Original article
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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Background

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.

Key words

apremilast
nail psoriasis
phosphodiesterase 4 inhibitor
psoriasis
scalp psoriasis
systemic therapy

Abbreviations used

BID
twice daily
ESTEEM
Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis
NAPSI
Nail Psoriasis Severity Index
NAPSI-50
50% reduction from baseline in target nail Psoriasis Severity Index score
PASI
Psoriasis Area and Severity Index
ScPGA
Scalp Physician Global Assessment
sPGA
static Physician Global Assessment

Cited by (0)

These studies were sponsored by Celgene Corporation.

Disclosures: Dr Bachelez received honoraria/research funding as an advisory board member and/or consultant for AbbVie, Amgen, Boehringer Ingelheim, Celgene Corporation, Eli Lilly and Company, Janssen Pharmaceuticals, LEO Pharma, Novartis, Pfizer, Merck Sharp & Dohme, and Pierre Fabre. Dr Crowley received honoraria/research funding as a consultant for AbbVie, Amgen, Celgene Corporation, and Eli Lilly and Company; was an investigator for AbbVie, Amgen, Celgene Corporation, Eli Lilly and Company, Janssen Pharmaceuticals, Merck, and Pfizer; and was a speaker for AbbVie, Amgen, and Celgene Corporation. Drs Goncalves, Day, and Chen are employees of Celgene Corporation. Dr Gooderham received honoraria/research funding as a consultant for Janssen Pharmaceuticals; was a data safety monitoring board member for Kyowa Hakko Kirin Pharma; was an investigator for AbbVie, Amgen, Celgene Corporation, Dermira, Dr Reddy, Eli Lilly and Company, Forward Pharma, Galderma Laboratories, Kyowa Hakko Kirin Pharma, Kythera, LEO Pharma, MedImmune, Merck & Co Inc, Novartis, Pfizer, Regeneron, Roche Laboratories, and Takeda Pharmaceuticals USA Inc; and was a speaker for AbbVie, Actelion, Amgen, Astellas Pharma US Inc, Celgene Corporation, Eli Lilly and Company, Galderma Laboratories, LEO Pharma, and Novartis. Dr Rich received honoraria/research funding as an advisory board member for Eli Lilly and Company and Sandoz; was a consultant for Polichem; and was an investigator for AbbVie, Amgen, Celgene Corporation, Eli Lilly and Company, Janssen, Merck & Co Inc, Novartis, and Pfizer.

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