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J Am Acad Dermatol. 2015 Jul;73(1):37-49. doi: 10.1016/j.jaad.2015.03.049.

Apremilast, an oral phosphodiesterase 4 (PDE4) inhibitor, in patients with moderate to severe plaque psoriasis: Results of a phase III, randomized, controlled trial (Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis [ESTEEM] 1).

Author information

1
Probity Medical Research, Waterloo, Ontario, Canada. Electronic address: kapapp@probitymedical.com.
2
Dermatologikum Hamburg, Hamburg, Germany.
3
Department of Dermatology, Saint Louis University School of Medicine, Saint Louis, Missouri.
4
Physicians Skin Care, PLLC, Louisville, Kentucky; Mount Sinai Medical Center, New York, New York.
5
University of Rome Tor Vergata, Rome, Italy.
6
Dalhousie University, Halifax, Nova Scotia, Canada.
7
Celgene Corporation, Summit, New Jersey.
8
Northwestern University, Chicago, Illinois.
9
University Hospitals Case Medical Center, Cleveland, Ohio.
10
Dermatology Center, Salford Royal Hospital, University of Manchester, Manchester, United Kingdom.

Abstract

BACKGROUND:

Apremilast works intracellularly to regulate inflammatory mediators.

OBJECTIVE:

ESTEEM 1 evaluated efficacy/safety of apremilast at 30 mg twice a day for moderate to severe plaque psoriasis.

METHODS:

This phase III, multicenter, double-blind, placebo-controlled study randomized adults (2:1) to apremilast or placebo. At week 16, the placebo group switched to apremilast through week 32, followed by a randomized treatment withdrawal phase to week 52. Binary end points were analyzed using χ(2) test; continuous end points used analysis of covariance.

RESULTS:

In all, 844 patients were randomized (n = 282, placebo; n = 562, apremilast). At week 16, significantly more patients taking apremilast achieved 75% or greater reduction from baseline Psoriasis Area and Severity Index score (PASI-75) (33.1%) versus placebo (5.3%, P < .0001; primary end point). Most (61.0%) patients rerandomized to apremilast at week 32 achieved PASI-75 at week 52 versus 11.7% rerandomized to placebo. Of patients rerandomized to apremilast at week 32, mean percentage change from baseline PASI score was -88% to -81% (weeks 32-52). During the placebo-controlled period, 55.7% and 69.3% of patients randomized to placebo and apremilast, respectively, had 1 or more adverse events. Most adverse events were mild/moderate in severity. No new significant adverse events emerged with continued apremilast exposure versus the placebo-controlled period.

LIMITATIONS:

Data were limited to 52 weeks and may not generalize to nonplaque psoriasis.

CONCLUSIONS:

Apremilast was effective in moderate to severe plaque psoriasis.

KEYWORDS:

ESTEEM; apremilast; clinical trial; phosphodiesterase 4 inhibitor; psoriasis; treatment

PMID:
26089047
DOI:
10.1016/j.jaad.2015.03.049
[Indexed for MEDLINE]
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