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)

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• 作者：Phoebe Rich ; MD^a ; ^{phoeberich@aol.com" class="auth_mail" title="E-mail the corresponding author} ; Melinda Gooderham ; MD^b ; Hervé ; Bachelez ; MD ; PhD^c ; Joana Goncalves ; MD^d ; Robert M. Day ; PhD^d ; Rongdean Chen ; PhD^d ; Jeffrey Crowley ; MD^e
• 关键词：apremilast ; nail psoriasis ; phosphodiesterase 4 inhibitor ; psoriasis ; scalp psoriasis ; systemic therapy
• 刊名：Journal of the American Academy of Dermatology
• 出版年：2016
• 出版时间：January 2016
• 年：2016
• 卷：74
• 期：1
• 页码：134-142
• 全文大小：660 K

文摘

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.

Objective

We sought to evaluate efficacy of apremilast in nail/scalp psoriasis in ESTEEM 1 and 2.

Methods

A total of 1255 patients were randomized (2:1) to apremilast 30 mg 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.

Results

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 52 weeks in patients with Psoriasis Area and Severity Index response at week 32.

Limitations

Baseline randomization was not stratified for nail/scalp psoriasis.

Conclusion

Apremilast reduces the severity of nail/scalp psoriasis.