Acta Dermato-Venereologica Suppl 219 AbstractPsoriasis2018 | Page 26

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5 th World Psoriasis & Psoriatic Arthritis Conference 2018

Conclusion: In pts treated with IXE, improvements in the signs and symptoms of PsA persisted up to 3 years. The safety profile was consistent with previous studies of IXE. Previously presented as Chandran et al. 2018 EULAR Congress. June 13-16th

P052 INCIDENCE OF SERIOUS GASTROINTESTINAL EVENTS AMONG TILDRAKIZUMAB-TREATED

PATIENTS WITH PSORIASIS Melinda Gooderham 1, Boni E Elewski 2, David M Pariser 3, Howard Sofen 4, Alan M Mendelsohn 5, Nicole Cichanowitz 6, Qing Li 6, Carmen La Rosa 6

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Probity Medical Research, Waterloo, and Skin Centre for Dermatology, Peterborough, Canada, 2 Department of Dermatology, University of Alabama at Birmingham School of Medicine, Birmingham, 3 Eastern Virginia Medical School and Virginia Clinical Research, Inc., Norfolk, 4 Department of Medicine( Dermatology) UCLA, Los Angeles, 5 Sun Pharmaceutical Industries, Inc., Princeton, 6 Merck & Co., Inc., Kenilworth, USA

Introduction: Tildrakizumab is a high-affinity, humanized, immunoglobulin G1κ monoclonal antibody against interleukin-23p19 for the treatment of chronic plaque psoriasis. Objectives: We evaluated gastrointestinal( GI) adverse events( AE) and, specifically, cases of inflammatory bowel disease( IBD; ie, Crohn’ s disease or ulcerative colitis) in the clinical development program for tildrakizumab. Methods: Patients with moderate to severe plaque psoriasis were randomized in 3 large clinical trials: P05495( phase 2; NCT01225731), reSURFACE 1( phase 3; NCT01722331), and reSURFACE 2( phase 3; NCT01729754) [ 1,2 ]. In this post hoc analysis, we sought to identify serious GI AEs and new-onset or exacerbation of pre-existing IBD from a pooled dataset of tildrakizumab-treated patients from these 3 trials, which followed patients up to 52( reSURFACE 2) or 64( reSURFACE 1) weeks. This analysis evaluated patients who received tildrakizumab 100 mg and 200 mg in P05495 and the reSURFACE trials. Results: In this analysis, we pooled 1911 patients from the 3 trials who received either tildrakizumab 100 or 200 mg. There were no new cases of IBD reported; among 6 patients with a history of IBD randomized to tildrakizumab, none experienced an exacerbation. The numbers( rate per 100 patient-years) of patients with serious GI AEs in the pooled dataset were 8( 0.80) for tildrakizumab 100 mg and 4( 0.43) for tildrakizumab 200 mg. These serious GI AEs included abdominal pain, constipation, diverticulum, dyspepsia, gastritis, thrombosed hemorrhoids, esophageal polyp, pancreatitis( 1 patient each) among patients treated with tildrakizumab 100 mg, and abdominal hernia, upper abdominal pain, acute pancreatitis, and salivary gland enlargement( 1 patient each) among patients treated with tildrakizumab 200 mg. Conclusion: In this post hoc analysis of patients from 3 large, randomized clinical trials, serious GI AEs were infrequent and there were no new cases of IBD or exacerbations of IBD. Acknowledgements: The studies were funded by Merck Sharp & Dohme, Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Reference: 1. Papp K, et al. Br J Dermatol. 2015; 173:930 – 939. 2. Reich K, et al. Lancet. 2017; 390:276 – 288.

P053 DURABLE REDUCTION IN ABSOLUTE PASI WITH CERTOLIZUMAB PEGOL IN PATIENTS WITH

CHRONIC PLAQUE PSORIASIS Alice B Gottlieb 1, Andrew Blauvelt 2, Diamant Thaçi 3, Craig Leonardi 4, Yves Poulin 5, Luke Peterson 6, Catherine Arendt 7, Marion Boehnlein 8, Kristian Reich 9

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Department of Dermatology, New York Medical College at Metropolitan Hospital, NY, NY, 2 Oregon Medical Research Center, Portland, OR, 3 University Hospital of Schleswig-Holstein Campus Lübeck, Lübeck, Germany,

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Central Dermatology and Saint Louis University School of Medicine, St. Louis, MO, 5 Centre de Recherche Dermatologique du Québec Métropolitain, Québec, Canada, 6 UCB Pharma, Raleigh, NC, 7 UCB Pharma, Brussels, Belgium, 8 UCB Pharma, Monheim, 9 SCIderm Research Institute, Hamburg, and Dermatologikum Berlin, Germany

Introduction: Certolizumab pegol( CZP), an Fc-free, PEGylated, anti-tumor necrosis factor, has shown efficacy in chronic plaque psoriasis( PSO).[ 1,2 ] Objectives: To assess the proportions of patients( pts) achieving selected PASI thresholds over 48 weeks of CZP treatment. Methods: Data were pooled from CIMPASI-1( NCT02326298) and CIMPASI-2( NCT02326272), ongoing phase 3 trials in adults with moderate to severe PSO ≥6 months( Psoriasis Area Severity Index [ PASI ] ≥12, ≥10 % body surface area affected, physician’ s global assessment ≥3 / 5). Pts were randomized 2:2:1 to CZP 400 mg every 2 weeks( Q2W), 200 mg Q2W( 400 mg loading dose [ LD ] at Weeks 0 / 2 / 4), or placebo( PBO). Week 16 PASI 50 responders receiving CZP continued the same dose to Week 48. We present the proportions of patients reaching PASI ≤ 1, 2, 3 and 5 at Weeks 16 and 48. Responder rate estimates were calculated using a logistic regression model. Pts not achieving PASI 50 at Weeks 16 / 32 / 40 / 48 were subsequently classed as non-responders. Other missing data were imputed using multiple imputation( Markov Chain Monte Carlo method). Results: At Week 0, 175, 186 and 100 pts were randomized to CZP 400 mg Q2W, CZP 200 mg Q2W, and PBO. Baseline mean PASI was comparable across CZP 400 mg Q2W / CZP 200 mg Q2W / PBO pts: 19.6( SD: 7.3)/ 19.2( 7.2)/ 18.6( 6.6). At Week 16, PASI ≤ 1 was achieved by 39.9 % pts receiving CZP 400 mg Q2W and 36.2 % CZP 200 mg pts, vs 2.6 % PBO pts. Similarly, a higher proportion of CZP vs PBO pts achieved PASI ≤ 2, PASI ≤ 3 and PASI ≤ 5( Table). In CZP-treated pts, PASI was maintained or further reduced to Week 48, with 48.2 % CZP 400 mg Q2W pts and 39.9 % CZP 200 mg Q2W pts achieving PASI ≤ 1 after 48 weeks’ treatment( Table). Conclusions: Higher proportions of CZP vs PBO pts met absolute PASI cut-offs over 16 weeks and response was maintained or further improved to Week 48. Although durability of response was observed with both doses, higher proportions of pts treated with CZP 400 mg Q2W than 200 mg Q2W were able to reach the most stringent cut-offs at Week 48. Reference: 1. Reich K,( 2017). Skin, 1; s23; 2. Augustin M,( 2017). Skin, 1; s24

Table. Pts achieving absolute PASI cut-offs at Weeks 16 and 48

PBO( n = 100) %( 95 % CI)

CZP 400 mg Q2W( n = 175) %( 95 % CI)

CZP 200 mg Q2Wa( n = 186) %( 95 % CI)

P054 RELATIONSHIPS BETWEEN TILDRAKIZUMAB DOSE, EXPOSURE, EFFICACY AND SAFETY IN PSORIASIS PHASE 3 STUDIES Bruce Strober 1, Howard Sofen 2, Paul Yamauchi 3, Alan Mendelsohn 4, Jeff Parno 4, Simon Lowry 4, Stephen Rozzo 4, Boni Elewski 5

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UConn Health, University of Connecticut, Farmington, CT, USA; Probity Medical Research, Waterloo, ON, Canada, 2 Ronald Reagan UCLA Medical Center, Los Angeles, CA, 3 University of California at Los Angeles Medical Center, Santa Monica, CA, 4 Sun Pharmaceutical Industries, Inc., Princeton, NJ, 5 University of Alabama at Birmingham Hospital, Birmingham, AL, USA Introduction: Tildrakizumab( TIL) is a high-affinity, humanized, www. medicaljournals. se / acta