Kybella effective in patients with mild, extreme submental fullness
CHICAGO — Kybella reduced submental fat in patients with mild or extreme submental fullness, according to study results presented in an oral abstract session at the American Society for Dermatologic Surgery annual meeting.
“We were we were able to show that Kybella can be used to treat submental fullness in an expanded range of patients,” researcher Richard G. Glogau, MD, of the University of California, San Francisco, told Healio.com/Dermatology. “The material can be dosed to treat patients on the mild end of the spectrum, while still being robust enough to handle even the extreme cases, all with the same safety profile seen in patients in the moderate to severe range.”
Richard G. Glogau
The FDA approved Kybella (deoxycholic acid, Allergan), also known as ATX-101, earlier this year for treating moderate to severe fullness associated with submental fat (SMF) in adults. Patients with mild or extreme SMF also may be dissatisfied with their appearance and seek intervention from a physician, Glogau reported in his presentation.
Glogau and colleagues studied 93 patients in a double blind phase 3b trial including 47 patients with mild SMF (grade 1) and 46 patients with extreme SMF (grade 4). The patients were randomly assigned deoxycholic acid 2 mg/cm2 or placebo in a 2:1 ratio, with treatments given every 28 ± 5 days for up to six sessions. Administration was 0.2 mL subcutaneous injections, spaced 1 cm apart.
The mean number of treatments included 4.9 for placebo and 4.2 for deoxycholic acid in the mild SMF cohort and 5.6 treatments of placebo and 4.9 treatments of deoxycholic acid in the extreme SMF cohort. Mean total injection volume ranged from 13.9 mL for deoxycholic acid in the mild SMF cohort to 38.4 for placebo in the extreme SMF cohort.
The responder rate of patients with mild SMF achieving a 1-grade improvement — measured by a composite clinician-rated and patient-rated submental fat rating scale — was 61.3% for patients treated with deoxycholic acid and 6.7% for placebo. In the extreme SMF cohort, the responder rate was 89.3% in the deoxycholic acid-treated patients and 13.3% in the placebo-treated patients.
No serious drug-related adverse events (AEs) were reported. The AEs were mild to moderate, with pain and hematoma reported most commonly, the researchers reported.
Skin laxity remained unchanged or improved from baseline in 100% of the patients treated with deoxycholic acid.
“Results in subjects with mild or extreme SMF are consistent with results in the labeled population of subjects with moderate to severe SMF,” the researchers concluded. “As ATX-101 treatment can be tailored to the amount and thickness of SMF for each individual, it may be appropriate for use in subjects with mild or extreme SMF.” – by Bruce Thiel
Glogau R. OA306. A Double-blind, Placebo-controlled, Phase 3b Safety Study of Deoxycholic Acid Injection for Reduction of Submental Fat in Subjects with Mild or Extreme Submental Fullness. Presented at: ASDS Annual Meeting; Oct. 15-18, 2015; Chicago.
Disclosure: Glogau reports serving as an investigator for Kythera Biopharmaceuticals.