ATX-101 for reduction of submental fat: A phase III randomized controlled trial Shannon Humphrey, MD, Jonathan Sykes, MD, Jonathan Kantor, MD, MSCE, MA,

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Presentation transcript:

ATX-101 for reduction of submental fat: A phase III randomized controlled trial Shannon Humphrey, MD, Jonathan Sykes, MD, Jonathan Kantor, MD, MSCE, MA, Vince Bertucci, MD, Patricia Walker, MD, PhD, Daniel R. Lee, MS, Paul F. Lizzul, MD, PhD, MPH, MBA, Todd M. Gross, PhD, Frederick C. Beddingfield, MD, PhD Journal of the American Academy of Dermatology Volume 75, Issue 4, Pages 788-797.e7 (October 2016) DOI: 10.1016/j.jaad.2016.04.028 Copyright © 2016 American Academy of Dermatology, Inc. Terms and Conditions

Fig 1 A, Standardized photographs and magnetic resonance imaging (MRI) of a 51-year-old man who underwent 6 treatment sessions with ATX-101 and achieved a composite improvement of 1 or more grades (Clinician-Reported Submental Fat Rating Scale [CR-SMFRS]/Patient-Reported Submental Fat Rating Scale [PR-SMFRS]) at 12 weeks after last treatment. Percentage reduction in submental volume as assessed by MRI was 14%. B, Standardized photographs and MRI of a 56-year-old woman who underwent 5 treatment sessions with ATX-101 and achieved a composite improvement of 1 or more grades (CR-SMFRS/PR-SMFRS) at 12 weeks after last treatment. Percentage reduction in submental volume as assessed by MRI was 2%. C, Standardized photographs of a 43-year-old woman who underwent 4 treatment sessions with ATX-101 and achieved a composite improvement of 2 or more grades (CR-SMFRS/PR-SMFRS) at 12 weeks after last treatment. BMI, Body mass index; PR-SMFIS, Patient-Reported Submental Fat Impact Scale; SMSLG, Submental Skin Laxity Grade; SSRS, Subject Self-Rating Scale. Journal of the American Academy of Dermatology 2016 75, 788-797.e7DOI: (10.1016/j.jaad.2016.04.028) Copyright © 2016 American Academy of Dermatology, Inc. Terms and Conditions

Fig 1 A, Standardized photographs and magnetic resonance imaging (MRI) of a 51-year-old man who underwent 6 treatment sessions with ATX-101 and achieved a composite improvement of 1 or more grades (Clinician-Reported Submental Fat Rating Scale [CR-SMFRS]/Patient-Reported Submental Fat Rating Scale [PR-SMFRS]) at 12 weeks after last treatment. Percentage reduction in submental volume as assessed by MRI was 14%. B, Standardized photographs and MRI of a 56-year-old woman who underwent 5 treatment sessions with ATX-101 and achieved a composite improvement of 1 or more grades (CR-SMFRS/PR-SMFRS) at 12 weeks after last treatment. Percentage reduction in submental volume as assessed by MRI was 2%. C, Standardized photographs of a 43-year-old woman who underwent 4 treatment sessions with ATX-101 and achieved a composite improvement of 2 or more grades (CR-SMFRS/PR-SMFRS) at 12 weeks after last treatment. BMI, Body mass index; PR-SMFIS, Patient-Reported Submental Fat Impact Scale; SMSLG, Submental Skin Laxity Grade; SSRS, Subject Self-Rating Scale. Journal of the American Academy of Dermatology 2016 75, 788-797.e7DOI: (10.1016/j.jaad.2016.04.028) Copyright © 2016 American Academy of Dermatology, Inc. Terms and Conditions

Fig 1 A, Standardized photographs and magnetic resonance imaging (MRI) of a 51-year-old man who underwent 6 treatment sessions with ATX-101 and achieved a composite improvement of 1 or more grades (Clinician-Reported Submental Fat Rating Scale [CR-SMFRS]/Patient-Reported Submental Fat Rating Scale [PR-SMFRS]) at 12 weeks after last treatment. Percentage reduction in submental volume as assessed by MRI was 14%. B, Standardized photographs and MRI of a 56-year-old woman who underwent 5 treatment sessions with ATX-101 and achieved a composite improvement of 1 or more grades (CR-SMFRS/PR-SMFRS) at 12 weeks after last treatment. Percentage reduction in submental volume as assessed by MRI was 2%. C, Standardized photographs of a 43-year-old woman who underwent 4 treatment sessions with ATX-101 and achieved a composite improvement of 2 or more grades (CR-SMFRS/PR-SMFRS) at 12 weeks after last treatment. BMI, Body mass index; PR-SMFIS, Patient-Reported Submental Fat Impact Scale; SMSLG, Submental Skin Laxity Grade; SSRS, Subject Self-Rating Scale. Journal of the American Academy of Dermatology 2016 75, 788-797.e7DOI: (10.1016/j.jaad.2016.04.028) Copyright © 2016 American Academy of Dermatology, Inc. Terms and Conditions

Fig 2 Mean change from baseline in the Total Scale Score and individual component scores of the Patient-Reported Submental Fat Impact Scale (PR-SMFIS) at 12 weeks after last treatment. P < .001 for all comparisons between ATX-101 and placebo. Tx, Treatment. Journal of the American Academy of Dermatology 2016 75, 788-797.e7DOI: (10.1016/j.jaad.2016.04.028) Copyright © 2016 American Academy of Dermatology, Inc. Terms and Conditions

Fig 3 Incidence, severity, and duration of injection-site adverse events (AE) (swelling/edema, bruising, and pain) for individual treatment sessions. At the top of the graph, the number of patients reporting the AE is listed in the first row; the total number of patients is listed in the second row. The number listed at the top of each bar is the median duration of the AE in a particular session. For session frequency, the data for the percentage of sessions for which the AE was reported are shown. A, ATX-101; P, placebo. Journal of the American Academy of Dermatology 2016 75, 788-797.e7DOI: (10.1016/j.jaad.2016.04.028) Copyright © 2016 American Academy of Dermatology, Inc. Terms and Conditions

Supplementary Fig 1 Study design. aPosttreatment, relative to the patient's last treatment session, irrespective of when that occurred. Analyses were made after the last patient completed visit 9 (week 32; 12 weeks after last treatment). MRI, Magnetic resonance imaging. Journal of the American Academy of Dermatology 2016 75, 788-797.e7DOI: (10.1016/j.jaad.2016.04.028) Copyright © 2016 American Academy of Dermatology, Inc. Terms and Conditions

Supplementary Fig 2 Patient disposition. The intent-to-treat population included all randomized patients and was used to evaluate efficacy. Magnetic resonance imaging (MRI) assessments were conducted on a subgroup of the intent-to-treat population. The safety population included all randomized patients who received 1 or more injections of study drug and was used to evaluate safety. SMF, Submental fat. Journal of the American Academy of Dermatology 2016 75, 788-797.e7DOI: (10.1016/j.jaad.2016.04.028) Copyright © 2016 American Academy of Dermatology, Inc. Terms and Conditions

Supplementary Fig 3 Photonumeric guide for assessment of submental fat (SMF) using the Clinician-Reported Submental Fat Rating Scale. Adapted from McDiarmid J, Ruiz JB, Lee D, et al. Results from a pooled analysis of two European, randomized, placebo-controlled, phase 3 studies of ATX-101 for the pharmacologic reduction of excess submental fat. Aesthetic Plast Surg. 2014;38:849-60.9 Journal of the American Academy of Dermatology 2016 75, 788-797.e7DOI: (10.1016/j.jaad.2016.04.028) Copyright © 2016 American Academy of Dermatology, Inc. Terms and Conditions

Supplementary Fig 4 Photonumeric guide for assessment of skin laxity using the Submental Skin Laxity Grade scale. Reproduced with permission from Jones DH, Carruthers J, Joseph JH, et al. REFINE-1, a multicenter, randomized, double-blind, placebo-controlled, phase 3 trial with ATX-101, an injectable drug for submental fat reduction. Dermatol Surg. 2016;42:38-49.8 Journal of the American Academy of Dermatology 2016 75, 788-797.e7DOI: (10.1016/j.jaad.2016.04.028) Copyright © 2016 American Academy of Dermatology, Inc. Terms and Conditions