Efficacy and safety of abobotulinumtoxinA for upper limb spasticity in children with cerebral palsy: a randomized repeat-treatment study.

AIM: To assess the efficacy and safety of repeat abobotulinumtoxinA injections in reducing upper limb spasticity in children with cerebral palsy (CP). METHOD: This was a double-blind, repeat-cycle study (NCT02106351) in children with CP (2-17y). Children were randomized to receive 2U/kg (control), 8U/kg, or 16U/kg abobotulinumtoxinA injections into the target muscle group (wrist or elbow flexors) and additional muscles alongside occupational therapy via a home-exercise therapy program (HETP; minimum five 15min sessions/wk). Children received 8U/kg or 16U/kg plus HETP in cycles 2 to 4. RESULTS: During cycle 1, 210 children (126 males, 84 females; mean age [SD] 9y [4y 5mo], range 2-17y; n=70/group) had at least one upper limb abobotulinumtoxinA injection and 209 complied with the HETP. At week 6 of cycle 1, children in the 8U/kg or 16U/kg groups had significantly lower Modified Ashworth scale scores versus the 2U/kg group (primary outcome: treatment differences of -0.4 [p=0.012] and -0.7 [p<0.001] respectively). All groups improved on Physician Global Assessment and children in all groups achieved their treatment goals at least as expected. Therapeutic benefits were sustained during cycles 2 to 4; muscular weakness was the only treatment-related adverse event reported in at least one child/group (4.3% and 5.7% vs 1.4% respectively). INTERPRETATION: Treatment with 8U/kg or 16U/kg abobotulinumtoxinA significantly reduced upper limb spasticity versus the 2U/kg control dose. Therapeutic benefits of abobotulinumtoxinA plus HETP were sustained with repeat treatment cycles. WHAT THIS PAPER ADDS: AbobotulinumtoxinA injections significantly reduced upper limb spasticity in children with cerebral palsy. Children treated with abobotulinumtoxinA and targeted home exercises showed global improvement and goal attainment. Benefits were sustained over 1 year with repeat cycles of abobotulinumtoxinA and home exercises. AbobotulinumtoxinA injections into the upper limb were well tolerated over 1 year.

AbobotulinumtoxinA for Equinus Foot Deformity in Cerebral Palsy: A Randomized Controlled Trial.

BACKGROUND: Although botulinum toxin is a well-established treatment of focal spasticity in cerebral palsy, most trials have been small, and few have simultaneously assessed measures of muscle tone and clinical benefit. METHODS: Global, randomized, controlled study to assess the efficacy and safety of abobotulinumtoxinA versus placebo in cerebral palsy children with dynamic equinus foot deformity. Patients were randomized (1:1:1) to abobotulinumtoxinA 10 U/kg/leg, 15 U/kg/leg, or placebo injections into the gastrocnemius-soleus complex (1 or both legs injected). In the primary hierarchical analysis, demonstration of benefit for each dose required superiority to placebo on the primary (change in Modified Ashworth Scale from baseline to week 4) and first key secondary (Physician's Global Assessment at week 4) end points. RESULTS: Two hundred and forty-one patients were randomized, and 226 completed the study; the intention to treat population included 235 patients (98%). At week 4, Modified Ashworth Scale scores significantly improved with abobotulinumtoxinA; mean (95% confidence interval) treatment differences versus placebo were -0.49 (-0.75 to -0.23; P = .0002) for 15 U/kg/leg and -0.38 (-0.64 to -0.13; P = .003) for 10 U/kg/leg. The Physician's Global Assessment treatment differences versus placebo of 0.77 (0.45 to 1.10) for 15 U/kg/leg and 0.82 (0.50 to 1.14) for 10 U/kg/leg were also significant (both Ps < .0001). The most common treatment-related adverse event was muscular weakness (10 U/Kg/leg = 2; placebo = 1). CONCLUSIONS: AbobotulinumtoxinA improves muscle tone in children with dynamic equinus resulting in an improved overall clinical impression and is well tolerated.

Biomechanics assessment of long term consequences of talocrural joint sprain in conservatively treated males.

The aim of the study was an assessment of isometric torque (IT) values under static conditions and relative torque (RT) for the plantar flexion muscles (PFM) and dorsal flexion muscles (DFM) and their mutual relations in males 5 years after talocrural joint sprain. IT measurements in PFM and DFM were performed using Biodex System 3. Group I consisted of 20 males on average 5 years after the sprain of the talocrural joint. Group II comprised 23 males with no history of talocrural joint injuries. The angles of measurement were: -15° of dorsiflexion (DF) and 0°, 15°, 30° and 45° for plantar flexion (PF) of the foot. In group I, the IT and RT obtained from PFM of involved leg were statistically significantly lower for most of the measured values of foot angle as compared to the contralateral joint and the results of the control group. The increase in the PF angle resulted in the decrease in IT values obtained from PFM, in favour of DFM. The IT values for PFM and DFM depend on the angle of foot and are represented by two different curves.

[Frequency of side effects after botulinum toxin A injections in neurology, rehabilitation and gastroenterology]. / Analiza czestosci wystepowania objawów ubocznych po podaniu toksyny botulinowej typu A w neurologii, rehabilitacji i gastroenterologii.

UNLABELLED: Botulinum toxin type A is one of the most potent biological toxins, recently used clinically (Botox, Dysport) for wide range of indications. THE AIM OF THE STUDY was to assess the frequency and severity of side effects during BTX-A therapy for different indications and underlying possible mechanisms. MATERIAL AND METHODS: Material consisted of 327 patients (F202, M125) who underwent 1043 sessions of BTX-A injections for: cervical dystonia--CD (n=58), blepharospasm--BLP (n=31), hemifacial spasm--HFS (n=39), spasticity due to cerebral palsy--CP (n=96), chronic anal fissure--CAF (n=96), esophageal achalasia--AE (n=7). RESULTS: In CD the following side effects were observed: dysphagia (27% of patients and 7% of sessions), weakness of neck muscles (6.7% and 1.3%), pain during swallowing (5.1% and 1%), flu-like syndrome (3.4%, 0.7%). Dysphagia appeared 8.2 days after injection and lasted 14.9 days on average. In BLP authors noticed: unilateral ptosis (22%, 6.3%), bilateral ptosis (3%, 1.9%), haematoma (3%, 0.6%) and in HFS: excessive weakness resulting in asymmetry of face--mild (28.2% and 20%) and moderate (46% and 26.7%). In spasticity due to CP authors noticed: excessive weakness of lower limbs which lasted 13.8 days on average (6.2% and 1.9%), pain (5.2% and 1.6%), flu-like syndrome (4.1% and 1.3%). In CAF: mild incontinence of the flatus and faeces (9% and 5% of sessions), haematoma (5%), flu-like syndrome (3%), inflammation of external anal varices (2%), epididymitis (1%). In AE: chest pain in 6 (at the day of injection and lasted 2-4 days) and reflux in 2 patients (4-8 weeks after injection, lasted 2-3 weeks) were observed. CONCLUSION: Therapy with BTX-A is a very safe procedure, especially when compared with high rate of effectiveness of injections. The side effects are transient, mostly local and completely reversible.