INTRODUCTION
Approximately 1.5% to 3% of the populations in the United States and Europe have been estimated to have psoriasis.1,2 Those with plaque psoriasis have a high incidence of certain comorbidities,3,4 including coronary artery disease,5 atherosclerosis,6 metabolic syndrome,7-9 and diabetes.10 Plaque psoriasis also reduces quality of life,4 is a significant disability burden,11 and is associated with higher healthcare utilization and costs.3 Monotherapies such as phototherapy, conventional systemic agents, and newer biologics are commonly used to treat plaque psoriasis; however, single therapies do not always adequately control patients’ symptoms.12 Rather than increasing the dosage of monotherapies, which may be limited due to concerns of accumulating toxicity, combination therapy is often employed to improve overall treatment response and minimize adverse effects.12 Studies in those with plaque psoriasis have shown that incorporating narrowband UVB phototherapy (NB-UVB) with a biologic could improve patients’ disease,13-18 could be more efficacious than a biologic alone,16,18-21 could restore an initial therapeutic response with a biologic that had waned,19,22,23 or could accelerate the therapeutic response of a biologic.16,18,20,21 Apremilast is a small-molecule, phosphodiesterase 4 inhibitor given orally,24 rather than by injection as biologics are given. Two large, phase 3 studies have demonstrated efficacy, a good safety profile, and improved health-related quality of life with apremilast in patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.25-27 In a retrospective chart review (n=81), 81% of plaque psoriasis patients who completed 12 weeks of apremilast with photo-, systemic or biologic therapy achieved a psoriasis area severity index (PASI) of 75 after 12 weeks, with 8 of the 9 patients (89%) who completed apremilast and NB-UVB therapy achieving that response.28 To date, the addition of NB-UVB to apremilast has not been formally evaluated. Thus, this pilot study examined the effectiveness and safety of apremilast in combination with NB-UVB for 12 weeks in patients with moderate to severe plaque psoriasis to determine if NB-UVB could enhance the efficacy of apremilast. The proportion of patients who achieved PASI 75 after 12 weeks of treatment with apremilast plus NB-UVB was evaluated.
METHODS
Study Design and Treatment
This was a single-center, 12-week, open-label, pilot study designed to evaluate the effectiveness and safety of apremilast (Otezla®, Celgene Corporation, Summit, NJ) combined with NB-UVB for the treatment of moderate to severe plaque psoriasis. The study protocol and informed consent were approved by an institutional review board and the study was conducted in