BACKGROUND: Apremilast, a specific inhibitor of phosphodiesterase 4, modulates 
pro-inflammatory and anti-inflammatory cytokine production.
OBJECTIVES: Apremilast's effect on patient-reported outcomes (PROs) in patients 
with moderate to severe psoriasis was evaluated in a phase IIb randomized, 
controlled trial (NCT00773734).
METHODS: In this 16-week, placebo-controlled study, 352 patients with moderate 
to severe plaque psoriasis received placebo or apremilast (10, 20, or 30 mg 
BID). PROs included Dermatology Life Quality Index (DLQI), pruritus visual 
analog scale (VAS), and Short-Form Health Survey (SF-36) to assess 
health-related quality of life (HRQOL). Changes from baseline and patients 
reporting improvements ≥minimum clinically important differences (MCID) were 
analyzed. Correlations between changes across various PRO instruments were 
explored.
RESULTS: Baseline DLQI (>10 points) and SF-36 MCS and domain scores indicated 
impairments in HRQOL. At 16 weeks, greater improvements from baseline in DLQI 
scores were reported with apremilast 20 (-5.9) and 30 mg BID (-4.4) compared 
with placebo (1.9; P≤0.005 for both), and a greater proportion of patients 
reported improvements ≥MCID (20 mg BID, 49.4%, 30 mg BID, 44.3%) versus placebo 
(25.0%; P<0.04). Greater improvements from baseline in pruritus VAS scores were 
reported with apremilast 20 (-35.5%) and 30 mg BID (-43.7%) versus placebo 
(-6.1%; P≤0.005). Significant and clinically meaningful improvements in SF-36 
mental component summary scores (P≤0.008) and Bodily Pain, Mental Health, and 
Role-Emotional domains were reported with all apremilast doses (P<0.05), and 
Social Functioning with 20 and 30 mg BID (P<0.05) and Physical Functioning with 
20 mg BID (P<0.03). Correlations between SF-36 scores and DLQI were moderate 
(r>0.30 and ≤0.60) and low between SF-36 and pruritus VAS (r≤0.30), indicating 
they measure different aspects of the disease.
CONCLUSIONS: Apremilast treatment resulted in improved HRQOL, including DLQI and 
pruritus VAS over 16 weeks of treatment, in patients with moderate to severe 
psoriasis.