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 © 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.
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Psoriasis is a chronic, systemic inflammatory disease affecting 1% to 4% of the world’s population.1-3 Although treatment options for moderate to severe psoriasis have expanded in recent years, many patients with all levels of psoriasis severity continue to experience undertreatment or receive no treatment.4-7 Systemic treatments are recommended for the management of moderate to severe psoriasis8; however, evidence suggests that treatment patterns for patients with psoriasis across all levels of disease severity (ie, mild and moderate to severe) are dominated by topical therapy alone.5,6,8 Some key drivers of undertreatment include patient and physician concerns about long-term safety, poor tolerability, lack or loss of efficacy, and treatment costs associated with both conventional oral systemic agents (ie, methotrexate) and biologics.6,7 Furthermore, approximately one-half of patients have reported that they are dissatisfied with their current therapy.5 Apremilast, an oral, small-molecule phosphodiesterase 4 inhibitor indicated for the treatment of psoriatic arthritis and psoriasis in patients who are candidates for phototherapy or systemic therapy, has been studied in phase 2 and phase 3 clinical trials in >2000 adult patients with moderate to severe plaque psoriasis.9-11 It is the first new oral systemic, nonbiologic medication approved by the US Food and Drug Administration for treatment of psoriasis in the past 20 years. Clinical trial data provide invaluable insight into the efficacy of apremilast versus placebo; however, these data do not fully provide insight into the effectiveness of apremilast at the patient level from populations that are re ective of the demographically and clinically diverse patients treated at dermatology practices. Real-world outcomes research in psoriasis is scarce in the United States because of the complexity required to collect valid, clinically relevant, granular data from a large number of dermatologists’