Abstract Details

Title Systematic Literature Review of AbobotulinumtoxinA in Clinical Trials for Therapeutic Uses

Topic Movement Disorders

Presentation(s) P02 - (-)

Poster/Presentation
Number 069

Objective

Background BACKGROUND: To provide a systematic review of published, controlled, clinical studies on ABO in upper and lower limb spasticity, blepharospasm, hemifacial spasm, sialorrhea, writers cramp and truncal dystonia.

Design/Methods DESIGN/METHODS: A systematic literature search (PubMed, Cochrane Library, EMBASE) was performed to identify randomized controlled trials and other comparative clinical studies of ABO published between 1991-Jan 2012. Study methodology, patient, and treatment-level data were extracted and summarized using descriptive statistics. Each included study underwent quality assessment for bias based on Cochrane metrics.

Results RESULTS: A total of 28 studies met the data extraction eligibility criteria. All included studies were randomized clinical trials with the exception of one study (observational comparative) for hemifacial spasm. Of the 28 studies, 20 focused on adult spasticity (12 upper limb, 8 lower limb) of various origins (17 post-stroke, 3 others). The other studies were: 2 each in blepharospasm, hemifacial spasm, and sialorrhea; 1 each in truncal dystonia and writers cramp. Overall, ABO demonstrated clinically or statistically significant efficacy for each disorder. The majority of studies fulfilled criteria for low risk reporting bias. Total ABO doses ranged between 500-1500 units for upper limb spasticity; 50-2000 units for lower limb spasticity; 100-182 units for blepharospasm; 51-70 units for hemifacial spasm; 37.5-450 units for sialorrhea; 500 units for truncal dystonia and 178 units for writers cramp.

Conclusions CONCLUSIONS: Based on data extracted from 20 randomized clinical studies, a strong evidence base exists for the use of ABO in limb spasticity. Based on data from 8 studies, ABO appears efficacious for blepharospasm, hemifacial spasm, sialorrhea, truncal dystonia, and writers cramp.

Authors/Disclosures
Jack J. Chen, PharmD BCPS CGP PRESENTER	No disclosure on file
Khashayar Dashtipour, MD, PhD	Dr. Dashtipour has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Neurocrine . Dr. Dashtipour has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for teva. Dr. Dashtipour has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for abbvie. Dr. Dashtipour has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for acadia. Dr. Dashtipour has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for kyowa kirin . Dr. Dashtipour has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for amneal . Dr. Dashtipour has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for neurocrine . Dr. Dashtipour has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for teva. Dr. Dashtipour has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for abbvie. Dr. Dashtipour has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for kyowa Kirin . Dr. Dashtipour has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for ipsen. Dr. Dashtipour has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for amneal . Dr. Dashtipour has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for acorda. The institution of Dr. Dashtipour has received research support from Abbvie. The institution of Dr. Dashtipour has received research support from ipsen. The institution of Dr. Dashtipour has received research support from amneal.
David H. Margolin, MD, PhD (Genzyme Corporation)	Dr. Margolin has received personal compensation for serving as an employee of uniQure, Inc.. Dr. Margolin has stock in Cerevance, Inc. Dr. Margolin has stock in Datacubed Health. Dr. Margolin has stock in uniQure, Inc.. Dr. Margolin has received intellectual property interests from a discovery or technology relating to health care.

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