SynopsisObjective To assess the impact of certolizumab pegol on dermatology life quality subdomains over the course of 144 weeks of treatment in patients with moderate to severe plaque psoriasis. Introduction • Certolizumab pegol (CZP) is an Fc-free, PEGylated, anti-tumor necrosis factor agent that has shown durable clinical improvements over 144 weeks of treatment in patients with moderate to severe plaque psoriasis (PSO).1,2 • PSO can negatively impact health-related quality of life (HRQoL), with links to pain and discomfort, social stigmatization, and psychological distress.3 Therefore, it is important to understand whether clinical responses translate into long-term improvements in HRQoL. • Here, we present Dermatology Life Quality Index (DLQI) results over 144 weeks of CZP treatment to evaluate the impact of CZP across different DLQI subdomains and to expand upon DLQI remission rates (DLQI 0/1) previously reported.2 Materials and Methods Study Design and Patients • Data were pooled from CIMPASI-1 (NCT02326298) and CIMPASI-2 (NCT02326272), phase 3 trials in adults with moderate to severe PSO; detailed study designs have been described previously (Figure 1).2,4 • DLQI by initial CZP randomization group through Week 144 is reported, as observed. • We report: – Absolute scores for total DLQI and DLQI subdomains through Weeks 0–144. – Rate of DLQI subdomain remission, defined as a score of 0, indicating no impact of skin disease on that concept, at Weeks 48 and 144. Results • Baseline demographics are shown in Table 1 and patient numbers with available DLQI data at each week are shown in Table 2. • Improvements in total DLQI observed over the first 48 weeks of CZP treatment were durable through to Week 144 (Figure 2). • Across all DLQI subdomains, baseline mean scores were similar between treatment groups (Table 3). • At baseline, the DLQI subdomains with the highest scores were symptoms and feelings, daily activities, and leisure, indicating greatest impact of disease on these areas (Table 3). • Improvements in the scores for these DLQI subdomains over the first 48 weeks were durable through to Week 144 for both treatment groups (Figure 3). • Remission rates at Week 48 across subdomains of interest were also maintained until Week 144 for both treatment groups (Figure 4). A. Blauvelt,1 R.B. Warren,2 K. Reich,3 F. Brock,4 F. Fierens,5 V. Ciaravino,6 M. Lebwohl7 BMI: body mass index; BSA: body surface area; CZP: certolizumab pegol; DLQI: dermatology life quality index; IL: interleukin; OC: observed case; PASI: Psoriasis Area and Severity Index; PGA: Physician’s Global Assessment; PSO: psoriasis; Q2W: every two weeks; SD: standard deviation; TNF: tumor necrosis factor. Remission is defined as a score of 0, indicating no impact of skin disease on that concept. Table 2 Patient numbers with available DLQI data Table 3 Baseline DLQI subdomain scores (OC) Figure 1 CIMPASI-1 and CIMPASI-2 study design Figure 2 Total DLQI through Weeks 0–144 (OC)Table 1 Demographic and baseline characteristics Figure 4 Remission rates for DLQI subdomains at Week 48 and 144 (OC) Figure 3 Absolute scores by DLQI subdomain through Weeks 0–144 (OC) aCZP 200 mg Q2W patients received CZP 400 mg Q2W at Weeks 0, 2 and 4. Adults with PSO ≥6 months (PASI >12, BSA affected ≥10% and PGA ≥3 on a 5-point scale) were enrolled. At Week 48, patients entering the open-label period from blinded treatment received CZP 200 mg Q2W, with subsequent dose adjustments permitted. Patients not achieving PASI 50 at Week 16 entered the escape arm for treatment with CZP 400 mg Q2W; at Week 48 these patients continued to receive CZP 400 mg Q2W or, if they achieved PASI 75, could have had their dose reduced at the investigator’s discretion. aLoading dose of CZP 400 mg Q2W at Weeks 0, 2 and 4 or Weeks 16, 18 and 20. bDose adjustments were mandatory or at the discretion of the Investigator, based on PASI response. aCZP 200 mg Q2W patients received CZP 400 mg Q2W at Weeks 0, 2 and 4. Lower scores indicate greater quality of life. All subdomains are scored 0–6 with the exception of work and school and treatment which are scored 0–3. Mean ± SD unless stated CZP 400 mg Q2W (N=175) CZP 200 mg Q2Wa (N=186) All CZP (N=361) Age (years) 45.0 ± 12.9 45.6 ± 13.2 45.3 ± 13.0 Male, n (%) 103 (58.9) 125 (67.2) 228 (63.2) BMI, kg/m2 31.2 ± 7.9 32.0 ± 7.8 31.6 ± 7.8 Duration of PSO (years) 18.5 ± 12.6 17.7 ± 12.9 18.1 ± 12.7 PASI 19.6 ± 7.3 19.2 ± 7.2 19.4 ± 7.3 BSA (%) 23.6 ± 14.3 23.5 ± 14.9 23.5 ± 14.6 PGA score, n (%) 3: moderate 126 (72.0) 128 (68.8) 254 (70.4) 4: severe 49 (28.0) 58 (31.2) 107 (29.6) Total DLQI 13.7 ± 6.9 14.3 ± 7.4 14.0 ± 7.1 Prior biologic use, n (%) 59 (33.7) 62 (33.3) 121 (33.5) anti-TNF 40 (22.9) 44 (23.7) 84 (23.3) anti-IL17 8 (4.6) 16 (8.6) 24 (6.6) anti-IL-12/IL-23 10 (5.7) 3 (1.6) 13 (3.6) Mean ± SD CZP 400 mg Q2W (n=173) CZP 200 mg Q2Wa (n=183) All CZP (n=356) Symptoms and feelings 4.1 ± 1.4 4.2 ± 1.5 4.2 ± 1.4 Daily activities 3.2 ± 1.7 3.2 ± 1.9 3.2 ± 1.8 Leisure 2.4 ± 1.9 2.7 ± 2.0 2.5 ± 2.0 Work and school 0.9 ± 1.0 0.9 ± 1.0 0.9 ± 1.0 Personal relationships 1.9 ± 1.9 2.0 ± 1.9 1.9 ± 1.9 Treatment 1.2 ± 1.1 1.3 ± 1.1 1.3 ± 1.1 Study Week 0 2 8 12 16 24 32 48 60 72 84 96 108 120 132 144 CZP 400 mg Q2W 173 172 171 168 170 159 152 148 140 141 136 131 124 123 114 113 CZP 200 mg Q2W 183 183 173 177 174 164 159 151 142 138 130 128 124 119 106 110 Institutions: 1Oregon Medical Research Center, Portland, OR; 2Dermatology Centre, Salford Royal NHS Foundation Trust, Manchester NIHR Biomedical Research Centre, The University of Manchester, Manchester, UK; 3Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg- Eppendorf and Skinflammation® Center, Hamburg, Germany; 4UCB Pharma, Slough, UK; 5UCB Pharma, Brussels, Belgium; 6UCB Pharma, Colombes, France; 7Icahn School of Medicine at Mount Sinai, New York, NY Presented at Fall Clinical Dermatology Conference 2020 | October 29–November 1 | Las Vegas, NV Conclusion Improvements in total DLQI were durable from Week 48 to Week 144 across both CZP treatment groups. This pattern was reflected in the DLQI subdomains (symptoms and feelings, daily activities, and leisure) which had the greatest impact on patients’ lives at baseline. Durability of DLQI Improvements Among Patients with Moderate to Severe Plaque Psoriasis Treated with Certolizumab Pegol: Three-Year Results from Two Phase 3 Trials (CIMPASI-1 and CIMPASI-2) References: 1Gordon K. BJD 2020; doi.org/10.1111/bjd.19393; 2Blauvelt A. BJD 2020; doi.org/10.1111/bjd.19314; 3Bhosle MJ. Health Qual Life Outcomes 2006;4:35; 4Gottlieb AB. JAAD 2018;79:302–14.e6; 5Finlay AY. Clin Exp Dermatol 1994;19:210–6. Author Contributions: Substantial contributions to study conception/design, or acquisition/analysis/interpretation of data: AB, RBW, KR, FB, FF, VC, ML; Drafting of the publication, or revising it critically for important intellectual content: AB, RBW, KR, FB, FF, VC, ML; Final approval of the publication: AB, RBW, KR, FB, FF, VC, ML. Author Disclosures: AB: Scientific adviser and/or clinical study investigator for AbbVie, Allergan, Almirall, Athenex, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Eli Lilly, Forte, Galderma, Incyte, Janssen, LEO Pharma, Novartis, Pfizer, Rapt, Regeneron, Sanofi Genzyme, Sun Pharma, and UCB Pharma; paid speaker for AbbVie; RBW: Consulting fees from AbbVie, Almirall, Amgen, Arena, Avillion, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Janssen, LEO Pharma, Novartis, Pfizer, Sanofi, and UCB Pharma; research grants from AbbVie, Almirall, Amgen, Celgene, Eli Lilly, Janssen, LEO Pharma, Novartis, Pfizer, and UCB Pharma; KR: Served as advisor and/or paid speaker for and/or participated in clinical trials sponsored by AbbVie, Affibody, Almirall, Amgen, Avillion, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Centocor, Covagen, Dermira, Eli Lilly, Forward Pharma, Fresenius Medical Care, Galapagos, GSK, Janssen, Kyowa Kirin, LEO Pharma, Medac, MSD, Miltenyi Biotec, Novartis, Ocean Pharma, Pfizer, Regeneron, Samsung Bioepis, Sanofi, Sun Pharma, Takeda, UCB Pharma, Valeant/Bausch Health, and Xenoport; FB, FF, VC: Employees of UCB Pharma; ML: Employee of Mount Sinai which receives research funds from AbbVie, Amgen, Arcutis, Boehringer Ingelheim, Dermavant, Eli Lilly, Incyte, Janssen, LEO Pharma, Ortho Dermatologics, Pfizer, and UCB Pharma; consultant for Aditum Bio, Allergan, Almirall, Arcutis, Avotres, BirchBioMed, BMD Skincare, Boehringer Ingelheim, Bristol Myers Squibb, Cara Therapeutics, Castle Biosciences, Corrona, Dermavant, Evelo, Facilitate International Dermatologic Education, Foundation for Research and Education in Dermatology, Inozyme Pharma, LEO Pharma, Meiji Seika Pharma, Menlo, Mitsubishi Pharma, Neuroderm, Pfizer, Promius/Dr. Reddy’s Laboratories, Serono, Theravance, and Verrica. Acknowledgements: This study was funded by UCB Pharma. We thank the patients and their caregivers in addition to the investigators and their teams who contributed to this study. The authors acknowledge Susanne Wiegratz, MSc, UCB Pharma, Monheim am Rhein, Germany for publication coordination, Ruth Moulson, MPH, Costello Medical, London and Joe Dixon, PhD, Costello Medical, Cambridge for medical writing and editorial assistance and the Costello Medical Design Team for design support. All costs associated with development of this poster were funded by UCB Pharma in accordance with the Good Publication Practice (GPP3) guidelines. A) Symptoms and feelings B) Daily activities C) Leisure D LQ I re m is si o n r a te ( % ) 100 80 60 40 20 0 Week 48 Week 144 D LQ I re m is si o n r a te ( % ) 100 80 60 40 20 0 Week 48 Week 144 D LQ I re m is si o n r a te ( % ) 100 80 60 40 20 0 Week 48 Week 144 52.7 40.4 47.8 40.9 76.4 66.2 71.7 71.8 83.8 74.8 78.8 79.1 CZP 400 mg Q2W CZP 200 mg Q2WCZP 400 mg Q2W CZP 200 mg Q2W CZP 400 mg Q2W CZP 200 mg Q2W A) Symptoms and feelings B) Daily activities C) Leisure Open-label period with possible dose adjustment Open-label period with possible dose adjustment Open-label period with possible dose adjustment S u b d o m a in s c o re ( m e a n ) 6 5 4 3 2 1 0 S u b d o m a in s c o re ( m e a n ) 0 S u b d o m a in s c o re ( m e a n ) 0 CZP 400 mg Q2W CZP 200 mg Q2W CZP 400 mg Q2W CZP 200 mg Q2W CZP 400 mg Q2W CZP 200 mg Q2W 6 5 4 3 2 1 0 6 5 4 3 2 1 0 16 32 48 64 80 96 112 128 144 0 16 32 48 64 80 96 112 128 144 0 16 32 48 64 80 96 112 128 144 0.4 0.4 0.4 0.3 0.5 0.5 0.6 0.4 0.9 1.2 0.8 1.1 Week WeekWeek Open-label period with possible dose adjustment T o ta l D LQ I (m e a n ) 30 25 20 15 10 5 0 CZP 400 mg Q2W CZP 200 mg Q2W 0 16 32 48 64 80 96 112 128 144 2.6 2.9 2.0 2.7 Week The DLQI questionnaire is comprised of 10 questions, each providing a score of 0–3 where higher scores indicate a greater impact of skin on that aspect of a patient’s quality of life.5 Here, we present analyses based on total DLQI and individual subdomains: The DLQI subdomains with the highest scores at baseline were symptoms and feelings, daily activities, and leisure. Remission rates (score of 0) in these subdomains after 144 weeks of treatment for patients randomized to CZP 400 mg Q2W and CZP 200 mg Q2W were as follows: Daily activities 71.7% 71.8% Leisure 78.8% 79.1% Symptoms and feelings 47.8% 40.9% CZP 400 mg Q2W CZP 200 mg Q2W Itchy/sore/ painful stinging Embarrassed/ self-conscious Interference with shopping/home/ garden Influence on clothes worn Problems with partners/friends/ relatives Any sexual di�culties • • • • • • • • • • A�ects social/ leisure activities Makes it di�cult to do any sports Symptoms and feelings Daily activities Personal relationships Leisure Prevents or causes problems with work or studying How much of a problem is treatment Work and school Treatment Methods Results Improvements in DLQI among CZP-treated patients were durable from Week 48 to Week 144. Conclusion Score range of 0–3 (1 question each) Score range of 0–6 (2 questions each) <PASI 50 Initial treatment period (double-blinded) Screening Maintenance period Safety follow-up Open-label extension period (dose adjustment possible)b LDa 48Week 32 152160 40 144 Mandatory At the Investigator's discretion Withdrawal Placebo Q2W CZP 400 mg Q2W Escape: Open-label CZP 400 mg Q2W CZP 200 mg Q2W CZP 200 mg Q2W 1: 2 :2 ra n d o m iz a ti o n CZP 400 mg Q2W ≥PASI 50, <PASI 75 LDa ≥PASI 75 <PASI 50 ≥PASI 75 ≥PASI 50 <PASI 75 <PASI 50 – withdrawn<PASI 50 – withdrawn ≥PASI 75