Objectives: Examine onabotulinumtoxinA utilization and effectiveness to treat spasticity in multiple sclerosis (MS) patients.
Design: Multicenter, international, prospective, observational registry (NCT01930786), examining adult patients with spasticity across multiple etiologies treated with onabotulinumtoxinA at their clinician’s discretion. Assessments: utilization (each visit) and clinician (next visit)/patient (5±1 weeks post-treatment) satisfaction.
Results: Patients (N=730) were on average 54y, 52% female, 63% continuing botulinum toxin treatment for spasticity. Common etiologies: stroke (n=411; 56%), MS (n=119; 16%). In MS patients, the most common upper limb presentation was flexed elbow (18%); onabotulinumtoxinA doses were 25-550U. Muscles injected: biceps brachii (100%), brachioradialis (54%), brachialis (46%), other (4%); anatomical localization (60%) was most frequently utilized. Most common lower limb presentation was equinovarus foot (61%); onabotulinumtoxinA doses were 15-875U. Muscles injected: gastrocnemius (79%), soleus (73%), tibialis posterior (46%), flexor digitorum longus (15%), other (11%), flexor hallucis longus (2%); EMG localization (57%) was most frequently utilized. Overall (N=730), ≥76% patients and ≥91% clinicians reported extreme satisfaction/satisfaction that onabotulinumtoxinA helped patient’s ability to participate in therapy/exercise; 92% patients and ≥98% clinicians would definitely/probably continue treatment. Overall (N=730), 261 patients reported 831 adverse events (AEs); 23 treatment-related. 94 patients reported 195 serious AEs; 3 treatment-related. No new safety signals were identified.
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, 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.
Mohamed Sakel– Director NeuroRehabilitation, Consultant Physician, Director Research & Development, East Kent Hospitals University NHS Foundation Trust, Kent & Canterbury Hospital
Daniel Bandari– Medical Director and Founder, Multiple Sclerosis Center of California & Research Group at the Hoag Neurosciences Institute
Angeli Mayadev– Physiatrist, Multiple Sclerosis Center – Swedish Neuroscience Institute
Alberto Esquenazi– Chief Medical Officer, MossRehab Gait and Motion Analysis Laboratory
Joan Largent– Director, Epidemiology and Outcomes Research, IQVIA Real-World Solutions
Aleksej Zuzek– Global Director, Medical Affairs - Spasticity & Movement Disorders, Allergan plc
Gerard Francisco– Chairman and Professor, Physical Medicine and Rehabilitation, University of Texas Health Science Center McGovern Medical School and TIRR Memorial Hermann