Real-World Clinical Experience With Apremilast in a Large US Retrospective Cohort Study of Patients With Moderate to Severe Plaque Psoriasis
December 2017 | Volume 16 | Issue 12 | Original Article | 1240 | Copyright © December 2017
April Armstrong MD MPH,a and Eugenia Levi PharmDb
aUniversity of Southern California, Keck School of Medicine, Los Angeles, CA bCelgene Corporation, Summit, NJ
OBJECTIVE: To examine real-world use and patient outcomes with apremilast, an oral PDE4 inhibitor, in the dermatology practice set-ting for treatment of patients with moderate to severe plaque psoriasis.
METHODS: This retrospective, multicenter, longitudinal, observational cohort study used Modernizing Medicine’s electronic medi-cal record (EMR) database of >5000 US dermatology providers. There were 7517 adults aged ≥18 years with a psoriasis diagnosis (ICD-9, ICD-10) who received apremilast therapy from October 1, 2015, to January 31, 2016, and were included in effcacy and safety analyses. Among patients who switched from non-apremilast to apremilast monotherapy, the majority (74.2%) switched from prior topical treatment.
RESULTS: At apremilast initiation, in systemic-naive and systemic-experienced patients, mean (SD) Physician Global Assessment (PGA) was 2.79 (0.13) and 2.48 (0.15); mean (SD) psoriasis-affected body surface area (BSA) was 17.85% (2.27) and 12.93% (2.59); and mean itch numeric rating scale (NRS; 0=no itch, 10=worst itch possible) score was 4.14 and 3.82, respectively. Within 6 months of apremilast initiation, PGA decreased (mean [SD]) in systemic-naive patients (−1.71 [0.19], P less than0.001) and systemic-experienced pa-tients (−1.02 [0.18], P less than 0.001); 26.8% (systemic-naive) and 25.5% (systemic-experienced) of patients achieved a PGA score of 0 or 1. Likewise, statistically signifcant reductions in BSA were noted in systemic-naive patients (~62% reduction from baseline; P less than 0.01) and systemic-experienced patients (~60% reduction from baseline; P=0.002). Mean itch NRS decreased to 2.38 in systemic-naive patients (P=0.139) and 0.0 in systemic-experienced patients (P=0.034). Of 160 patients with ≥1 assessment of patient-perceived overall treatment effectiveness, 138 (86.2%) strongly/somewhat agreed apremilast was effective in clearing their skin of psoriasis. For safety analyses, body weight was available in the EMR database and decreased in systemic-naive patients (−1.75 kg) and systemic-experienced patients (−1.09 kg).
Conclusions: Findings support the effectiveness of apremilast in patients with moderate to severe psoriasis in dermatology clinical practices. Patients perceived apremilast to be effective.
J Drugs Dermatol. 2017;16(12):1240-1245.