Real-World Safety And Effectiveness Of OnabotulinumtoxinA Treatment Of Crow’s Feet Lines And Glabellar Lines: Results Of A Korean Postmarketing Surveillance Study

Abstract

Purpose

OnabotulinumtoxinA is approved in the Republic of Korea for the treatment of moderate-to-severe crow’s feet lines (CFL) and glabellar lines (GL), separately or in combination. We assessed safety and effectiveness of onabotulinumtoxinA in real-world clinical practice.

Patient and methods

This 4-year postmarketing surveillance study was conducted in the Republic of Korea in subjects with moderate-to-severe CFL. Subjects aged 18 to 75 years received onabotulinumtoxinA injections for CFL alone or in combination with GL. Safety assessments included adverse events (AEs), serious AEs (SAEs), and unexpected AEs (not noted in Korean prescribing information). Investigators assessed effectiveness via change from baseline in CFL.

Results

The full analysis set comprised 695 subjects; 667 were in the safety set and 376 in the effectiveness set. In the safety set, mean ± SD age was 40.9±13.0 years; most subjects (87.3%) were female. More subjects were treated for CFL (69.9%) than CFL and GL simultaneously (30.1%). Eleven subjects experienced 14 AEs; 12 were mild in severity and 11 resolved without sequelae. Two cases of injection site pain in 2 subjects each were deemed possibly related to onabotulinumtoxinA. One unexpected SAE (acute renal failure) occurred in 1 subject (0.15%). All unexpected AEs (n=4) were mild and considered unrelated to treatment. Overall change from baseline showed CFL was improved in 375 subjects (99.7%) and unchanged in 1 subject (0.3%).

Conclusion

OnabotulinumtoxinA was well tolerated and effective for treatment of CFL with or without GL in a real-world Korean population. No new safety concerns were identified.

Keywords:

• aesthetics
• Botox
• botulinum toxins
• type A
• skin aging

Acknowledgments

The authors thank Daniel Chung for providing useful insight that facilitated the research, Zhanying Bai for biostatistical support, and Suzanne Magante for study management. Writing and editorial assistance was provided to the authors by Peloton Advantage, LLC, an OPEN Health company, and funded by Allergan plc, Dublin, Ireland. This research was funded by Allergan plc, Dublin, Ireland. Medical writing and editorial support were provided by Peloton Advantage, LLC, an OPEN Health company, and were sponsored by Allergan plc. No honoraria or other forms of payment were made for authorship.

Abbreviations

AE, adverse event; CFL, crow’s feet lines; CI, confidence interval; GL, glabellar lines; ISAPS, International Society of Aesthetic Plastic Surgery; MFDA, Korean Ministry of Food and Drug Safety; PMS, postmarketing surveillance; SAE, serious adverse event.

Data Sharing Statement

Data reported in this manuscript are available within the article and/or its supplementary materials. Allergan will share de-identified patient-level data and/or study-level data, including protocols and clinical study reports, for phase 2–4 trials completed after 2008 that are registered on ClinicalTrials.gov or EudraCT. The primary manuscript from the trial must be published prior to data sharing. To request access to the data, the researcher must sign a data user agreement. All shared data are to be used for noncommercial purposes only. More information can be found at www.allerganclinicaltrials.com/.

Author Contributions

All authors contributed to conceptualization and methodology. D-JY, SH, and JHS were study investigators. IY, KAS, and SSt.R participated in data curation and formal analysis. All authors had full access to the data, contributed to the interpretation of the data, drafting and revising the article, gave final approval of the version to be published, and agree to be accountable for all aspects of the work.

Disclosure

IY, KAS, and SSt.R are employees of Allergan plc and may own stock/options in the company. JHS has served as a lecturer for Alcon and Novartis and as a consultant for Allergan plc. He also reports personal fees from Allergan, during the conduct of the study and outside the submitted work. D-JY reports personal fees from Allergan plc, during the conduct of the study; personal fees from Medytox, Hugel, lnc., LG Chem, and Aesthetics, outside the submitted work. SH reports personal fees from Allergan, during the conduct of the study; personal fees from Wonik, outside the submitted work. The authors report no other conflicts of interest in this work.