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Open-label Study Finds DaxibotulinumtoxinA for Injection Safe for Glabellar Lines

Researchers found that daxibotulinumtoxinA for injection (DAXI), a novel botulinum toxin in development, is safe with high response rates in the treatment of glabellar lines. The study confirmed the results previously established in two pivotal, phase 3, randomized, placebo-controlled studies (SAKURA 1 and SAKURA 2). The present results were presented as a poster abstract at the American Academy of Dermatology Virtual Meeting Experience 2020.

Dr Katz video shotWatch Dr Katz, an investigator in SAKURA 1 and SAKURA 2, discuss DAXI, the development of a biosimilar for onabotulinumtoxinA, and the state of cosmetic dermatology, in an exclusive video interview with The Dermatologist!

In this open-label study (SAKURA-OLS), the safety profile of DAXI 40U was evaluated for long-term use with single and repeat treatments in a large patient population (N=2691) at 65 centers. In addition, the efficacy of single and repeat treatments was assessed.

Patients were evaluated at baseline and weeks 1, 2, and 4 and subsequently every 4 weeks through week 36 for treatment cycles 1 and 2, and through week 12 for treatment cycle 3. Overall, the study included a total of 3830 DAXI treatment cycles (2380 treatments in cycle 1, 882 treatments in cycle 2, and 568 treatments in cycle 3).

Upon analysis, DAXI was found to have a low treatment-related adverse event (TRAE) rate. Cycle 1 had 400 (16.8%) TRAEs, cycle 2 had 86 (9.8%), and cycle 3 had 40 (7.0%). TRAEs were most commonly mild (90%) or moderate (9%), transient with a median duration of 2 day, occurred soon after treatment (median onset, 1 day), and resolved fully (96% of TRAEs). The most common TRAEs included headache, injection site pain, injection site erythema, injection site edema, and eyelid ptosis. Most notably, TRAE rate decreased with successive treatments.

The study also found that peak response rates at weeks 2 and 4 (>96%) as determined by Investigator Frown Wrinkle Severity Scale (IGA-FWS), with a median time to loss of none or mild of 24 weeks and a median time to return to baseline of 28 weeks.

Guillen-Fabi S, Green JB, Liu Y, Rubio RG, Gallagher CJ, Gross TM. Results of a large open-label safety study of daxibotulinumtoxina for injection in glabellar lines. Presented at:  American Academy of Dermatology Virtual Meeting Experience 2020; June 12-14, 2020.

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