Apremilast improves QoL in adults with scalp psoriasis

Treatment with apremilast led to significantly improved patient-reported quality of life (QoL) outcomes in patients with moderate-to-severe plaque psoriasis of the scalp, according to the STYLE* study presented at EADV 2020.

This phase III, multicentre, double-blind, placebo-controlled trial evaluated 303 patients with moderate-to-severe scalp psoriasis** and plaque psoriasis***. Patients were randomly assigned in a 2:1 ratio to receive either apremilast 30 mg twice daily (n=201; mean age 47.0 years) or placebo (n=102; mean age 46.7 years) for 16 weeks. Dermatology Life Quality Index (DLQI) scores were used to assess health-related QoL at 16 weeks. [EADV 2020, abstract P1345-1445]

At week 16, patients who received apremilast had a significantly greater improvement in DLQI total score, indicating a better QoL, compared with placebo (mean change from baseline, -6.7 vs -3.9; p<0.0001).

Significantly more patients in the apremilast group also achieved a ≥4 point reduction in DLQI MCID⁺ from baseline to week 16 (76.1 percent vs 47.9 percent; p<0.0001) than those in the placebo group.

Although not significant, apremilast recipients also achieved a numerically higher DLQI subscale scores for symptoms and feelings (-2.0 vs -0.9), daily activities (-1.6 vs -0.7), leisure (-1.1 vs -0.9), work and school (-1.0 vs -0.7), and overall treatment (-0.4 vs -0.3) compared with placebo recipients.

In a post hoc analysis, a higher percentage of apremilast-treated patients achieved a DLQI score of 0 or 1 for DLQI total score (23.2 percent vs 6.0 percent) and several individual DLQI item scores, such as Q1⁺⁺ (62.0 percent vs 41.0 percent), Q2⁺⁺ (64.2 percent vs 40.6 percent), and Q3^# (67.7 percent vs 50.0 percent), compared with placebo-treated patients.

“[The] achievement of DLQI score of 0 or 1 … with apremilast … increased overtime and was concordant with [Scalp Physician’s Global Assessment] (ScPGA) score of 0 or 1,” said study co-investigator Dr Linda Stein Gold from Henry Ford Health System in West Bloomfield, Michigan, US.

“In STYLE, patients with moderate-to-severe psoriasis of the scalp experienced improvements in QoL outcomes, including many DLQI subscales and individual items assessing the impact of psoriasis on patients’ lives,” Gold concluded.

“Significant and clinically meaningful improvement in DLQI total score was observed in apremilast vs placebo at week 16,” she highlighted.

*STYLE: A Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Moderate to Severe Plaque Psoriasis of the Scalp

**Scalp Physician’s Global Assessment (ScPGA) score of ≥3 (defined as moderate or greater); psoriasis-involved scalp surface area of ≥20 percent

***Psoriasis Area and Severity Index of ≥12; psoriasis-involved body surface area of ≥10 percent; static PGA of ≥3 (defined as moderate or greater)

⁺MCID: Minimal clinically important difference

⁺⁺Q1: Itchy, sore, painful, stinging skin

⁺⁺Q2: Embarrassed, self-conscious

^#Q3: Interfered with shopping, home, yard