Poster 131 IncobotulinumtoxinA (XEOMIN; botulinum neurotoxin type A, free from accessory proteins): Flexibility of Dosing and Injection Intervals in Cervical Dystonia

V. H. Evidente, Merz, consulting fees or other remuneration; Teva, consulting fees or other remuneration; Ipsen, consulting fees or other remuneration; Allergan, research grants; Allon, research grants; UCB, research grants. To assess repeated incobotulinumtoxinA injections at 2 dose levels and variable ≥6-week intervals for the treatment of cervical dystonia. A ≤20-week, placebo-controlled, randomized, double-blind trial (n=233) with a 48-week extension period (n=214). 37 U.S. centers. Patients with cervical dystonia. Patients received placebo or a set of 120 or 240 U of incobotulinumtoxinA injections. In the extension period, the patients were rerandomized to 120 or 240 U of incobotulinumtoxinA (up to 5 injection sessions at ≥6-week intervals at the physician's discretion based on the patient's symptoms). Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) and adverse events (AE). In 214 patients, incobotulinumtoxinA (120 or 240 U) significantly improved the mean TWSTRS-Total score 4 weeks after each injection session (P<.001) regardless of botulinum toxin pretreatment; 22.5% of patients had median injection intervals ≤10 weeks; 24.6% had >10 to ≤12 weeks; 19.4% had >12 to ≤14 weeks; and 33.5% had >14 weeks. In all groups, TWSTRS-Total score was significantly improved at 4 weeks after each injection session (P<.001). No difference in the mean improvement of TWSTRS-Total score was noted between dosing groups and injection interval groups. Overall, the most common AEs were dysphagia, neck pain, and muscular weakness. There was no effect of injection interval on the overall occurrence of AEs. Moreover, AE incidences tended to decrease, which suggests that repeated doses had no cumulative effect. Repeated incobotulinumtoxinA injections at ≥6-week intervals demonstrated sustained efficacy for cervical dystonia. These results indicate the potential of effective flexible dosing regimens for individual patients.