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 IIbrandomized, 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 improvementsfrom
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). Greaterimprovements 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 withmoderate to severe psoriasis.