Evidence map›Paper›PMID 34515975›Full record

ReviewAdvances in therapy2021

Immunogenicity of Botulinum Toxin Formulations: Potential Therapeutic Implications.

Warner W Carr, Neal Jain, J Wesley Sublett

Registry-linked trialOpen access · hybridAbstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Advances in therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05884528 (Assessment of Long-term Clinical Response to BoNT in Cervical Dystonia - Real-world Evidence of LongevitY of Botulinum Toxin in Cervical Dystonia), which is not on this map. Cited by 50 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
50citing papers in PubMed, 5 pooled it
5.7field-weighted citation impact, top 3% 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.

NCT05884528 completednot on this mapstarted 2023, after this paper: background citation

Assessment of Long-term Clinical Response to BoNT in Cervical Dystonia - Real-world Evidence of LongevitY of Botulinum Toxin in Cervical Dystonia

TypeobservationalSponsorMerz Therapeutics GmbHRan2023 to 2024Enrolled270ConditionsCervical DystoniaArmsCC BoNT/A, CF BoNT/A, CF to CC BoNT/A, CC to CF BoNT/A
3 · Its place in the literature

Who cites it

50 citing papers in PubMed, 5 syntheses or guidelines pooled it, 79 citations in OpenAlex.

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  7. NivobotulinumtoxinA in the Treatment of Lateral Canthal Lines Alone and With Concurrent Treatment of Glabellar Lines.Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.] · 2026
    Trial
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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

3 authors at 1 institution in 1 country.

Warner W CarrAllergy and Asthma Associates of Southern California, Southern California Research, 27800 Medical Center Rd Ste 244, Mission Viejo, CA, 92691, USA. warnercarr@hotmail.com.
Neal JainArizona Allergy & Immunology Research LLC, Gilbert, AZ, USA.
J Wesley SublettFamily Allergy and Asthma, Louisville, KY, USA.
Family Allergy and Asthma Research Institute · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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 that use biologic drugs for treatment, and clinically relevant immunogenicity reduction has been achieved through engineering smaller protein constructs and reducing unnecessary formulation components. A similar approach has influenced the evolution of BoNT formulations. Three BoNT-A products and one BoNT-B product have been approved by the Food and Drug Administration (FDA) for therapeutic use: onabotulinumtoxinA, abobotulinumtoxinA, incobotulinumtoxinA, and rimabotulinumtoxinB; a fourth BoNT-A product, daxibotulinumtoxinA, is currently under regulatory review. Additionally, prabotulinumtoxinA is a BoNT-A product that has been approved for aesthetic indications but not therapeutic use. Here, we discuss the preclinical and clinical immunogenicity data that exist within the scientific literature and provide a perspective for considering immunogenicity as a key factor in choice of BoNT formulation.

Indexed as

Botulinum ToxinsHumansUnited StatesBotulinum ToxinsAbobotulinumtoxinAAntibodiesBiologicsClinical responseIncobotulinumtoxinANeutralizingOnabotulinumtoxinASecond generation

Identifiers

PMID34515975
PMCPMC8478757
OpenAlexW3201236289

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

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.