INTRODUCTION • Management of moderate psoriasis remains a signifi cant challenge, with some evidence suggesting patients with moderate disease are often undertreated and experience unsatisfactory clinical outcomes.1,2 However, there is a lack of consensus on how to defi ne moderate psoriasis, and no explicit guidelines exist for the treatment of this patient population. • Apremilast (APR), an oral phosphodiesterase 4 inhibitor, is the fi rst new oral systemic, nonbiologic medication approved for the treatment of psoriasis in the past 20 years, and is approved in the United States for treatment of adult patients with active psoriatic arthritis (PsA) and patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.3 • Given the lack of guidance for treating patients with moderate psoriasis and the recent availability of APR, the objectives of the current investigation were (1) to determine how dermatologists in the real-world clinical setting defi ne and treat moderate plaque psoriasis, and (2) to describe real-world clinical characteristics and 6-month treatment outcomes among patients with moderate psoriasis treated with APR. METHODS Dermatologist Survey • The survey portion of the investigation was conducted between October 2015 and July 2016. • US dermatologists treating patients with psoriasis were invited to complete an online survey which asked: – How they typically assess psoriasis severity – What cutoff criteria they use to defi ne moderate psoriasis – Which treatments they commonly prescribe to patients with moderate plaque psoriasis • Eligible survey participants were US dermatologists who: – Treat ≥20 adult patients with plaque psoriasis per month, ≥1% of whom must be considered to have moderate psoriasis – Spend ≥40% of practice time in medical dermatology or ≥70% in medical and surgical dermatology – Have been in practice for 2 to 30 years – Spend >75% of practice time in direct patient care Prospective 6-Month Patient Chart Review • Surveyed dermatologists were also asked to provide data from charts of 4 patients with a diagnosis of moderate plaque psoriasis whom they had seen in the last month, including ≥1 patient treated with APR; 6 months later they were invited to provide follow-up patient chart information. • The patients were required to meet the following criteria: – Adult patient (≥18 years of age), diagnosed with plaque psoriasis and currently living – Moderate disease severity (as determined by the surveyed, treating dermatologist) – Seen by the dermatologist within the month before the dermatologist took the survey – Using prescription topical or systemic medication for the treatment of moderate plaque psoriasis at the time of the survey METHODS (cont’d) • Chart information included: – Patient demographic characteristics – Clinical disease characteristics – Treatment patterns, including treatment shifts and discontinuations – Effectiveness of treatment – Safety and tolerability RESULTS Dermatologist Survey Respondent Dermatologists • A total of 150 dermatologists responded to the survey. • Dermatologists had an average of 13.5 years in practice; most currently worked in a single-physician or multiphysician dermatology specialty practice (83%). They saw an average of 72 patients with psoriasis per month. Scales Used to Assess Psoriasis Severity • The large majority of dermatologists (95%) reported they assessed disease severity based on the percentage of psoriasis-affected body surface area (BSA) (Figure 1). – 59% of dermatologists responded that they also considered location of the affected area in their assessment of severity. Figure 1. Criteria Used to Assess Psoriasis Severity Dermatology Life Quality Index 0 20 40 60 80 100 Physician Global Assessment Psoriasis Area and Severity Index Patient assessment of their disease Location of affected areas BSA 95% 17% 20% 25% 41% 59% Location Mentioned Palms 88% Genital Area 85% Feet 81% Face 78% Scalp 75% Nails 50% Legs 43% Arms 42% Dermatologist (n=150) response to questions: Which of the following metrics do you use to determine if a patient has moderate plaque psoriasis? What locations do you use to determine if a patient has moderate plaque psoriasis? Defi ning Moderate Plaque Psoriasis • Dermatologist-reported BSA cutoffs to defi ne moderate psoriasis varied widely, revealing a lack of consensus among dermatologists (median: 5% to 10%) (Figure 2). RESULTS (cont’d) Figure 2. Dermatologist-Reported BSA Cutoffs for Moderate Psoriasis 0 Overall Range Mean Range D er m at ol og is t- Re po rt ed B SA Su m m ar y St at is tic s (n = 14 2) Psoriasis-Affected BSA (%) Median Range 20 40 60 80 100 5–10 8–18 1–70 BSA low and high cutoff values reported by dermatologists who use BSA to assess disease severity (n=142) in response to the question: For the following metrics [including BSA], what are your typical cutoffs for moderate/severe psoriasis patients? Please enter numbers for each. Treatment of Moderate Plaque Psoriasis • When asked to estimate what proportions of their patients with moderate plaque psoriasis receive various types of medications as their primary treatment, dermatologists reported that 47% were receiving biologic agents, 28% prescription topicals, 18% oral systemics, 5% phototherapy, and 2% over-the-counter (OTC) topical agents (Figure 3). Figure 3. Primary Treatments for Moderate Plaque Psoriasis Proportion of PatientsPrimary Treatment Phototherapy 5% OTC Topical 2% Prescription Topical 28% Oral Systemics APR Methotrexate Acitretin Cyclosporine 18% 7% 7% 3% 1% Infliximab 0% Biologics Adalimumab Ustekinumab Etanercept Secukinumab 47% 19% 13% 11% 4% Dermatologist (n=150) response to the question: What percentage of your moderate plaque psoriasis patients are currently on the following types of treatment as their primary therapy? Must add to 100%. 6-Month Prospective Chart Review of Patients With Moderate Psoriasis Treated With APR Patient Disposition and Demographic/Clinical Features • The participating dermatologists identifi ed 270 patients with moderate psoriasis who had ≥1 follow-up visit within the 6-month follow-up period. Among these, 70 patients who had ≥1 follow-up visit (mean visits=2) within the 6-month follow-up period were initially receiving APR. RESULTS (cont’d) • At the 6-month chart review, among patients treated with APR at baseline, 91% (64/70) remained on APR; 3 patients were new to APR (Figure 4). • 65 patients (24%) were receiving APR as their primary therapy. • APR discontinuation occurred in 6 patients; reasons for discontinuation included loss of effi cacy (n=2), poor tolerability (n=3), and noncompliance (n=2); 1 patient discontinued due to both poor tolerability and noncompliance. Figure 4. 6-Month Disposition of APR-Treated Patients 270 patients with moderate psoriasis with ≥1 visit within the 6-month follow-up period 200 patients were taking other therapies 70 patients were taking APR 6 discontinued APR 64 continuing APR 3 new to APR 67 patients currently taking APR • 1 patient switched from biologic + topical steroid • 2 patients added APR to topical • Demographic and clinical characteristics of the patients receiving primary treatment with APR included in the current prospective chart review are summarized in Table 1. • Patients given APR had been treated by the responding dermatologists for a mean of 24.8 months, with offi ce visits occurring at a mean of every 2.8 months. Table 1. Demographic and Clinical Characteristics Among Patients With Moderate Psoriasis Receiving APR as Primary Treatment Characteristic Patients With Moderate Psoriasis Receiving APR as Primary Treatment* n=65 Age, mean (range), years 47.3 (20–75) Male, % 45 Weight, mean (range), lb. 163.7 (130–245) Race, % White 92 Hispanic 3 African American 3 Asian 2 Employed full-time, % 62 Any comorbidity, % 57 Comorbidities in >5% of patients, % Hypertension 23 Obesity 9 Dyslipidemia 19 Diabetes§ 8 PsA 9 Depression 6 *Primary therapy as defi ned by the surveyed dermatologist. §Includes type 2 diabetes mellitus. RESULTS (cont’d) Clinical Effectiveness of APR Treatment for Moderate Psoriasis • In patients receiving APR as their primary therapy, mean BSA changed from 9.9% at initial chart review to 4.9% at the 6-month chart review (Figure 5). Figure 5. Change in BSA at 6 Months With APR Treatment 12 10 8 Ps or ia si s- Af fe ct ed B SA (% ) 6 4 2 0 Initial Chart Review 6-Month Chart Review 9.9 4.9 • Of patients receiving APR as their primary therapy, 54% were rated as having mild psoriasis at the 6-month chart review, marking a shift for these patients from moderate psoriasis at baseline (Figure 6). Figure 6. Disease Severity at 6 Months, Among Patients With Moderate Psoriasis Treated With APR Mild NOTE: 100% of patients were considered to have moderate disease severity at baseline Moderate Severe 5% 54% 42% Data shown refl ect dermatologist (n=150) response to question: What would you consider to be this patient’s current disease severity level? Note: Percentages shown may not add to 100 because of rounding. • At the 6-month chart review, 65% of patients receiving APR as primary therapy were rated by dermatologists as having shown at least some improvement; 17% were rated as having shown signifi cant improvement (Figure 7). • When asked about their clinical experience with APR, 68% of dermatologists stated that APR exceeded or met their expectations. RESULTS (cont’d) Figure 7. Dermatologist Assessment of Condition Change at 6 Months in Patients Treated With APR Seen significant improvement Seen moderate improvement Seen some improvement Been stable Deteriorated 17% 34% 31% 17% 2% Data shown refl ect dermatologist (n=150) response to the question: How has this patient’s condition changed over the past 6 months? Note: Percentages shown may not add to 100 because of rounding. Side Effects With APR Reported During the 6-Month Chart Review Period • Among patients with available safety information, 8/66 (12%) reported side effects during treatment; these included diarrhea (n=5), nausea (n=3), abdominal pain (n=3), and headache (n=1). – All side effects were considered mild, except 1 case of diarrhea that was considered moderate; 2 patients took loperamide to manage diarrhea. • On average, side effects resolved within 2 weeks, with the exception of abdominal pain, which persisted for an average of 7 weeks. • 1 patient temporarily discontinued APR because of diarrhea but was re-initiated and continued on treatment. CONCLUSIONS • In the real-world clinical setting, widely varying BSA cutoff values to identify moderate psoriasis reveal a lack of consensus surrounding the defi nition of moderate psoriasis among US dermatologists. • Based on patient chart review, APR is well tolerated and effective for treatment of moderate psoriasis. REFERENCES 1. Armstrong AW, et al. JAMA Dermatol. 2013;149:1180-1185. 2. Lebwohl MG, et al. J Am Acad Dermatol. 2014;70:871-881. 3. Otezla [package insert]. Summit, NJ: Celgene Corporation; June 2017. ACKNOWLEDGMENT The authors acknowledge fi nancial support for this study from Celgene Corporation. The authors received editorial support in the preparation of this report from Amy Shaberman, PhD, of Peloton Advantage, LLC, Parsippany, NJ, USA, funded by Celgene Corporation, Summit, NJ, USA. The authors, however, directed and are fully responsible for all content and editorial decisions for this poster. CORRESPONDENCE Melissa L. F. Knuckles – mlfk@aol.com DISCLOSURES MLFK: AbbVie, Allergan, Amgen, Celgene Corporation, Eli Lilly, Galderma, Novartis, and Sun Pharma – advisory board member, consultant, and/or speaker. AbbVie, Amgen, Bayer, Biogen, Crown Labs, Eli Lilly, Johnson and Johnson, LEO Pharma, and Medimetriks – investigator. EL: Celgene Corporation – employment. JS: AbbVie, Allergan, Amgen, Celgene Corporation, Eli Lilly, Genentech, Genzum, Janssen, Kadmon, Merz, Pfi zer, and Regeneron – advisory board member, investigator, and/or speaker. Presented at: the 2017 Fall Clinical Dermatology Conference; October 12–15, 2017; Las Vegas, NV. Defi ning and Treating Moderate Plaque Psoriasis in a Real-World Clinical Setting: A Dermatologist Survey and Prospective 6-Month Chart Review of Patients Treated With Apremilast Melissa L. F. Knuckles, MD, PSC1; Eugenia Levi, PharmD2; Jennifer Soung, MD3 1Melissa L. F. Knuckles, M.D., P.S.C. Dermatology, Richmond, KY; 2Celgene Corporation, Summit, NJ; 3Southern California Dermatology, Santa Ana, CA FC17PosterCelgeneKnucklesDefiningTreatingMPP.pdf