Background: Various botulinumtoxinA formulations are approved for glabellar lines treatment worldwide, including abobotulinumtoxinA (Dysport®).
Objectives: Assess abobotulinumtoxinA superiority versus placebo and non-inferiority versus active comparator (onabotulinumtoxinA; Botox®), for the treatment of Chinese patients with moderate/severe glabellar lines.
Methods: Phase 3, randomized study (NCT02450526) comprising a double-blind (cycle 1) phase and an open-label (cycles 2-5) phase. Patients received abobotulinumtoxinA 50 units or matching placebo (5:1), active comparator (onabotulinumtoxinA 20 units) or matching placebo (5:1). In cycles 2-5, eligible patients were retreated with abobotulinumtoxinA only. Responders had glabellar lines of none/mild severity.
Primary endpoint: responder rates at cycle 1, day 29 at maximum frown with abobotulinumtoxinA versus placebo (for superiority; by investigator's live assessment [ILA] and subject's self-assessment [SSA]), and versus active comparator (for non-inferiority; by ILA). Treatment-emergent adverse events were recorded.
Results: Overall, 520 patients were randomized. Superiority and non-inferiority, respectively, were demonstrated for abobotulinumtoxinA versus placebo (ILA, SSA; both p < 0.0001) and abobotulinumtoxinA versus active comparator. AbobotulinumtoxinA efficacy was maintained over open-label cycles; median time to onset of efficacy was 2.0 days. After 6 months, 17% of patients treated with abobotulinumtoxinA remained responders. AbobotulinumtoxinA was well-tolerated. Safety results were in line with the known profile of abobotulinumtoxinA; adverse events rate decreased with repeated treatment.
Conclusions: After a single injection, abobotulinumtoxinA demonstrated superiority versus placebo and non-inferiority versus onabotulinumtoxinA for the treatment of moderate-to-severe glabellar lines in Chinese patients. Multiple injections of abobotulinumtoxinA demonstrated efficacy and safety in the treatment of glabellar lines in Chinese patients.
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Botulinum toxin injections can be used to smooth frown lines that appear between the eyebrows (known as glabellar lines) in patients who have moderate or severe frown lines. This study looked at how injections of a botulinum toxin (abobotulinumtoxinA [aboBoNT-A]) could help with smoothing frown lines in patients from China compared with an injection of another botulinum toxin called onabotulinumtoxinA (onaBoNT-A) or placebo (saltwater, no treatment). The study included 520 patients from China, 18–65 years old, who had moderate or severe frown lines. All patients received a first injection of either aboBoNT-A, onaBoNT-A, or saltwater, and were studied for 12 weeks. After the first injection, patients could receive up to four more injections of aboBoNT-A, given at 12-week intervals, if their frown lines became moderate or severe again. Most patients (92%) had not previously received any botulinum toxin injections. The results showed that single and repeat injections of aboBoNT-A helped to smooth moderate and severe frown lines. The researchers found that after a single injection, aboBoNT-A was superior to no treatment and was similar to onaBoNT-A. Patients recorded a response to aboBoNT-A after 2 days and the response lasted for 6 months in 17% of patients. The effect on frown lines was maintained after repeat injections and aboBoNT-A was well tolerated by patients. These results suggest that aboBoNT-A is a suitable treatment for smoothing frown lines in patients from China with moderate to severe frown lines.
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