
What would less frequent injections mean to your patients?
When stiffness returns too early, the struggle resumes... Use Dysport for symptom* relief that lasts between injections.
*Symptoms of spasticity can include abnormal increase in muscle tone and muscle spasm.
When efficacy wears off, even something as simple as getting out of the car can become a challenge again.
Patient experience
Annika talking about lower limb spasticity: “Your muscles get tight, your hips pop. It makes it harder to run … Getting in and out of the car can be difficult. It makes running and playing harder, it slows me down.”
Annika’s experience between injections of Dysport: “[After treatment] she starts walking better, as in tripping less. Then slowly she starts tightening up again and luckily it’s time to go back in before it gets unmanageable. [Injection works for] about 3-4 months.” Wendi
A History of FDA Approval
Duration of FDA approval is not intended to imply superiority in efficacy or safety of Dysport
Efficacy-PULS
Dysport has an established efficacy in reducing muscle tone in pediatric patients with upper limb spasticity at week 6, and improvement could last beyond the minimum retreatment period1
In the treatment of pediatric patients (aged 2 years and older) with spasticity, start Dysport for lasting symptom relief1
The majority of patients in the clinical study were retreated between 16 and 28 weeks; however, some had a longer duration of response1,2
Dysport is FDA approved for the treatment of spasticity in children aged 2 years and older
Study Design1,2
The efficacy and safety of Dysport were evaluated in a randomized, prospective, double-blind, multicenter, phase III, low-dose controlled, multiple treatment study with pediatric patients aged 2 to 17 years with upper limb spasticity.
The primary efficacy endpoint was mean change from baseline in muscle tone by Modified Ashworth Scale (MAS) in the primary targeted muscle group (PTMG) at week 6. Secondary efficacy endpoints were mean change in the Physician’s Global Assessment (PGA) at week 6, and mean Goal Attainment Scale (GAS) score at week 6.
Patients were randomized to receive Dysport 2 Units/kg (n=70), 8 Units/kg (n=70), or 16 Units/kg (n=70) for the first treatment cycle. The completion of 1 cycle occurred when the patient received their next injection. Patients were assessed for retreatment eligibility at week 16. If ineligible for retreatment, they were evaluated every 6 weeks (plus or minus 2 weeks) until eligible. There had to be a minimum of 16 weeks between each injection session, and patients could receive a maximum of 4 sessions over the course of the study. After completing their first treatment cycle, patients receiving Dysport 2 Units/kg were rerandomized to receive Dysport 8 Units/kg or 16 Units/kg. Patients receiving the higher doses remained at their dose unless an adjustment up (not exceeding 16 Units/kg) or down was mandated by the investigator. The study remained double blind for the remaining 3 cycles, or until patients exited the study at 1 year and 9 months.

Established efficacy
- Recommended maximum total dose per treatment session produced statistically significant results vs low-dose Dysport1,2
- High-Dose Dysport significantly loosened muscles at week 61

CI=confidence interval; ITT=intent-to-treat; LS=least squares; MAS=Modified Ashworth Scale
Although week 16 analysis was prespecified, being a tertiary endpoint, appropriate multiplicity adjustments were not applied; therefore, the results need cautious interpretation and could represent chance findings.
At week 6, patients receiving 16 Units/kg demonstrated a 35% greater reduction in muscle tone than those receiving 2 Units/kg
The most frequently reported adverse reactions (≥10%) were upper respiratory tract infection and pharyngitis
Time to retreatment
The effect of Dysport lasted beyond the minimum 16-week retreatment period in some pediatric patients; a majority of patients did not need retreatment until week 22 and effects lasted even after week 34 in some patients.2,*

Time to retreatment was not a primary endpoint. Retreatment for upper limb spasticity should occur no sooner than 16 weeks after the first injection1
Out of the patients receiving Dysport 8 Units/kg, 15.8% were retreated between weeks 34 and 52. Of that number, 3 patients were withdrawn, while 6 did not need a reinjection, or data were missing2
Out of the patients receiving Dysport 16 Units/kg, 20% were retreated between weeks 34 and 52. Of that number, 3 patients were withdrawn, while 7 did not need a reinjection, or data were missing2
The optimal dose of Dysport, muscles to be injected, and retreatment eligibility should be selected based on the patient’s progress and response to treatment1,2
Eligibility for retreatment was assessed by the investigator at every visit onward from week 16 for upper limb spasticity2
*Patients who remained in the upper limb study after week 16 were permitted additional discretionary follow-up visits at week 22, week 28, week 34, or beyond3
Efficacy-PLLS
Dysport has an established efficacy in reducing muscle tone in pediatric patients with lower limb spasticity at week 4, and improvement could last beyond the minimum retreatment period1
In the treatment of pediatric patients (aged ≥2 years) with spasticity, start Dysport for lasting symptom relief1
The majority of patients in the clinical study were retreated between 16 and 22 weeks; however, some had a longer duration of treatment
Dysport is FDA approved for the treatment of spasticity in children aged 2 years and older
Study design1,2
The efficacy and safety of Dysport were evaluated in a multicenter, prospective, double-blind, randomized, placebo-controlled study assessing Dysport in pediatric patients aged 2 to 17 years with lower limb spasticity causing dynamic equinus foot deformity.
The co-primary efficacy endpoints were the reduction in ankle plantar flexor muscle tone at week 4, as measured by the mean change from baseline in Modified Ashworth Scale (MAS*) score and the improvement in response to treatment at week 4, as measured by mean Physician’s Global Assessment (PGA**) of response to treatment score.
Time to retreatment was not the primary endpoint
PGA and MAS were assessed by separate investigators2
*The MAS is an updated version of the Ashworth Scale used to measure muscle tone and includes an additional scoring component to measure resistance during movement.6
**The PGA is a global assessment of a physician’s impression of a patient’s response to treatment.2

*The ITT population (N=235) included all randomized subjects who received at least one injection of study treatment and who had a MAS score in the gastroc-soleus muscle complex assessed both at baseline and at week 4.
In the pivotal clinical trial, doses of Dysport 10 Units/kg/leg or Dysport 15 Units/kg/leg or placebo were injected intramuscularly into the gastrocnemius and soleus muscles1
The 12-week follow-up visit included assessment for retreatment eligibility
Pediatric patients who remained in the study after week 12 were permitted additional discretionary follow-up visits at week 16, week 22, and week 28 to assess eligibility for retreatment6
Established efficacy
- Dysport significantly reduced muscle tone at week 4 compared to placebo1
Reduction in ankle plantar flexor muscle tone vs placebo as assessed by the mean change in Modified Ashworth Scale (MAS) at week 41

CI=confidence interval; ITT=intent-to-treat; LS=least squares; MAS=Modified Ashworth Scale
MAS score at baseline (mean [SD]): placebo, 3.2 (+/–0.4); Dysport 10 Units/kg/leg, 3.1 (+/–0.3); Dysport 15 Units/kg/leg, 3.1 (+/–0.3)1,2
- Physicians noted a significant response to treatment in patients receiving Dysport at week 41
Dysport had significantly greater response to retreatment vs placebo as assessed by the mean PGA at week 4 (co-primary endpoint) and week 12 (tertiary endpoint)3
The most frequently reported adverse reactions (≥10%) were nasopharyngitis, cough, and pyrexia
Response to treatment vs placebo as assessed by the mean Physician’s Global Assessment (PGA) at week 4 and week 121

ITT=intent-to-treat; LS-least squares; PGA=Physician’s Global Assessment.
Children on Dysport had a significantly greater response to treatment as assessed by PGA at week 4 (co-primary endpoint) and week 12 (tertiary endpoint)1
Time to retreatment
The effect of Dysport lasted beyond the minimum 12-week retreatment period; most pediatric patients did not need retreatment until week 16 and effects lasted even after week 28 in some patients.1,2,*
Time to retreatment was not a primary endpoint. Repeat Dysport treatment should be administered no sooner than 12 weeks after the previous injection1
*Pediatric patients who remained in the study after week 12 were permitted additional discretionary follow-up visits at week 16, week 22, and week 28 to assess eligibility for retreatment.6
‡4.4% of pediatric patients were retreated after week 28.2
The degree and pattern of muscle spasticity and the overall clinical benefit at the time of reinjection may necessitate alterations in the dose of Dysport (abobotulinumtoxinA) and muscles to be injected1
Eligibility for retreatment was assessed by the investigator at every visit from week 12 onwards
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