Abstract Details

Title OnabotulinumtoxinA Efficacy in Lower Limb Spasticity: Results of Three Studies

Topic Neural Repair/Rehabilitation

Presentation(s) P03 - (-)

Poster/Presentation
Number 264

Objective

Background BACKGROUND: Approximately 66% of post-stroke patients with lower-limb spasticity have involvement of ankle-joint muscles which contributes to clinically significant functional disturbances; eg, decreased mobility/compromised balance.

Design/Methods DESIGN/METHODS: Three placebo-controlled studies (Study 1,N=120; Study 2, N=85; Study 3, N=78) utilizing a similar criteria for patient selection and injection paradigm are included in this efficacy evaluation of onabotulinumtoxinA treatment (median dose=300U) administered to ankle plantar-flexors in adults with lower-limb spasticity with modified Ashworth score (MAS) or Ashworth score (AS) ?3 at baseline.

Results RESULTS: Greater AS ankle score improvements and higher response rates for patients receiving onabotulinumtoxinA versus placebo were reported in all three studies. In Study 1, reductions in MAS ankle score were greater in onabotulinumtoxinA versus placebo, with significant differences at weeks 4, 6, and 8 (p<0.001). Proportion of responders (?1 point reduction from baseline muscle tone ankle score) was greater with onabotulinumtoxinA than placebo at weeks 4, 6, and 8 (p<0.001). Study 2 demonstrated a significant difference between onabotulinumtoxinA 300U and placebo in AS at week 8 (p=0.011); the 200U dose did not differentiate from placebo. Physician Global Assessment of Response improved with onabotulinumtoxinA versus placebo, with significant differences at weeks 4, 6, and 8 (p<0.05) in Study 1 (results similar in studies 2 and 3). Study 3 demonstrated clinically and statistically significant improvements with onabotulinumtoxinA relative to placebo in functioning measured by Goal Attainment Scale. In all three studies, significant correlations between measures of muscle tone and study-specific global measure by physician were observed at relevant time-points (p?0.008). OnabotulinumtoxinA treatment in lower-limb spasticity was safe and well-tolerated in all three studies.

Conclusions CONCLUSIONS: OnabotulinumtoxinA (300U) significantly decreases ankle flexor tone in adults with post-stroke lower-limb spasticity.

Authors/Disclosures
Rozalina Dimitrova, MD, MPH (Allergan, Inc) PRESENTER	No disclosure on file
Ryuji Kaji, MD, FAAN (Tokushima University Graduate School of Medicine)	Dr. Kaji has nothing to disclose.
	No disclosure on file
	No disclosure on file
	No disclosure on file
Nancy L. Earl, MD	No disclosure on file
Massimo Filippi, MD, FAAN (Ospedale San Raffaele, Neuroimaging Research Unit)	Dr. Filippi has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Alexion, Almirall, Biogen, Merck, Novartis, Roche, Sanofi. Dr. Filippi has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion, Biogen, Bristol-Myers Squibb, Merck, Novartis, Roche, Sanofi, Sanofi-Aventis, Sanofi-Genzyme, Takeda. Dr. Filippi has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Bayer, Biogen, Celgene, Chiesi Italia SpA, Eli Lilly, Genzyme, Janssen, Merck-Serono, Neopharmed Gentili, Novartis, Novo Nordisk, Roche, Sanofi, Takeda, and TEVA. Dr. Filippi has received personal compensation in the range of $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Springer Nature. The institution of Dr. Filippi has received research support from Biogen Idec, Merck-Serono, Novartis, Roche, the Italian Ministry of Health, the Italian Ministry of University and Research, and Fondazione Italiana Sclerosi Multipla.

��ɫ��

��ɫ��