{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,17]],"date-time":"2026-07-17T15:39:47Z","timestamp":1784302787581,"version":"3.55.0"},"reference-count":43,"publisher":"MDPI AG","issue":"9","license":[{"start":{"date-parts":[[2022,8,25]],"date-time":"2022-08-25T00:00:00Z","timestamp":1661385600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Merz Therapeutics GmbH"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Toxins"],"abstract":"<jats:p>IncobotulinumtoxinA, a pure botulinumtoxinA formulation, is free of accessory proteins. This analysis provides pooled safety data from phase 3 trials of children\/adolescents (2\u201317 years), investigating incobotulinumtoxinA for the treatment of spasticity associated with cerebral palsy (at doses \u226420 U\/kg (max. 500 U) per injection cycle (IC) for \u22646 ICs; three trials) or sialorrhea associated with neurologic disorders (at total doses of 20\u201375 U per IC for \u22644 ICs; one trial) for \u226496 weeks. Safety endpoints included the incidences of different types of treatment-emergent adverse events (TEAEs) and immunogenicity. IncobotulinumtoxinA dose groups were combined. Of 1159 patients (mean age 7.3 years, 60.4% males) treated with incobotulinumtoxinA, 3.9% experienced treatment-related TEAEs, with the most common being injection site reactions (1.3%) (both indications), muscular weakness (0.7%) (spasticity), and dysphagia (0.2%) (sialorrhea). Two patients (0.2%) experienced a treatment-related treatment-emergent serious adverse event, and 0.3% discontinued the study due to treatment-related TEAEs. No botulinumtoxinA-na\u00efve patients developed neutralizing antibodies (NAbs) after incobotulinumtoxinA. All children\/adolescents with known pre-treatment status and testing positive for Nabs at final visit (n = 7) were previously treated with a botulinumtoxinA other than incobotulinumtoxinA. IncobotulinumtoxinA was shown to be safe, with very few treatment-related TEAEs in a large, diverse cohort of children\/adolescents with chronic conditions requiring long-term treatment and was without new NAb formation in treatment-na\u00efve patients.<\/jats:p>","DOI":"10.3390\/toxins14090585","type":"journal-article","created":{"date-parts":[[2022,8,31]],"date-time":"2022-08-31T02:09:36Z","timestamp":1661911776000},"page":"585","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Safety Profile and Lack of Immunogenicity of IncobotulinumtoxinA in Pediatric Spasticity and Sialorrhea: A Pooled Analysis"],"prefix":"10.3390","volume":"14","author":[{"given":"Steffen","family":"Berweck","sequence":"first","affiliation":[{"name":"Sch\u00f6n Klinik Vogtareuth, Krankenhausstra\u00dfe 20, 83569 Vogtareuth, Germany"},{"name":"Dr. von Hauner Children\u2019s Hospital, Munich University, Lindwurmstrasse 4, 80337 Munich, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marta","family":"Banach","sequence":"additional","affiliation":[{"name":"Jagiellonian University Medical College, \u015awi\u0119tej Anny 12, 31-008 Krakow, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6827-4241","authenticated-orcid":false,"given":"Deborah","family":"Gaebler-Spira","sequence":"additional","affiliation":[{"name":"Shirley Ryan AbilityLab, Northwestern Feinberg School of Medicine, 355 E. Erie St, Chicago, IL 60611, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4372-0780","authenticated-orcid":false,"given":"Henry G.","family":"Chambers","sequence":"additional","affiliation":[{"name":"Rady Children\u2019s Hospital, 3030 Children\u2019s Way MC 5062, San Diego, CA 92123, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A. S.","family":"Schroeder","sequence":"additional","affiliation":[{"name":"Division of Paediatric Neurology and Developmental Medicine, LMU Center for Children with Medical Complexity, Dr. von Hauner Children\u2019s Hospital, Ludwig Maximilian University of Munich, Lindwurmstrasse 4, 80337 Munich, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thorin L.","family":"Geister","sequence":"additional","affiliation":[{"name":"Merz Therapeutics GmbH, Eckenheimer Landstra\u00dfe 100, 60318 Frankfurt am Main, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Althaus","sequence":"additional","affiliation":[{"name":"Merz Therapeutics GmbH, Eckenheimer Landstra\u00dfe 100, 60318 Frankfurt am Main, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Angelika","family":"Hanschmann","sequence":"additional","affiliation":[{"name":"Merz Therapeutics GmbH, Eckenheimer Landstra\u00dfe 100, 60318 Frankfurt am Main, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matteo","family":"Vacchelli","sequence":"additional","affiliation":[{"name":"Merz Therapeutics GmbH, Eckenheimer Landstra\u00dfe 100, 60318 Frankfurt am Main, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michaela V.","family":"Bonfert","sequence":"additional","affiliation":[{"name":"Division of Paediatric Neurology and Developmental Medicine, LMU Center for Children with Medical Complexity, Dr. von Hauner Children\u2019s Hospital, Ludwig Maximilian University of Munich, Lindwurmstrasse 4, 80337 Munich, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3872-6136","authenticated-orcid":false,"given":"Florian","family":"Heinen","sequence":"additional","affiliation":[{"name":"Division of Paediatric Neurology and Developmental Medicine, LMU Center for Children with Medical Complexity, Dr. von Hauner Children\u2019s Hospital, Ludwig Maximilian University of Munich, Lindwurmstrasse 4, 80337 Munich, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edward","family":"Dabrowski","sequence":"additional","affiliation":[{"name":"Beaumont Pediatric Physical Medicine & Rehabilitation\u2013Royal Oak, 3535 W 13 Mile Rd #307, Royal Oak, MI 48073, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2022,8,25]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1055\/s-0039-1694988","article-title":"Botulinum toxin in children with cerebral palsy: An update","volume":"51","author":"Hareb","year":"2020","journal-title":"Neuropediatrics"},{"key":"ref_2","doi-asserted-by":"crossref","unstructured":"S\u00e4til\u00e4, H. 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