Benefit of Multiple IncobotulinumtoxinA Injections for Pain Reduction in Adult Patients with Limb Spasticity: an Analysis of Pooled Data from Phase 2 and 3 Studies (P12-11.009)

Abstract

<h3>Objective:</h3> To assess pain relief after multiple incobotulinumtoxinA (incoA) injections in a large sample of patients (pts) with limb spasticity-associated pain (SAP) using pooled data from six phase 2/3 studies (four placebo-controlled). <h3>Background:</h3> Repeated treatment with incoA has shown pain-relieving benefits in pts with limb spasticity in individual studies. <h3>Design/Methods:</h3> Adults with upper limb SAP received up to 4 incoA injections (total dose ≤400U) administered at 12- to 14-week intervals (injection cycles [ICs] 1–4; total observation period up to 56 weeks). Only IC 1 was placebo-controlled. Pain severity was assessed at control visits (CVs; 4 weeks after each injection) using the Disability Assessment Scale (DAS; pain scores ranging from 0 [no pain] to 3 [severe pain]). The proportions of pts with a response (defined as a reduction by ≥1 point in the DAS score from baseline to each CV) and with a complete response (DAS pain score=0) were assessed at every CV. Data were descriptively analyzed. As placebo-treated pts in IC 1 received incoA in subsequent cycles, they contributed data to the appropriate incoA CVs 1–4. <h3>Results:</h3> 515 pts with SAP at baseline were included in this analysis (515, 297, 263, and 181 pts at CVs 1–4, respectively). Response rates increased over time, being 53.0%, 63.3%, 66.9%, and 72.4% at CVs 1–4, respectively. Likewise, the proportion of pts with complete response increased over time, being 27.6%, 38.4%, 39.5%, and 43.6% at CVs 1–4, respectively. <h3>Conclusions:</h3> In pts with upper limb SAP, treatment response rates were sustained and showed a cumulative effect over 56 weeks after multiple incoA injections, with a complete pain relief in &gt;40.0% of pts. Results support the use of incoA in reducing upper limb SAP in affected adults. <b>Disclosure:</b> Jorg Wissel has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. Jorg Wissel has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merz. Jorg Wissel has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Abbvie. Jorg Wissel has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merz. Jorg Wissel has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Ipsen. Jorg Wissel has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Medtronic. Dr. Camoes-Barbosa has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for MERZ, ABBVIE, IPSEN. Dr. Camoes-Barbosa has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for MERZ, ABBVIE, IPSEN. Mr. Comes has received personal compensation for serving as an employee of Merz Pharmaceuticals GmbH. Michael Althaus has received personal compensation for serving as an employee of Merz Pharmaceuticals. Astrid Scheschonka has received personal compensation for serving as an employee of Merz Therapeutics. 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.