Reasearch Awards nomination

Email updates

Keep up to date with the latest news and content from HQLO and BioMed Central.

Open Access Highly Accessed Research

Improvements in patient-reported outcomes with apremilast, an oral phosphodiesterase 4 inhibitor, in the treatment of moderate to severe psoriasis: results from a phase IIb randomized, controlled study

Vibeke Strand1*, David Fiorentino2, ChiaChi Hu3, Robert M Day3, Randall M Stevens3 and Kim A Papp4

Author Affiliations

1 Division of Immunology and Rheumatology, Stanford University, Palo Alto, California, USA

2 Department of Dermatology, Stanford University School of Medicine, Redwood City, California, USA

3 Celgene Corporation, Summit, New Jersey, USA

4 Probity Medical Research, Waterloo, Ontario, Canada

For all author emails, please log on.

Health and Quality of Life Outcomes 2013, 11:82  doi:10.1186/1477-7525-11-82

Published: 10 May 2013

Abstract

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.

Keywords:
Apremilast; Dermatology Life Quality Index; Phosphodiesterase 4; Psoriasis; Quality of life; SF-36