Long‐Term Safety of AbobotulinumtoxinA for the Treatment of Glabellar Lines: Results From a 36‐Month, Multicenter, Open‐Label Extension Study. Issue 2 (26th December 2013)

• Record Type: Journal Article
• Authors: Schlessinger, Joel; Dover, Jeffrey S.; Joseph, John; Monheit, Gary; Nelson, Diane B.; Albright, Craig D.; Axford‐Gatley, Robert A.; Cohen, Joel L.
• Is Part Of: Dermatologic surgery. Volume 40:Issue 2(2014)
• Page Start: 176
• Page End: 183
• Publication Date: 2013-12-26
• Subjects: Skin -- Surgery -- Periodicals; Skin -- Diseases -- Surgery -- Periodicals; 617.477
• DOI: 10.1111/dsu.12404
• Languages: English
• ISSNs: 1076-0512

Abstract

<abstract abstract-type="main" id="dsu12404-abs-0001"> <title> <x xml:space="preserve">Abstract</x> </title> <sec id="dsu12404-sec-0001" sec-type="section"> <title>Background</title> <p>Because abobotulinumtoxinA treatment for glabellar lines must be repeated regularly to prevent recurrence, understanding the safety and effectiveness of long‐term, repeated administration of abobotulinumtoxinA is important.</p> </sec> <sec id="dsu12404-sec-0002" sec-type="section"> <title>Objective</title> <p>To report the long‐term safety and efficacy of abobotulinumtoxinA in patients with moderate to severe glabellar lines.</p> </sec> <sec id="dsu12404-sec-0003" sec-type="section"> <title>Methods and Materials</title> <p>AbobotulinumtoxinA was administered to 1, 415 patients in multiple cycles over 24 months as a fixed dose of 50 U or as a dose based on muscle mass and sex (women: 50–70 U; men: 60–80 U). Adverse events were assessed after each visit on days 7, 14, and 30 and monthly thereafter; monitoring continued every 3 months for a total safety monitoring duration of 36 months or less.</p> </sec> <sec id="dsu12404-sec-0004" sec-type="section"> <title>Results</title> <p>Nine hundred ninety‐one (70%) patients reported treatment‐emergent adverse effects (TEAEs); most events were mild (70%) or moderate (20%) in severity. The rate of TEAEs did not increase over 24 months of repeated treatment (mean 5.6 cycles; range 1–9). Treatment‐related eyelid ptosis followed 53 of 7, 938 (0.7%) treatments, all of which resolved spontaneously.</p> </sec> <sec id="dsu12404-sec-0005" sec-type="section"> <title>Conclusions</title> <p>Multiple cycles of abobotulinumtoxinA treatment over 24 months were well tolerated and effective for the correction of glabellar lines, with no evidence of cumulative safety problems.</p> </sec> </abstract>