Category: Clinical Practice (assessment, diagnosis, treatment, knowledge translation/EBP, implementation science, program development); International
Objective :
To identify patient demographics and clinical characteristics that impact onabotulinumtoxinA treatment adherence from the Adult Spasticity International Registry (ASPIRE) study.
Design : Prospective, observational registry (NCT01930786) over 2 years.
Setting : International clinical sites.
Participants (or Animals, Specimens, Cadavers) : Adult patients with focal spasticity across multiple etiologies.
Interventions : OnabotulinumtoxinA at the clinician’s discretion.
Main Outcome Measure(s) :
A clinically meaningful threshold for treatment adherence was used for this analysis. Treatment adherent was defined as patients receiving ≥3 treatment sessions with onabotulinumtoxinA; non-adherent was defined as patients receiving ≤2 treatment sessions. Patient demographics and clinical characteristics were assessed using univariate logistic regression. Data are presented as odds ratios (OR) with 95% confidence intervals (CI).
Results :
Of the total patient population in ASPIRE (N=730), 523 patients (71.6%) were categorized as treatment adherent and 207 patients (28.4%) as non-adherent. On average, adherent patients received 5.3 (SD:1.6) treatment sessions, non-adherent patients received 1.5 (SD:0.5). Patients with traumatic brain injury (TBI; 57.8%) were less likely to be adherent than patients with other underlying etiologies (72.6%; OR:0.52, CI:0.28-0.96; P=0.036). While patients with cerebral palsy (80.5%) trended towards more likely to adhere compared to other etiologies (70.6%; OR:1.72, CI:0.96-3.10; P=0.070). Additionally, patients naïve to botulinum toxins for spasticity were less likely to adhere to treatment than non-naïve patients (63.6% vs. 76.4%, respectively; OR:0.54, CI:0.39-0.75; P<0.001). Patient characteristics that did not impact treatment adherence included age, gender, and pattern or severity of spasticity.
Conclusions :
This preliminary analysis from ASPIRE suggests that TBI patients or those naïve to botulinum toxins for spasticity are at increased risk of treatment non-adherence. Further analysis of risk factors that impact onabotulinumtoxinA treatment adherence can help optimize spasticity management strategies to improve long-term patient care.
Nicole Jensky
– Medical Science Liaison , AllerganKristina Fanning
– Senior Statistician/Project Director, Vedanta Research, Wilmington, North CarolinaAleksej Zuzek
– Director, Medical Affairs, Allergan plc, Irvine, California
Gerard Francisco
– Department Chairman and Chief Medical Officer, University of Texas McGovern Medical School and TIRR Memorial Hermann, Houston, TexasDaniel Bandari
– Medical Director and Founder, Multiple Sclerosis Center of California & Research Group at the Hoag Neurosciences Institute, Newport Beach, CaliforniaWuwei (Wayne) Feng
– Division Chief, Duke University School of Medicine
George F. Wittenberg
– Professor of Neurology and Director, VA Pittsburgh Healthcare System, University of Pittsburgh; and University of Maryland (at the time of the study), Pittsburgh, PennsylvaniaPhilippe Gallien
– Physician, Pole Saint Helier, RennesAlessio Baricich
– Assistant Professor, Physical and Rehabilitation Medicine, Università del Piemonte Orientale, Novara, Italy
Alberto Esquenazi
– Department Chair and Chief Medical Officer, MossRehab Gait and Motion Analysis Laboratory, Elkins Park, Pennsylvania