Objective: To assess the impact of 2 different injection schedules of incobotulinumtoxinA on patient-reported assessments in cervical dystonia (CD).

Background: There is individual variation in the reported waning of botulinum toxin (BoNT) treatment benefit in patients with CD, even among patients who experience a favorable peak response. Thus, some patients prefer injection intervals shorter than the standard 12 weeks. This study assesses whether individualized treatment intervals can lead to improved patient experience without compromising safety.

Method: An open-label, randomized, phase IV study (CD Flex; NCT01486264) was designed to compare 2 incobotulinumtoxinA injection intervals (short-flex: 8±2 weeks [N=142]; long-flex: 14±2 weeks [N=140]) in BoNT-responsive subjects with CD who report typical waning of clinical benefit at <10 weeks. Subjects received 8 injections over a period of up to 2 years. Patient-reported outcomes (4 weeks post-injection 8) included satisfaction (10-point scale), patient-reported global response (9-point Likert scale), and the CD impact profile (CDIP-58). Additional endpoints included a physician-assessed global response and a clinical global impression of severity.

Results: Subject satisfaction was significantly improved vs study baseline over 8 cycles in the short-flex group (mean change=1.2 points, P=0.0007), but not in the long-flex group. A significant improvement was also observed in the short-flex group in the physician-assessed global impression of severity 4 weeks after injection 8. Most domains of the CDIP-58 analysis (pain/discomfort, sleep, annoyance) demonstrated numerical trends favoring the short-flex group. At 4 weeks post-injection 8, a similar distribution of scores was observed for both groups on the subject- and physician-rated global response assessments with no relevant difference between groups. No differences in safety profile were noted.

Conclusion: Subjects with shorter incobotulinumtoxinA injection intervals reported improved satisfaction after 8 injections. Trends favoring short-flex were observed in both the CDIP-58 analysis and physician-rated clinical global impression of severity. Evidence suggests that individualizing injection intervals to treat CD may improve patient-reported outcomes without compromising safety.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/treatment-of-cervical-dystonia-using-shorter-incobotulinumtoxina-injection-intervals-improves-patient-reported-outcomes-in-those-with-inadequate-benefits-from-standard-intervals/