Shannon Humphrey1, Jonathan Sykes2, Jonathan Kantor3, Vince Bertucci4, Patricia Walker5, Daniel R Lee5, Paul F Lizzul5, Todd M Gross5, Frederick C Beddingfield6. 1. University of British Columbia, Vancouver, British Columbia, Canada; Carruthers & Humphrey, Vancouver, British Columbia, Canada. Electronic address: shannon@carruthers-humphrey.com. 2. University of California, Davis, Sacramento, California. 3. Florida Center for Dermatology PA, St. Augustine, Florida; University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania. 4. University of Toronto and Women's College Hospital, Toronto, Ontario, Canada; Bertucci MedSpa, Woodbridge, Ontario, Canada. 5. Kythera Biopharmaceuticals, Inc, Westlake Village, California. 6. Kythera Biopharmaceuticals, Inc, Westlake Village, California; David Geffen School of Medicine, University of California, Los Angeles, California.
Abstract
BACKGROUND:ATX-101, an injectable form of deoxycholic acid, causes adipocytolysis when injected subcutaneously into fat. OBJECTIVE: We sought to evaluate the efficacy and safety of ATX-101. METHODS: In this phase III trial (REFINE-2), adults dissatisfied with their moderate or severe submental fat (SMF) were randomized to ATX-101 or placebo. Coprimary end points, evaluated at 12 weeks after last treatment, were composite improvements of 1 or more grades and 2 or more grades in SMF observed on both the validated Clinician- and Patient-Reported SMF Rating Scales. Other end points included magnetic resonance imaging-based assessment of submental volume, assessment of psychological impact of SMF, and additional patient-reported outcomes. RESULTS: Among those treated with ATX-101 or placebo (n = 258/treatment group), 66.5% versus 22.2%, respectively, achieved a composite improvement of 1 or more grades (Mantel-Haenszel risk ratio 2.98; 95% confidence interval 2.31-3.85) and 18.6% versus 3.0% achieved a composite improvement of 2 or more grades in SMF (Mantel-Haenszel risk ratio 6.27; 95% confidence interval 2.91-13.52; P < .001 for both). Those treated with ATX-101 were more likely to achieve submental volume reduction confirmed by magnetic resonance imaging, greater reduction in psychological impact of SMF, and satisfaction with treatment (P < .001 for all). Overall, 85.7% of adverse events in the ATX-101 group and 76.9% in the placebo group were localized to the injection site. LIMITATIONS: Follow-up was limited to 44 weeks. CONCLUSION:ATX-101 is an alternative treatment for SMF reduction.
RCT Entities:
BACKGROUND:ATX-101, an injectable form of deoxycholic acid, causes adipocytolysis when injected subcutaneously into fat. OBJECTIVE: We sought to evaluate the efficacy and safety of ATX-101. METHODS: In this phase III trial (REFINE-2), adults dissatisfied with their moderate or severe submental fat (SMF) were randomized to ATX-101 or placebo. Coprimary end points, evaluated at 12 weeks after last treatment, were composite improvements of 1 or more grades and 2 or more grades in SMF observed on both the validated Clinician- and Patient-Reported SMF Rating Scales. Other end points included magnetic resonance imaging-based assessment of submental volume, assessment of psychological impact of SMF, and additional patient-reported outcomes. RESULTS: Among those treated with ATX-101 or placebo (n = 258/treatment group), 66.5% versus 22.2%, respectively, achieved a composite improvement of 1 or more grades (Mantel-Haenszel risk ratio 2.98; 95% confidence interval 2.31-3.85) and 18.6% versus 3.0% achieved a composite improvement of 2 or more grades in SMF (Mantel-Haenszel risk ratio 6.27; 95% confidence interval 2.91-13.52; P < .001 for both). Those treated with ATX-101 were more likely to achieve submental volume reduction confirmed by magnetic resonance imaging, greater reduction in psychological impact of SMF, and satisfaction with treatment (P < .001 for all). Overall, 85.7% of adverse events in the ATX-101 group and 76.9% in the placebo group were localized to the injection site. LIMITATIONS: Follow-up was limited to 44 weeks. CONCLUSION:ATX-101 is an alternative treatment for SMF reduction.
Authors: Steven H Dayan; Joel Schlessinger; Kenneth Beer; Lisa M Donofrio; Derek H Jones; Shannon Humphrey; Jean Carruthers; Paul F Lizzul; Todd M Gross; Frederick C Beddingfield; Christine Somogyi Journal: Aesthet Surg J Date: 2018-08-16 Impact factor: 4.283
Authors: Craig F Teller; Annie Chiu; Cameron D Chesnut; Deborah Sherman; José Raul Montes; Sara Gaspard; Terrence Keaney; Neil S Sadick; Steve Yoelin; Sara Sangha; Sachin M Shridharani Journal: Plast Reconstr Surg Glob Open Date: 2021-07-12