Apremilast, an oral phosphodiesterase 4 inhibitor, in patients with difficult-to-treat nail and scalp psoriasis: Results of 2 phase III randomized, controlled trials (ESTEEM 1 and ESTEEM 2)

Abstract

In the phase III double-blind Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis (ESTEEM) 1 and 2, apremilast, an oral phosphodiesterase 4 inhibitor, demonstrated efficacy in moderate to severe psoriasis. We sought to evaluate efficacy of apremilast in nail/scalp psoriasis in ESTEEM 1 and 2. A total of 1255 patients were randomized (2:1) to apremilast 30mg twice daily or placebo. At week 16, placebo patients switched to apremilast through week 32, followed by a randomized withdrawal phase to week 52. A priori efficacy analyses included patients with nail (target nail Nail Psoriasis Severity Index score ≥1) and moderate to very severe scalp (Scalp Physician Global Assessment score ≥3) psoriasis at baseline. At baseline, 66.1% and 64.7% of patients had nail psoriasis; 66.7% and 65.5% had moderate to very severe scalp psoriasis in ESTEEM 1 and 2. At week 16, apremilast produced greater improvements in Nail Psoriasis Severity Index score versus placebo; mean percent change: -22.5% versus +6.5% (ESTEEM 1; P<.0001) and -29.0% versus -7.1% (ESTEEM 2; P=.0052). At week 16, apremilast produced greater NAPSI-50 response (50% reduction from baseline in target nail Nail Psoriasis Severity Index score) versus placebo (both studies P<.0001) and ScPGA response (Scalp Physician Global Assessment score 0 or 1) versus placebo (both studies P<.0001). Improvements were generally maintained over 52weeks in patients with Psoriasis Area and Severity Index response at week 32. Baseline randomization was not stratified for nail/scalp psoriasis. Apremilast reduces the severity of nail/scalp psoriasis.