Ipsen announced positive data from the ENGAGE Phase IIIb/IV clinical trial of Dysport (abobotulinumtoxinA) to treat upper and lower limb spasticity in adults with a Guided Self-rehabilitation Contract.
Paris-based Ipsen announced positive data from the ENGAGE Phase IIIb/IV clinical trial of Dysport (abobotulinumtoxinA) to treat upper and lower limb spasticity in adults with a Guided Self-rehabilitation Contract (GSC).
The trial evaluated Dysport in patients with spastic hemiparesis in both upper and lower limbs in combination with GSC, which is a personalized diary-based rehabilitation program. The primary efficacy endpoint was percentage of patients classified as responders at the sixth week after the second injection.
Dysport is also prescribed as an injection for temporary improvement in moderate to severe frown lines. It, similar to Allergan’s Botox, is a formulation of the botulinum toxin.
Spastic hemiparesis, or spastic hemiplegia, refers to movement on one side of the body, and is usually weak, but not paralyzed. It is often associated with cerebral palsy (CP) or in some cases stroke or head and brain injuries or some diseases.
“This study provides insight into treatment strategies that can improve the outcomes of patients living with spastic paresis, specifically the role of Guided Self-rehabilitation Contracts combined with Dysport for the improvement of voluntary movement, an area of limited data availability,” said Jean-Michel Gracies, Professor and Chair in the Department of Neurorehabilitation at Hospital Henry Mondor, in Creteil, France, and primary investigator of the ENGAGE trial. “Importantly, stronger active motion improvements and a longer time to reinjection was seen in ENGAGE versus previous Dysport studies, which suggests a synergistic effect of adding a GSC intervention to treatment with Dysport for patients with UL [upper limb] and LL [lower limb] spasticity.”
In ENGAGE, patients received two open-label injection cycles of Dysport along with a personalized GSC. At each injection cycle, they received a total dose of 1,500 U Dysport across the primary treatment target (PTT) and non-PTT limbs.
The study demonstrated 72.1% of patients classified as responders, hitting the predefined CXA improvement threshold in the PTT limb of equal to or greater than 35 degrees in upper limbs or greater than or equal to five degrees in the lower limbs.
The company notes that systemic standardized rehabilitation protocols are uncommon in most abobotulinumtoxinA spasticity studies. Also, trials of Dysport in these patients usually focus on either UL or LL treatment strategies. But in the real world, patient often present with spasticity in both upper and lower limbs at the same time.
“Over the last two decades there has been a shift from patients being recipients of healthcare to active participants empowered in their own health journey,” stated Antony Fulford-Smith, vice president of Medical Affairs, Neurosciences, R&D, at Ipsen. “Through ENGAGE, we have been able to demonstrate for the first time the benefit of combining treatment with Dysport with a systematic rehabilitation protocol, validating the positive impact of encouraging patients to take an active role in their own treatment. At Ipsen, we are constantly searching for ways to improve disease management and comprehensive care with a patient-centered approach. By using active range of motion as its primary measure, ENGAGE offers important insights on the potential benefit of using Dysport with GSC combination therapy in the contexts of meaningful functional outcomes for patients.”
