Objectives: The primary objective of the APPEAL study was to assess overall subject satisfaction of glabellar lines (GL) treatment after 3 injection cycles of abobotulinumtoxinA (aboBoNT-A). Secondary objectives included a description of injection practices, with a focus on interval times between injection cycles.
Introduction: Hyperfunctional lines, such as GL, are caused by prolonged contraction of facial muscles and can lead to wrinkles, negative facial expressions or an aged appearance. Severe GL can have a negative psychological impact on a patient. Botulinum neurotoxin type A injections can temporarily weaken hyperfunctional muscles, and repeated treatments are required to maintain therapeutic advantage. The APPEAL study assessed subject and physician satisfaction of long-term GL treatment with aboBoNT-A in a real-life setting. Here we present injection interval data between Cycles 1 and 2, and 2 and 3.
Materials / method: The APPEAL study (NCT02353897) was a multicentre, non-interventional, prospective, longitudinal study in subjects with moderate-to-severe GL, who received ≥3 cycles of aboBoNT-A injections. Subjects completed a subject satisfaction questionnaire 3 weeks (±7 days) after each cycle. Shortest injection interval was 12 weeks, according to the local summary of product characteristics (SmPC) and maximum interval time was 6 months, determined at the investigators discretion. Descriptive statistics were performed for injection interval times overall, between Cycles 1 and 2, and between Cycles 2 and 3.
Results: After Cycle 3, 99% of subjects (n=134/135) were ‘very satisfied’ (74%) or ‘satisfied’ (25%) with GL correction. Median drug exposure was 309.5 days (range, 1–426 days). 137 (91%) subjects received 3 injection cycles, 3 (2%) received 2 cycles and 10 (7%) received 1 cycle. Overall interval data were available for 140 subjects. Median overall interval time (days [range]) was 10.6 months (320 [228–426] days). Median injection interval time (days [range]) was 5.0 months (152 [85–267] days) between Cycles 1 and 2 (n=140), and 5.3 months (161 [104–211] days) between Cycles 2 and 3 (n=137).
Conclusion: In the APPEAL study, there was a high level of satisfaction following 3 injection cycles of aboBoNT-A. Furthermore, physicians’ injection practices and the interval time between injection cycles aligned with the recommendations of local SmPCs, with a median retreatment interval of 5 months.
Disclosures
Did you receive any funding to support your research for this TOPIC?
Yes
Please specify entities (individual, company, society): Ipsen
Were you provided with any honoraria, payment or other compensation for your work on this study?
No
Do you have any financial relationship with any entity which may closely compete with the medications, materials or instruments covered by your study?
No
Do you own or have you applied for any patents in conjunction with the instruments, medications or materials discussed in your study?
No
This work is presented thanks to the support of: Ipsen