September 15, 2020
1 min read
Fabi reports she served as a clinical trial investigator and consultant for Revance Therapeutics in addition to owning stock in the company. Please see the study for all other authors’ relevant financial disclosures.
In an open-label study, daxibotulinumtoxinA for injection demonstrated efficacy and safety outcomes in moderate or severe glabellar lines that were comparable to previous findings.
Sabrina G. Fabi, MD, of the University of California, San Diego, and Cosmetic Laser Dermatology in San Diego, and colleagues wrote that daxibotulinumtoxinA for injection (DAXI) is a botulinum toxin type A formulated with a novel peptide excipient. “Two pivotal, single-treatment, placebo-controlled trials demonstrated efcacy and safety for moderate or severe glabellar lines,” they wrote.
In the repeat-treatment SAKURA 3 phase 3 study, they aimed to further assess DAXI in a cohort of 2,691 participants. The study population had been enrolled in the prior SAKURA 1 or 2 phase 3 studies or were new patients. Protocols dictated that patients were treated with 40 U DAXI.
Patients who underwent repeat injections were eligible for re-treatment only when they had reached baseline levels as assessed by Investigator Global Assessment-Frown Wrinkle Severity (IGA-FWS) and Patient FWS (PFWS) scales at or after 12 weeks and up to 36 weeks after treatment.
Results indicated a 96% response rate as assessed by the IGA-FWS scale after each of three treatments. The researchers defined this as a “high” response rate, with none or mild severity in frown wrinkles.
Peak IGA-FWS responses were observed between weeks 2 and 4 of treatment, with a response rate of more than 90% observed as early as the first week in all three treatment cycles.
By 24 weeks, 32% or more of the cohort demonstrated a response of none or mild severity.
Looking at PFWS scale results, peak response rates of 92% or higher were reported between weeks 2 and 4.
Participants demonstrated a return to moderate or severe frown wrinkle severity as assessed by PFWS over a median duration of 24 weeks.
Safety data showed no new signals as compared with previous DAXI trials.
“The efcacy of DAXI was highly consistent across successive treatment cycles and multiple endpoints evaluating response rates and duration of effect,” the researchers wrote. “The results of this large study conrm the high and extended response rates, as well as the median 24-week duration of clinical benet with DAXI seen in the pivotal phase 3 trials.”