AbobotulinumtoxinA Plus Self-Rehabilitation Contract Improves Spasticity in Phase 3/4 Trial

  • AbobotulinumtoxinA
  • Brain Injury
  • Movement disorders
  • Neuromuscular disease
  • Phase 3 clinical trial
  • Phase 4 clinical trial
  • Spasticity

Simultaneous treatment with abobotulinumtoxinA (BoNT-A)(Dysport; Ipsen, Cambridge, MA) and a guided self-rehabilitation contract (GSC) improved voluntary movement for 72.1% (98/136; 95% CI: 64.0, 78.9) of adults with spastic hemiparesis in both their upper and lower extremities who were treated. Improvements in voluntary movement were measured by composite active range of motion (CXA) outcome 6 weeks after a second injection of BoNT-A. Response to treatment was defined as at least a 35 degree increase in range of motion for the upper extremity and at least a 5 degree increase for the lower extremity. 

The time to reinjection was used to corroborate favorable outcomes (investigators cou8ld reinject based on clinical judgement) and was 110.1+/-25.2 days, longer than in previous studies that did not include GSC as part of the treatment with BoNT-A. 

Professor Jean-Michel Gracies, professor and chair in the Department of Neurorehabilitation at Hospital Henri Mondor, in Créteil, France, and the primary investigator for ENGAGE said: “This study provides insight into treatment strategies that can improve the outcomes of patients living with spastic paresis, specifically the role of GSC combined with Dysport for the improvement of voluntary movement, an area of limited data availability. 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 and LL spasticity.” 

Participants were treated with 2 open-label injection cycles of BoNT-A. A total dose of 1,500 U BoNT-A was administered across primary treatment target (PTT) and nonPTT limbs at each injection cycle. The minimum dose was 750 U to the PTT limb, and total dose determined by the investigators, providing no more than 1,500 U was delivered across PTT and nonPTT limbs. Participants were asked to carry out the exercises detailed in their individualized GSC – with a minimum cumulative 10 minutes of submaximal self-stretch postures per muscle – on a daily basis throughout the study. They kept diaries of the exercises done and were contacted by phone every 2 weeks to promote adherence to the GSC. 

Typically, systematic standardized rehabilitation protocols are not used in studies of BoNT-A and studies focus only on upper or lower extremity, not both. This study provides insight into health care providers real-world experience administering BoNT. 

Antony Fulford-Smith, vice president Medical Affairs, Neurosciences, R&D, at Ipsen said: “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. 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-centerd 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 context of meaningful functional outcomes for patients.” 

These results were presented at the International Congress of Parkinson’s Disease and Movement Disorders (MDS) in Nice, France, 22-26 September 2019.

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