Abstract Details

Title OnabotulinumtoxinA in Lower Limb Spasticity: Safety Results from a Pooled Analysis

Topic Neural Repair/Rehabilitation

Presentation(s) P03 - (-)

Poster/Presentation
Number 266

Objective

Background BACKGROUND: Approximately 80% of post-stroke spasticity patients have lower limb involvement and 66% of post-stroke spasticity patients have involvement of ankle joint muscles, the most commonly affected muscle group.

Design/Methods DESIGN/METHODS: Eight study results were integrated, including 625 adult patients with lower limb spasticity treated with onabotulinumtoxinA (median dose=300U; range=25U[minus]800U). Overall safety population was summarized across all onabotulinumtoxinA doses for double-blind placebo-controlled (DBPC) exposure (onabotulinumtoxinA=415; placebo=265) and any onabotulinumtoxinA exposure (N=625).

Results RESULTS: Overall adverse event (AE) rates during DBPC exposure were 62.2% (258/415) in the all onabotulinumtoxinA group compared with 55.1% (146/265) in the placebo group and were 68.0% (425/625) during any onabotulinumtoxinA exposure. During DBPC exposure, most frequently reported AEs (? 2% of patients) in the all onabotulinumtoxinA group that were ? 1% higher incidence than placebo were fall (7.2%), peripheral edema (4.1%), urinary tract infection (3.9%), headache (3.4%), arthralgia (2.9%), and joint sprain (2.2%). Treatment-related musculoskeletal and administration site AEs are consistent with known onabotulinumtoxinA safety and tolerability. Incidence of serious AEs during DBPC exposure was 11.1% (46/415) for all onabotulinumtoxinA group and 8.7% (23/265) for placebo group. Discontinuation rate due to AEs was 1.4% (6/415) in the all onabotulinumtoxinA group and no patients in placebo group during DBPC exposure. Serious AEs and discontinuations due to AEs represented co-morbidities and underlying post-stroke conditions. No reported events were associated with distant spread of toxin and no clinically relevant changes were noted in laboratory tests and physical examinations.

Conclusions CONCLUSIONS: OnabotulinumtoxinA treatment in lower limb spasticity was found to be safe and well-tolerated. Majority of AEs were considered not related to onabotulinumtoxinA and treatment-related AEs are consistent with the known mechanism of action of onabotulinumtoxinA.

Authors/Disclosures
Nancy L. Earl, MD PRESENTER	No disclosure on file
Lynn M. James (Allergan Plc)	Ms. James has received personal compensation for serving as an employee of AbbVie. Ms. James has stock in AbbVie.
	No disclosure on file
	No disclosure on file
Kottil W. Rammohan, MD (University of Miami)	Dr. Rammohan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen. Dr. Rammohan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. Dr. Rammohan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Genentech. Dr. Rammohan has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Alexion. Dr. Rammohan has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Genzyme. Dr. Rammohan has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for EMD Serono. The institution of Dr. Rammohan has received research support from Genentech. The institution of Dr. Rammohan has received research support from Genzyme. The institution of Dr. Rammohan has received research support from EMD Serono. The institution of Dr. Rammohan has received research support from Alexion.
	No disclosure on file
Rozalina Dimitrova, MD, MPH (Allergan, Inc)	No disclosure on file

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