Journal of Clinical and Aesthetic Dermatology

MauiDerm 2017

An evidence-based, peer-reviewed journal for practicing clinicians in the field of dermatology

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S25 JCAD journal of clinical and aesthetic dermatology May 2017 • Volume 10 • Number 5 (Supplement 1) p ercent of APR/APR, and 59.4 percent of E TN/APR patients. Improvements were seen in nail and scalp psoriasis, and responses continued to improve with APR treatment over 104 weeks and in patients who switched from ETN to APR. At Week 104, NAPSI-50 response was 48.6 percent (PBO/APR), 60.4 p ercent (APR/APR), and 65.2 percent (ETN/APR); ScPGA score of 0 or 1 was achieved by 50 percent (placebo/APR), 59.2 percent (APR/APR), and 56.6 percent of patients. Exposure-adjusted incidence rates (EAIR)/100 patient-years of common adverse events (AEs; ≥5% of patients), including diarrhea, nausea, nasopharyngitis, upper respiratory tract infection, and headache, did not increase with prolonged APR exposure in the APR/APR group versus patients who received APR during 0 to 16 weeks. No increase in EAIR/100 patient-years of serious AEs occurred during the APR extension phase (3.45–5.49, across groups) versus 0 to 16 weeks (7.91 ETN; 12.57 APR). Changes in laboratory parameters were infrequent and transient; EAIR/100 patient-years remained low across groups through 104 weeks. Conclusion: APR demonstrated efficacy through Week 104 in patients who continued APR and patients who switched from PBO or ETN to APR at Week 16. AEs did not increase with prolonged APR exposure, and no new safety or tolerability issues were observed through Week 104 in patients with moderate-to-severe plaque psoriasis. A Retrospective Cohort Study of Real-world Experience with Apremilast in Patients with Moderate to Severe Plaque Psoriasis Presenters: April Armstrong, MD, MPH, 1 Eugenia Levi, PharmD 2 A ffiliations: 1 U niversity of Southern C alifornia, Keck School of Medicine, Los Angeles, CA; 2 Celgene Corporation, Summit, NJ Introduction: Apremilast (APR), an oral PDE4 inhibitor, is FDA approved for treatment of adult patients with active psoriatic arthritis and patients w ith moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy. APR has been studied in Phase 2/3 clinical trials in >1,200 adult patients with moderate-to-severe plaque psoriasis. Limited real-world data exist regarding use of APR in the dermatology practice setting. This retrospective, multicenter, longitudinal, observational cohort study sought to characterize real-world patient characteristics, clinical effectiveness, and prescribing patterns of APR in patients with psoriasis using Modernizing Medicine's electronic medical record (EMR) database of >550,000 psoriasis patients. Study Methods: Adults aged ≥18 years with a psoriasis diagnosis (ICD-9, ICD-10) and receiving APR during the study period (10/1/2014–1/31/2016) were included. Clinical effectiveness of APR was assessed in patients with ≥2 data points (i.e., at time of prescription and ≥1 within 6 months) using Physician Global Assessment (PGA) and affected body surface area (BSA). The patient population was stratified by prior oral systemic treatment while in the EMR database. Patient-perceived overall treatment effectiveness (POTE) was evaluated in patients receiving APR for ≥90 days. Results: A total of 7,517 patients with mean (SD) age of 52.3 (14.8) years received APR during the specified study period; 52 percent were female, 63.8 percent were white, and 52.4 percent had psoriasis-related comorbidities during the study, i ncluding cardiovascular disease ( 33.1%), arthritis (23.7%), diabetes (13.2%), and depression (10.1%). Among patients who switched from non-APR treatment to APR monotherapy, 74.2 percent changed from topical monotherapy to APR monotherapy. The majority of patients ( >75%) who initiated phototherapy, methotrexate, adalimumab, or ustekinumab during the study period and who received APR did so as add- on therapy to their ongoing treatment. The effect of APR on PGA and BSA was evaluated in a subset of patients who met inclusion criteria. At APR initiation, adjusted mean (SD) PGA was 2.79 (0.13) in systemic-naive patients (n=173) and 2.48 (0.15) in systemic-experienced patients (n=208). Within six months of APR treatment initiation, PGA decreased by mean (SD) -1.71 (0.19) (P<0.001) and by -1.02 (0.18) (P<0.001) among systemic-naive and systemic-experienced patients, respectively. At APR initiation, adjusted mean (SD) BSA (%) was 17.85 (2.27) in systemic-naive patients (n=196) and 12.93 (2.59) in systemic- experienced patients (n=177); statistically significant reductions in BSA were noted in both groups after six months of APR treatment, with ~62 percent (−11.12 [2.02], P<0.01) and ~60 percent (−7.70 [2.49], P=0.002) reductions in BSA in systemic-naive and systemic-experienced patients, respectively. Of 160 patients with ≥1 POTE assessment, 138 (86.2%) strongly or somewhat agreed that APR was effective in clearing their skin of psoriasis. Conclusion: Findings suggest APR is effective in reducing PGA and BSA scores in patients with moderate-to- severe psoriasis in the real-world setting. Patient-perceived effectiveness of APR was high.

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