Muscle Selection and Dosing in a Phase 3, Pivotal Study of AbobotulinumtoxinA Injection in Upper Limb Muscles in Children With Cerebral Palsy

Background: Guidelines recommend botulinum toxin-A in pediatric upper limb spasticity as part of routine practice. Appropriate dosing is a prerequisite for treatment success and it is important that injectors have an understanding on how to tailor dosing within a safe and effective range. We report...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	Joyce Oleszek, Ann Tilton, Jorge Carranza del Rio, Nigar Dursun, Marcin Bonikowski, Edward Dabrowski, Simon Page, Benjamin Regnault, Catherine Thompson, Mauricio R. Delgado
Formato:	article
Lenguaje:	EN
Publicado:	Frontiers Media S.A. 2021
Materias:	abobotulinumtoxinA botulinum toxin cerebral palsy dose dosing Dysport Neurology. Diseases of the nervous system RC346-429
Acceso en línea:	https://doaj.org/article/b69d87904986410a935300621a28ef93
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:b69d87904986410a935300621a28ef93
record_format	dspace
spelling	oai:doaj.org-article:b69d87904986410a935300621a28ef932021-11-05T15:49:24ZMuscle Selection and Dosing in a Phase 3, Pivotal Study of AbobotulinumtoxinA Injection in Upper Limb Muscles in Children With Cerebral Palsy1664-229510.3389/fneur.2021.728615https://doaj.org/article/b69d87904986410a935300621a28ef932021-10-01T00:00:00Zhttps://www.frontiersin.org/articles/10.3389/fneur.2021.728615/fullhttps://doaj.org/toc/1664-2295Background: Guidelines recommend botulinum toxin-A in pediatric upper limb spasticity as part of routine practice. Appropriate dosing is a prerequisite for treatment success and it is important that injectors have an understanding on how to tailor dosing within a safe and effective range. We report upper limb dosing data from a phase 3 study of abobotulinumtoxinA injections in children with cerebral palsy.Methods: This was a double-blind, repeat-treatment study (NCT02106351). In Cycle 1, children were randomized to abobotulinumtoxinA at 2 U/kg control dose or clinically relevant 8 U/kg or 16 U/kg doses. Doses were divided between the primary target muscle group (PTMG, wrist or elbow flexors) and additional muscles tailored to clinical presentation. During Cycles 2–4, children received doses of 8 U/kg or 16 U/kg and investigators could change the PTMG and other muscles to be injected. Injection of muscles in the other upper limb and lower limbs was also permitted in cycles 2–4, with the total body dose not to exceed 30 U/kg or 1,000 U (whichever was lower) in the case of upper and lower limb treatment.Results: 212 children were randomized, of which 210 received ≥1 abobotulinumtoxinA injection. Per protocol, the elbow and wrist flexors were the most commonly injected upper limb muscles. Across all 4 cycles, the brachialis was injected in 89.5% of children (dose range 0.8–6 U/kg), the brachioradialis in 83.8% (0.4–3 U/kg), the flexor carpi ulnaris in 82.4% (0.5–3 U/kg) and the flexor carpi radialis in 79.5% (0.5–4 U/kg). Other frequently injected upper limb muscles were the pronator teres(70.0%, 0.3–3 U/kg). adductor pollicis (54.3%, 0.3-1 U/kg), pronator quadratus (44.8%, 0.1–2 U/kg), flexor digitorum superficialis (39.0%, 0.5-4 U/kg), flexor digitorum profundus (28.6%, 0.5–2 U), flexor pollicis brevis/opponens pollicis (27.6%, 0.3-1 U/kg) and biceps (27.1%, 0.5–6 U/kg). AbobotulinumtoxinA was well-tolerated at these doses; muscular weakness was reported in 4.3% of children in the 8 U/kg group and 5.7% in the 16 U/kg group.Conclusions: These data provide information on the pattern of injected muscles and dose ranges used in this study, which were well-tolerated. Per protocol, most children received injections into the elbow and wrist flexors. However, there was a wide variety of other upper limb muscles injected as physicians tailored injection patterns to clinical need.Joyce OleszekAnn TiltonJorge Carranza del RioNigar DursunMarcin BonikowskiEdward DabrowskiSimon PageBenjamin RegnaultCatherine ThompsonMauricio R. DelgadoFrontiers Media S.A.articleabobotulinumtoxinAbotulinum toxincerebral palsydosedosingDysportNeurology. Diseases of the nervous systemRC346-429ENFrontiers in Neurology, Vol 12 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	abobotulinumtoxinA botulinum toxin cerebral palsy dose dosing Dysport Neurology. Diseases of the nervous system RC346-429
spellingShingle	abobotulinumtoxinA botulinum toxin cerebral palsy dose dosing Dysport Neurology. Diseases of the nervous system RC346-429 Joyce Oleszek Ann Tilton Jorge Carranza del Rio Nigar Dursun Marcin Bonikowski Edward Dabrowski Simon Page Benjamin Regnault Catherine Thompson Mauricio R. Delgado Muscle Selection and Dosing in a Phase 3, Pivotal Study of AbobotulinumtoxinA Injection in Upper Limb Muscles in Children With Cerebral Palsy
description	Background: Guidelines recommend botulinum toxin-A in pediatric upper limb spasticity as part of routine practice. Appropriate dosing is a prerequisite for treatment success and it is important that injectors have an understanding on how to tailor dosing within a safe and effective range. We report upper limb dosing data from a phase 3 study of abobotulinumtoxinA injections in children with cerebral palsy.Methods: This was a double-blind, repeat-treatment study (NCT02106351). In Cycle 1, children were randomized to abobotulinumtoxinA at 2 U/kg control dose or clinically relevant 8 U/kg or 16 U/kg doses. Doses were divided between the primary target muscle group (PTMG, wrist or elbow flexors) and additional muscles tailored to clinical presentation. During Cycles 2–4, children received doses of 8 U/kg or 16 U/kg and investigators could change the PTMG and other muscles to be injected. Injection of muscles in the other upper limb and lower limbs was also permitted in cycles 2–4, with the total body dose not to exceed 30 U/kg or 1,000 U (whichever was lower) in the case of upper and lower limb treatment.Results: 212 children were randomized, of which 210 received ≥1 abobotulinumtoxinA injection. Per protocol, the elbow and wrist flexors were the most commonly injected upper limb muscles. Across all 4 cycles, the brachialis was injected in 89.5% of children (dose range 0.8–6 U/kg), the brachioradialis in 83.8% (0.4–3 U/kg), the flexor carpi ulnaris in 82.4% (0.5–3 U/kg) and the flexor carpi radialis in 79.5% (0.5–4 U/kg). Other frequently injected upper limb muscles were the pronator teres(70.0%, 0.3–3 U/kg). adductor pollicis (54.3%, 0.3-1 U/kg), pronator quadratus (44.8%, 0.1–2 U/kg), flexor digitorum superficialis (39.0%, 0.5-4 U/kg), flexor digitorum profundus (28.6%, 0.5–2 U), flexor pollicis brevis/opponens pollicis (27.6%, 0.3-1 U/kg) and biceps (27.1%, 0.5–6 U/kg). AbobotulinumtoxinA was well-tolerated at these doses; muscular weakness was reported in 4.3% of children in the 8 U/kg group and 5.7% in the 16 U/kg group.Conclusions: These data provide information on the pattern of injected muscles and dose ranges used in this study, which were well-tolerated. Per protocol, most children received injections into the elbow and wrist flexors. However, there was a wide variety of other upper limb muscles injected as physicians tailored injection patterns to clinical need.
format	article
author	Joyce Oleszek Ann Tilton Jorge Carranza del Rio Nigar Dursun Marcin Bonikowski Edward Dabrowski Simon Page Benjamin Regnault Catherine Thompson Mauricio R. Delgado
author_facet	Joyce Oleszek Ann Tilton Jorge Carranza del Rio Nigar Dursun Marcin Bonikowski Edward Dabrowski Simon Page Benjamin Regnault Catherine Thompson Mauricio R. Delgado
author_sort	Joyce Oleszek
title	Muscle Selection and Dosing in a Phase 3, Pivotal Study of AbobotulinumtoxinA Injection in Upper Limb Muscles in Children With Cerebral Palsy
title_short	Muscle Selection and Dosing in a Phase 3, Pivotal Study of AbobotulinumtoxinA Injection in Upper Limb Muscles in Children With Cerebral Palsy
title_full	Muscle Selection and Dosing in a Phase 3, Pivotal Study of AbobotulinumtoxinA Injection in Upper Limb Muscles in Children With Cerebral Palsy
title_fullStr	Muscle Selection and Dosing in a Phase 3, Pivotal Study of AbobotulinumtoxinA Injection in Upper Limb Muscles in Children With Cerebral Palsy
title_full_unstemmed	Muscle Selection and Dosing in a Phase 3, Pivotal Study of AbobotulinumtoxinA Injection in Upper Limb Muscles in Children With Cerebral Palsy
title_sort	muscle selection and dosing in a phase 3, pivotal study of abobotulinumtoxina injection in upper limb muscles in children with cerebral palsy
publisher	Frontiers Media S.A.
publishDate	2021
url	https://doaj.org/article/b69d87904986410a935300621a28ef93
work_keys_str_mv	AT joyceoleszek muscleselectionanddosinginaphase3pivotalstudyofabobotulinumtoxinainjectioninupperlimbmusclesinchildrenwithcerebralpalsy AT anntilton muscleselectionanddosinginaphase3pivotalstudyofabobotulinumtoxinainjectioninupperlimbmusclesinchildrenwithcerebralpalsy AT jorgecarranzadelrio muscleselectionanddosinginaphase3pivotalstudyofabobotulinumtoxinainjectioninupperlimbmusclesinchildrenwithcerebralpalsy AT nigardursun muscleselectionanddosinginaphase3pivotalstudyofabobotulinumtoxinainjectioninupperlimbmusclesinchildrenwithcerebralpalsy AT marcinbonikowski muscleselectionanddosinginaphase3pivotalstudyofabobotulinumtoxinainjectioninupperlimbmusclesinchildrenwithcerebralpalsy AT edwarddabrowski muscleselectionanddosinginaphase3pivotalstudyofabobotulinumtoxinainjectioninupperlimbmusclesinchildrenwithcerebralpalsy AT simonpage muscleselectionanddosinginaphase3pivotalstudyofabobotulinumtoxinainjectioninupperlimbmusclesinchildrenwithcerebralpalsy AT benjaminregnault muscleselectionanddosinginaphase3pivotalstudyofabobotulinumtoxinainjectioninupperlimbmusclesinchildrenwithcerebralpalsy AT catherinethompson muscleselectionanddosinginaphase3pivotalstudyofabobotulinumtoxinainjectioninupperlimbmusclesinchildrenwithcerebralpalsy AT mauriciordelgado muscleselectionanddosinginaphase3pivotalstudyofabobotulinumtoxinainjectioninupperlimbmusclesinchildrenwithcerebralpalsy
_version_	1718444186233995264

Muscle Selection and Dosing in a Phase 3, Pivotal Study of AbobotulinumtoxinA Injection in Upper Limb Muscles in Children With Cerebral Palsy

Ejemplares similares