April 2020 HSC Section 4 - Plastic and Reconstructive Problems

ATX - 1 0 1 FOR M I LD AND EXTR EME SMF

In conclusion, based on both clinician and subject assessments, ATX-101 signi fi cantly reduced SMF in subjects with mild or extreme SMF. Most AEs were mild or moderate, transient, and related to the injection site. The total dose of ATX-101 adminis- tered at each session can be tailored to the thickness and volume of SMF, allowing for treatment of a wide range of patients. As such, ATX-101 may be appropriate for use in subjects with mild or extreme SMF. Acknowledgments The authors thank the additional investigators from this study, including Steve Fagien and Derek Jones. This study was sponsored by Kythera Biopharmaceuticals, Inc., an af fi liate of Allergan. The FACE-Q is owned by Memorial Sloan Kettering Cancer Center. Writing and editorial assistance was provided to the authors by Evidence Scienti fi c Solutions, Philadelphia, PA, and funded by Allergan plc, Dublin, Ireland. All authors met the ICMJE authorship criteria. Neither honoraria nor payments were made for authorship. References 1. Baumann L, Shridharani SM, Humphrey S, Gallagher CJ. Personal (self) perceptions of submental fat among adults in the United States. Dermatol Surg 2019;45:124 – 30. 2. Raveendran SS, Anthony DJ, Ion L. An anatomic basis for volumetric evaluation of the neck. Aesthet Surg J 2012;32:685 – 91. 3. Schlessinger J, Weiss SR, Jewell M, Narurkar V, et al. Perceptions and practices in submental fat treatment: a survey of physicians and patients. Skinmed 2013;11:27 – 31. 4. Koehler J. Complications of neck liposuction and submentoplasty. Oral Maxillofac Surg Clin North Am 2009;21:43 – 52. 5. Rotunda AM, Suzuki H, Moy RL, Kolodney MS. Detergent effects of sodium deoxycholate are a major feature of an injectable phosphatidylcholine formulation used for localized fat dissolution. Dermatol Surg 2004;30:1001 – 8. 6. Thuangtong R, Bentow JJ, Knopp K, Mahmood NA, et al. Tissue-selective effects of injected deoxycholate. Dermatol Surg 2010;36:899 – 908. 7. Ascher B, Hoffmann K, Walker P, Lippert S, et al. Ef fi cacy, patient- reported outcomes and safety pro fi le of ATX-101 (deoxycholic acid), an injectable drug for the reduction of unwanted submental fat: results from a phase III, randomized, placebo-controlled study. J Eur Acad Dermatol Venereol 2014;28:1707 – 15. 8. Humphrey S, Sykes J, Kantor J, Bertucci V, et al. ATX-101 for reduction of submental fat: a phase III randomized controlled trial. J Am Acad Dermatol 2016;75:788 – 797.e7. 9. Jones DH, Carruthers J, Joseph JH, Callender VD, 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.

Figure 5. Skin laxity (as rated by the clinician using the SMSLG) over time by treatment and baseline submental fat severity (mild or extreme). The SMSLG scale includes grades of none (1), mild (2), moderate (3), and severe (4). SMSLG, Submental Skin Laxity Grade.

ATX-101 treatment was generally well tolerated in this study, and the observed AEs were similar to those seen across the Phase 3 ATX-101 trials. 7 – 10 Consis- tent with the mode of administration and tissue response to ATX-101, most AEs involved the injec- tion site/treatment area. Swelling is an expected outcome due to the mechanism of action of ATX- 101, 18 and patients should be counseled on this point. Most ATX-101 – treated subjects achieved ef fi cacy outcomes despite AEs. The durability of the ATX-101 treatment response is not known for subjects with mild or extreme SMF. However, >90% of subjects in an open-label ATX- 101 study, which included those with moderate to extreme SMF who were CR-1 responders at 12 weeks after last treatment, sustained their response at 12 months after last treatment. 19 Similar percentages of long-term responders were seen in 2- year extensions of the Phase 3 trials, which included subjects with moderate or severe SMF. 20 It should also be noted that SMF reduction continues beyond the 28-day interval used in the current study. 21 Many clinicians report extending the interval between treatments to allow for complete realiza- tion of the effects of ATX-101, which may reduce the number of treatments required for successful outcomes.

DE RMATOLOG I C S URG E RY

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