AbobotulinumtoxinA: Evidence for Long Duration of Response from 5 Patient Populations is being shared during the TOXINS 2021 conference, which is taking place virtually between
Spasticity is one of the most common and disabling conditions associated with many neurological conditions in adults and is characterized by velocity-dependent muscle hypertonia. Spasticity can lead to disabilities related to muscle stiffness, including impaired walking and hand use, pain, disfigurement and contractures.29
The new analyses of pivotal Phase III clinical trial data included randomized clinical trials and respective open-label extensions to assess treatment intervals over repeat cycles of Dysport in the management of cervical dystonia (CD), adult lower-limb (ALL) and upper-limb (AUL) spasticity, and pediatric lower-limb (PLL) and upper-limb (PUL) spasticity. Flexible study designs allowed patients to be reinjected after week 12 (or, for PUL, week 16), according to clinical need.1
Results from the five patient populations highlighted that Dysport offered a long duration of response when injected at the recommended and approved dose, with a large proportion of study patients not requiring retreatment for more than 12/16 weeks (% patients injected week-16 or later): in the CD study: 72.6-81.5%, ALL study: 20.1-32.0%, AUL study: 24.0-36.9%, PLL studies: 72.8-93.8%; (% children injected week-22 or later in PUL study: 19.6-67.0%) in the five pivotal studies of Dysport, whilst safety outcomes were as expected.1
The results observed in Ipsen's Phase III clinical studies were reinforced by real-world data from the ULIS-III observational study - the largest observational study investigating a structured approach to goal setting and outcome measurement.
Dr.
'We are constantly striving to uncover new insights into the therapeutic use of botulinum toxins, including key aspects of treatment such as duration of response,' said Prof. Dr.
About spasticity
Spasticity is estimated to affect more than 12 million people worldwide.30 It is a condition in which certain muscles are continuously contracted causing stiffness or tightness of the muscles, which can interfere with normal movement, gait and speech.31 Spasticity is usually caused by damage to the parts of the brain or spinal cord that control voluntary movement,31-32 leading to a change in the balance of signals between the nervous system and the muscles which leads to increased activity in the muscles.31 Spinal cord injury, multiple sclerosis, cerebral palsy, stroke, brain or head trauma and metabolic diseases can all cause spasticity.32 Spasticity is experienced by approximately 34% of stroke survivors within 18 months following a stroke.33
About cervical dystonia
Cervical dystonia (CD), also known as spasmodic torticollis, is a movement disorder in which involuntary muscular contractions occur primarily in the neck muscles.34,35 This can cause the head to turn to one side or to be pulled backward or forward.34,36 CD is relatively uncommon, affecting 57 to 280 people per million.37 It can occur at any age, although symptoms generally appear in middle age, often beginning slowly and usually reaching a plateau over a few months or years.38 The degeneration of the spine, irritation of nerve roots or frequent headaches can make CD particularly painful.38 In most cases the cause is unknown and no cure exists.37
About Dysport
Dysport (abobotulinumtoxinA) is an injectable form of a botulinum neurotoxin type A (BoNT-A) product, which is a substance derived from Clostridium bacteria producing BoNT-A that inhibits the effective transmission of nerve impulses and thereby reduces muscular contractions. It is supplied as a lyophilized powder. AbobotulinumtoxinA has marketing authorization in more than 90 countries, more than 30 years of clinical experience and six million treatment years of patient experience.
The detailed recommendations for the use of Dysport are described in the Summary of Product Characteristics (SmPC) for Dysport (300 units) Powder and Dysport (500 units) Powder, and the
About Ipsen
Ipsen is a global specialty-driven biopharmaceutical group focused on innovation and Specialty Care. The Group develops and commercializes innovative medicines in three key therapeutic areas - Oncology, Neuroscience, and Rare Diseases. Ipsen also has a well-established
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