Persistence to Botulinum Toxin A and Factors Associated With Discontinuation: A Retrospective Cohort Study
Michael Wainberg1, Jinming Zhang2, Simon Page3, Jonathan Bouchard2, Amandeep Mann2, Mathieu Beneteau4, Billie Schultz1
1Department of Physical Medicine and Rehabilitation, Mayo Clinic, Rochester, Minnesota, 2Ipsen, Cambridge, United States, 3Ipsen, London, United Kingdom, 4Ipsen, Paris, France
Objective:
To investigate real-world botulinum toxin A (BoNT-A) treatment persistence.
Background:
Adherence to BoNT-A therapy is critical to achieving treatment goals; however, evidence on BoNT-A treatment persistence and discontinuation drivers is limited.
Design/Methods:
Mayo Clinic electronic health records were used to characterize BoNT-A persistence in adult patients with ≥1 treatment cycle, overall and across mutually-exclusive International Classification of Diseases 9/10-defined cohorts: stroke, migraine, bladder dysfunction (BD), cervical dystonia (CD), and adult cerebral palsy (CP). Index date was first BoNT-A treatment; patients were followed for two years post-index. Persistence/non-persistence were defined by evaluating if all treatment intervals post-index were ≤80th percentile of all patients in the cohort (persistent) or if any were >80th percentile (non-persistent). Reasons for discontinuation were identified by analyzing physicians’ free-text notes.
Results:
Of 24,212 patients (mean age 52 years, 73.6% female) persistency was evaluable for 23,746; 11.1% were persistent. Cross-cohorts persistency was 5.7% (stroke, 23/407), 7.4% (migraine, 408/5543), 10.5% (BD, 62/593), 10.3% (CD, 102/989) and 14.8% (CP, 8/54). Persistent (vs non-persistent) patients were generally younger (stroke, BD) and more often female (stroke, BD, CD cohorts); neither trend was seen in the migraine cohort. Mean (95% confidence interval) BoNT-A treatments was 3.35 (3.32–3.39) cycles overall, lowest in the BD cohort (1.99 [1.87–2.11]); highest in the migraine cohort (3.90 [3.83–3.98]). Cardiovascular comorbidities were highest for the stroke cohort; depression and anxiety were common across all cohorts (cross-cohort range: 17.6–35.4% and 28.5–57.4%, respectively). Overall, antidepressant use ranged from 16.7–39.5% across cohorts; higher among persistent (41.0%) vs non-persistent (28.4%) patients. The most common reasons for discontinuation in all cohorts were patient- or physician-described lack of treatment effectiveness (cross-cohort range: 17.4–40.4% and 12.3–32.6%, respectively).
Conclusions:
BoNT-A persistence was low across disease cohorts over a 2-year follow-up. Understanding drivers of discontinuation may inform strategies to manage BoNT-A persistence.
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