Clinical Implications of Difference in Antigenicity of Different Botulinum Neurotoxin Type A Preparations: Clinical Take-Home Messages from Our Research Pool and Literature

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

doi:10.3390/toxins12080499

Cited by 22 publications

(47 citation statements)

References 31 publications

(73 reference statements)

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“…In children with CP secondary non-response was associated with neutralizing antibody (NAB) formation in up to 75% [ 22 ]. This is consistent with recent cross-sectional studies in adult CD-patients showing a non-linear increase of NAB-formation with duration of therapy [ 31 , 32 , 33 ]. Nevertheless, the current opinion seems to be that “NAB formation occurs only in a small percentage” of BoNT/A treated patients and does not explain secondary non-response and discontinuation of BoNT therapy in the majority of CD-patients.…”

Section: Introductionsupporting

confidence: 93%

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The Impact of the Course of Disease before Botulinum Toxin Therapy on the Course of Treatment and Long-Term Outcome in Cervical Dystonia

Hefter¹,

Schomaecker²,

Schomaecker³

et al. 2021

Toxins

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This study analyses the influence of the course of the disease of idiopathic cervical dystonia (CD) before botulinum toxin (BoNT) therapy on long-term outcomes. 74 CD-patients who were treated on a regular basis in the botulinum toxin outpatient department of the University of Düsseldorf and had received at least 3 injections were consecutively recruited after written informed consent. Patients were asked to rate the amount of change of CD in relation to the severity of CD at begin of BoNT therapy (IMPQ). Then they had to draw the course of disease of CD from onset of symptoms until initiation of BoNT therapy (CoDB-graph) on a sheet of paper into a square of 10 × 10 cm2 size. Remaining severity of CD was estimated by the treating physician using the TSUI-score. Demographical and treatment related data were extracted from the charts of the patients. Depending on the curvature four different types of CoDB-graphs could be distinguished. Time to BoNT therapy, increase of dose and improvement during BoNT treatment were significantly (p < 0.05) different when patients were split up according to CoDB-graph types. The lower the age at onset of symptoms, the shorter was the time to therapy (p < 0.02). Initial dose (p < 0.04) and actual dose (p < 0.009) were negatively correlated with the age of the patients at recruitment. The course of disease of CD before BoNT therapy has influence on long-term outcome. This has implications on patient management and information on the efficacy of BoNT treatment.

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Section: Introductionsupporting

confidence: 93%

“…Three different phases of the spontaneous course of CD have been described by neurosurgeons [ 45 , 46 ]. Deterioration is observed during the first 5 years, stable condition during the next 5 years and possible improvement thereafter [ 33 ]. In a recent review remission in dystonia was analyzed [ 46 ].…”

Section: Introductionmentioning

confidence: 99%

The Impact of the Course of Disease before Botulinum Toxin Therapy on the Course of Treatment and Long-Term Outcome in Cervical Dystonia

Hefter¹,

Schomaecker²,

Schomaecker³

et al. 2021

Toxins

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“…Common signs of clinical resistance include increasing the frequency or dose of the drug administered to elicit results, complete nonresponse, and partial nonresponse (Fig. 2) [25,42,43].…”

Section: Immunogenicity In Response To Biologic Drugsmentioning

confidence: 99%

“…Common signs of clinical resistance include increasing the frequency or dose of the drug administered to elicit results. Over time, this can lead to clinical nonresponse [25,42,43]. nAb, neutralizing antibody alternative mechanism of action [25,48].…”

Section: Clinical Challenges Of Immunogenicity To Biologic Drugsmentioning

confidence: 99%

Immunogenicity of Botulinum Toxin Formulations: Potential Therapeutic Implications

Carr¹,

Jain²,

Sublett

2021

Adv Ther

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Botulinum neurotoxins (BoNTs) are proteins produced by bacteria of the Clostridium family. Upon oral ingestion, BoNT causes the neuroparalytic syndrome botulism. There are seven serotypes of BoNT (serotypes A-G); BoNT-A and BoNT-B are the botulinum toxin serotypes utilized for therapeutic applications. Treatment with BoNT injections is used to manage chronic medical conditions across multiple indications. As with other biologic drugs, immunogenicity after long-term treatment with BoNT formulations may occur, and repeated use can elicit antibody formation leading to clinical nonresponsiveness. Thus, approaching BoNT treatment of chronic conditions with therapeutic formulations that minimize stimulating the host immune response while balancing patient responsiveness to therapy is ideal. Immunogenicity is a clinical limitation in many settings

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“…In patients who reliably worsen despite an increase of dose the BoNT preparation should be switched to a complex protein free BoNT/A preparation [ 25 ] well before a complete secondary treatment failure was developed [ 26 ]. In most of the partial secondary non-responders, switching to rimaBoNT/B yields only a transient improvement.…”

Section: Discussionmentioning

confidence: 99%

The Extreme Ends of the Treatment Response Spectrum to Botulinum Toxin in Cervical Dystonia

Samadzadeh

Brauns

Hefter

2020

Toxins

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Background: The response to BoNT is not uniform; a broad spectrum of responses and side-effects usually occurs. This study aimed to show special cervical dystonia cases with therapy response very different to normal treatment course which indicate the extreme ends of therapy spectrum. Patients: Clinical data and course of treatment of five long-term treated patients with cervical dystonia out of therapy response norms are presented: a patient who was supersensitive to standard dose and has required dose adjustment to lower dose of BoNT; one patient who worsened under a standard dose, but responded excellently to twice the standard dose; one insensitive patient who responded poorly for years to a dose well above the standard dose, but responded when dose was further increased; and two patients with a totally different response pattern to BoNT/A preparation 1, but the development of a neutralizing antibody induced secondary treatment failure in both cases and a totally different response after switch to BoNT/A preparation 2. Conclusions: These five patients indicate that the response of a patient to a BoNT preparation may be unexpected. Therefore, cautious onset of BoNT therapy is recommended as well as consequent dose adjustment later on and even switch to another BoNT/A preparation when a patient has already developed NABs against BoNT/A.

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Clinical Implications of Difference in Antigenicity of Different Botulinum Neurotoxin Type A Preparations: Clinical Take-Home Messages from Our Research Pool and Literature

Cited by 22 publications

References 31 publications

The Impact of the Course of Disease before Botulinum Toxin Therapy on the Course of Treatment and Long-Term Outcome in Cervical Dystonia

The Impact of the Course of Disease before Botulinum Toxin Therapy on the Course of Treatment and Long-Term Outcome in Cervical Dystonia

Immunogenicity of Botulinum Toxin Formulations: Potential Therapeutic Implications

The Extreme Ends of the Treatment Response Spectrum to Botulinum Toxin in Cervical Dystonia

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