Real-World Experience With 100 Consecutive Patients Undergoing Neck Contouring With ATX-101 (Deoxycholic Acid): An Updated Report With A 2-Year Analysis

Abstract

BACKGROUNDDeoxycholic acid (DCA; ATX-101) injection was approved for the treatment of mild-to-moderate convexity associated with submental fat in 2015.OBJECTIVETo evaluate the experience with DCA injections in a clinical practice setting.MATERIALS AND METHODSThis ongoing, prospective, single-center, single-arm, observational study evaluated 100 consecutive patients treated with subcutaneous DCA (2 mg/cm2) injections (maximum 6 sessions at ≥1-month intervals). Treatment response was assessed using the clinician-reported submental fat rating scale (CR-SMFRS) and confirmed by independent physician review of photographs at 1 and 5 to 7 weeks after treatment.RESULTSSince the previous published report, 17 patients have undergone additional treatment sessions, with a total of 100 patients having undergone 195 treatment sessions: 41, 36, 14, 6, 2, and 1 patient underwent 1, 2, 3, 4, 5, and 6 sessions, respectively. Overall, 91.7% of patients in the single treatment session group and 100% in the multiple treatment session group had an improvement of ≥1 point on the CR-SMFRS. The mean (SD) duration of local edema, numbness, and tenderness after treatment was 7.1 (5.1), 27.9 (11.3), and 3.5 (3.5) days, respectively.CONCLUSIONDeoxycholic acid injections were generally well tolerated, and ≥2 treatment sessions were required to achieve the desired aesthetic goal in a private practice setting.

Uncommon Adverse Effects of Deoxycholic Acid Injection for Submental Fullness: Beyond the Clinical Trials

“…Three separate large case series reporting real-world AEs were identified and reviewed. [8][9][10][11] One case series published an update resulting in 2 publications on the same cohort. 8,9 Nine additional case report publications of uncommon AEs were reviewed, with a focus on the timing of the AEs, number of subjects, treatment, and additional notes concerning recovery.…”

“…The 3 large case series of real-world experience in the literature are summarized in Table 2. [8][9][10][11] A total of 392 patients were reported, including 100 patients (aged 18-80 years) in the study reported by Shridharani, 8,9 202 patients The information in this table represents the different adverse reactions experienced by patients who received the Belkyra deoxycholic acid injection and those who received a placebo injection. This information is reported from the Belkyra product monograph published by Kythera Biopharmaceuticals, Inc. 7…”

“…(5.7:1 female:male ratio) in the retrospective study by Humphrey et al, 10 and 90 patients in the study by Zarbafian et al 11 Shridharani presented early treatment experience in a clinical practice setting with deoxycholic acid injection using a single-center, prospective, single-arm, observational study 8 with a follow-up, 2-year assessment recently published. 9 All 100 patients received injections into the submental area for a maximum of 6 sessions at more than 1-month intervals and a total of 195 treatment sessions. Typical symptoms, including numbness, tenderness, and local edema, were reported; 2 patients experienced marginal mandibular nerve paresis.…”

Best Clinical Practices with ATX-101 for Submental Fat Reduction: Patient-related Factors and Physician Considerations

“…Male patients seek out ATX-101 treatment less often than females, but once they did, treatment-naive men returned for additional treatments at higher rates than women (19%–27% versus 12.9%–16.1%, respectively). 20 , 21 …”

“…7 In our experience, temporary MMN injury occurs at a much lower rate in clinical practice than in the REFINE trials, with an incidence of 0.2% among ATX-101–treated patients in the CONTOUR trial. 16 Patient and physician concern about MMN injury may unnecessarily limit the treatment area [which is from the anterior border of the sternocleidomastoid muscle (SCM) to the anterior border of the contralateral SCM 21 ] and result in poor outcomes. Several cases attributed to MMN were likely pseudo-MMN, as has been described and proposed as direct injury or inflammation of the platysma, which could cause injury and dysfunction to the muscle.…”