Acta Dermato-Venereologica Suppl 219 AbstractPsoriasis2018 | Page 18

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5 th World Psoriasis & Psoriatic Arthritis Conference 2018

References: 1) J Rheumatol. 2017; 56( 11): 1993-03. 2) Rheumatology 2017; 56:1993-03; 3) Arthritis Rheumatol. 2017; 69( s10); 4) PANLAR 2018, A718

Table: ACR20 / 50 responses at Week 16 by TNFi status and concomitant MTX use

P031 IMPACT OF ADALIMUMAB VS. NON-BIOLOGIC TREATMENTS ON SKIN OUTCOMES OF PSORIATIC ARTHRITIS PATIENTS: REAL-WORLD DATA FROM

THE COMPLETE STUDY Majed Khraishi 1, Louis Bessette 2, Boulos Haraoui 3, Valencia

Remple 4 1

Memorial University of Newfoundland, St. John’ s NL, 2 Laval University, Centre Hospitalier de l’ Université Laval, Quebec, 3 Centre hospitalier de l’ Université de Montréal, 4 AbbVie Corporation, Montreal, QC, Canada

Background: Previous studies have shown the efficacy of anti- TNFα agents in improving nail, skin and joint manifestations of psoriatic arthritis( PsA). However, real-world data on the comparative effectiveness of switching to or adding these agents vs. continuing non-biologic treatments in patients having failed prior non-biologic treatment are necessary to support the integration of treatment algorithms into routine care. Objectives: The aim of this analysis was to compare the effect of adalimumab( ADA) vs. non-biologic treatments( nbDMARD: NSAIDs and DMARDs) on skin outcomes and patient reported outcomes following initial treatment failure. In addition, the impact of the extent of baseline skin disease on treatment outcomes was examined. Methods: Patients eligible for COMPLETE PsA are anti-TNFα naïve adults, with active PsA who require change in their treatment regimen, per the judgment of the treating physician. In the current analysis patients enrolled between July / 2011 – Jun / 2016 who had available information on baseline psoriasis body surface area( BSA) were included. Outcome measures analyzed were: BSA, Dermatology Life Quality Index( DLQI), Short Form Health Survey( SF-12), and the Beck Depression Inventory( BDI). Analyses were conducted by initial group assignment( intent-to-treat approach). Results: A total of 392 patients were included( ADA n = 249, nbDMARD n = 143). Baseline demographics and disease duration were comparable between treatment groups. However, patients initiating ADA were more likely to have BSA≥3 %( 44.6 % vs. 35 %, p = 0.063) and had higher DLQI( 6.2 vs. 4.3, p = 0.006) scores. No differences were observed in SF-12 physical( PCS) and mental( MCS) component scores at baseline. During treatment, BSA levels significantly improved in both groups but more patients achieved a BSA < 3 % when treated with ADA vs. nbDMARD both at 6 months( 89.7 % vs. 80.2 %, p = 0.027) and 12 months( 89.0 % vs. 83.7 %, p = 0.222). Furthermore, upon adjusting for baseline scores, patients in the ADA group experienced greater improvements in DLQI( ΔLSM =-1.62, p = 0.004), particularly in the daily activities, leisure, and work / school domains, and SF-12 PCS( ΔLSM = 0.36, p < 0.001). These differences between groups in BSA levels and DLQI improvement were more profound among patients with BSA≥3 % at baseline. During follow-up, 9.2 % of ADA patients initiated another biologic and 32.2 % of patients in the nbDMARD group initiated biologic treatment( p < 0.001). Conclusions: PsA patients starting ADA following initial failure of non-biologic treatment in Canadian routine clinical care experience greater benefits in skin outcomes and quality of life compared to switching to different non-biologic treatment. These benefits are particularly evident among patients with more severe skin disease at baseline.

P032 IXEKIZUMAB IMPROVES NAIL AND SKIN PSORIASIS THROUGH 52 WEEKS OF TREATMENT IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS: RESULTS FROM TWO RANDOMIZED, DOUBLE-BLIND, PHASE 3, CLINICAL TRIALS( SPIRIT-P1 AND SPIRIT-P2) Joseph F. Merola 1, Mitsumasha Kishimoto 2, David Adams 3, So Young Park 3, Diamant Thaçi 4

1

Department of Dermatology and Medicine, Division of Rheumatology, Harvard Medical School, Brigham and Women’ s Hospital, Boston, MA, USA, 2 Immuno-Rheumatology Center, St. Luke’ s International University, St. Luke’ s International Hospital, Tokyo, Japan, 3 Eli Lilly and Company, Indianapolis, IN, USA, 4 Comprehensive Center for Inflammation Medicine, University Hospital, Schleswig-Holstein Campus Luebeck, Luebeck, Germany

Introduction: Ixekizumab( IXE), a high-affinity monoclonal antibody that selectively targets interleukin-17A, is approved for treatment of patients( pts) with active psoriatic arthritis( PsA) and provides persistent efficacy through 52 weeks( wks) of treatment. Objective: To evaluate the efficacy of IXE treatment over 52 wks on nail and skin psoriasis in biologic disease-modifying anti-rheumatic drug( bDMARD)-naïve and-experienced pts with active PsA. Methods: Adult pts with active PsA were bDMARD-naïve( SPI- RIT-P1) or-experienced( SPIRIT-P2, TNF inhibitor inadequate responders [ TNFi-IR ] or intolerant). Pts were randomized to IXE 80 mg every 2( Q2W) or 4 wks( Q4W), placebo, or( in SPIRIT- P1) 40 mg adalimumab Q2W. Efficacy of IXE on nail and skin psoriasis in patients randomized to IXE was measured by the Nail Psoriasis Severity Index( NAPSI), Psoriasis Area and Severity Index( PASI), and static Physician Global Assessment( sPGA). Missing data were imputed using nonresponder imputation for categorical variables and modified baseline observation carried forward for continuous variables. Results: IXE provided high clinical response in skin and nail psoriasis that persisted through 52 wks of treatment, regardless of IXE dosing or prior bDMARD use( Table).

SPIRIT-P1( bDMARD Naïve)

IXE Q4W IXE Q2W n = 107 n = 103

SPIRIT-P2( TNFi-IR or Intolerant)

IXE Q4W IXE Q2W n = 122 n = 123

Unless otherwise indicated, values are presented as: n / Nx(%), where Nx is a pts with baseline BSA≥3 %, b pts with baseline sPGA≥3, or c pts with baseline fingernail psoriasis

Conclusions: In these two phase 3 clinical trials in patients with active PsA, ixekizumab provided persistent high clinical response for improvement or clearance of nail and skin psoriasis through 52 wks of treatment.

P034 IXEKIZUMAB MAKES THERAPEUTIC THRESHOLDS POSSIBLE IN ACTIVE PSORIATIC ARTHRITIS PATIENTS: RESULTS FROM SPIRIT TRIALS Laura C Coates 1, M. Elaine Husni 2, Eric Lespessailles 3, Lisa Kerr 4, Gaia Gallo 4

1

University of Oxford, Leeds, UK, 2 Cleveland Clinic, Cleveland, OH, USA,

3

Université d’ Orléans, Orléans, EA, France, 4 Eli Lilly and Company, Indianapolis, IN, USA

Introduction: Treatment goals in psoriatic arthritis( PsA) are moving toward attainment of absolute therapeutic thresholds rather than relative improvement. Objective: To explore the effect of ixekizumab( IXE), an anti-IL- 17A monoclonal antibody, as assessed by composite endpoints, up to 52 weeks( wks) for the SPIRIT-P1 and SPIRIT-P2 trials. www. medicaljournals. se / acta