Session Information
Date: Sunday, October 7, 2018
Session Title: Dystonia
Session Time: 1:45pm-3:15pm
Location: Hall 3FG
Objective: To report patient distribution data for duration of response with abobotulinumtoxinA (aboBoNT-A; Dysport®) from two open-label (OL) studies in patients with cervical dystonia (CD).
Background: AboBoNT-A has been shown to be an effective treatment for CD.
Methods: The safety and efficacy of aboBoNT-A (500 U) in patients with CD were investigated in two Phase 3 double-blind (DB) placebo-controlled studies. Patients who completed the DB studies were invited to enrol in OL extension studies. Study 045b: patients could receive ≤3 additional aboBoNT A treatment cycles at ≥4 week intervals for ≤2 years. Study 731: patients could receive ≤4 additional aboBoNT A treatment cycles up to 64 weeks. Need for retreatment was defined as a Toronto Western Spasmodic Torticollis Rating Scale score within 10% of DB baseline score. In both OL studies, patients received a single aboBoNT A 500 U injection in Cycle 1; further doses were individually titrated (250–1000 U) as determined by the investigator based upon efficacy and side effects.
Results: Study 045b: median time to retreatment for patients entering Cycle 1 was 14 weeks (range: 4–98 weeks) with a mean of 18.3 (±12.0 SD) weeks. Similarly, for Cycles 2 and 3, median time to retreatment was 15 weeks (range: 4–68 and 4–65 weeks, respectively) with a mean of 19.4 (±11.4 SD) and 19.6 weeks (±11.1 SD), respectively. The majority of patients were retreated with aboBoNT A >12 weeks (Cycle 1, 68%; Cycle 2, 73%; Cycle 3, 80%) and almost 50% were not retreated until ≥16 weeks. Study 731: the median time to retreatment for patients entering Cycles 1 and 2 was 13 weeks (range: 4–34 and 6–39 weeks, respectively) and in Cycles 3 and 4 was 15 weeks (range: 17–55 and 16–37 weeks, respectively). Mean retreatment times for Cycles 1, 2, 3 and 4 were 14.7 (±5.9 SD), 14.9 (±4.9 SD), 16.2 (±6.5 SD) and 15.9 (±4.8 SD) weeks, respectively. Similar to Study 045b, the majority of patients were retreated >12 weeks (Cycle 1, 53%; Cycle 2, 64%; Cycle 3, 73%; Cycle 4, 78%) and almost 40% of patients were retreated at ≥16 weeks.
Conclusions: AboBoNT-A has a long duration of response (an overall median of 14 weeks) in patients with CD, meaning fewer injections per year for patients, which may reduce the treatment burden for patients.
To cite this abstract in AMA style:
R. Hauser, D. Truong, M. Jog, D. Grimes, P. Picaut, A. Mann. Duration of response with abobotulinumtoxinA in cervical dystonia: Patient distribution results from two open label extension studies [abstract]. Mov Disord. 2018; 33 (suppl 2). https://www.mdsabstracts.org/abstract/duration-of-response-with-abobotulinumtoxina-in-cervical-dystonia-patient-distribution-results-from-two-open-label-extension-studies/. Accessed October 7, 2024.« Back to 2018 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/duration-of-response-with-abobotulinumtoxina-in-cervical-dystonia-patient-distribution-results-from-two-open-label-extension-studies/