Evidence map›Paper›PMID 37368654›Full record

ArticleToxins2023

Pooled Safety Analysis of IncobotulinumtoxinA in the Treatment of Neurological Disorders in Adults.

Wolfgang H Jost, Petr Kaňovský, Michael A Hast, Angelika Hanschmann, Michael Althaus, Atul T Patel

Open access · goldAbstract read
In one paragraph

Article in Toxins, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
1.2field-weighted citation impact, top 20% 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

1 citing paper in PubMed, 6 citations in OpenAlex.

  1. Trial
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

6 authors at 3 institutions in 3 countries.

Wolfgang H JostParkinson-Klinik Ortenau, 77709 Wolfach, Germany.ORCID 0000-0002-8574-3297
Petr KaňovskýFaculty of Medicine and Dentistry and University Hospital, Palacký University Olomouc, 779 00 Olomouc, Czech Republic.ORCID 0000-0002-9009-3241
Michael A HastMerz Pharmaceuticals, LLC, Raleigh, NC 27615, USA.
Angelika HanschmannMerz Therapeutics GmbH, 60318 Frankfurt am Main, Germany.
Michael AlthausMerz Therapeutics GmbH, 60318 Frankfurt am Main, Germany.
Atul T PatelKansas City Bone and Joint Clinic, Overland Park, KS 66211, USA.ORCID 0000-0003-2765-7953
Merz (United States) · USParkinson-Klinik Ortenau · DEUniversity Hospital Olomouc · CZ

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The pooled incidences of treatment-emergent adverse events (TEAEs) were examined by indication using the integrated clinical database of Merz-sponsored, placebo-controlled, or repeat-dose studies of incobotulinumtoxinA in adults with cervical dystonia, blepharospasm, limb spasticity, sialorrhea, or essential tremor of the upper limb. Overall incidences of TEAEs, serious TEAEs, TEAEs leading to discontinuation, fatal TEAEs, TEAEs of special interest (TEAESIs; indicating possible toxin spread), and treatment-related (TR) events were determined for incobotulinumtoxinA and placebo after a single injection and for repeated dose cycles of incobotulinumtoxinA. The most frequent events after a single dose of incobotulinumtoxinA are summarized. After a single cycle, incidences of overall TEAEs were similar between incobotulinumtoxinA and the placebo in most indications, although between-indication differences were observed. Few TEAEs led to incobotulinumtoxinA discontinuation; there were no fatal TEAEs with incobotulinumtoxinA. In general, repeated cycles did not increase the incidence of any event. The most frequent TR-TEAEs were indication-dependent, including dysphagia for indications affecting the head or neck. The TR-TEAESIs across all indications were most commonly muscular weakness, dysphagia and dry mouth. Overall, the results of this pooled analysis support and extend the favorable safety and tolerability profile of incobotulinumtoxinA for the treatment of adult neurological disorders established by individual clinical studies.

Indexed as

Botulinum Toxins, Type ADeglutition DisordersNervous System DiseasesNeuromuscular AgentsTorticollisAdultDouble-Blind MethodHumansTreatment OutcomeBotulinum Toxins, Type AincobotulinumtoxinANeuromuscular Agentsblepharospasmcervical dystoniaessential tremorimmunogenicityincobotulinumtoxinAmotor disordersneurological disorderssafetysialorrheaspasticity

Identifiers

PMID37368654
PMCPMC10301625
OpenAlexW4378086914

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.