In clinical trials, overall treatment success required at least a 2-grade improvement from baseline by both investigator and subject assessments.
MORE THAN HALF
MAY LAST UP TO
*A secondary endpoint based on Kaplan-Meier estimates of cumulative rate of time to onset of response. The median time to onset of response was 3 days in GL-1 (Dysport 55/105 [52%], Placebo 3/53 [6%] and GL-2 (Dysport 36/71 [51%], Placebo 9/71 [13%]), and 2 days in GL-3 (Dysport 110/200 [55%], Placebo 4/100 [4%]).1-3
†GL-1 and GL-3 evaluated subjects for at least 150 days following treatment. Based on investigator assessment, response was maintained for up to 4 months in both GL-1 (Dysport 24/105 [23%], Placebo 2/53 [4%]) and GL-3 (Dysport 58/200 [29%], Placebo 1/100 [1%]).2-4
Success was defined as post-treatment glabellar line severity of none or mild for the combined investigator and subject assessments (composite assessment) on Day 30 with at least a 2-grade improvement.5
The following scale was used to assess efficacy at maximum frown:
0 none 1 mild 2 moderate 3 severe
- A subject had to improve from a score of 3 (severe) to a score of 1 or 0 (mild or none), or a score of 2 (moderate) to a score of 0 (none) in order to meet the requirements for overall treatment success.
Three double-blind, randomized, placebo-controlled clinical studies evaluated the efficacy of Dysport® for use in the temporary improvement of the appearance of moderate to severe glabellar lines. These 3 studies enrolled healthy adults (ages 19–75) with glabellar lines of at least moderate severity at maximum frown. Subjects were excluded if they had marked ptosis, deep dermal scarring, or a substantial inability to lessen glabellar lines, even by physically spreading them apart. The subjects in these studies received either Dysport or placebo. The total dose was 50 units delivered in equally divided aliquots to specified injection sites.
Additional endpoints for each of the studies were post-treatment glabellar line severity of none or mild with at least a 1-grade improvement from baseline for separate investigator and subject assessments at Day 30.
- Studies GL-1 and GL-3 were 6- and 5-month (respectively) single-dose studies comparing Dysport to placebo
- GL-2 was a study of Dysport vs placebo in subjects who had received up to 4 treatments of Dysport over the course of the study
Improvement demonstrated with up to 4 repeated treatments5,1
|Improvement in glabellar line severity at maximum frown at Day 30 after up to 4 treatment cycles (Study GL-2)5,1|
|Dysport 1+ grade
|Placebo 1+ grade
GL-2 was a repeat-dose, double-blind, multicenter, randomized, placebo-controlled study. The study was initiated with 2 or 3 open-label treatment cycles of 50 units of Dysport. After the open-label treatments, subjects were randomized to receive either placebo or 50 units of Dysport. Subjects could have received up to 4 treatments. Efficacy was assessed in the final randomized treatment cycle. The study enrolled 311 subjects into the first treatment cycle, and 142 subjects were randomized into the final treatment cycle.
- At Day 30, 52% of Dysport-treated subjects achieved treatment success: a composite 2-grade improvement of glabellar line severity at maximum frown.
- Proportion of responders in the final treatment cycle was comparable to a proportion of responders in all prior treatment cycles5
Treatment-emergent adverse events
|Treatment-emergent adverse events (TEAEs) with >1% incidence**|
|Adverse events by body system||Dysport n=398 (%)a||Placebo n=496 (%)a|
|General Disorders and
Administration Site Conditions
|Injection Site Pain||3||
|Injection Site Reaction||3||<1|
|Infections and Infestations|
|Upper Respiratory Tract Infection||3||2|
|Blood Urine Present||2||<1|
|Nervous System Disorders|
|**Subjects who received treatment with placebo and Dysport are counted in both treatment columns.|
TEAEs were generally mild to moderate5,2,1
- Safety studied for up to 12 repeat administrations
- Eyelid ptosis rates (2%)—incidence did not increase with multiple retreatments in long-term studies
- As with any therapeutic proteins, there is a potential for immunogenicity.
- The incidence of antibodies among products in this class varies depending on the sensitivity and specificity of the assay. Comparisons of the incidence of antibodies across products in this class may be misleading.
- There was no evidence of neutralizing antibodies in 1,554 clinical study subjects who received up to 9 treatment cycles of Dysport for the treatment of moderate to severe glabellar lines.
- Two subjects (0.13%) tested positive for binding antibodies at baseline, and 3 additional subjects tested positive for binding antibodies after receiving Dysport treatment. None of the subjects tested positive for neutralizing antibodies.
Dysport is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with procerus and corrugator muscle activity in adult patients less than 65 years of age.
DOSAGE AND ADMINISTRATION
The potency Units of Dysport are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of Dysport cannot be compared to or converted into units of any other botulinum toxin products assessed with any other specific assay method.
- Dysport is contraindicated in patients with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation.
- This product may contain trace amounts of cow's milk protein. Patients known to be allergic to cow's milk protein should not be treated with Dysport.
- Dysport is contraindicated for use in patients with infection at the proposed injection site(s).
WARNINGS AND PRECAUTIONS
Pre-existing Neuromuscular Disorders
- Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis or neuromuscular junction disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome) should be monitored particularly closely when given botulinum toxin.
- Patients with neuromuscular disorders may be at increased risk of clinically significant effects including severe dysphagia and respiratory compromise from typical doses of Dysport.
Please see additional Important Safety Information, including Boxed Warning, for Dysport below.
- Data on file. MA-Y-97-52120-085 (GL-2) Clinical Study Report. Fort Worth, TX: Galderma Laboratories, L.P., 2007.
- Data on file. MA-Y-97-52120-718 (GL-3) Clinical Study Report. Fort Worth, TX: Galderma Laboratories, L.P., 2007.
- Data on file. MA-Y-97-52120-719 (GL-1) Clinical Study Report. Fort Worth, TX: Galderma Laboratories, L.P., 2007.
- Dysport for Injection Package Insert. Fort Worth, TX: Galderma Laboratories, L.P.; December 2016.
- Dysport Prescribing Information. Fort Worth, TX: Galderma Laboratories, L.P. December 2016.