Improvement in psoriasis symptoms and involvement in special areas: 32-week results from advance

Document Type

Conference Proceeding

Publication Date

6-8-2022

Publication Title

Australas J Dermatol

Abstract

Aim: Report Week 32 apremilast safety and efficacy results from ADVANCE. Method: ADVANCE randomised adults with mild to moderate psoriasis 1:1 to apremilast 30 mg BID or placebo for 16 weeks, followed by a 16-week apremilast extension phase. Efficacy was assessed from baseline at Weeks 16 and 32 by sPGA response (primary endpoint) and in special areas by ScPGA response and NAPSI score. General assessments including WBI-NRS response from baseline and a post hoc analysis of achievement of DLQI≥5-point improvement or DLQI score of 0 or 1 at Week 32 were also performed. Results: 595 patients were randomised (apremilast:297; placebo:298); 503 patients entered the extension phase. Mean age was 49 years, 54.6% of patients were men. At baseline, 69.1% of all patients had ScPGA scores ≥2, slightly more apremilast-treated patients had ScPGA scores of 3 or 4 than placebo. 29.4% of patients had NAPSI scores ≥1, baseline NAPSI scores were similar between groups (table). At Week 16, statistically significant and clinically meaningful improvements were observed in sPGA, itch, and QOL, as well as in special areas with apremilast versus placebo (all P < 0.05). At Week 32, efficacy was maintained in patients who continued apremilast (fig. 1&2): sPGA response (24.9%). ScPGA response (41.1%). NAPSI-0 (38.2%). WBI-NRS response (43.4%). DLQI ≥5-point improvement (62.0%). DLQI 0 or 1(27.6%). NAPSI scores decreased with apremilast treatment at Week 16 and were maintained through Week 32(-1.6; fig.3). Similar improvements were observed in these efficacy endpoints at Week 32 in patients on placebo for 16 weeks then apremilast for the extension phase (fig. 1-3). Adverse events were consistent with the known safety profile of apremilast.Conclusion: Apremilast treatment resulted in statistically significant and clinically meaningful improvement in psoriasis in special areas, as well as general symptoms itching and overall QOL. These improvements were sustained through Week 32.

Volume

63

Issue

SUPPL 1

First Page

82

Last Page

84

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