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

2021 ◽  
Vol 12 ◽  
Author(s):  
Joyce Oleszek ◽  
Ann Tilton ◽  
Jorge Carranza del Rio ◽  
Nigar Dursun ◽  
Marcin Bonikowski ◽  
...  

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.

Toxicon ◽  
2021 ◽  
Vol 190 ◽  
pp. S53
Author(s):  
Joyce Oleszek ◽  
Ann Tilton ◽  
Jorge Carranza ◽  
Nigar Dursun ◽  
Marcin Bonikowski ◽  
...  

2015 ◽  
Vol 56 (1) ◽  
pp. 271 ◽  
Author(s):  
Eun Sook Park ◽  
Ji-Woon Joo ◽  
Seon Ah Kim ◽  
Dong-Wook Rha ◽  
Soo Jin Jung

2006 ◽  
Vol 15 (4) ◽  
pp. 247-256 ◽  
Author(s):  
Frank Fitoussi ◽  
Amadou Diop ◽  
Nathalie Maurel ◽  
El Mostafa Laassel ◽  
Georges François Penneçot

JBJS Reviews ◽  
2020 ◽  
Vol 8 (3) ◽  
pp. e0119 ◽  
Author(s):  
Sara M. Farag ◽  
Manal O. Mohammed ◽  
Tamer A. EL-Sobky ◽  
Nadia A. ElKadery ◽  
Abeer K. ElZohiery

2017 ◽  
Vol 40 (12) ◽  
pp. 1361-1371 ◽  
Author(s):  
Simon Garbellini ◽  
Yvette Robert ◽  
Melinda Randall ◽  
Catherine Elliott ◽  
Christine Imms

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