April 2020 HSC Section 4 - Plastic and Reconstructive Problems

G LOGAU E T A L

Figure 2. Percentage of subjects who achieved a $ 1-grade improvement in SMF from baseline at 12 weeks after last treatment among subjects with (A) mild or (B) extreme SMF. Responders are defined as subjects who achieved a $ 1-grade improvement in SMF from baseline based on clinician assessment (CR-1), subject assessment (PR-1), or both clinician and subject assessment (composite CR-1/PR-1). ATX-101 difference from placebo: * p < .001; † p < .005; ‡ p < .05. SMF, submental fat.

treatment] to 2.0 mL [ fi nal treatment] for subjects with mild SMF; from 7.8 to 5.2 mL for those with extreme SMF). Similar reductions were observed in the placebo groups.

At baseline, subjects reported a high level of psycho- logical impact from their SMF (mean PR-SMFIS TSS of 7.3/10 [greatest negative impact] in both ATX-101 treatment groups). Mean reduction in PR-SMFIS TSS 12 weeks after last treatment was signi fi cantly greater for ATX-101 – treated subjects versus placebo-treated subjects regardless of baseline SMF severity ( p # .001 for each; Figure 4). Signi fi cant reductions from base- line were also seen for each of the 6 individual com- ponents of the PR-SMFIS TSS. Signi fi cantly more ATX-101 – treated subjects with mild SMF were satis fi ed (reported being slightly sat- is fi ed, satis fi ed, or extremely satis fi ed on the SSRS) with the appearance of their face/chin after treatment compared with placebo-treated subjects (80.0% vs 46.7%, respectively; p = .024). Subjects with extreme SMF who were treated with ATX-101 experienced similar satisfaction after treatment (71.4% vs 0%; p < .001). Signi fi cant differences were observed between the ATX-101 and placebo groups in mean change from baseline in SMF thickness, regardless of baseline SMF

Efficacy

At 12 weeks after last treatment, a signi fi cantly greater percentage of ATX-101 – treated subjects versus placebo-treated subjects achieved a com- posite CR-1/PR-1 response regardless of baseline SMF severity (Figure 2). Individual CR-1 and PR-1 response rates were also signi fi cantly higher among ATX-101 – treated subjects compared with placebo-treated subjects (Figure 2). Among sub- jects with extreme SMF, 42.9% of ATX-101 – treated subjects versus 0% of placebo-treated subjects achieved a composite CR-2/PR-2 response ( p < .001), 71.4% versus 13.3% achieved a CR-2 response ( p < .001), and 60.7% versus 20.0% achieved a PR-2 response ( p = .003). Representative photographs of subjects who achieved a $ 1-grade improvement in SMF are shown in Figure 3.

0 0 : 0 0 : MONTH 2 0 1 9

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