Sarecycline effective for acne vulgaris in patients with skin of colour

Sarecycline demonstrated efficacy for the treatment of moderate-to-severe facial acne vulgaris in patients with skin of colour, according to a post hoc analysis of two phase III trials presented at AAD 2023.

Sarecycline is a narrow-spectrum, tetracycline-derived, oral antibiotic that has been proven safe and effective in treating moderate-to-severe acne vulgaris in two pivotal phase III trials. [J Drugs Dermatol 2018;17:987-996]

The researchers analysed 887 patients aged 9–45 years with moderate-to-severe facial acne who identified themselves as Black/African American (n=146), Asian (n=155), and Hispanic/Latino (n=275). Participants were randomly assigned to receive either sarecycline 1.5 mg/kg once daily (n=445) or placebo (n=442) for 12 weeks. [AAD 2023, abstract 43102]

Reductions in lesion count

At week 12, significant reductions in inflammatory lesion count were observed among Asian patients treated with sarecycline compared with those treated with placebo (least squares [LS] mean change from baseline, -20.2 vs -9.3; p<0.01). Sarecycline also outdid placebo in the Hispanic/Latino subgroup (LS mean change from baseline, 16.4 percent vs -11.3; p<0.0001).

Among Black/African American patients, a numerically greater reduction in inflammatory lesion count from baseline to week 12 was observed with sarecycline vs placebo (LS mean change from baseline, -15.7 vs -13.1). However, the difference between groups was not statistically significant.

In the pooled analysis of all patients, those treated with sarecycline achieved significant improvement in lesion counts as opposed to those receiving placebo at week 3 (LS mean change from baseline, -27.3 vs -21.7; p<0.05). Sarecycline consistently trumped placebo during the other time points (LS mean change from baseline, -42.5 vs -31.2 [week 6], -49.5 vs -38.5 [week 9], and -54.6 vs -39.5 [week 12]; p<0.0001 for all).

IGA success

Significantly more Hispanic/Latino patients on sarecycline achieved an IGA* score of 0 or 1 (clear or almost clear status) with ≥2-point improvement from baseline to week 12 compared with those treated with placebo (24.5 percent vs 15.3 percent; p<0.01).

This trend was also seen in the Black/African American (23.2 percent vs 14.2 percent) and Asian subgroups (31.3 percent vs 15.5 percent), but the between-group comparisons did not achieve statistical significance.

Regardless of skin colour, significantly more sarecycline-treated patients had an IGA status of clear or almost clear compared with placebo-treated patients at week 12 (24.5 percent vs 14.7 percent; p<0.001).

“Overall, sarecycline is efficacious for the treatment of moderate-to-severe facial acne vulgaris, with significant improvements observed as early as week 3 and continued improvement through week 12, in patients with skin of colour,” the researchers concluded.

*IGA: Investigator's Global Assessment