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Type A Botulinum Toxin Study Demonstrates Safety in Clinical Research for Naïve and Treatment-experienced Patients

Glabellar lines are one of the most commonly requested sites for neuromodulator injection, and clinical trials for a new type A botulinum toxin (BoNTA), daxibotulinumtoxinA (DAXI), demonstrated similar safety and efficacy outcomes in patients who were both new to and previously had this treatment. A poster abstract from the American Academy of Dermatology Virtual Meeting Experience (AAD VMX) 2020 highlighted these significant results and its implication for future research.

Two phase 3 trials, SAKURA 1 and SAKURA 2, permitted the enrollment of participants who had a previous history of BoNTA treatment in their glabella, given that the patient had a 6-month wash-out period. These previous patients and their outcomes were compared with patients who were naïve to BoNTA. A third trial, SAKURA 3, was an open-label study. The poster at AAD VMX 2020 compared the pooled data of patients who received 40 U of DAXI in SAKURA 1 and SAKURA 2 (n=406) along with the results from SAKURA 3 (n=2380).

In pooled safety data from participants’ first treatment with DAXI, no substantial difference in treatment-related adverse events (TRAE) was found. Of the 1119 patients in the previous treatment group, 18% experienced at least 1 TRAE; in the treatment-naïve group (n=1667), 16.6% experienced at least 1 TRAE. Most common TRAEs included:

  • Headache (4.6% experienced, 4.6% naïve);
  • Injection site pain (3.8% experienced, 3.2% naïve);
  • Injection site erythema (3.1% experienced, 2.0% naïve); and
  • Injection site edema (2.6% experienced, 1.9% naïve).

Further, the present study found similar efficacy and duration of response was observed regardless of treatment history. In the pooled SAKURA 1/SAKURA 2 data, patients who were previously treated with BoNTA experienced a return to baseline assessments (Investigator Frown Wrinkle Severity Scale [IGA-FWS], Patient Frown Wrinkle Severity Scale [PFWS]) after 195 days, whereas treatment-naïve patients saw a return to baseline IGA-FWS and PFWS after 171 days. For the same measurement, patients in SAKURA 3 demonstrated 196 days to return to baseline for both the treatment-experienced and treatment-naïve groups.

“These data suggest that BoNTA treatment history did not influence efficacy or safety outcomes,” concluded the study authors. “Future clinical studies need not restrict recruitment based on prior BoNTA treatment history as long as an appropriate wash-out period is observed.”

Reference

Cohen JL, Green LJ, Beer KR, Liu Y, Gallagher CJ. DaxibotulinumtoxinA for injection is similarly effective in experienced BoNT patients and in those naïve to treatment. Presented at:  American Academy of Dermatology Virtual Meeting Experience; June 12-14, 2020.

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