Phase 3 Studies Evaluating Dysport in Spasticity Patients Presented at AAP Meeting
Multiple Phase 3 studies that evaluated the treatment of Dysport (abobotulinumtoxinA) in sustained spasticity patients were presented at the annual meeting of the Association of Academic Physiatrists (AAP), held from February 13-17, 2018 in Atlanta.
AbobotulinumtoxinA is an injection of botulinum toxin type A (BoNT-A) which is indicated to treat adult patients with cervical dystonia and spasticity. It is the first and only FDA-approved botulinum toxin that treats lower limb spasticity in pediatric patients 2 years of age and older.
Spasticity is a condition in which muscle tone or stiffness increases in one or more muscles, affecting movement and mobility. The disease is often a result of damaged nerve pathways in the brain or spinal cord that control muscle movement. Patients with cerebral palsy, previous spinal cord injuries, multiple sclerosis (MS), stroke and brain or head trauma are more likely to develop spasticity.
Lower limb spasticity commonly involves the gastrocnemius and soleus muscle complex in the calf which raise the heel from the ground while walking. Symptoms of the condition include increased muscle tone, rapid muscle contractions, exaggerated deep tendon reflexes, and/or muscle spasms. Patients with spasticity can experience mild muscle stiffness to severe and uncontrollable muscle spasms.
Approximately 12-million people worldwide are diagnosed with spasticity.
The first oral presentation at the AAP meeting included results from 3 randomized, placebo-controlled Phase 3 studies of abobotulinumtoxinA. The studies evaluated time to retreatment in 3 patient groups, showing that 37% of hemiparetic patients with adult upper limb spasticity, 20% of hemiparetic patients with adult lower limb spasticity, and 74% of pediatric patients with lower limb spasticity resulting from cerebral palsy did not need reinjection of abobotulinumtoxinA until after 16 weeks.
Another study evaluated the long-term efficacy and safety of abobotulinumtoxinA in treating adult lower limb spasticity in hemiparetic patients with impaired walking ability showed improvements in muscle tone after a single injection. Comfortable barefoot walking speed in patients who took abobotulinumtoxinA had progressive improvement across cycles.
Regarding safety signals, abobotulinumtoxinA has a Boxed Warning in the United States stating that the botulinum toxin in the drug has the potential to spread to areas of the body that are not directly treated by the injection. Some of these symptoms include difficulties breathing and swallowing that could be fatal.
“The data being presented at this year’s AAP meeting indicate that Dysport provides sustained spasticity relief for both adult and pediatric patients,” said David Cox, Vice President, US Medical Affairs, HEOR & Commercial Regulatory Affairs, Ipsen, in a press release
“Improved outcomes from long-term therapy along with longer time between injections can be important factors in the management of these conditions, and we’re pleased to share these data to help inform physician and patient treatment decisions.”
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