Is repeat Botulinum Toxin A injection valuable for neurogenic detrusor overactivity—A systematic review and meta‐analysis

Ni, Jianshu; Wang, Xiaohu; Cao, Nailong; Si, Jiemin; Gu, Baojun

doi:10.1002/nau.23354

Cited by 26 publications

(16 citation statements)

References 27 publications

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“…However, we did not fully share their conclusion that “repeat BTX‐A injections allow sustained improvements in patients with NDO.” Indeed, the 39.8% discontinuation rate and 28.9% failure rate they reported at 7 years raise some concerns that should, in our view, draw attention of the neurourological community. Indeed, this report confirms, in the largest cohort to date and with a remarkable methodology, recent findings from smaller series, with long‐term discontinuation rates of up to 45.2% …”

supporting

confidence: 87%

Failures and long‐term discontinuations of intradetrusor botulinum toxin injections for neurogenic detrusor overactivity: A new challenge in neurourology

Peyronnet

Gamé

2017

Neurourology and Urodynamics

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supporting

confidence: 87%

Failures and long‐term discontinuations of intradetrusor botulinum toxin injections for neurogenic detrusor overactivity: A new challenge in neurourology

Peyronnet

Gamé

2017

Neurourology and Urodynamics

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“…BoNT use may have a cumulative immunogenic effect over time in patients with lifelong conditions, such as cervical dystonia [13,98], as well as in patients who receive multiple BoNT-A treatments for a range of different indications (both aesthetic and therapeutic) during their lifetime. Both the FDA [22] and the European Medicines Agency (EMEA) [99] recommend evaluating and mitigating adverse immunologically related responses associated with therapeutic protein products and encourage risk reduction.…”

Section: Immunologists' Perspective: Immunogenicity Should Be a Key Factor In Choice Of Bont Therapymentioning

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 2009, Pannek et al reported an approximate long-term success rate of 74% [ 26 ]. In a recent review [ 27 ], summarizing 18 studies with a total of 1533 patients, discontinuation rates between 12.1 and 45.2% were described. A 10-year observation period in 140 patients showed an estimated 10-year discontinuation-free survival rate of 49.1% [ 13 ] and a discontinuation rate of 40% [ 12 ].…”

Section: Discussionmentioning

confidence: 99%

“…In accordance with this finding, a gradually decreased therapeutic effect after the 4th BoNT-A injection in SCI/D patients with NDO was reported [ 33 ]. Furthermore, a significant decrease in quality of life in patients who received five or more injections was described [ 27 ].…”

Section: Discussionmentioning

confidence: 99%

Can clinical and urodynamic parameters predict the occurrence of neutralizing antibodies in therapy failure of intradetrusor onabotulinumtoxin A injections in patients with spinal cord injury?

et al. 2020

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Background The aim of the study was to clarify whether clinical and/or urodynamic parameters could be used to infer the probability of neutralizing antibody (NAb) formation as a possible cause of therapy failure (non-response, NR) in patients with neurogenic detrusor overactivity (NDO) due to acquired spinal cord injury/disease (SCI/D) treated with intradetrusor botulinum neurotoxin A (BoNT-A) injections. Methods A retrospective chart review was performed of all patients with SCI/D who underwent both intradetrusor onabotulinumtoxin A injections and the determination of neutralizing antibodies against BoNT-A between January 1, 2002, and December 31, 2018. NR was defined as urodynamically confirmed persistent or reappearing NDO. Results A total of 2700 BoNT-A injections in 414 patients were ascertained. In 69 patients with primary NR after the first BoNT-A injection ( n = 6) or with secondary NR after more than one BoNT-A injection ( n = 63), an antibody analysis was performed. Antibody examination showed 36 (52.2%) negative, 5 (7.2%) borderline and 14 (each 20.3%) each of positive and highly positive values. Subgroup analysis indicated a correlation between NAb formation and the duration of BoNT-A therapy ( p = 0.015), the mean number of BoNT-A injections ( p = 0.011) and the time interval between BoNT-A applications (< 7 months, p = 0.022). Urodynamic data analysis indicate significant differences with cut-off values of MCC (< 225 ml, p = 0.038) and MDP (> 45 cmH 2 O, p = 0.040). However, in the regression analysis models, the predictive value for the occurrence of NAb was too low (MCC: ROC AUC 0.62, MDP: ROC AUC 0.52) to distinguish with sufficient certainty between NAb-positive and NAb-negative NR patients. Conclusions Despite significant correlations, clinical and urodynamic parameters are only partially suitable for predicting antibody formation against BoNT-A.

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Is repeat Botulinum Toxin A injection valuable for neurogenic detrusor overactivity—A systematic review and meta‐analysis

Abstract: Our study demonstrated that repeat BTX-A injections allow sustained improvements in patients with NDO. The rate of AEs was stable and low. However, additional high-quality, large-scale, and long-term trials are necessary to establish the efficacy and safety of ≥5 repeat BTX-A injections.

Cited by 26 publications

References 27 publications

Failures and long‐term discontinuations of intradetrusor botulinum toxin injections for neurogenic detrusor overactivity: A new challenge in neurourology

Failures and long‐term discontinuations of intradetrusor botulinum toxin injections for neurogenic detrusor overactivity: A new challenge in neurourology

Immunogenicity of Botulinum Toxin Formulations: Potential Therapeutic Implications

Can clinical and urodynamic parameters predict the occurrence of neutralizing antibodies in therapy failure of intradetrusor onabotulinumtoxin A injections in patients with spinal cord injury?

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