BC07 Patient-reported outcomes across repeat treatments for moderate-to-severe platysma prominence with onabotulinumtoxinA in a long-term, phase III, open-label extension study

Abstract Platysma prominence (PP) refers to an aesthetically undesirable blunting of the jawline with vertical bands along the neck. A single treatment with onabotulinumtoxinA (onabotA) improved PP with favourable patient-reported outcomes (PROs) in two phase III, multicentre, double-blind, placebo-controlled studies. In an open-label extension, PROs were evaluated in participants receiving up to three onabotA treatments. Clinical and PRO measures were developed per regulatory guidance from the US Food and Drug Administration and the European Medicines Agency. In the lead-in double-blind, placebo-controlled study, adults with bilateral, moderate-to-severe PP, who were bothered by their PP, received onabotA or placebo. In the open-label study, participants received up to three onabotA treatments. PRO endpoints at days 14, 30, 60, 90 and 120 after each treatment were assessed using the Appearance of Neck and Lower Face Questionnaire (ANLFQ) Satisfaction subscale, the Bother Assessment Scale-Platysma Prominence (BAS-PP) and the Participant Global Impression of Severity-Jawline (PGIS-Jawline). The percentages of participants were recorded who reported (i) ‘very satisfied’ or ‘satisfied’ with the effect of treatment on the ANLFQ Satisfaction subscale (at follow-up); (ii) ‘not at all’ or ‘a little bothered’ on the BAS-PP and (iii) ‘no or mild sagging/drooping’ on the PGIS-Jawline (among those with at least moderate sagging or drooping at baseline). Change from baseline on the ANLFQ Impacts summary score was used to assess psychosocial impact. Analyses were conducted on the intent to treat (ITT) population, consisting of all participants enrolled in the study, and on the modified ITT (mITT) population, consisting of ITT participants with a baseline ANLFQ Impacts summary score ≥ 19 on day 1 of the lead-in study. The participants (n = 292; mean age 49.6 years) were mostly female (93.5%) and White (90.8%), with 89.7% completing the study. At day 14, responder rates in cycles 1, 2, 3 and 4 were, respectively, 67.0%, 74.8%, 69.2% and 78.0% on the ANLFQ Satisfaction subscale; 56.6%, 66.9%, 61.3% and 78.0% for vertical neck bands and 59.2%, 61.5%, 56.9% and 68.0% for jawline appearance on BAS-PP; and 58.6%, 65.2%, 55.1% and 73.5% on PGIS-Jawline. The changes from baseline in ANLFQ Impacts summary scores were −8.0, −8.5, −8.3 and −10.1, respectively, indicating reduction in psychosocial impact. Similar efficacy profiles for all PRO endpoints were observed across all treatment cycles, and in the mITT population. PROs including treatment satisfaction are important in evaluating comprehensive and holistic treatment benefits. Repeated treatment of PP with onabotA demonstrated consistently high satisfaction, less bother from jawline and vertical neck band appearance, less jawline drooping and sagging, and reduced psychosocial burden associated with PP, across each of the four treatment cycles, in both the ITT and mITT populations. This research was funded by a commercial organization. No honoraria or payments were made for authorship.