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.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/duration-of-response-with-abobotulinumtoxina-in-cervical-dystonia-patient-distribution-results-from-two-open-label-extension-studies/