Original article
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)

Presented at the 72nd Annual Meeting of the American Academy of Dermatology in Denver, Colorado, on March 21-25, 2014 (oral presentation), and at the 71st Annual Meeting of the American Academy of Dermatology in Miami Beach, Florida, on March 1-5, 2013 (poster).
https://doi.org/10.1016/j.jaad.2015.03.049Get rights and content
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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 χ2 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.

Key words

apremilast
clinical trial
ESTEEM
phosphodiesterase 4 inhibitor
psoriasis
treatment

Abbreviations used

AE
adverse event
ESTEEM
Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis
FDA
Food and Drug Administration
IL
interleukin
PASI
Psoriasis Area and Severity Index
PASI-75
75% or greater reduction from baseline Psoriasis Area and Severity Index score
PDE4
phosphodiesterase 4
SAE
serious adverse event
sPGA
static Physician Global Assessment
Th
T helper

Cited by (0)

This study was sponsored by Celgene Corporation.

Author disclosures are available at the end of the article.

Reprints not available from the authors.