EMBRACE: 52-week data for apremilast in patients with plaque psoriasis affecting high-impact areas

Psoriasis affecting high-impact or visible areas – such as the scalp, nails, genitals, or face – can significantly impair quality of life, even when overall skin involvement is limited. Despite this burden, many patients with moderate disease do not receive systemic therapy, and topical treatments often provide insufficient control.

The EMBRACE trial (NCT03774875) was a phase IV, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of apremilast in patients with chronic plaque psoriasis involving at least one high-impact area, limited skin involvement (Psoriasis Area and Severity Index score ³3 and ≤10), and impaired quality of life. We have previously published the 16-week outcomes. Augustin et al. recently reported the 52-week results in Dermatology and Therapy, presenting long-term data on clinical response and quality-of-life outcomes.¹

Key learnings

At Week 52, 64.5% (98/152) of patients receiving continuous apremilast and 69.6% (48/69) of patients receiving placebo/apremilast achieved a DLQI response (≥4-point improvement from baseline). Mean itch NRS scores improved, with a change from baseline of −3.3 and −3.9 in the continuous apremilast and placebo/apremilast groups, respectively.

At Week 52, PASI <3 was achieved in 37.5% (57/152) of patients receiving continuous apremilast and 50.7% (35/69) of patients receiving placebo/apremilast; mean BSA involvement was reduced from baseline by 32.0% and 49.9% in each treatment group, respectively.

During apremilast exposure (N = 254), 85.4% of patients reported ≥1 TEAE; the most common were diarrhea (30.3%), headache (20.5%), nausea (17.7%), and nasopharyngitis (15.4%). Rates of serious TEAEs (7.1%) and TEAEs leading to withdrawal (12.2%) were low. 

Benefits of apremilast across quality of life, itch, pain, and skin outcomes were sustained through 52 weeks, with no new safety signals observed. These findings support its use as a long-term systemic option for psoriasis in high-impact areas.