Evidence map›Paper›PMID 37235376›Full record

SynthesisToxins2023

Neutralizing Antibody Formation with OnabotulinumtoxinA (BOTOX

Joseph Jankovic, Jean Carruthers, Markus Naumann, Patricia Ogilvie, Terry Boodhoo, Mayssa Attar, Swati Gupta, Ritu Singh, John Soliman, Irina Yushmanova and 2 more

Open access · goldAbstract readMeta-Analysis
In one paragraph

Synthesis in Toxins, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
7.2field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 35 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 5 institutions in 3 countries.

Joseph JankovicBaylor College of Medicine, Houston, TX 77030, USA.
Jean CarruthersDepartment of Ophthalmology, University of British Columbia, Vancouver, BC V6T 1Z4, Canada.
Markus NaumannDepartment of Neurology and Clinical Neurophysiology, University Hospital, 86156 Augsburg, Germany.
Patricia OgilvieSkin Concept, 80333 Munich, Germany.ORCID 0000-0002-4908-6787
Terry BoodhooAbbVie, Irvine, CA 92612, USA.
Mayssa AttarAbbVie, Irvine, CA 92612, USA.
Swati GuptaAbbVie, Irvine, CA 92612, USA.
Ritu SinghAbbVie, Irvine, CA 92612, USA.
John SolimanAbbVie, Irvine, CA 92612, USA.
Irina YushmanovaAbbVie, Irvine, CA 92612, USA.
Mitchell F BrinAbbVie, Irvine, CA 92612, USA.
Jie ShenAbbVie, Irvine, CA 92612, USA.
AbbVie (United States) · USBaylor College of Medicine · USUniversity Hospital Augsburg · DEUniversity of British Columbia · CAUniversity of California, Irvine · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

Botulinum Toxins, Type ANeuromuscular AgentsAntibodies, NeutralizingAntibody FormationHumansProspective StudiesTreatment OutcomeAntibodies, NeutralizingBotulinum Toxins, Type ANeuromuscular Agentsaestheticsbladderblepharospasmcervical dystoniahyperhidrosismigraine disordersneurotoxinsoveractivespasticitytype A botulinum toxins

Identifiers

PMID37235376
PMCPMC10224273
OpenAlexW4377107809

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.