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)

Phoebe Rich, Melinda Gooderham, Hervé Bachelez, Joana Goncalves, Robert M. Day, Rongdean Chen, Jeffrey Crowley

Research output: Contribution to journalArticle

49 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)134-142
Number of pages9
JournalJournal of the American Academy of Dermatology
Volume74
Issue number1
DOIs
StatePublished - Jan 1 2016

Fingerprint

Phosphodiesterase 4 Inhibitors
Nails
Scalp
Psoriasis
Randomized Controlled Trials
Placebos
apremilast
Physicians
Random Allocation

Keywords

  • apremilast
  • nail psoriasis
  • phosphodiesterase 4 inhibitor
  • psoriasis
  • scalp psoriasis
  • systemic therapy

ASJC Scopus subject areas

  • Dermatology

Cite this

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). / Rich, Phoebe; Gooderham, Melinda; Bachelez, Hervé; Goncalves, Joana; Day, Robert M.; Chen, Rongdean; Crowley, Jeffrey.

In: Journal of the American Academy of Dermatology, Vol. 74, No. 1, 01.01.2016, p. 134-142.

Research output: Contribution to journalArticle

@article{71957a3b51be4a6b85ee5a96a17b2879,
title = "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 = "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.",
keywords = "apremilast, nail psoriasis, phosphodiesterase 4 inhibitor, psoriasis, scalp psoriasis, systemic therapy",
author = "Phoebe Rich and Melinda Gooderham and Herv{\'e} Bachelez and Joana Goncalves and Day, {Robert M.} and Rongdean Chen and Jeffrey Crowley",
year = "2016",
month = "1",
day = "1",
doi = "10.1016/j.jaad.2015.09.001",
language = "English (US)",
volume = "74",
pages = "134--142",
journal = "Journal of the American Academy of Dermatology",
issn = "0190-9622",
publisher = "Mosby Inc.",
number = "1",

}

TY - JOUR

T1 - Apremilast, an oral phosphodiesterase 4 inhibitor, in patients with difficult-to-treat nail and scalp psoriasis

T2 - Results of 2 phase III randomized, controlled trials (ESTEEM 1 and ESTEEM 2)

AU - Rich, Phoebe

AU - Gooderham, Melinda

AU - Bachelez, Hervé

AU - Goncalves, Joana

AU - Day, Robert M.

AU - Chen, Rongdean

AU - Crowley, Jeffrey

PY - 2016/1/1

Y1 - 2016/1/1

N2 - 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.

AB - 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.

KW - apremilast

KW - nail psoriasis

KW - phosphodiesterase 4 inhibitor

KW - psoriasis

KW - scalp psoriasis

KW - systemic therapy

UR - http://www.scopus.com/inward/record.url?scp=84953638606&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84953638606&partnerID=8YFLogxK

U2 - 10.1016/j.jaad.2015.09.001

DO - 10.1016/j.jaad.2015.09.001

M3 - Article

VL - 74

SP - 134

EP - 142

JO - Journal of the American Academy of Dermatology

JF - Journal of the American Academy of Dermatology

SN - 0190-9622

IS - 1

ER -