Reply to Comment on Re-Visiting Immunogenicity Associated with Botulinum Toxin Treatment. Toxins 2019, 11, 491

Bellows, Steven T.; Jankovic, Joseph

doi:10.3390/toxins12020072

Cited by 7 publications

(10 citation statements)

References 15 publications

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“…It seems to be common sense that NAB formation occurs only in a small percentage of BoNT/A-treated patients [ 3 , 4 ]. Unfortunately, in many studies reporting antibody rates or prevalence of NABs, antibody tests are only performed in selected patients.…”

Section: Introductionmentioning

confidence: 99%

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The complex relationship between antibody titers and clinical outcome in botulinum toxin type A long-term treated patients with cervical dystonia

et al. 2022

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Background Repeated injections with abo- or onabotulinumtoxin type A (aboBoNT/A, onaBoNT/A) may lead to induction of neutralizing antibodies (NABs) and/or a secondary treatment failure (STF). The relation between NABs and STF is still unclear. Aim of the study To demonstrate that a significant improvement can be observed in patients with STF after abo- or onaBoNT/A-treatment when switched to incobotulinumtoxin type A (incoBoNT/A) and that in NAB-positive patients without STF abo- or onaBoNT/A-treatment can be continued without significant worsening. Methods Paralysis times (PT) of the mouse hemidiaphragm assay (MHDA) and clinical outcome (TSUI-score) was analyzed in 60 patients with cervical dystonia (CD) and STF after abo- or onaBoNT/A-treatment (STF-group) who were switched to incobotulinumtoxin type A (incoBoNT/A). These data were compared to those of 34 patients who were exclusively treated with incoBoNT/A (INCO-group). Furthermore, PTs and TSUI-scores were followed up over 7 years in 9 patients with NABs but without STF who were switched to inco-BoNT/A (SWI-group) and 9 other patients with NABs who remained on their previous BoNT/A preparation (NO-SWI-group). Results In the STF-group, a significant improvement of TSUI-scores could be detected after switch to incoBoNT/A. This improvement was less pronounced than in the INCO-group. There was no significant difference in long-term outcome between the SWI- and NO-SWI-group. Conclusion The best strategy is to avoid the induction of NABs. A switch to incoBoNT/A may lead to improvement in patients with STF. However, in some patients with NABs without STF, BoNT/A-treatment can be continued without significant worsening.

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Section: Introductionmentioning

confidence: 99%

“…Nevertheless, the relationship between secondary non-responsiveness or secondary treatment failure (STF) and NABs is unclear [ 3 , 4 ]. The difficulty on the one hand is that STF is not precisely defined.…”

Section: Introductionmentioning

confidence: 99%

The complex relationship between antibody titers and clinical outcome in botulinum toxin type A long-term treated patients with cervical dystonia

et al. 2022

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“…In the other two groups IMPD was smaller than IMPTSUI (37% vs. 47% in the CO-group; 41% vs. 55% in the DO-group. This is the typical situation, that physicians rate the improvement of their therapy better than the patients (for details see [ 35 , 36 ]).…”

Section: Discussionmentioning

confidence: 99%

“…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. [ 21 , 27 , 34 , 35 ].…”

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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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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“…In a previous meta-analysis, 0.49% of the 2240 subjects were converted from NAb negative at baseline to NAb positive at one or most post-treatment time points across five indications (cervical dystonia, post-stroke spasticity, axillary hyperhidrosis, neurogenic overactive bladder, and glabellar lines) using different routes of administration [ 4 ]. Although rare, NAb formation remains a relevant consideration for clinical practice involving onabotulinumtoxinA treatment [ 6 , 11 ] This updated meta-analysis was therefore undertaken to evaluate the frequency of the NAb formation that follows onabotulinumtoxinA treatment based on the clinical study data from nearly 30,000 longitudinal subject records across 10 therapeutic and aesthetic indications. To further explore the risk factors associated with NAb formation, this analysis also examines the relationships between NAb formation and gender, indication (dose route and location), dose level, dosing intervals, and number of treatment cycles.…”

Section: Introductionmentioning

confidence: 99%

Neutralizing Antibody Formation with OnabotulinumtoxinA (BOTOX®) Treatment from Global Registration Studies across Multiple Indications: A Meta-Analysis

Jankovic

Carruthers

Naumann

et al. 2023

Toxins

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Though the formation of neutralizing antibodies (NAbs) during treatment with botulinum neurotoxin is rare, their presence may nonetheless affect the biological activity of botulinum toxin and negatively impact clinical response. The goal of this updated meta-analysis was to evaluate and characterize the rate of NAb formation using an expanded dataset composed of 33 prospective placebo-controlled and open-label clinical trials with nearly 30,000 longitudinal subject records prior to and following onabotulinumtoxinA treatment in 10 therapeutic and aesthetic indications. Total onabotulinumtoxinA doses per treatment ranged from 10 U to 600 U administered in ≤15 treatment cycles. The NAb formation at baseline and post-treatment was tested and examined for impact on clinical safety and efficacy. Overall, 27 of the 5876 evaluable subjects (0.5%) developed NAbs after onabotulinumtoxinA treatment. At study exit, 16 of the 5876 subjects (0.3%) remained NAb positive. Due to the low incidence of NAb formation, no clear relationship was discernable between positive NAb results and gender, indication, dose level, dosing interval, treatment cycles, or the site of injection. Only five subjects who developed NAbs post-treatment were considered secondary nonresponders. Subjects who developed NAbs revealed no other evidence of immunological reactions or clinical disorders. This comprehensive meta-analysis confirms the low NAb formation rate following onabotulinumtoxinA treatment across multiple indications, and its limited clinical impact on treatment safety and efficacy.

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Reply to Comment on Re-Visiting Immunogenicity Associated with Botulinum Toxin Treatment. Toxins 2019, 11, 491

Abstract: We appreciate the commentary on our article by Foster and Beard, both employees of Ipsen [...]

Cited by 7 publications

References 15 publications

The complex relationship between antibody titers and clinical outcome in botulinum toxin type A long-term treated patients with cervical dystonia

The complex relationship between antibody titers and clinical outcome in botulinum toxin type A long-term treated patients with 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

Neutralizing Antibody Formation with OnabotulinumtoxinA (BOTOX®) Treatment from Global Registration Studies across Multiple Indications: A Meta-Analysis

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