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, neces-sitating 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 com-pleted 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 improve-ment in affected body surface area (BSA) and PASI was observed with apremilast versus placebo at Week 16. There were also significantly greater improvements with apremi-last 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 achieve-ment 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.

Low incidence rate of respiratory and viral infections over 5 years of treatment with tildrakizumab in patients with moderate‐to‐severe psoriasis: pooled analysis from reSURFACE 1 and reSURFACE 2 phase 3 trials

P. Gisondi
2021-01-01

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, neces-sitating 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 com-pleted 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 improve-ment in affected body surface area (BSA) and PASI was observed with apremilast versus placebo at Week 16. There were also significantly greater improvements with apremi-last 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 achieve-ment 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.
2021
psoriasis; tildrakizumab; safety
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11562/1091090
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