Improvement in patient- and physician-reported outcomes with apremilast treatment in patients with mild to moderate plaque psoriasis in the phase 3 ADVANCE trial: Analyses by baseline BSA and PASI
Recommended Citation
Stein Gold LF, Papp K, Pariser D, Green L, Bhatia N, Sofen H, Albrecht L, Gooderham M. Improvement in patient- and physician-reported outcomes with apremilast treatment in patients with mild to moderate plaque psoriasis in the phase 3 ADVANCE trial: Analyses by baseline BSA and PASI. Australas J Dermatol 2022; 63(SUPPL 1):84-85.
Document Type
Conference Proceeding
Publication Date
6-8-2022
Publication Title
Australas J Dermatol
Abstract
Aim: Subgroup analysis of ADVANCE trial apremilast-treated patients stratified by baseline BSA and PASI score. Method: ADVANCE randomised adults with mild to moderate plaque psoriasis 1:1 to apremilast 30 mg BID or placebo for 16 weeks. Achievement of response was assessed from baseline through sPGA response (primary endpoint), BSA reduction ≥75% (BSA-75), BSA≤3%, WBI-NRS response and ScPGA response. Changes from baseline in BSA, PASI, and DLQI scores were also analysed. All endpoints were assessed at Week 16, and results were stratified by baseline BSA and PASI. Results: In the overall ADVANCE population (N = 595), at baseline 47.7% had BSA≤5% (apremilast:143; placebo:141) and 52.3% had BSA >5% (apremliast:154; placebo:157), 63.2% had PASI≤7 (apremilast:191; placebo:185) and 36.8% had PASI>7 (apremilast:106; placebo:113).See Table for mean baseline BSA, PASI, and DLQI scores for apremilast-treated patients. Baseline values within subgroups were similar between the apremilast and placebo groups. A significantly greater proportion of patients achieved sPGA response, BSA-75, BSA≤3%, and ScPGA response at Week 16 with apremilast versus placebo in both BSA≤5% and BSA >5% as well as PASI≤7 and PASI>7 subgroups (Fig.1 and 2). Accordingly, greater change from baseline in BSA, PASI, and DLQI scores were consistently observed in patients treated with apremilast versus placebo regardless of baseline BSA or PASI. Similar results were observed for patient-reported outcomes; significant improvements were observed in WBI-NRS and DLQI at Week 16 with apremilast versus placebo for all subgroups (Fig.3 and 4). Safety was consistent with the known profile of apremilast, including for those with limited skin involvement.Conclusions: Apremilast demonstrated consistent efficacy in patients with BSA≤5% and BSA >5% at baseline, as well as PASI≤7 and PASI>7 subgroups, with no new safety signals. Findings suggest apremilast is an effective treatment for patients with psoriasis regardless of baseline severity of symptoms or involved skin area.
Volume
63
Issue
SUPPL 1
First Page
84
Last Page
85
