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:
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Authors | Kim Papp, Kristian Reich, Craig L Leonardi, Leon Kircik, Sergio Chimenti, Richard G B Langley, ChiaChi Hu, Randall M Stevens, Robert M Day, Kenneth B Gordon, Neil J Korman, Christopher E M Griffiths |
Journal | Journal of the American Academy of Dermatology
(J Am Acad Dermatol)
Vol. 73
Issue 1
Pg. 37-49
(Jul 2015)
ISSN: 1097-6787 [Electronic] United States |
PMID | 26089047
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2015 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved. |
Chemical References |
- Phosphodiesterase 4 Inhibitors
- Thalidomide
- apremilast
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Topics |
- Administration, Oral
- Double-Blind Method
- Female
- Humans
- Male
- Middle Aged
- Phosphodiesterase 4 Inhibitors
(administration & dosage)
- Psoriasis
(drug therapy)
- Severity of Illness Index
- Thalidomide
(administration & dosage, analogs & derivatives)
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