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) - PubMed (original) (raw)
Clinical Trial
doi: 10.1016/j.jaad.2015.03.049.
Kristian Reich 2, Craig L Leonardi 3, Leon Kircik 4, Sergio Chimenti 5, Richard G B Langley 6, ChiaChi Hu 7, Randall M Stevens 7, Robert M Day 7, Kenneth B Gordon 8, Neil J Korman 9, Christopher E M Griffiths 10
Affiliations
- PMID: 26089047
- DOI: 10.1016/j.jaad.2015.03.049
Free article
Clinical Trial
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)
Kim Papp et al. J Am Acad Dermatol. 2015 Jul.
Free article
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.
Copyright © 2015 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.
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