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Kybella found to be safe, efficacious as submental fat treatment
Kybella treatment for submental fat reduction was safe and efficacious in clinician- and patient-assessed measures, according to recently published results from the REFINE-1 phase 3 trial.
Derek H. Jones, MD, and colleagues studied 506 patients (83.2% women) at 35 centers throughout the United States and Canada between February 2012 and August 2013. Patients were dissatisfied with moderate or severe submental fat.
Derek H. Jones
Two hundred fifty-six patients (mean age, 49.5 years.) received Kybella (deoxycholic acid injection, Allergan), otherwise known as ATX-101 at 2 mg/cm2 and 250 patients (mean age, 49.4 years) received placebo. Validated scales were used to measure composite ≥ 1-grade and ≥ 2- grade improvements in clinician-assessed or patient-assessed submental fat severity 12 weeks after the final treatment.
Seventy percent of the patients treated with ATX-101 achieved a ≥ 1-grade composite response and 13.4% achieved a ≥ 2-grade composite response, compared with 18.6% and 0% of the placebo-treated patients, respectively.
“The proportion of MRI responders was more than eight times higher with ATX-101 than placebo (46.3% vs. 5.3%; P < .001),” the researchers wrote.
Improvement in psychological impact of submental fat and satisfaction with treatment were reported by patients treated with ATX-101 (P < .001 for all assessments vs. placebo). A 1-grade improvement in clinician in physician-assessed submental fat was reported in 55% of patients treated with ATX-101 after two treatments and 75% after four treatments.
Adverse events were mild or moderate and occurred primarily at the injection site (primary local reactions, 84.3% in ATX-101-treated cohort vs. 69% in the placebo-treated cohort).
“Marginal mandibular nerve paresis, an [adverse event] of special interest that typically presented as an asymmetric smile, was reported in 11 ATS-101–treated subjects (4.3%; 1.0% of all ATX-101 treatments sessions); no instances were reported with placebo,” the researchers wrote. “All events were temporary and resolved without sequelae.”
“ATX-101 was consistently assessed to be efficacious by clinician-evaluated, patient-reported, and objective measures,” the researchers concluded. “ATX-101 treatment resulted in high levels of subject satisfaction as was well tolerated. Results … support the utility of ATX-101 as an effective and minimally invasive treatment option for [submental fat] reduction.” – by Bruce Thiel
Disclosure: Jones reports receiving honoraria, payment or other compensation for work on the trial. Please see the full study for a list of other researchers’ other relevant financial disclosures.