Pooled Safety Analysis of IncobotulinumtoxinA in the Treatment of Neurological Disorders in Adults
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...
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MDPI AG
2023-05-01
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| Series: | Toxins |
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| Online Access: | https://www.mdpi.com/2072-6651/15/6/353 |
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| author | Wolfgang H. Jost Petr Kaňovský Michael A. Hast Angelika Hanschmann Michael Althaus Atul T. Patel |
| author_facet | Wolfgang H. Jost Petr Kaňovský Michael A. Hast Angelika Hanschmann Michael Althaus Atul T. Patel |
| author_sort | Wolfgang H. Jost |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-11T01:51:56Z |
| format | Article |
| id | doaj.art-4808435d9442408e993c0b3626073ad2 |
| institution | Directory Open Access Journal |
| issn | 2072-6651 |
| language | English |
| last_indexed | 2024-03-11T01:51:56Z |
| publishDate | 2023-05-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Toxins |
| spelling | doaj.art-4808435d9442408e993c0b3626073ad22023-11-18T12:55:10ZengMDPI AGToxins2072-66512023-05-0115635310.3390/toxins15060353Pooled Safety Analysis of IncobotulinumtoxinA in the Treatment of Neurological Disorders in AdultsWolfgang H. Jost0Petr Kaňovský1Michael A. Hast2Angelika Hanschmann3Michael Althaus4Atul T. Patel5Parkinson-Klinik Ortenau, 77709 Wolfach, GermanyFaculty of Medicine and Dentistry and University Hospital, Palacký University Olomouc, 779 00 Olomouc, Czech RepublicMerz Pharmaceuticals, LLC, Raleigh, NC 27615, USAMerz Therapeutics GmbH, 60318 Frankfurt am Main, GermanyMerz Therapeutics GmbH, 60318 Frankfurt am Main, GermanyKansas City Bone and Joint Clinic, Overland Park, KS 66211, USAThe 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.https://www.mdpi.com/2072-6651/15/6/353incobotulinumtoxinAcervical dystoniablepharospasmspasticitysialorrheaessential tremor |
| spellingShingle | Wolfgang H. Jost Petr Kaňovský Michael A. Hast Angelika Hanschmann Michael Althaus Atul T. Patel Pooled Safety Analysis of IncobotulinumtoxinA in the Treatment of Neurological Disorders in Adults Toxins incobotulinumtoxinA cervical dystonia blepharospasm spasticity sialorrhea essential tremor |
| title | Pooled Safety Analysis of IncobotulinumtoxinA in the Treatment of Neurological Disorders in Adults |
| title_full | Pooled Safety Analysis of IncobotulinumtoxinA in the Treatment of Neurological Disorders in Adults |
| title_fullStr | Pooled Safety Analysis of IncobotulinumtoxinA in the Treatment of Neurological Disorders in Adults |
| title_full_unstemmed | Pooled Safety Analysis of IncobotulinumtoxinA in the Treatment of Neurological Disorders in Adults |
| title_short | Pooled Safety Analysis of IncobotulinumtoxinA in the Treatment of Neurological Disorders in Adults |
| title_sort | pooled safety analysis of incobotulinumtoxina in the treatment of neurological disorders in adults |
| topic | incobotulinumtoxinA cervical dystonia blepharospasm spasticity sialorrhea essential tremor |
| url | https://www.mdpi.com/2072-6651/15/6/353 |
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