Contributions
Abstract: P640
Type: Poster Sessions
Abstract Category: Therapy - Others
Background: OnabotulinumtoxinA treatment for spasticity is individualized and dependent on numerous factors. This analysis examines onabotulinumtoxinA utilization and effectiveness to treat spasticity in multiple sclerosis (MS) patients.
Methods: International, multicenter, prospective, observational registry (NCT01930786) examining adults with spasticity treated with onabotulinumtoxinA at the clinician's discretion. Assessments include onabotulinumtoxinA utilization (each visit) and clinician (next visit)/patient (5±1 weeks post-treatment) satisfaction.
Results: Patients (N=731) were on average 54 years old, female (52%), and continuing botulinum toxins for spasticity (63%). Most patients had spasticity due to stroke (n=411; 56%) or MS (n=119; 16%). In MS patients (n=119), the most common upper limb presentation was flexed elbow (18%), with onabotulinumtoxinA doses ranging from 25-550U. Muscles injected include: biceps brachii (100%), brachioradialis (54%), brachialis (46%), and other (4%); anatomical localization (60%) was most frequently utilized. The most common lower limb presentation was equinovarus foot (61%), with onabotulinumtoxinA doses ranging from 15-875U. Muscles injected include: gastrocnemius (79%), soleus (73%), tibialis posterior (46%), flexor digitorum longus (15%), other (11%), and flexor hallucis longus (2%); EMG localization (57%) was most frequently utilized. Overall (N=731), ≥72% patients and ≥91% clinicians reported extreme satisfaction/satisfaction that onabotulinumtoxinA helped patient's ability to participate in therapy/exercise, and 92% of patients and ≥98% of clinicians would definitely/probably continue treatment. Overall (N=731), 261 patients reported 831 adverse events (AEs); 23 AEs in 20 patients were considered treatment-related. 94 patients reported 195 serious AEs; 3 serious AEs in 2 patients were considered treatment-related. No new safety signals were identified.
Conclusions: ASPIRE provides valuable, real-world data on dosing, injection guidance, and muscle targeting over 2 years, that may help guide clinical strategies. ASPIRE captured the individualized nature of onabotulinumtoxinA utilization for spasticity in MS patients, while consistently demonstrating high satisfaction among patients and clinicians, with the majority indicating that onabotulinumtoxinA helped patients participate in therapy/exercise. These results add to the body of evidence on the safety and effectiveness of onabotulinumtoxinA for spasticity.
Disclosure: D. Bandari - Consultant, speaker for Accorda, Biogen, Genentech, Genzyme, EMD-Serono, Mallinckrodt and Teva and received research support from Biogen, Genentech, Allergan, Genzyme and Med-day.
A. Mayadev - Nothing to disclose.
M. Sakel - Received research grant from Rex Bionic Plc.
A. Esquenazi - Participated in advisory boards and consulted for Allergan. Received research grants from Allergan and Ipsen.
A. Zuzek - Full-time employee of Allergan plc.
J. Largent - Full-time employee of IQVIA (formerly QuintilesIMS), the contract research organization responsible for the management of this study and was formerly a full-time employee of Allergan plc.
G. Francisco - Consulted for, and received research grants from, Allergan, Merz, and Ipsen.
Abstract: P640
Type: Poster Sessions
Abstract Category: Therapy - Others
Background: OnabotulinumtoxinA treatment for spasticity is individualized and dependent on numerous factors. This analysis examines onabotulinumtoxinA utilization and effectiveness to treat spasticity in multiple sclerosis (MS) patients.
Methods: International, multicenter, prospective, observational registry (NCT01930786) examining adults with spasticity treated with onabotulinumtoxinA at the clinician's discretion. Assessments include onabotulinumtoxinA utilization (each visit) and clinician (next visit)/patient (5±1 weeks post-treatment) satisfaction.
Results: Patients (N=731) were on average 54 years old, female (52%), and continuing botulinum toxins for spasticity (63%). Most patients had spasticity due to stroke (n=411; 56%) or MS (n=119; 16%). In MS patients (n=119), the most common upper limb presentation was flexed elbow (18%), with onabotulinumtoxinA doses ranging from 25-550U. Muscles injected include: biceps brachii (100%), brachioradialis (54%), brachialis (46%), and other (4%); anatomical localization (60%) was most frequently utilized. The most common lower limb presentation was equinovarus foot (61%), with onabotulinumtoxinA doses ranging from 15-875U. Muscles injected include: gastrocnemius (79%), soleus (73%), tibialis posterior (46%), flexor digitorum longus (15%), other (11%), and flexor hallucis longus (2%); EMG localization (57%) was most frequently utilized. Overall (N=731), ≥72% patients and ≥91% clinicians reported extreme satisfaction/satisfaction that onabotulinumtoxinA helped patient's ability to participate in therapy/exercise, and 92% of patients and ≥98% of clinicians would definitely/probably continue treatment. Overall (N=731), 261 patients reported 831 adverse events (AEs); 23 AEs in 20 patients were considered treatment-related. 94 patients reported 195 serious AEs; 3 serious AEs in 2 patients were considered treatment-related. No new safety signals were identified.
Conclusions: ASPIRE provides valuable, real-world data on dosing, injection guidance, and muscle targeting over 2 years, that may help guide clinical strategies. ASPIRE captured the individualized nature of onabotulinumtoxinA utilization for spasticity in MS patients, while consistently demonstrating high satisfaction among patients and clinicians, with the majority indicating that onabotulinumtoxinA helped patients participate in therapy/exercise. These results add to the body of evidence on the safety and effectiveness of onabotulinumtoxinA for spasticity.
Disclosure: D. Bandari - Consultant, speaker for Accorda, Biogen, Genentech, Genzyme, EMD-Serono, Mallinckrodt and Teva and received research support from Biogen, Genentech, Allergan, Genzyme and Med-day.
A. Mayadev - Nothing to disclose.
M. Sakel - Received research grant from Rex Bionic Plc.
A. Esquenazi - Participated in advisory boards and consulted for Allergan. Received research grants from Allergan and Ipsen.
A. Zuzek - Full-time employee of Allergan plc.
J. Largent - Full-time employee of IQVIA (formerly QuintilesIMS), the contract research organization responsible for the management of this study and was formerly a full-time employee of Allergan plc.
G. Francisco - Consulted for, and received research grants from, Allergan, Merz, and Ipsen.