PND8 NETWORK META-ANALYSIS OF DYSPORT (ABOBOTULINUMTOXINA), BOTOX (ONABOTULINUMTOXINA) AND XEOMIN (INCOBOTULINUMTOXINA) FOR THE TREATMENT OF ADULT LOWER LIMB SPASTICITY (ALLS) IN POST-STROKE POPULATION

Abstract

Botulinum toxins type A (BoNT-As) including abobotulinumtoxinA (abo), onabotulinumtoxinA (ona) and incobotulinumtoxinA (inco) represent common treatments for ALLS, but comparative clinical data are limited. The objective was to compare efficacy and safety of BoNT-As in post-stroke ALLS. A Bayesian network metaanalysis (NMA) was conducted based on a systematic literature review (SLR) of randomized clinical trials (RCT). The outcomes included change from baseline (CFB) in Modified Ashworth Scale (MAS) or Ashworth Scale (AS) scores at week 4 and 12, responder rates (percentage of patients with at least 1-unit change), and all-cause adverse events. Out of total 2,384 references identified in the SLR, 7 RCTs were included in the NMA analysis based on inclusion criteria. The analysis of CFB on MAS/AS scores and responder rates at week 4 and 12 showed wide overlapping 95% Credible CI (CrI) between the different BoNT-As and the treatments were deemed comparable. There was a numerically better trend for abo compared with ona and inco with differences in responder rates of 13% and 27% in favor of abo vs ona and inco at week 4, and 18% and 22% at week 12, respectively. In the ranking analysis, at week 4, abo showed a 56% probability of being the best treatment on MAS/AS, and 66% at week 12. Sensitivity analyses confirmed the base case findings. Analyses of all-cause adverse events showed similarly wide overlapping 95% CrI. The treatments were again deemed comparable, with a small numerical difference favoring ona. No comparable tolerability data on inco were publicly available. Variability and scarcity of published data hinders definite conclusion comparative efficacy and safety between the BoNT-As. There was a numerical trend and ranking in favor of abo for efficacy outcomes and a smaller numerical trend and ranking in favor of ona for all-cause adverse events.