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.