Category: Clinical Practice (assessment, diagnosis, treatment, knowledge translation/EBP, implementation science, program development); International
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).
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.
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 , Allergan
Kristina Fanning– Senior Statistician/Project Director, Vedanta Research, Wilmington, North Carolina
Aleksej 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, Texas
Daniel Bandari– Medical Director and Founder, Multiple Sclerosis Center of California & Research Group at the Hoag Neurosciences Institute, Newport Beach, California
Wuwei (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, Pennsylvania
Philippe Gallien– Physician, Pole Saint Helier, Rennes
Alessio 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