Long‐term efficacy and tolerability of 4‐monthly versus yearly botulinum toxin type A treatment for lower‐limb spasticity in children with cerebral palsy

Abstract

In this study, we compared the long‐term efficacy and tolerability of two dosage regimens of the potent botulinum toxin type A (BoNT‐A; Dysport; Ipsen Ltd, Slough, UK) in children with cerebral palsy (CP) and lower‐limb spasticity. Children aged 1 to 8 years with diplegic CP who were able to walk (aided or unaided) were randomized (1:1) to 30 LD50 units/kg total body weight of BoNT‐A (injected into gastrocnemius muscles) every 4 months or once yearly for 2 years in this multicentre, assessor‐blinded, parallel‐group study. In the 4‐monthly group (n=110, 39 males, 71 females), mean age was 3 years 8 months (SD 1y 6mo, range 1–8y). In the yearly group (n=104, 47 males, 57 females), mean age was 4 years 4 months (SD 1y 6mo, range 2–8y). Both treatment groups had similar baseline Gross Motor Function Measure scores. At month 28 (primary endpoint; intention‐to‐treat group), median maximum passive ankle dorsiflexion was 12.00° in the 4‐monthly and 11.00° in the yearly group. Between‐group difference of 1.67° was not statistically significant (p=0.055). Other efficacy endpoints showed no significant difference between the regimens. The results of the study do not allow a clear conclusion of the preferred injection regimen.

Emerging Opportunities for Serotypes of Botulinum Neurotoxins

“…Additionally, there is a study in patients with upper limb spasticity that revealed no neutralizing antibodies following injections of IncobotulinumtoxinA or a placebo [112]. Approximately 1% of 1080 subjects from an IncobotulinumtoxinA development program presented with neutralizing antibodies; however, each of the patients had been previously exposed to BoNT which contained complexing proteins [22].…”

Consenso chileno sobre Abobotulinumtoxina A (Dysport®): indicaciones, técnicas

“…Adultos (desde los 40 kilos): hasta 2.000 unidades 5,7,8,13,16,17,[43][44][45][46][47][48][49][50] .…”

Injection frequency of botulinum toxin A for spastic equinus: a randomized clinical trial

“…In contrast to the consensus and evidence about dose, no consensus and little evidence exists about injection frequency for spastic equinus in children with CP. In the only injection frequency randomized clinical trials published to date, Kanovský et al were unable to detect a significant difference between 12‐monthly and 4‐monthly injections over a 2‐year period. This was a large study with well‐accepted outcome measures, including ankle dorsiflexion by standard goniometry and the Gross Motor Function Measure …”

“…An essential part of the scientific method is to replicate novel studies. The primary aim of this study was therefore to investigate the optimal frequency of BoNT‐A injections for the treatment of spastic equinus, using similar injection regimens but with different outcome measures …”

“…This was a large study with wellaccepted outcome measures, including ankle dorsiflexion by standard goniometry and the Gross Motor Function Measure. 17 Elsewhere in the literature, recommendations regarding injection intervals range between 3 months and 12 months, based largely upon factors such as clinical intuition, avoidance of antibody formation, convenience, and cost. 7,9,10 Prescribing information supplied with Botox (Allergan Pharmaceuticals, Irvine, CA, USA) does not include evidence-based recommendations for frequency of treatment to the lower limbs in children with CP.…”