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) - 17/06/15
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 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.
Le texte complet de cet article est disponible en PDF.Key words : apremilast, clinical trial, ESTEEM, phosphodiesterase 4 inhibitor, psoriasis, treatment
Abbreviations used : AE, ESTEEM, FDA, IL, PASI, PASI-75, PDE4, SAE, sPGA, Th
Plan
This study was sponsored by Celgene Corporation. |
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Author disclosures are available at the end of the article. |
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Reprints not available from the authors. |
Vol 73 - N° 1
P. 37-49 - juillet 2015 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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