Synopsis Patients with moderate to severe plaque psoriasis were treated with certolizumab pegol for up to 144 weeks, initially dosed at either 200 mg or 400 mg every two weeks. High proportions of patients achieved and maintained stringent absolute PASI thresholds. Patients • Patient inclusion and exclusion criteria have been reported previously.2 Statistical Analysis • Proportions of patients achieving an absolute PASI score <5, <3, and <2 through Weeks 0–144 (Week 0 CZP-randomized patients) or Weeks 16–144 (placebo-randomized Week 16 PASI 50 non-responders) are reported. • Patients who were withdrawn at Week 32 or later due to lack of PASI 50 response, and those randomized to CZP who entered the escape arm at Week 16, were treated as non-responders at subsequent timepoints. All other missing data were imputed using Markov Chain Monte Carlo (MCMC) multiple imputation methodology. Responder rates reflect the simple average response; calculations included patients who did and did not dose adjust during the OLE. Results Patient Population and Baseline Characteristics • At Week 0, 175 and 186 patients were randomized to CZP 400 mg Q2W and CZP 200 mg Q2W, respectively. • 72 placebo-randomized patients did not achieve PASI 50 at Week 16 and entered the open-label CZP 400 mg Q2W escape arm. • Baseline demographics are shown in Table 1. Achievement and Maintenance of Low Absolute PASI Thresholds • Patients randomized to CZP demonstrated an initial rapid response, maintained to Week 48 (Figure 2). – In CZP 400 mg Q2W-randomized patients, responder rates decreased during the OLE following mandatory dose reduction (Figure 2A). – In CZP 200 mg Q2W-randomized patients, improvements were sustained to Week 144 (Figure 2B). • 32 weeks after switching to open-label CZP 400 mg Q2W treatment (study Week 48), 66.0% of patients initially randomized to placebo achieved PASI <2, and 75.9% achieved PASI <3 (Figure 2C). Responder rates were maintained through 128 weeks of CZP treatment (study Week 144). Conclusions High proportions of patients dosed with both CZP 400 mg Q2W and CZP 200 mg Q2W achieved and maintained stringent absolute PASI thresholds. Objectives To assess the long-term maintenance of absolute PASI <5, <3, and the more stringent <2 over three years in patients enrolled in two identically designed CZP in PSO phase 3 trials, the data from which were pooled. Background • Plaque psoriasis (PSO) is an immune-mediated, inflammatory disease that affects around 2−4% of adults.1 • Certolizumab pegol (CZP) is an Fc-free, PEGylated anti-tumor necrosis factor (anti-TNF) with demonstrated efficacy and safety in the treatment of moderate to severe PSO.2,3 • An absolute Psoriasis Area and Severity Index (PASI) score ≤5 has been associated with good quality of life in patients with PSO,4 while a PASI score ≤3 is considered excellent.5,6 Methods Study Design • Data were pooled from two phase 3 trials in adults with PSO: CIMPASI-1 (NCT02326298) and CIMPASI-2 (NCT02326272). • At Week 0, patients were randomized 2:2:1 to receive CZP 200 mg every 2 weeks (Q2W) (400 mg loading dose at Weeks 0, 2, and 4), CZP 400 mg Q2W, or placebo. • Patients included in this analysis were either: – Randomized to CZP 200 mg Q2W or CZP 400 mg Q2W at Week 0, or; – Randomized to placebo at Week 0, did not achieve ≥50% improvement from baseline in PASI (PASI 50) at Week 16, and entered the open-label escape arm where they received CZP 400 mg Q2W for up to 128 weeks (Figure 1). • Patients receiving double-blinded treatment who achieved PASI 50 at Week 48 received CZP 200 mg Q2W upon entry to the open-label extension (OLE). • Dosing adjustment was permitted from Week 48 onwards based on PASI response and the investigator’s discretion. A.B. Gottlieb,1 A. Blauvelt,2 D. Thaçi,3 Y. Poulin,4 F. Brock,5 C. Arendt,6 M. Boehnlein,7 K. Reich8 Figure 1 Study design: CIMPASI-1 and CIMPASI-2 Figure 2 Achievement and maintenance of low absolute PASI thresholds through to Week 144 Author Affiliations: 1Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA; 2Oregon Medical Research Center, Portland, OR, USA; 3Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany; 4Centre de Recherche Dermatologique du Québec Métropolitain, Québec, Canada; 5UCB Pharma, Slough, UK; 6UCB Pharma, Brussels, Belgium; 7UCB Pharma, Monheim am Rhein, Germany; 8Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, and Skinflammation® Center, Hamburg, Germany. Presented at Fall Clinical Dermatology Conference 2020 | October 29–November 1 | Las Vegas, NV Reductions in Absolute PASI Over 144 Weeks of Treatment with Certolizumab Pegol in Patients with Plaque Psoriasis: Pooled Analysis from Two Phase 3 Trials (CIMPASI-1 and CIMPASI-2) References: 1Parisi R. J Invest Dermatol 2013;133:377–85; 2Gottlieb AB. JAAD 2018;79:302–14; 3Lebwohl M. JAAD 2018;79:266–76; 4Zweegers J. et al. Br J Dermatol 2017;176:786–93; 5Carrascosa Carrillo JM. J Dermatolog Treat 2017;29:140–4; 6Puig L. Eur J Dermatol 2015;25:410–7. Author Contributions: Substantial contributions to study conception/design, or acquisition/analysis/interpretation of data: ABG, AB, DT, YP, FB, CA, MB, KR; Drafting of the publication, or revising it critically for important intellectual content: ABG, AB, DT, YP, FB, CA, MB, KR; Final approval of the publication: ABG, AB, DT, YP, FB, CA, MB, KR. Author Disclosures: ABG: Received honoraria as an advisory board member and consultant for Avotres Therapeutics, Beiersdorf, Boehringer Ingelheim, Bristol-Myers Squibb Co., Eli Lilly, Incyte, Janssen, LEO Pharma, Novartis, Sun Pharma, UCB Pharma, and Xbiotech (only stock options which she has not used); and has received research/educational grants from Boehringer Ingelheim, Incyte, Janssen, Novartis, Sun Pharma, UCB Pharma, and 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 Inc., Eli Lilly, Forte, Galderma, Janssen, LEO Pharma, Novartis, Ortho, Pfizer, Regeneron, Sandoz, Sanofi Genzyme, Sun Pharma, and UCB Pharma, and as a paid speaker for AbbVie; DT: Honoraria for participation on advisory boards, as a speaker and for consultancy from AbbVie, Almirall, Amgen, Biogen-Idec, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, DS-Biopharma, Eli Lilly, Galapagos, Janssen, LEO Pharma, Morphosis, Novartis, Pfizer, Regeneron, Samsung, Sandoz-Hexal, Sanofi and UCB Pharma; Research grants received from Celgene, LEO Pharma 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; FB, CA, MB: Employees of 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. Acknowledgements: 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, MSc, UCB Pharma, Monheim am Rhein, Germany for publication coordination and Dan Smith, BA (Hons), Costello Medical, Cambridge, UK 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. BSA: body surface area; CZP: certolizumab pegol; DLQI: Dermatology Life Quality Index; IL: interleukin; LD: loading dose; MCMC: Markov Chain Monte Carlo; OLE: open-label extension; PASI: Psoriasis Area and Severity Index; PASI 50/75: 50%/75% or greater improvement from baseline in PASI; PGA: Physician’s Global Assessment; PsA: psoriatic arthritis; PSO: plaque psoriasis; Q2W: every two weeks; SD: standard deviation; TNF: tumor necrosis factor. Week 0 14416 4832 Initial treatment period (double-blinded) Maintenance period (double-blinded) Open-label treatment