ATX-101 for reduction of submental fat: A phase III randomized controlled trial - 18/09/16
, Jonathan Sykes, MD c, Jonathan Kantor, MD, MSCE, MA d, e, Vince Bertucci, MD f, g, Patricia Walker, MD, PhD h, Daniel R. Lee, MS h, Paul F. Lizzul, MD, PhD, MPH, MBA h, Todd M. Gross, PhD h, Frederick C. Beddingfield, MD, PhD h, iAbstract |
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.
Le texte complet de cet article est disponible en PDF.Key words : aesthetics, ATX-101, contouring, deoxycholic acid, efficacy, injectable, minimally invasive, nonsurgical, safety, submental fat
Abbreviations used : AE, MMN, MRI, PR-SMFIS, SMF
Plan
| Kythera Biopharmaceuticals, Inc is an affiliate of Allergan plc, Dublin, Ireland. |
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| The REFINE-2 trial was sponsored by Kythera Biopharmaceuticals, Inc, an affiliate of Allergan plc, Dublin, Ireland. Writing and editorial assistance was provided to the authors by Karen Stauffer, PhD, CMPP, an employee of Evidence Scientific Solutions, Philadelphia, PA, which contracted with Kythera Biopharmaceuticals, Inc to provide professional medical writing assistance and project management support in the development of this manuscript; work by Dr Stauffer was funded by Allergan plc, Dublin, Ireland. |
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| Drs Humphrey and Sykes (receiving funding) and Drs Kantor and Bertucci (receiving institutional funding) served as investigators for Kythera Biopharmaceuticals, Inc. Drs Humphrey, Sykes, and Bertucci served as speakers, consultants, and advisory board members (receiving honoraria) for Kythera Biopharmaceuticals, Inc. Dr Walker was a salaried employee of Kythera Biopharmaceuticals, Inc during the execution of this trial. Mr Lee was a salaried employee and stockholder of Kythera Biopharmaceuticals, Inc during the execution of this trial. Dr Lizzul was Senior Medical Director; Dr Gross was Vice President of Clinical Development, Biostatistics, and Data Management; and Dr Beddingfield was Chief Medical Officer at Kythera Biopharmaceuticals, Inc, where they were salaried employees, stockholders, and holders of stock options during the execution of this trial. Drs Lizzul and Beddingfield are current employees of Sienna Biopharmaceuticals, Inc, Westlake Village, California. All authors met International Committee of Medical Journal Editors authorship criteria. Neither honoraria nor payments were made for authorship. |
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| Table I, the Supplementary Table I, and the Supplementary Fig 1, Supplementary Fig 2, Supplementary Fig 3, Supplementary Fig 4 are available at www.jaad.org. |
Vol 75 - N° 4
P. 788 - octobre 2016 Retour au numéro
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