Objective: To report baseline data from ENGAGE, an international phase 3b/4, prospective, single-arm, open-label study (NCT02969356) conducted in France, the Czech Republic, Russia and the USA.

Background: The ENGAGE study assessed effects of Guided Self-rehabilitation Contracts (GSC) combined with co-injection of abobotulinumtoxinA (aboBoNT-A) into the upper (UL) and lower limbs (LL) on active movements, in patients with chronic hemiparesis resulting from acquired brain injury. GSCs are a diary-based and antagonist-targeting strategy, in which therapists identify target muscles against which to prescribe patients daily, home-based self-stretching and active training programmes.

Method: Patients with spasticity, stratified with UL or LL as primary treatment target (PTT), received 2 consecutive injections of aboBoNT-A 1500 U across PTT and non-PTT limbs, together with personalised GSC. Primary efficacy endpoint was the proportion of responders in the PTT (improvement in composite active range of motion [CXA] of ≥35 or 5 in UL or LL, respectively) at Cycle 2 Week 6.

Results: Of 160 patients enrolled, 157 were included in the safety population, 153 in the intention-to-treat (ITT) population and 136 in the modified ITT population (mITT) (Figure 1). Baseline characteristics are presented in Table 1: 91% of patients had experienced stroke; median time since brain injury was 4.5 years. The proportion of patients split by PTT was 52% versus 48% for UL and LL, respectively. 74% of patients were GSC-naïve and 27% were naïve to botulinum toxin (BoNT) for both UL and LL spasticity (34% UL-naïve; 58% LL-naïve). Baseline aboBoNT-A doses administered were 1000 U in PTT, regardless of whether the PTT was UL or LL (Table 2). Degree of CXA in UL or LL at baseline is presented in Table 3. Some variability between countries was observed in baseline data, especially in CXA, which seemed to be higher in the LL of patients from the Czech Republic and lower in those from Russia, and higher in the UL of patients from the USA.

Conclusion: The ENGAGE study will provide insights into the safety and efficacy of the combination of GSC with aboBoNT-A, simultaneously injected into UL and LL, in adults with spastic hemiparesis. [figure1 ] [table1] [table2] [table3]

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MDS Abstracts - https://www.mdsabstracts.org/abstract/guided-self-rehabilitation-contracts-combined-with-simultaneous-injections-of-abobotulinumtoxina-into-upper-and-lower-limbs-in-spastic-hemiparesis-baseline-data-from-the-engage-study/