Acta Dermato-Venereologica Suppl 219 AbstractPsoriasis2018 | Page 18

16

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