Previously presented at AAD 2020Presented at the 5th Annual 2020 PA & NP Fall Clinical Dermatology Conference, Orlando, Florida, November 13–15, 2020 OBJECTIVE • To assess the long-term efficacy of and durability of response to certolizumab pegol dosed at 400 mg every two weeks in patients with moderate to severe plaque psoriasis who achieve PASI 75 after an initial 16 weeks of treatment. Outcomes • Outcomes are reported for Week 0 placebo-randomized patients who did not achieve PASI 50 at Week 16, and entered the CZP 400 mg Q2W escape arm (Weeks 16–144). • We report PASI 75, PASI 90, PGA 0/1 and Dermatology Life Quality Index (DLQI) 0/1 responses to Week 144. • Missing data were imputed using Markov Chain Monte Carlo (MCMC) methodology. • Responder rates reflect the simple average response and include patients who did and did not dose adjust during the open-label period. RESULTS • 116 placebo-randomized patients had a PASI <50 at Week 16 and entered the CZP 400 mg Q2W escape arm. • Baseline characteristics of included patients are shown in Table 1. • Patients demonstrated a rapid response during the first 16 weeks of CZP 400 mg Q2W treatment, with 74.7% achieving a PASI 75 response and 48.7% a PASI 90 response. – These responses were durable over 128 weeks of treatment: PASI 75 and PASI 90 responses were 75.5% and 57.6%, respectively, at Week 144 (Figure 2). • Of the patients who achieved PASI 75 after 16 weeks’ CZP treatment, 65.9% also achieved PASI 90. – After a further 128 weeks’ CZP treatment, 82.4% of these patients maintained PASI 75 and 64.4% achieved PASI 90 (Figure 2). • Similar trends were reported for PGA 0/1 (Figure 3) and DLQI 0/1 (Figure 4). BACKGROUND • Certolizumab pegol (CZP), an Fc-free, PEGylated anti-tumor necrosis factor (anti-TNF), has demonstrated efficacy and safety in moderate to severe plaque psoriasis (PSO).1,2 METHODS Study Design • Pooled data from the CIMPASI-1 (NCT02326298), CIMPASI-2 (NCT02326272), or CIMPACT (NCT02346240) phase 3 studies are reported (Figure 1). • Patient inclusion criteria: – ≥18 years of age with PSO for ≥6 months; – Psoriasis Area and Severity Index (PASI) ≥12; – ≥10% body surface area (BSA) affected; – Physician’s Global Assessment (PGA) ≥3 on a 5-point scale; – Candidates for systemic PSO therapy, phototherapy and/or photochemotherapy. References 1. Gottlieb A.B. et al. JAAD 2018;79:302–14.e6; 2. Lebwohl M. et al. JAAD 2018;79:266–76.e5. Author Contributions Substantial contributions to study conception/design, or acquisition/analysis/interpretation of data: KG, RBW, ABG, AB, DT, YP, MB, FB, CA, KR; Drafting of the publication, or revising it critically for important intellectual content: KG, RBW, ABG, AB, DT, YP, MB, FB, CA, KR; Final approval of the publication: KG, RBW, ABG, AB, DT, YP, MB, FB, CA, KR. Author Disclosures KG: Honoraria and/or research support from AbbVie, Almirall, Amgen, Boehringer Ingelheim, Bristol- Myers Squibb, Celgene, Dermira Inc., Eli Lilly, Janssen, Novartis, Pfizer, Sun Pharma, and UCB Pharma; RBW: Research grants and/or consulting fees from AbbVie, Almirall, Amgen, Arena, Avillion, Bristol- Myers Squibb, Boehringer Ingelheim, Celgene, Eli Lilly, Janssen, Leo Pharma, Novartis, Pfizer, Sanofi, UCB Pharma; ABG: Current consulting/advisory board agreements with AbbVie, Avotres Therapeutics, Beiersdorf, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, Incyte, Janssen, Leo Pharma, Novartis, Sun Pharma, UCB Pharma, XBiotech; Research and educational grants from Boehringer Ingelheim, Incyte, Janssen, Novartis, UCB Pharma, XBiotech; AB: Served as a scientific adviser and/or clinical study investigator for AbbVie, Aclaris, Allergan, Almirall, Athenex, Boehringer Ingelheim, Bristol- Myers Squibb, Dermavant, Dermira, Eli Lilly and Company, FLX Bio, Forte, Galderma, Janssen, Leo, Novartis, Ortho, Pfizer, Regeneron, Sandoz, Sanofi Genzyme, Sun Pharma, and UCB Pharma, and as a paid speaker for AbbVie; DT: Honoraria for participation on ad boards, as a speaker or for consultancy from AbbVie, Almiral, Amgen, Boehringer Ingelheim, Celgene, Dignity, Dr. Reddy’s Laboratories, Galapagos, GSK, Janssen, Leo Pharma, Morphosis, MSD, Lilly, Novartis, Pfizer, Sandoz-Hexal, Pfizer, Regeneron/Sanofi, UCB Pharma; Research grants from Celgene and Novartis; YP: Investigator (research grants) from AbbVie, Baxter, Boehringer Ingelheim, Celgene, Centocor/Janssen, Eli Lilly, EMD Serono, GSK, Leo Pharma, MedImmune, Merck, Novartis, Pfizer, Regeneron, Takeda, and UCB Pharma; Speaker (honoraria) from AbbVie, Celgene, Janssen, Eli Lilly, Leo Pharma, Novartis, Regeneron, and Sanofi Genzyme; MB, FB, CA: Employees of UCB Pharma; KR: AbbVie, Affibody, Amgen, Biogen, Boehringer Ingelheim, Celgene, Centocor, Covagen, Forward Pharma, GSK, Janssen-Cilag, Kyowa Kirin, LEO Pharma, Eli Lilly, Medac, Merck Sharp & Dohme Corp., Novartis, Ocean Pharma, Pfizer, Regeneron, Samsung Bioepis, Sanofi, Takeda, UCB Pharma, Valeant and Xenoport. Acknowledgments The studies were funded by Dermira Inc. in collaboration with UCB Pharma. UCB is the regulatory sponsor of certolizumab pegol in psoriasis. 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, UCB Pharma, Monheim, Germany for publication coordination and Joe Dixon, PhD, Costello Medical, Cambridge, UK for medical writing and editorial assistance. All costs associated with development of this poster were funded by UCB Pharma. CONCLUSIONS • CZP dosed at 400 mg Q2W offers a durable, long-term treatment option for patients with moderate to severe PSO. Durable Efficacy of Certolizumab Pegol Dosed at 400 mg Every Two Weeks Over 128 Weeks in Patients with Plaque Psoriasis Enrolled in Three Phase 3 Trials (CIMPASI-1, CIMPASI-2 and CIMPACT) K. Gordon,1 R. B. Warren,2 A. B. Gottlieb,3 A. Blauvelt,4 D. Thaçi,5 Y. Poulin,6 M. Boehnlein,7 F. Brock,8 C. Arendt,9 K. Reich10,11 1Department of Dermatology, Medical College of Wisconsin, Milwaukee, WI, USA; 2Dermatology Centre, Salford Royal NHS Foundation Trust, Manchester NIHR Biomedical Research Centre, The University of Manchester, UK; 3Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA; 4Oregon Medical Research Center, Portland, OR, USA; 5Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany; 6Centre de Recherche Dermatologique du Québec Métropolitain, Québec, Canada; 7UCB Pharma, Monheim, Germany; 8UCB Pharma, Slough, UK; 9UCB Pharma, Brussels, Belgium; 10Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf; 11Skinflammation® Center, Hamburg, Germany aCIMPASI-1: NCT02326298; CIMPASI-2: NCT02326272; CIMPACT: NCT02346240; bLoading dose of CZP 400 mg Q2W at Week 0, 2, and 4; cDepending on PASI response, any dose adjustments were either mandatory or at the investigators discretion: BW: twice per week; CZP: certolizumab pegol; ETN: etanercept; LD: loading dose; PASI 50/75: 50%/75% improvement from Baseline in Psoriasis Area Severity Index; Q2W: every two weeks. aDepending on PASI response, dose reductions to CZP 200 mg Q2W were permitted at the discretion of the investigator. CZP: certolizumab pegol; PASI 75/90: 75/90% improvement from Baseline in Psoriasis Area Severity Index; Q2W: every two weeks. aDepending on PASI response, dose reductions to CZP 200 mg Q2W were permitted at the discretion of the investigator. CZP: certolizumab pegol; PGA 0/1: Physician’s Global Assessment score of 0 or 1 (“clear” or “almost clear”) with ≥2-point improvement from baseline; Q2W: every two weeks. Figure 1. Study design of CIMPASI-1 and 2 and CIMPACT CIMPASI-1 and CIMPASI-2a CIMPACTa Figure 2. PASI 75 and PASI 90 responses to Week 144 Figure 3. PGA 0/1 response to Week 144 Figure 4. DLQI 0/1 response to Week 144 aDepending on PASI response, dose reductions to CZP 200 mg Q2W were permitted at the discretion of the investigator. CZP: certolizumab pegol; DLQI 0/1: Dermatology Life Quality Index of 0 or 1; no effect of disease on quality of life; PASI 75: 75% improvement from baseline in Psoriasis Area Severity Index; Q2W: every two weeks. 0 16 4840 443212 36Week 144