Abstract
IntroductionThe efficacy and safety of abobotulinumtoxinA in the management of cervical dystonia has been established in randomized, controlled trials that use a selected trial population. In this meta-analysis of observational data, we evaluated the real-life effectiveness of abobotulinumtoxinA as delivered in routine clinical practice. MethodsMeta-analysis of patient-level data for adult patients with cervical dystonia treated with abobotulinumtoxinA from three prospective, multicenter, observational studies (NCT01314365, NCT00833196 and NCT01753349). ResultsWe report data for patients treated with abobotulinumtoxinA over one injection cycle at 181 neurology centers in 35 countries. CD clinical features as assessed by Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total scores (N = 920) significantly reduced by a mean [95%CI] of −12.9 [−13.9, −11.8] points at Week 4 (N = 449) and −3.2 [−3.8, −2.7] points at the end of the injection cycle (N = 890). All three TWSTRS domains (symptom severity, disability and pain) contributed to the overall improvement. Patients were generally content with symptom control at peak effect of the treatment cycle, with 86% reporting overall satisfaction. ConclusionFindings from this meta-analysis of observational studies confirm the effectiveness of abobotulinumtoxinA in routine practice. Despite inclusion of a broader population sample, the magnitude of improvements observed is consistent with that seen in the pivotal, randomized controlled trials.
Highlights
The efficacy and safety of abobotulinumtoxinA in the management of cervical dystonia has been established in randomized, controlled trials that use a selected trial population
Satisfaction with symptom control at peak effect was assessed in INTEREST IN CD2 using a 5-point Likert scale [15] and satisfaction with relief from symptoms was assessed in ANCHOR-Cervical dystonia (CD) using Item 2 (7-point scale) of the Treatment Satisfaction Questionnaire for Medication (TSQM) [12]
Patients were generally satisfied (86% satisfaction) with the symptom control afforded by the treatment at peak effect
Summary
The efficacy and safety of abobotulinumtoxinA in the management of cervical dystonia has been established in randomized, controlled trials that use a selected trial population. In this meta-analysis of observational data, we evaluated the real-life effectiveness of abobotulinumtoxinA as delivered in routine clinical practice. Cervical dystonia (CD) is a neurological syndrome characterized by involuntary, sustained, contractions of cervical muscles causing abnormal postures of the neck [1]. It is a heterogeneous disorder, with numerous possible patterns of head and neck deviations. The clinical utility of oral therapies in the management of CD is limited by a narrow therapeutic window and side-effect profile [2]
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