Abstract
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.
Highlights
Botulinum neurotoxins (BoNTs) are potent toxins that inhibit neurotransmitter release, which results in flaccid paralysis underpinning their therapeutic use [1]
In the upper limb study, if the patient had not demonstrated a decrease from baseline of at least one grade in the Modified Ashworth Scale (MAS) score in the primary targeted muscle group and had no improvement on the Physician’s Global Assessment (PGA; i.e., a score ≤0) and if, based on the investigator’s judgment, there was no unacceptable safety risk for the subject to receive the treatment cycle, the patient was injected on the same study day
In the pediatric lower limb study, if the patient had not demonstrated a decrease from baseline of ≥1 grade in the MAS score in the gastrocnemius–soleus complex (GSC) at the ankle joint and had no improvement in PGA score, the patient was injected on the same study day
Summary
Botulinum neurotoxins (BoNTs) are potent toxins that inhibit neurotransmitter release, which results in flaccid paralysis underpinning their therapeutic use [1]. Injection of BoNT into specific muscles of patients with movement disorders, such as dystonia and spastic paresis, causes muscle relaxation, which may lead to symptom relief and facilitate rehabilitation [2, 3]. There are currently three BoNTA products available worldwide: abobotulinumtoxinA (aboBoNTA; Dysport R , Ipsen, Paris, France), onabotulinumtoxinA (Botox R , Allergan, Irvine, USA), and incobotulinumtoxinA (Xeomin R , Merz Pharmaceuticals GmbH, Frankfurt, Germany). For each of these BoNTA products, there is a unique manufacturing process that results in each containing different excipients [6]. 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
Sign-in/Register to view highlights & summary 
Published Version (
Free)
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call