Simultaneous upper and lower limb abobotulinumtoxinA injections and guided self-rehabilitation contracts in spastic hemiparesis: Baseline data from the engage study

Abstract

Guided self-rehabilitation contracts (GSC) are a diary-based and antagonist-targeting strategy, in which therapists identify muscles against which to prescribe patients daily, home-based self-stretching and active training programmes. Patients record a diary of exercises performed between visits. The ENGAGE study assesses effects of abobotulinumtoxinA (aboBoNT-A) on voluntary movements, following co-injection of upper (UL) and lower limbs (LL), alongside GSC in patients with chronic hemiparesis resulting from acquired brain injury. An interim analysis of ENGAGE baseline data is presented here. International phase 3b/4, prospective, single-arm, open-label study ( NCT02969356 ). Patients, stratified with UL or LL as primary treatment target (PTT), receive two consecutive injections of aboBoNT-A 1500 U, together with personalised GSC. Primary efficacy endpoint is the proportion of responders (improvement in composite active range of motion [CX A ] of ≥ 35° or 5° in UL or LL, respectively) in the PTT at Cycle 2 Week 6. Baseline data were analysed for 157 patients (data cut-off December 2017). Baseline characteristics are presented in Table 1 ; 91% of patients had experienced stroke; mean time since brain injury was 79.5 months. PTT split was 52% versus 48% for UL and LL, respectively. Twenty-seven percent of patients were naïve to botulinum toxin (BoNT) for both UL and LL spasticity (34% UL-naïve; 58% LL-naïve), and 74% were naïve to GSC. Baseline BoNT doses administered are shown in Table 2 . Degree of CX A in UL or LL at baseline are presented in Table 3 . 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.