholine release from the neuromuscular junction and therefore paralyzing muscles. Nowadays, a novel botulinum toxin A free of CPs (chinbotulinumtoxin A, A/Chin) is produced, and the present study comprehensively evaluated the dynamic paralytic effect of A/Chin on the gastrocnemius muscle of rats. Different doses (0.01, 0.1, 0.5, 1, 2, and 4 U) of A/Chin and other BTX‐As with and without CPs were administered to the gastrocnemius muscles of rats and muscle strength was measured and compared at different postinjection timepoints (from day 0 to 84). With the dose increased, time‐to‐peak paralytic effect of other BTX‐As varied from day 3 to day 14, while A/Chin groups showed rapid and steady time to peak on day 3. At the lowest dose of 0.01 U, A/Chin showed significantly better peak paralytic effect than the others on day 3. When the dose increased to 0.5 U and more, A/Chin group also showed significant paralytic effect when the paralytic effect of other BTX‐As was worn off. Moreover, the paralytic effect of A/Chin was confirmed as muscle atrophy while hematoxylin–eosin staining was performed. In conclusion, compared with other BTX‐As, A/Chin showed rapid and steady time‐to‐peak paralytic effect and long‐term paralytic efficacy at the same dose level. And it might lay a solid foundation for further wide application of A/Chin in both clinical and cosmetic areas.

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“…Patients were classified as patients with primary treatment failure (PTF) when their improvement during the entire course of treatment (assessed using the TSUI scale [19]) was lower than 3 points. Patients were classified as secondary non-responders (STF) when they experienced an improvement of at least 3 TSUI points, followed by a systematic worsening of at least 2 TSUI points over at least two treatment cycles during their course of treatment (for details of the definition of secondary non-responders, see [22]). Two patients were primary non-responders (open symbols in Figures 1 and 2), and four patients were secondary non-responders (full black symbols in Figures 1 and 2).…”

Section: Methodsmentioning

confidence: 99%

“…A mean BTSUI of 3.75 was observed after a treatment period of 1354 days (corresponding to 15 injections), with a mean dose of 843 U aboBoNT/A (=281 uDU). The mean BTSUI was 3.83 in a group of CD patients exclusively treated with 321 U onabotulinum neurotoxin type A(onaBoNT/A; Botox ® ) over 1085 days (corresponding to 12 injections), and was 1.71 in a group of CD patients exclusively treated with 267 U incoBoNT/A over 920 days (corresponding to 10 injections) [22]. Having reached its best value, the TSUI score slowly increases again when the dose of BoNT/A is not increased.…”

Section: Reasons For the Excellent Outcome In The Present Cohortmentioning

confidence: 99%

Exploring the Interplay between the Clinical and Presumed Effect of Botulinum Injections for Cervical Dystonia: A Pilot Study

Hefter,

Samadzadeh

2023

Toxins

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Background: Repetitive intramuscular injections of botulinum neurotoxin type A (BoNT/A) are the treatment of choice in patients with cervical dystonia (CD). As soon as BoNT therapy is initiated, the natural course of CD cannot be observed anymore. Nevertheless, the present study focuses on the “presumed” course of disease severity under the assumption that no BoNT therapy had been performed. The “experienced” benefit is compared with the “presumed” worsening. Methods: Twenty-seven BoNT/A long-term-treated CD patients were recruited. They had to assess the remaining severity of CD in percent of its severity at the start of BoNT therapy (RS-%). Then, they had to draw the course of severity from the onset of symptoms to the start of BoNT/A therapy (CoDB graph), as well as the course of severity from the start of BoNT/A therapy until the day of recruitment (CoDA graph). Then, they were instructed to presume the development of CD severity from the day of the start of BoNT/A therapy until the day of recruitment under the assumption that no BoNT/A therapy had been performed, and to assess the maximal severity they could presume in percent of the severity at the start of BoNT therapy (IS-%). Then, they had to draw the “presumed” development of CD severity (CoDI graph). The “experienced” change in disease severity and the “presumed” change since the start of BoNT/A therapy were compared and correlated with a variety of demographical and treatment-related data, including the actual severity of CD at the day of recruitment, which was assessed using the TSUI score and the actual dose per session (ADOSE). Results: No CD patients expected an improvement without BoNT therapy. “Presumed” worsening ((IS-%)-100) was about 50% in the mean and did not correlate with the “experienced” benefit (100-(RS-%)). However, IS-% was significantly correlated with ATSUI and ADOSE. Conclusion: Obviously, CD patients have the opinion that their CD would have further progressed and worsened if no BoNT/A therapy had been performed. Thus, the total benefit of BoNT/A therapy for a patient with CD is a combination of the “experienced” benefit under BoNT/A therapy and the prevented worsening of CD that the patient expects to occur without BoNT/A therapy.

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Significant Long-Lasting Improvement after Switch to Incobotulinum Toxin in Cervical Dystonia Patients with Secondary Treatment Failure

Cited by 9 publications

References 50 publications

Improvement in Quality-of-Life-Related Outcomes Following Treatment with IncobotulinumtoxinA in Adults with Limb Spasticity: A Pooled Analysis

Improvement in Quality-of-Life-Related Outcomes Following Treatment with IncobotulinumtoxinA in Adults with Limb Spasticity: A Pooled Analysis

Dynamic muscle paralytic effects of a novel botulinum toxin A free of neurotoxin‐associated proteins

Exploring the Interplay between the Clinical and Presumed Effect of Botulinum Injections for Cervical Dystonia: A Pilot Study

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