Efficacy and Safety of ATX-101 by Treatment Session: Pooled Analysis of Data From the Phase 3 REFINE Trials

• Published in: Aesthetic surgery journal 2018-08, Vol.38 (9), p.998-1010
• Main Authors: Dayan, Steven H, Schlessinger, Joel, Beer, Kenneth, Donofrio, Lisa M, Jones, Derek H, Humphrey, Shannon, Carruthers, Jean, Lizzul, Paul F, Gross, Todd M, Beddingfield, Frederick C, Somogyi, Christine
• Format: Article
• Language: English
• Subjects: Adult; Chin; Cholagogues and Choleretics - administration & dosage; Cholagogues and Choleretics - adverse effects; Clinical Trials, Phase III as Topic; Cosmetic Medicine; Cosmetic Techniques - adverse effects; Deoxycholic Acid - administration & dosage; Deoxycholic Acid - adverse effects; Esthetics; Female; Humans; Injections, Subcutaneous - adverse effects; Male; Middle Aged; Patient Satisfaction; Postoperative Complications - diagnosis; Postoperative Complications - epidemiology; Postoperative Complications - etiology; Randomized Controlled Trials as Topic; Severity of Illness Index; Subcutaneous Fat - drug effects; Treatment Outcome; Young Adult
• ISSN: 1090-820X; 1527-330X
• DOI: 10.1093/asj/sjy008

Abstract Background ATX-101 (deoxycholic acid injection) is the only injectable drug approved for submental fat (SMF) reduction. In the phase 3 REFINE trials, adults with moderate or severe SMF who were dissatisfied with the appearance of their face/chin were eligible to receive up to 6 treatment sessions with ATX-101 (2 mg/cm2) or placebo. Primary and secondary endpoints, evaluated at 12 weeks after last treatment, significantly favored ATX-101 supporting its efficacy for reducing SMF and the psychological impact of SMF, and increasing satisfaction with the appearance of the face/chin. Objectives To evaluate the efficacy and safety of ATX-101 by treatment session. Methods This post hoc analysis used pooled data from the REFINE trials to evaluate efficacy endpoints and adverse events following each treatment session to further characterize the ATX-101 treatment response and safety profile. Results In both treatment groups, mean injection volume declined over subsequent treatment sessions, though more markedly in the ATX-101 group. The majority of ATX-101-treated patients achieved a ≥1-grade improvement in SMF within 2 to 4 treatment sessions based on either clinician or patient assessment. Furthermore, 19.1% of ATX-101-treated patients (vs 3.9% of placebo-treated patients) received fewer than 6 treatment sessions owing to patient satisfaction with treatment or lack of sufficient SMF for further treatment. In both treatment groups, the incidence/severity of common injection-site adverse events declined over subsequent treatment sessions. Conclusions Although up to 6 treatment sessions were permitted in the REFINE trials, most ATX-101-treated patients achieved an improvement in SMF within 2 to 4 treatment sessions. Level of Evidence: 3