Acta Dermato-Venereologica Suppl 219 AbstractPsoriasis2018 | Page 28

26

5 th World Psoriasis & Psoriatic Arthritis Conference 2018

1.1, serious infections 1.0; non-melanoma skin cancer 0.7; active TB < 0.1; and All-TEAEs leading to death 0.2. Standardized mortality ratio was 0.34( 95 % CI, 0.25 – 0.46), indicating the observed number of deaths was below expected in an age-, sex- and country-matched population. PGA clear / minimal was achieved by 57.0 %, 58.7 %, 59.1 %, 62.6 %, 61.9 %, 63.8 %, 65.5 %, and 45.0 % of pts at 12, 24, 36, 48, 60, 72, 84, and 96 mos, respectively. In 4202 US pts, mean change from baseline in Dermatology Quality of Life Index, total work productivity impairment, and total activity impairment at 12-mo intervals were-3.1 /-5.5 /-8.3,-3.2 /-5.4 /-9.1,-3.3 /-5.3 /-8.4,-3.5 /-5.6 /-8.7,-3.9 /-5.8 /-9.3,-3.7 /-6.3 /-8.7,-5.1 /- 9.1 /-11.4, and-5.9 /-7.5 /-13.8. Conclusions: In this 8-y interim analysis, no new safety signals were observed and safety was consistent with the known safety profile of ADA. The number of TE deaths in the registry was below the expected rate. As-observed effectiveness of ADA and improvement from baseline in PROs were maintained through 96 mos.

P057 DURABILITY OF RESPONSE IN CERTOLIZUMAB PEGOL-TREATED PATIENTS OVER 48 WEEKS IN

CIMPASI-1 & 2 TRIALS Kristian Reich 1, Andrew Blauvelt 2, Diamant Thaçi3, Craig Leonardi 4, Yves Poulin 5, Luke Peterson 6, Catherine Arendt 7, Alice B

Gottlieb 8 1

SCIderm Research Institute, Hamburg, and Dermatologikum Berlin, Germany, 2 Oregon Medical Research Center, Portland, USA, 3 University Hospital of Schleswig-Holstein Campus Lübeck, Lübeck, Germany, 4 Central Dermatology and Saint Louis University School of Medicine, St. Louis, USA, 5 Centre de Recherche Dermatologique du Québec Métropolitain, Québec, Canada, 6 UCB Pharma, Raleigh, USA, 7 UCB Pharma, Brussels, Belgium, 8 Department of Dermatology, New York Medical College at Metropolitan Hospital, NY, USA

Introduction: Certolizumab pegol( CZP), the only Fc-free, PE- Gylated, anti-tumor necrosis factor biologic, has shown clinical improvements and a safety profile consistent with the class in adults with chronic plaque psoriasis( PSO).[ 1,2,3 ] Objectives: To assess durability to Week 48 of the initial Week 16 clinical response with CZP in PSO patients( pts) in two identical phase 3 trials. Methods: Data were pooled from CIMPASI-1( NCT02326298) and CIMPASI-2( NCT02326272), ongoing CZP phase 3 trials in adults with PSO ≥6 months( Psoriasis Area Severity Index [ PASI ] ≥12, ≥10 % body surface area affected, physician’ s global assessment [ PGA ] ≥3 / 5). Pts were randomized 2:2:1 to CZP 400 mg every two weeks( Q2W), 200 mg Q2W( 400 mg loading dose [ LD ] at Weeks 0 / 2 / 4), or placebo( PBO). At Week 16, PASI 50 responders receiving CZP continued the same dose through the maintenance period to Week 48. PASI 50 non-responders at Weeks 32 / 40 / 48 were classed as non-responders at subsequent time points. These analyses do not include PBO pts or Week 16 PASI 50 non-responders. We report number needed to treat( NNT) to achieve PASI 75 at Week 16, and PASI 75 at Week 48 in pts who achieved PASI 75 at Week 16. Week 16 NNT, 95 % confidence intervals( 95 % CI) and Week 48 PASI 75 responder rates were estimated using logistic regression in which missing data and patients withdrawn due to relapse( < PASI 50 during the maintenance period) were imputed using multiple imputation( Markov Chain Monte Carlo [ MCMC ] method). Sensitivity analyses on PASI 75 were conducted using non-responder imputation( NRI). Results: At Week 16, NNT to achieve a PASI 75 response was 1.41( 95 % CI: 1.26 – 1.60) for the CZP 400 mg Q2W dose group and 1.53( 1.35 – 1.77) for the CZP 200 mg Q2W dose group. Of the pts randomized to CZP 400 mg Q2W and CZP 200 mg Q2W at Week 0 who entered the blinded maintenance phase, 132 / 149 and 130 / 150 achieved PASI 75, respectively. Out of Week 16 PASI 75 responders, 98.0 % of patients treated with CZP 400 mg Q2W and 87.5 % of patients treated with CZP 200 mq Q2W also reported a PASI 75 response at Week 48( Table). Sensitivity analyses using NRI showed similar trends with both doses, and similar trends were seen in PASI 90 response rates. Conclusions: These analyses show that patients in both CZP dose groups demonstrate durability of their initial Week 16 high-level response to Week 48, with greatest durability seen in the CZP 400 mg Q2W dose group( 98.0 % maintenance between Weeks 16 and 48). Reference: 1. Blauvelt A( 2018). Skin, 2: s16; 2. Reich K( 2017). Skin, 1; s23; 3. Augustin M( 2017). Skin, 1; s24

Table: Pts achieving PASI 75 at Week 48 among Week 16 PASI 75 responders pooled for CIMPASI-1 and CIMPASI-2

CZP 400 mg Q2W CZP 200 mg Q2Wa

P058 PRIMARY EFFICACY AND SAFETY OF ADALIMUMAB IN NAIL PSORIASIS FROM THE FIRST 26 WEEKS OF A PHASE-3, RANDOMIZED, PLACEBO-CONTROLLED TRIAL WITH SUBANALYSIS IN PATIENTS WITH AND WITHOUT PSORIATIC ARTHRITIS Boni E. Elewski 1, Pheobe A. Rich 2, Frank Behrens 3, Gérard Guillet 4, Ziqian Geng 5, Ofelia Reyes Servin 5

1

University of Alabama at Birmingham, School of Medicine, Birmingham, AL, USA, 2 Oregon Health and Science University Hospital, Portland, OR, USA, 3 Goethe University Medical Center, Frankfurt, Germany, 4 Hopital La Miletrie, Service de Dermatologie, CHU Poitiers, France, 5 AbbVie Inc, North Chicago, IL, USA

Introduction: Psoriasis( Ps) disease burden for patients with psoriasis( Ps) and concomitant fingernail Ps plus psoriatic arthritis( PsA) is higher compared with patients with Ps alone. Objective: We report safety and efficacy of originator adalimumab( ADA) in patients with fingernail Ps, and also for patients with or without concomitant PsA. Methods: Results are reported from the double-blind PBOcontrolled, Period A in which 217 patients with moderate to severe plaque Ps and fingernail Ps were included and randomized 1:1 to receive 40 mg ADA every other week( eow) from week 1( initial 80mg dose at week 0), or matching PBO, for 26 weeks. The primary endpoints were the proportion of patients with ≥75 % improvement in modified Nail Ps Severity Index( mNAPSI 75) and the proportion of patients with Physician’ s Global Assessment of Fingernail Psoriasis( PGA-F) of clear( 0) or minimal( 1) with ≥2-grade reduction from baseline( primary in US only; for regulatory purposes). Missing data were handled by multiple imputation. Safety was assessed using treatment-emergent adverse events( AEs). Results: Of the 217 randomized patients( 108 PBO, 109 ADA), 84.3 % were male; mean age was 46.7 years; 188( 86.6 %) completed 26 weeks of treatment or early escaped to Period B according to protocol. At baseline, 28.6 % had PsA( 29.6 % PBO, 27.5 % ADA) with mean duration 7.91 years [ SD 8.314 ]. Total fingernail mNAPSI 75 was achieved by 0.5 % PBO vs 61.5 % ADA of patients with PsA and 4.6 % PBO vs 40.9 % ADA without PsA( p < 0.001 for both groups). PGA-F 0 or 1 with ≥2-grade reduction was achieved by 4.4 % PBO vs 59.3 % ADA with PsA and 7.9 % PBO vs 44.9 % ADA without PsA( p < 0.001 for both groups). Adverse www. medicaljournals. se / acta