Abstract Details

Title Pain Reduction in Adult Patients with Limb Spasticity Following a Single IncobotulinumtoxinA Injection: an Analysis of Pooled Data from Phase 2 and 3 Studies

Topic Movement Disorders

Presentation(s) P14 - Poster Session 14 (11:45 AM-12:45 PM)

Poster/Presentation
Number 5-008

Objective To assess pain relief in a large cohort of incobotulinumtoxinA-treated pts with spasticity-associated pain (SAP) using pooled data from mostly placebo-controlled phase 2/3 studies.

Background IncobotulinumtoxinA (incoA) has shown pain-relieving benefits in patients (pts) with limb spasticity in individual studies; data from large pt cohorts are lacking.

Design/Methods Pain severity was assessed with the Disability Assessment Scale (DAS; 0–3) in adults with upper limb SAP. A ≥1 point reduction in the DAS pain score from baseline [BL] to 4 weeks was defined as response. Between-treatment group response rates (overall and by BL pain severity – DAS mild, moderate, severe) and the proportion of pts with complete pain relief (DAS pain score=0) at 4 weeks after 1 injection of incoA (total dose ≤400U) or placebo were analyzed using χ² test. Overall between-group response rate differences were analyzed using logistic regression (presented as odds ratio [OR] and 95% confidence interval [CI]).

Results 542 (incoA: 413, placebo: 129) pts reported SAP at BL. At 4 weeks, a significantly higher proportion of incoA- vs placebo-treated pts achieved a response (52.1% vs 28.7%; p<0.0001). IncoA-treated pts were more likely to achieve pain response vs placebo-treated pts (OR 2.7 [95% CI:1.6–4.3]; p<0.0001). Irrespective of BL pain severity, significantly higher response rates were observed with incoA vs placebo at 4 weeks (p<0.02 all comparisons). Complete pain relief was achieved by significantly more incoA- vs placebo-treated pts at 4 weeks (26.9% vs 12.4%; p=0.0007).

Conclusions Pts receiving incoA vs placebo are significantly, by 2.7 times, more likely to achieve reduced upper limb SAP, irrespective of baseline pain severity, at 4 weeks post-injection thus supporting use of incoA in this setting.

Authors/Disclosures
Jorg Wissel PRESENTER	No disclosure on file
	No disclosure on file
Georg Comes (Merz Therapeutics)	Georg Comes has received personal compensation for serving as an employee of Merz Therapeutics GmbH.
Michael Althaus (Merz Pharmaceuticals GmbH)	Michael Althaus has received personal compensation for serving as an employee of Merz Pharmaceuticals.
Astrid Scheschonka	No disclosure on file
David M. Simpson, MD, FAAN (Icahn School of Medicine at Mount Sinai)	Dr. Simpson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Allergan. Dr. Simpson has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merz.

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