Benefit of Repeated Injections of IncobotulinumtoxinA for Pain Reduction in Adults with Cervical Dystonia and Moderate or Severe Baseline Pain: An Analysis of Pooled Data
Alberto Albanese1, Jorg Wissel2, Wolfgang Jost3, Anna Castagna4, Michael Althaus5, Georg Comes5, Astrid Scheschonka5, Matteo Vacchelli5, Hyder Jinnah6
1IRCCS Humanitas Research Hospital, Rozzano, 2Vivantes Hospital Spandau, 3Parkinson-Klinik Ortenau, 4Fondazione Don Carlo Gnocchi, 5Merz Therapeutics GmbH, 6Emory University
Objective:
This pooled analysis assessed pain reduction during repeated incobotulinumtoxinA (incoA) injections in adults with moderate or severe cervical dystonia (CD)-related pain at baseline.
Background:
Pain is a common and disabling symptom of CD.
Design/Methods:
Pooled pain data from four phase 3 and 4 studies in adults with moderate/severe CD-related pain at baseline were analyzed over five injection cycles (IC1‒IC5). One study was placebo-controlled, such that patients who received placebo in IC1 received incoA in IC2‒IC5 (placebo/incoA group). All other patients received incoA at every IC (incoA group). Pain was assessed at each injection visit (IV) and control visit (CV) 4 weeks post-injection using the TWSTRS-pain severity scale or a pain VAS; score range 0‒10 for both scales and pain scores of 3.5‒10 categorized as moderate/severe. Response was defined as ≥30% or ≥50% reduction in baseline pain score, reflecting clinically relevant improvements.
Results:
Of 451 patients with moderate/severe baseline pain, 396 (87.8%) received incoA and 55 (12.2%) placebo in IC1. Of these incoA- and placebo-treated patients, 47.7% and 12.7% achieved ≥30% pain reduction at CV1 (p<0.0001 Wald-test for difference); the corresponding data for ≥50% pain reduction were 28.8% and 7.3% (p<0.0001 Wald-test for difference). During IC2‒IC5, where all patients received incoA, pain response rates at CVs in either group ranged from 41.2‒58.3% for ≥30% pain reduction and from 25.0‒36.8% for ≥50% pain reduction.
Conclusions:
Patients with moderate/severe CD-related pain at baseline experienced clinically relevant and sustained improvements in pain over repeated incoA injection cycles.