First “Real-World” Insights on Apremilast Treatment for Patients With Plaque Psoriasis From the LAPIS-PSO Study: An Interim Analysis Kristian Reich, MD1; Stefanie Bomas, MD2; Bernhard Korge, MD3; Maria Manasterski, MD4; Uwe Schwichtenberg, MD5; Hannah Mentz, PhD6; Kathrin Groegel, PhD6; Natalie Núnez Gómez, MD6 1Dermatologikum Hamburg and SCIderm Research Institute, Hamburg, Germany; 2Praxis Dr. med. S. Rotterdam, Gelsenkirchen-Feldmark, Germany; 3Priv. Doz. Dr. med. Korge, Düren, Germany; 4Hautarztpraxis Manasterski und Dues, Berlin, Germany; 5Derma Nord Hautarztpraxen Dr. med. Schwichtenberg, Bremen, Germany; 6Celgene GmbH, Munich, Germany INTRODUCTION • This national, multicenter, prospective, noninterventional study is assessing long-term treatment with apremilast in patients with plaque psoriasis in Germany (LAPIS-PSO; ClinicalTrials.gov: NCT02626793). • This study aims to determine patients’ quality of life and satisfaction with apremilast 30 mg twice daily (APR) treatment, as well as the clinical effi cacy of APR, in a real-world setting of patients who have previously received conventional systemic therapy. • A subgroup analysis of the LAPIS-PSO interim analysis is presented here. METHODS Study Design • The subgroup analysis was stratifi ed based on the number of prior conventional systemic treatments (≤1 vs. >1) (Table 1). • Scope: Baseline until Visit 2 (~4 months), n=111 (Figure 1) • Patients: Moderate to severe plaque psoriasis (N=500, 100 sites planned) – Indication and inclusion according to apremilast Summary of Product Characteristics1 – Patients previously treated with biologics were not observed • No strict visit schedule was performed; visits were timed according to clinical practice. Figure 1. Study Design 0 1 2 3 4 5 6 7 8 9 10 11 12 13 VISIT 5 End of ObservationVISIT 4VISIT 3 VISIT 1 Optional VISIT 0 BL Patients (%) with DLQI score ≤5 or DLQI improvement by ≥5 points vs. baseline (BL) Time [≈ months]Primary End Point VISIT 2 Stratifi cation • Two subgroups were defi ned following stratifi cation: – Subgroup 1: Patients with treatment failure (lack of effi cacy or intolerance) of ≤1 prior conventional systemic treatment – Subgroup 2: Patients with treatment failure (lack of effi cacy or intolerance) of >1 prior conventional systemic treatment End Points Primary End Point • The primary end point was the percentage of patients achieving Dermatology Life Quality Index (DLQI) score ≤5 or improvement from baseline in DLQI score by ≥5 points at Visit 2. Secondary End Points (Interim Analysis at Visit 2) • Percentage of patients achieving DLQI score ≤5 or improvement from baseline in DLQI score by ≥5 points at all other visits • Effi cacy on skin: Physician’s Global Assessment (PGA) and body surface area (BSA) involvement • In addition, the following were assessed: – Scalp involvement – Nail involvement – Patient’s Global Assessment (PaGA) • Safety and tolerability RESULTS Patient Demographics and Disease Characteristics • Baseline patient demographics and disease characteristics for the full analysis set (FAS) are shown in Table 1. Table 1. Baseline Patient Demographics and Disease Characteristics Characteristic Subgroup 1 (≤1 prior conventional systemic) n=43 Subgroup 2 (>1 prior conventional systemic) n=30 Male (%) 51.2 43.3 Age at inclusion, mean (SD), years 49.2 (13.22) 53.3 (12.99) Body mass index, mean (SD), kg/m2 27.74 (5.21) 28.37 (5.92) Age at initial diagnosis, mean (SD), years 32.1 (17.01) 27.7 (12.54) Scalp involvement, n (%) 36 (83.7) 27 (93.1) Nail involvement, n (%) 21 (48.8) 15 (50.0) Number of affected nails, mean (SD) 6.6 (3.82; n=17) 6.1 (3.50; n=13) Palmoplantar involvement, n (%) 11 (26.2) 6 (20.7) PGA score, mean (SD) 3.1 (0.86) 3.2 (0.63) PaGA score, mean (SD) 3.0 (0.92) 3.4 (0.57) RESULTS (cont’d) DLQI Response • Characteristics at baseline were comparable (mean [SD] DLQI score was 14.6 [6.31]; n=73). • The percentage of patients achieving DLQI score of ≤5 or DLQI improvement from baseline by ≥5 (primary end point) was 65.8% in subgroup 1 vs. 61.5% in subgroup 2 (Table 2). Table 2. DLQI Response at Visit 2: Stratifi cation (FAS) Stratifi cation Achievement of DLQI Score ≤5 or DLQI Improvement From BL by ≥5, n/N (%) Achievement of DLQI Score ≤5, n/N (%) Change From BL in DLQI Score, Mean (SD) Subgroup 1 (≤1 prior conventional systemic) 25/38 (65.8) 22/38 (57.9) −8.3 (8.09) Subgroup 2 (>1 prior conventional systemic) 16/26 (61.5) 9/26 (34.6) −6.4 (5.94) PGA and PaGA Response • A higher percentage of patients achieved PGA and PaGA scores of 0 or 1 at Visit 2 in subgroup 1 (30.8% and 36.8%, respectively) compared with subgroup 2 (22.2% and 22.2%, respectively) (Figure 2). Figure 2. PGA and PaGA* Response of 0 or 1 at Visits 1 and 2 17.9 13.2 30.8 36.8 0 5 10 15 20 25 30 35 40 10.7 3.7 22.2 22.2 0 5 10 15 20 25 30 35 40 Subgroup 1 (≤1 prior conventional systemic) Subgroup 2 (>1 prior conventional systemic) PGA (0 or 1) PaGA (0 or 1) PGA (0 or 1) PaGA (0 or 1) 7/39 5/38 3/28 1/2712/39 14/38 6/27 6/27n/N= Visit 1 Visit 2 Pa tie nt s Ac hi ev in g Re sp on se (% ) Pa tie nt s Ac hi ev in g Re sp on se (% ) *The PGA and PaGA are 5-point scales ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), to 4 (severe). Effi cacy on Nail Psoriasis: Target-Nail Psoriasis Severity Index (Target-NAPSI) • The mean (SD) Target-NAPSI in subgroup 1 (4.0 [2.06]) was better than that in subgroup 2 (4.6 [2.53]). • The mean (SD) percentage change in Target-NAPSI was −58.22% (53.423) in subgroup 1 and −48.61% (37.241) in subgroup 2. • Target-NAPSI-50 response was identical between subgroups at Visit 2 (66.7%) (Figure 3). Figure 3. Target-NAPSI-50 Response Subgroup 1 (≤1 prior conventional systemic) Subgroup 2 (>1 prior conventional systemic) n/N= 0 10 20 30 40 50 60 70 80 0 10 20 30 40 50 60 70 80 Pa tie nt s Ac hi ev in g Re sp on se (% ) Pa tie nt s Ac hi ev in g Re sp on se (% ) Visit 2 12/18 Visit 1 5/18 Visit 2 8/12 Visit 1 2/12 66.7 27.8 66.7 16.7 • Scalp manifestation was comparable at baseline and had slightly greater improvements in subgroup 1 at ~4 months. Safety • The overall incidence of AEs (Table 3) is lower than that in clinical studies. • Only 1 patient was affected by severe AEs (obstipation, tremor, palpitations). RESULTS (cont’d) Table 3. Overview of Adverse Events Patients, n (%) Subgroup 1 n=61 Subgroup 2 n=47 ≥1 AE 14 (23.0) 13 (27.7) ≥1 AE (APR treatment-related) 11 (18.0) 7 (14.9) ≥1 AE leading to drug withdrawal 6 (9.8) 3 (6.4) ≥1 SAE (APR treatment-related: disorders of the nervous system: tremor and heart diseases: palpitations) 1 (1.6) 0 (0.0) AE=adverse event; SAE=serious adverse event. • The most common AE was diarrhea (8.3%) (Table 4). Table 4. Most Common Adverse Events Patients,* n (%) SAP n=108 Diarrhea 9 (8.3) Nausea 2 (1.9) Upper respiratory tract infection 1 (0.9) Headache 2 (1.9) *Most common AEs that occurred in ≥5% of patients in phase 3 clinical trials of apremilast. Interim analysis includes total number of SAEs and related AEs. Nonserious AEs were asked to be reported upon termination. SAP=safety analysis population (all patients who received ≥1 dose of APR and fulfi lled the inclusion criteria). CONCLUSIONS • The LAPIS-PSO interim analysis presents the fi rst data on APR for the treatment of patients with moderate to severe plaque psoriasis under routine clinical care in Germany. • This interim analysis suggests that the effi cacy of APR in daily practice is comparable to clinical trial results and responses may be improved in patients who have received fewer prior conventional systemic therapies. • Patient quality of life is rapidly and signifi cantly improved by APR (as shown by DLQI response within 4 weeks at Visit 1). • The safety profi le in this real-world setting was consistent with clinical trials of APR in psoriasis.2,3 • There was a signifi cant improvement in disease in both subgroups. REFERENCES 1. Otezla 30mg tablets. Summary of product characteristics. Uxbridge, UK: Celgene Ltd; January 2017. 2. Papp K, et al. J Am Acad Dermatol. 2015;73:37-49. 3. Paul C, et al. Br J Dermatol. 2015;173:1387-1399. ACKNOWLEDGMENTS 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 Kristian Reich – kreich@dermatologikum.de DISCLOSURES KR: AbbVie, Amgen, Biogen, Boehringer Ingelheim, Celgene Corporation, Centocor, Covagen, Eli Lilly, Forward Pharma, GlaxoSmithKline, Janssen-Cilag, LEO Pharma, Medac, Merck Sharp & Dohme Corp, Novartis, Ocean Pharma, Pfi zer (Wyeth), Regeneron, Takeda, UCB Pharma, and XenoPort – honoraria as a consultant and/or advisory board member and/or acted as a paid speaker and/or participated in clinical trials. SB: No confl icts or potential confl icts of interest to disclose. BK: No confl icts or potential confl icts of interest to disclose. MM: AbbVie, Janssen, and Novartis – paid consultant or study investigator. US: AbbVie Deutschland GmbH, Almirall Hermal GmbH, Astellas Pharma GmbH, Beiersdorf Derma Medical GmbH, Celgene GmbH, Janssen Cilag GmbH, Johnson & Johnson GmbH, LEO Pharma GmbH, L´Oréal GmbH, MEDA Pharma GmbH, Merz Pharmaceuticals GmbH, MSD SHARP & DOHME GmbH, Novartis Pharma GmbH, Pfi zer GmbH, and Medical Project Design GmbH – paid speaker, advisory board member, investigator, and/or stockholder. HM, KG & NNG: Celgene GmbH – employment. Presented at: the 2017 Fall Clinical Dermatology Conference; October 12–15, 2017; Las Vegas, NV. FC17PosterCelgeneReichFirstRealWorld.pdf