Subject satisfaction and psychological well‐being with escalating abobotulinumtoxinA injection dose for the treatment of moderate to severe glabellar lines

Abstract

Background Previous studies indicate that the efficacy and durability of a single AbobotulinumtoxinA (ABO) treatment for moderate to severe glabellar lines may be enhanced with increasing dose, while safety outcomes remain consistent with those of the licensed dose (50 U). Aims Evaluation of subject‐reported indicators of treatment efficacy, satisfaction, and psychological well‐being with ABO dose escalation. Methods A Phase 2, 36‐week, multicenter, randomized, dose‐ranging, double‐blind, placebo‐controlled study was conducted in adults with moderate to severe glabellar lines. Subjects received a single ABO treatment, dosed at 50, 75, 100, or 125 U, or placebo. Efficacy endpoints comprised subject‐assessed improvement in line severity of ≥1‐grade from baseline at maximum frown, global aesthetic improvement scale (GAIS) grade, FACE‐Q™ appraisal of lines, psychological well‐being and age, and subject satisfaction. Results The study included 399 subjects (88.2% were female). Respective responder rates (≥1‐grade improvement) with ABO 50–125 U doses ranged between 96.3%–100% at Week 4, 65.0%–67.9% at Week 24, and 33.8%–44.4% at Week 36. GAIS responder rate and FACE‐Q appraisal of lines showed a similar pattern of change. Satisfaction was high and psychological well‐being was improved from Week 4 through Week 36, with natural, youthful, and refreshed appearance reported for all ABO doses. Conclusions A single ABO treatment (dosed at 50–125 U) provided significant and sustained improvements in glabellar line severity over durations up to 36 weeks, versus placebo. Treatment satisfaction was high with all doses. Participants reported natural and youthful appearance, alongside improvements in psychological well‐being.

Real-World, Retrospective, Multicenter, Observational Study on the Use of the First Liquid AbobotulinumtoxinA in Italy

“…Fast improvement and long-term duration can mainly explain the high percentage of patients (98.2%) who declared to be “highly satisfied” compared to the 85% of “satisfied” or “very satisfied” patients reported in the literature [ 4 , 5 , 12 ]. Although assessment scales used in this study are different from those used in RCTs and no direct comparison can be done, in almost 40% of the patients the treatment results lasted for 6 months, a greater percentage of patients compared with the 27% reported in RCTs [ 4 , 5 ]; these results are of particular interest since our cohort included a high percentage of non-toxin treatment-naïve patients, while only toxin treatment-naïve patients had been included in clinical trials.…”

“…In particular, clinicians almost always decided to switch from the five-point to the three-point injection technique, reducing the overall amount of units injected in both botulinum toxin treatment-naïve and non-treatment-naïve patients, an approach not described in previous studies. Controlled clinical studies on the efficacy of botulinum toxin at decreasing/lower dose could be of interest, in addition to the existing data with escalating dose [ 12 ].…”

Tailored Indications for Different Neurotoxins

“…On the contrary, if patients want to have obvious results that last longer, utilizing higher units with ABO toxin can be better. 30 It is also important to reveal any unrealistic expectations that patients may have, as these have to be clarified, and treatment may need to be canceled if there is disconcordance with what is expected versus what can be achieved. 31…”

LetibotulinumtoxinA Attenuates the Psychological Burden of Glabellar Lines and Is Associated With High Subject Satisfaction in Phase 3 Clinical Trials

“…5 Furthermore, studies leveraging patient-reported outcome (PRO) assessments after glabellar line treatment with BoNT/A have revealed benefits to patients' self-esteem, perception of age, and quality of life (QoL) across multiple dimensions. [6][7][8][9] LetibotulinumtoxinA, a proprietary formulation of purified 900 kDa Clostridium botulinum neurotoxin type A complex manufactured by Hugel, Inc. (Chuncheon, Republic of Korea) from strain CBFC26, is an investigational drug under review by the FDA and was recently shown to be well-tolerated and superior to placebo in reducing glabellar line severity posttreatment. 10 Its impact on psychosocial health-related QoL and subject satisfaction with treatment have yet to be fully reported.…”

“…5 Furthermore, studies leveraging patient-reported outcome (PRO) assessments after glabellar line treatment with BoNT/A have revealed benefits to patients' self-esteem, perception of age, and quality of life (QoL) across multiple dimensions. 6–9…”