Acta Dermato-Venereologica Suppl 219 AbstractPsoriasis2018 | Page 24

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5 th World Psoriasis & Psoriatic Arthritis Conference 2018

land, Brisbane, Australia, 3 Diakonhjemmet Hospital, Oslo, Norway, 4 Pitié Salpêtrière Hospital, AP-HP, Paris, France, 5 Swedish Medical Centre and University of Washington, Seattle, USA, 6 RTI Health Solutions, Barcelona, Spain, 7 Novartis Pharmaceuticals Corp., East Hanover, USA, 8 Novartis Pharma AG, Basel, Switzerland, 9 Medical University of Vienna, Vienna, Austria

Introduction: DAPSA and MDA are validated composite indices used in psoriatic arthritis( PsA) to measure disease activity states( 1). Objectives: To assess the proportion of pts treated with secukinumab( SEC) reaching DAPSA remission( REM) or low disease activity( LDA) and those who reached either MDA or very low disease activity( VLDA) at Weeks( wks) 16 and 104 in the FU- TURE 2 study( 2). Methods: DAPSA-REM, DAPSA-REM / LDA, MDA, and VLDA and their core components were assessed in the overall population and in pts stratified by prior anti-TNF use( TNF-Naïve / IR) and time since first PsA diagnosis( ≤ 2 / > 2 years) using as observed data. Results: At Wk16, in the overall population, the proportion of pts treated with SEC 300 / 150 mg achieving remission was 14 %/ 10 %( DAPSA-REM) and 8 %/ 6 %( VLDA) and achieving LDA was 42 %/ 44 %( DAPSA-REM / LDA) and 28 %/ 23 %( MDA). A higher proportion of anti-TNF-naïve pts and pts with early diagnosis( ≤ 2 years) treated with SEC achieved and sustained DAPSA-REM / LDA and MDA than in the overall population( Table). DAPSA- REM / LDA and MDA responses with SEC were sustained through Wk104. Conclusions: In the overall population, a higher proportion of SEC treated pts at Wk16 achieved DAPSA-REM, VLDA, DAPSA-REM / LDA, and MDA than those treated with placebo with a greater number of pts achieving DAPSA-REM or LDA than VLDA or MDA, respectively. These responses were sustained through Wk104. References: 1. Coates, Helliwell. Ann Rheum Dis 2016; 75:640-43. 2. McInnes et al. Rheumatol. 2017; 56:1993-2003.

Table.

DAPSA-REM / LDA

MDA ≤ 2 / > 2

P048 PREDICTORS OF RESPONSE TO TILDRAKIZUMAB FOR MODERATE TO SEVERE CHRONIC PLAQUE

PSORIASIS Andrew Blauvelt 1, Kristian Reich 2, Kim A Papp 3, Stephen K Tyring 4, Rodney Sinclair 5, Diamant Thaçi 6, Melinda Gooderham 7, Qing Li 8, Nicole Cichanowitz, Carmen La Rosa 8

1

Oregon Medical Research Center, Portland, OR, USA, 2 SCIderm Research Institute and Dermatologikum Hamburg, Hamburg, Germany, 3 Probity Medical Research, Waterloo, ON, Canada, 4 Department of Dermatology, University of Texas, Houston, TX, USA, 5 University of Melbourne, Melbourne, VIC, Australia, 6 University of Lübeck, Lübeck, Germany, 7 Queens University, SKiN Centre for Dermatology and Probity Medical Research, Peterborough, and Queens University, Kingston, ON, Canada, 8 Merck & Co., Inc., Kenilworth, NJ, USA

Introduction: Efficacy of tildrakizumab( TIL), a high affinity, humanized, immunoglobulin G1κ monoclonal antibody against interleukin-23p19, has been evaluated for chronic plaque psoriasis( PsO) in 2 phase 3 randomized controlled trials. Objective: The aim of our analysis was to determine predictors of response to TIL treatment in the 2 trials. Methods: Patients( pts) with moderate to severe PsO were randomized in reSURFACE 1( phase 3; NCT01722331) and reSURFACE 2( phase 3; NCT01729754) [ 1 ]. In Part 1( Week [ W ] 1 – W12), pts received subcutaneous TIL 200 mg, TIL 100 mg, or placebo( PBO) at W0 and W4. Pts receiving PBO in Part 1 were rerandomized to TIL 200 mg or 100 mg in Part 2( W12 – W28). For each trial, continuous variables of mean baseline Psoriasis Area and Severity Index( PASI), body mass index( BMI), Physician’ s Global Assessment( PGA), and PASI component for head region as well as dichotomous variables of baseline PASI > 20 or ≤ 20 and PASI 50 response or nonresponse at W8 were evaluated as predictors of response. Response was defined in this analysis as PASI 50 or PASI 90 at W12 and W28. Results: None of the continuous variables appeared to be consistently predictive of PASI 50 or PASI 90 response, nor were baseline PASI > 20 or ≤ 20 definitive predictors of response. PASI 50 response vs nonresponse at W8 with TIL 200 mg appeared to be predictive of a PASI 50 response at W12( percentage of patients ± SD: 98 %± 0.9 % vs 59 %± 6.1 %, respectively, in reSURFACE 1, and 99 %± 0.8 % vs 57 %± 5.7 %, respectively, in reSURFACE 2) and of a PASI 90 response at W12( 47 %± 3.3 % vs 0 %± 0 %, respectively, in reSURFACE 1, and 50 %± 3.3 % vs 5 %± 2.6 %, respectively, in reSURFACE 2). The percentage of patients with PASI 50 response vs nonresponse at W8 with TIL 200 mg who achieved PASI 50 by W28 was 99 %± 0.6 % vs 90 %± 3.8 %, respectively, in reSURFACE 1, and 99 %± 0.8 % vs 86 %± 4.0 %, respectively, in reSURFACE 2; the percentage who achieved PASI 90 by W28 was 70 %± 3.1 % vs 23 %± 5.4 %, respectively, in reSURFACE 1, and 70 %± 3.1 % vs 21 %± 4.7 %, respectively, in reSURFACE 2. Similar trends in predictive responses were observed with TIL 100-mg treatment. Conclusions: Achievement of PASI 50 by W8 was predictive of a PASI 50 and PASI 90 response at W12 and W28. Most of the patients who had not achieved PASI 50 by W8 were able to achieve a PASI 50 response by W28. Baseline PASI score, PGA, and BMI were not predictive of PASI 50 or PASI 90 response. Reference: 1. Reich K, et al. Lancet. 2017; 390:276 – 288. Acknowledgements: The studies were funded by Merck Sharp & Dohme, Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Analyses were presented at the American Academy of Dermatology Annual Meeting, February 16 – 20, 2018, San Diego, CA, USA.

P049 LONG-TERM EFFICACY OF GUSELKUMAB TREATMENT AFTER DRUG WITHDRAWAL AND RETREATMENT IN PATIENTS WITH MODERATE- SEVERE PLAQUE PSORIASIS: RESULTS FROM

VOYAGE 2 Kenneth Gordon 1, April Armstrong 2, Peter Foley 3, Yasmine Wasfi 4, Michael Song 4, Yaung-Kaung Shen 4, Shu Li 4, Ernesto J Muñoz- Elías 4, Bruce Randazzo 4, Kristian Reich 5

1

Medical College of Wisconsin, Milwaukee, WI, 2 University of Southern California, Los Angeles, CA, USA, 3 The University of Melbourne, St. Vincent’ s Hospital, Melbourne and Skin & Cancer Foundation Inc., Carlton, VIC, Australia, 4 Janssen Research & Development, LLC, 5 Dermatologikum Hamburg and SCIderm Research Institute, Hamburg, Germany

Objective: To report long-term efficacy of guselkumab( GUS) after drug withdrawal and retreatment in patients with moderate-severe psoriasis( PsO) in the Phase 3 VOYAGE 2 study. Methods: At Wk28, patients initially randomized to GUS who achieved a PASI90 response were re-randomized to either PBO / withdrawal( with retreatment upon loss of ≥50 % PASI improvement achieved at Wk28 or at Wk72 if retreatment criteria were not met) or continued GUS treatment through Wk72. Results: Among 375 patients initially randomized to GUS who achieved a PASI90 response at Wk28, 182 were re-randomized to PBO / withdrawal and 193 to GUS / maintenance treatment. Efficacy for the continued GUS treatment group was maintained through Wk72, while responses for the withdrawal group diminished, with PASI90 responses of 86.0 % vs 11.5 % respectively at www. medicaljournals. se / acta