DaxibotulinumtoxinA for Injection for the Treatment of Glabellar Lines: Efficacy Results From SAKURA 3, a Large, Open-Label, Phase 3 Safety Study

Abstract

Background: DaxibotulinumtoxinA for Injection (DAXI) is botulinum toxin Type A formulated with a novel peptide excipient. Two pivotal, single-treatment, placebo-controlled trials demonstrated efficacy and safety for moderate or severe glabellar lines.

Objective: To further evaluate DAXI in a large, open-label, repeat-treatment study.

Methods: Subjects (n = 2,691) were enrolled from the preceding pivotal trials or de novo and received 40U DAXI. Those who received repeat treatments could be retreated when they returned to baseline on the Investigator Global Assessment-Frown Wrinkle Severity (IGA-FWS) and Patient FWS (PFWS) scales at/after 12 weeks and up to 36 weeks after treatment.

Results: High (>96%) response rates (none or mild severity) on the IGA-FWS scale were seen after each of the 3 treatments, with peak response between Weeks 2 to 4. At Week 24, ≥32% had a response of none or mild severity. Peak response rates of ≥92% were observed at Weeks 2 to 4 on the PFWS scale. The median duration for return to moderate or severe severity was 24 weeks. The safety profile was favorable and consistent with previous trials.

Conclusion: DaxibotulinumtoxinA for Injection efficacy was highly consistent across treatment cycles. These results confirm the previously observed efficacy rates and duration of response.

Trial registration: ClinicalTrials.gov NCT03004248.

Conflict of interest statement

Neither honoraria nor payments were made for authorship. S.G. Fabi served as clinical trial investigator and consultant for Revance Therapeutics, Inc. in addition to owning stock in the company. J.L Cohen and L.J. Green served as clinical trial investigators and consultants for Revance Therapeutics, Inc. S. Dhawan, T.C. Kontis, and L. Baumann served as clinical trial investigators for Revance Therapeutics, Inc. T.M. Gross, C.J. Gallagher, J. Brown, and R.G. Rubio are employees of, and hold stock/stock options in, Revance Therapeutics, Inc.

Copyright © 2020 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Society for Dermatologic Surgery, Inc.

Figures

Figure 1:

Proportion of subjects with none or mild severity based on the (A) IGA-FWS and (B) PFWS scales after Treatments 1, 2, and 3.

Figure 2:

Proportion of subjects with a ≥1-point improvement on the IGA-FWS scale over 36 weeks after Treatments 1 and 2, and over 12 weeks after Treatment 3.

Figure 3:

(A) Time to loss of none or mild severity and (B) Time to return to baseline severity on both IGA-FWS and PFWS scales after Treatments 1 and 2.

Figure 4:

(A) Investigator and (B) subject ratings on the Global Aesthetic Improvement Scale across study visits after Treatments 1, 2, and 3.

Figure 5:

(A) Example of a 23-year-old female subject with a 2-point improvement on IGA-FWS and PFWS scales at Week 4. The 2-point improvement was sustained through Week 16 and a 1-point improvement through Week 24. (B). Example of a 44-year-old female subject with a 2-point improvement on IGA-FWS and PFWS scales at Week 4. She had a 1-point improvement on both IGA-FWS and PFWS scales at Week 16 and at Week 24; she maintained a 1-point improvement on the IGA-FWS scale and returned to baseline on the PFWS. IGA-FWS, Investigator Global Assessment–Frown Wrinkle Severity; PFWS, Patient FWS.