Article Dans Une Revue Journal of the European Academy of Dermatology and Venereology Année : 2022

Efficacy and safety of apremilast in patients with limited skin involvement, plaque psoriasis in special areas and impaired quality of life: Results from the EMBRACE randomized trial

Ulrich Mrowietz
Jonathan Barker
  • Fonction : Auteur
Curdin Conrad
Paolo Gisondi
Andrea Flower
  • Fonction : Auteur
Jyotsna Reddy
  • Fonction : Auteur
Maria Paris
  • Fonction : Auteur
Hernan Picard
  • Fonction : Auteur
Shauna Jardon
  • Fonction : Auteur
Matthias Augustin

Résumé

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, placebocontrolled, 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 (≥4point 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.

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hal-04953295 , version 1 (18-02-2025)

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Ulrich Mrowietz, Jonathan Barker, Curdin Conrad, Denis Jullien, Paolo Gisondi, et al.. Efficacy and safety of apremilast in patients with limited skin involvement, plaque psoriasis in special areas and impaired quality of life: Results from the EMBRACE randomized trial. Journal of the European Academy of Dermatology and Venereology, 2022, 37, pp.348 - 355. ⟨10.1111/jdv.18689⟩. ⟨hal-04953295⟩
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