Background: Botulinum toxin-A is a well-established treatment for adult and pediatric spastic paresis and cervical dystonia. While guidelines and approved labels indicate that treatment should not occur more frequently than every 12 weeks, studies and real-world evidence show that the timing of symptom recurrence between treatments may vary. Methods: We report retreatment criteria and response duration (retreatment intervals) from four pivotal, double-blind, placebo-controlled studies with open-label extensions involving patients treated with abobotulinumtoxinA (aboBoNTA) for upper limb (NCT01313299) or lower limb (NCT01249404) spastic paresis in adults, lower limb spastic paresis in children (NCT01249417), and cervical dystonia in adults (NCT00257660). We review results in light of recently available preclinical data. Results: In spastic paresis, 24.0-36.9% of upper limb patients treated with aboBoNTA and 20.1-32.0% of lower limb patients did not require retreatment before 16 weeks. Moreover, 72.8-93.8% of aboBoNTA-treated pediatric patients with lower limb spastic paresis did not require retreatment before 16 weeks (17.7-54.0% did not require retreatment before 28 weeks). In aboBoNTA-treated patients with cervical dystonia, 72.6-81.5% did not require retreatment before 16 weeks. Conclusion: AboBoNTA, when dosed as recommended, offers symptom relief beyond 12 weeks to many patients with spastic paresis and cervical dystonia. From recently available preclinical research, the amount of active neurotoxin administered with aboBoNTA might be a factor in explaining this long duration of response.
May 9, 2019April 9, 2019Free AccessEconomic evaluation of abobotulinumtoxinA vs onabotulinumtoxinA in real-life clinical management of post-stroke upper limb spasticity (P5.6-020)Natalya Danchenko, Jonas Lundkvist, Andreas Lysandropoulos, and Pascal MaisonobeAuthors Info & AffiliationsApril 9, 2019 issue92 (15_supplement) Letters to the Editor
To investigate trends in FDA regulatory approvals and development decisions for neurology and related therapies, analyzing Center for Drug Evaluation and Research (CDER) data.
Objective: To describe the development of the Spasticity-related Quality of Life 6-Dimensions instrument (SQoL-6D) and its sensitivity to clinical change (responsiveness). Design: Multicentre, prospective, longitudinal cohort study at 8 UK sites (NCT03442660). Patients: Adults (n = 104) undergoing focal treatment of upper limb spasticity. Methods: No condition-specific health-related quality of life tool is available for upper-limb spasticity of any aetiology. The SQoL-6D was developed to fulfil this need, designed to complement the Upper Limb Spasticity Index (which incorporates the Goal Attainment Scaling evaluation of upper limb spasticity [GASeous] tool) with targeted standardized measures. The 6 dimensions of the SQoL-6D (score range 0–4) map onto common treatment goal areas identified in upper-limb spasticity studies. A Total score (0–100) provides overall spasticity-related health status. To assess responsiveness, the SQoL-6D, Global Assessment of Benefit scale and ”GASeous” were administered at enrolment and 8 weeks. Results: Significant differences in mean SQoL-6D Total score change and effect sizes across patients rating ”some benefit” (0.51) and ”great benefit” (0.88) supported responsiveness. Conclusion: The SQoL-6D is a promising new measure of health status in upper limb spasticity, that enables systematic assessment of the impact of this condition in relation to patients’ priority treatment goals. A psychometric evaluation of SQoL-6D is presented separately.
In this ethnographic study we investigated changes in symptom burden and their effects/interference on patient functioning and quality of life throughout the duration of a botulinum toxin type A (BoNT-A) treatment cycle.
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