Real-World Safety And Effectiveness Of OnabotulinumtoxinA Treatment Of Crow’s Feet Lines And Glabellar Lines: Results Of A Korean Postmarketing Surveillance Study
Received 16 August 2019
Accepted for publication 26 October 2019
Published 19 November 2019 Volume 2019:12 Pages 851—856
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 3
Editor who approved publication: Dr Jeffrey Weinberg
Dong-Jin Yi,1 Seongjin Hwang,2 JunHyuk Son,3 Irina Yushmanova,4 Krystal Anson Spenta,5 Suzanne St.Rose6
1BLS Clinic, Seoul, Republic of Korea; 2Fulore Clinic, Seoul, Republic of Korea; 3Department of Ophthalmology, Yeungnam University College of Medicine, Daegu, Republic of Korea; 4Global Patient Safety and Epidemiology, Allergan plc, Irvine, CA, USA; 5Global Medical Trial Management, Allergan plc, Irvine, CA, USA; 6Global Patient Safety and Epidemiology, Allergan Holdings Ltd, Marlow, Buckinghamshire, UK
Correspondence: Suzanne St.Rose
Allergan Holdings, Ltd., Marlow International, The Parkway, Marlow, Buckinghamshire SL7 1YL, UK
Tel +44 16 2849 4299
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
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