- L’obiettivo dell’EMBRACE, trial internazionale di fase 4, randomizzato, controllato con il placebo, è stato quello di valutare l’impatto sulla qualità di vita, l’efficacia e la sicurezza di apremilast 30 mg 2 volte die nei pazienti con psoriasi con coinvolgimento cutaneo limitato in aree speciali e compromissione della qualità di vita.
- Apremilast ha migliorato significativamente la qualità di vita dei pazienti e il profilo di sicurezza è risultato in linea con gli studi precedenti.
Abstract
Introduction/background
Manifestations of psoriasis in special areas are difficult to treat and are associated with a high disease burden and significant quality of life (QoL) impairment. Topical therapies may be inadequate for these patients, necessitating systemic treatment.
Objective
The objective of EMBRACE was to evaluate the impact on QoL, efficacy, and safety of apremilast 30 mg BID in patients with limited skin involvement with plaque psoriasis manifestations in special areas and impaired QoL.
Methods
EMBRACE (NCT03774875) was a phase 4, randomized, placebo-controlled, multinational study. Patients had plaque psoriasis not controlled by topical therapy; lack of response, contraindication, or intolerance to conventional first-line systemic therapy; psoriasis in ≥1 special area (including visible locations, scalp, nails, genital areas, or palmoplantar areas); Psoriasis Area and Severity Index (PASI) ≥3 to ≤10; and Dermatology Life Quality Index (DLQI) >10. The primary endpoint was DLQI response (≥4-point reduction) at Week 16.
Results
Of 277 randomized patients (apremilast: n = 185; placebo: n = 92), 221 completed Week 16 (apremilast: n = 152; placebo: n = 69). The primary endpoint (≥4-point reduction in DLQI at Week 16) was met by significantly more patients receiving apremilast (73.3%) versus placebo (41.3%; p <0.0001). Significantly greater improvement in affected body surface area (BSA) and PASI was observed with apremilast versus placebo at Week 16. There were also significantly greater improvements with apremilast versus placebo in itch numeric rating scale (-2.5 vs -0.9, p <0.0001) and skin discomfort/pain visual analog scale (-21.5 vs -5.4, p = 0.0003) and greater achievement of Patient Benefit Index ≥1 (77 vs 40%, p <0.0001) at Week 16. No new safety signals were observed.
Conclusions
Apremilast significantly improved skin-related QoL in patients with limited skin involvement with plaque psoriasis in special areas and highly impaired QoL. The safety profile was consistent with prior apremilast studies.