Presented at Fall Clinical Dermatology Conference 2019 | Las Vegas, NV, USA | 17–20 October, 2019 Previously Presented at the 6th Congress of the Skin Inflammation & Psoriasis International Network BACKGROUND • Plaque psoriasis (PSO) is an immune-mediated, inflammatory disease; treatment options include systemic medication, phototherapy and biologic agents. • Certolizumab pegol (CZP) is a unique, Fc-free, PEGylated, anti-tumor necrosis factor (TNF) biologic approved for the treatment of adults with moderate to severe PSO by the FDA and EMA.1,2 • CZP has demonstrated sustained improvements in the skin disease of adults with moderate to severe PSO in phase 3 trials.3,4 • In the RAPID-PsA phase 3 trial of CZP in psoriatic arthritis (PsA), 54% of patients achieved total resolution of their nail disease after 48 weeks’ CZP treatment, increasing to 71% after 4 years.5 However, nail disease outcomes from the CZP in PSO phase 3 trials have not yet been reported. • Here, nail disease outcomes in patients with PSO who received double-blinded CZP over 48 weeks in three phase 3 trials are presented. METHODS Study Design • Patients with PSO were enrolled in three phase 3, placebo-controlled, double-blind trials of CZP in adults with moderate to severe PSO: CIMPASI-1 (NCT02326298), CIMPASI-2 (NCT02326272) and CIMPACT (NCT02346240) (Figure 1).3,4 Patients • Inclusion criteria: ≥18 years of age with PSO for ≥6 months with Psoriasis Area Severity Index (PASI) ≥12, ≥10% body surface area affected, Physician’s Global Assessment ≥3 on a 5-point scale. Candidates for systemic PSO therapy, phototherapy and/or photochemotherapy. • Exclusion criteria: previous treatment with CZP or >2 biologics; previous treatment with etanercept (ETN) (CIMPACT only); treatment with ETN within the first 12-weeks of enrolment (CIMPASI-1 and CIMPASI-2 only); history of primary failure to any biologic or secondary failure to >1 biologic; erythrodermic, guttate or generalized PSO types; current or history of chronic or recurrent viral, bacterial or fungal infections. • Presence or absence of concomitant PsA (+PsA and –PsA respectively) was self-reported by patients at baseline. • This analysis includes patients with nail disease at baseline (defined as a modified Nail Psoriasis Severity Index [mNAPSI] score >0) who received the same dose of CZP through 48 weeks. Study Assessments and Statistical Analyses • mNAPSI 75 (≥75% improvement from baseline), total resolution of nail disease (mNAPSI=0) and change from baseline in mNAPSI are reported at Week 48 (post-baseline mNAPSI was not measured prior to Week 48). • Observed data are reported for patients who received CZP 200 mg every two weeks (Q2W) and CZP 400 mg Q2W, stratified by self-reported PsA at baseline. • Data are pooled for CIMPASI-1 and CIMPASI-2. References 1. Certolizumab Pegol Prescribing Information. Available at http:// www.accessdata.fda.gov; 2. Certolizumab Pegol Summary of Product Characteristics. Available at http://www.ema.europa.eu/ema; 3. Gottlieb AB. et al. JAAD 2018;79:302–14.e6; 4. Lebwohl M. et al. JAAD 2018;79:266–76.e5; 5. van der Heijde D. RMD Open 2018;4:e000582. Author Contributions Substantial contributions to study conception/design, or acquisition/ analysis/interpretation of data: ABG, DT, CL, YP, SK, MB, KR; Drafting of the publication, or revising it critically for important intellectual content: ABG, DT, CL, YP, SK, MB, KR; Final approval of the publication: ABG, DT, CL, YP, SK, MB, KR. Author Disclosures ABG: AbbVie, Allergan, Beiersdorf Inc., Bristol-Myers Squibb, Celgene, Dermira Inc., Eli Lilly, Janssen, Incyte, LEO Pharma, Novartis, Reddy Labs, Sun Pharma, UCB Pharma, Valeant; DT: AbbVie, Almirall, Amgen, Boehringer-Ingelheim, Celgene, Dignity, Dr. Reddy, Galapagos, GSK, Janssen, LEO Pharma, Morphosis, MSD, Eli Lilly, Novartis, Pfizer, Sandoz- Hexal, Regeneron/Sanofi, UCB Pharma; CL: AbbVie, Actavis, Amgen, Boehringer Ingelheim, Celgene, Coherus, Corrona, Dermira Inc., Eli Lilly, Galderma, Glenmark, Janssen, LEO Pharma, Merck, Novartis, Novella, Pfizer, Sandoz, Stiefel, Wyeth, UCB Pharma, Vitae. Treasurer of the International Psoriasis Council. Fellow of the American Academy of Dermatology. Member of the American Dermatological Association. Adjunct Professor of Dermatology at St. Louis University School of Medicine. Private practice in St. Louis, MO; YP: AbbVie, Baxter, Boehringer Ingelheim, Celgene, Centocor/Janssen, Eli Lilly, EMD Serono, GSK, LEO Pharma, MedImmune, Merck, Novartis, Pfizer, Regeneron, Sanofi Genzyme, Takeda, UCB Pharma; SK, MB: 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, 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 Bartosz Łukowski, MSc, UCB Pharma, Brussels, Belgium for publication coordination and Hinal Tanna, PhD, Costello Medical, Cambridge, UK for medical writing and editorial assistance. All costs associated with development of this poster were funded by UCB Pharma. Since conducting this work KR has moved institute and is now affiliated with Skinflammation® Center, Hamburg, and Dermatologikum Berlin, Berlin, Germany. CONCLUSIONS • Substantial proportions of patients with PSO treated with CZP over 48 weeks showed improved nail disease, with more than 6 in every 10 patients achieving total resolution. • CZP demonstrated similar efficacy in treating nail disease in PSO patients with and without concomitant PsA. • The efficacy of CZP treatment on nail disease outcomes observed in patients with PSO is comparable with previously reported efficacy in patients with PsA. OBJECTIVE • To report the impact of 48 weeks’ certolizumab pegol treatment on nail disease outcomes in patients with moderate to severe plaque psoriasis. Nail Outcome Improvements with Certolizumab Pegol in Moderate to Severe Plaque Psoriasis: Results from Phase 3 Trials A. B. Gottlieb,1 D. Thaçi,2 C. Leonardi,3 Y. Poulin,4 S. Kavanagh,5 M. Boehnlein,6 K. Reich7 1Icahn School of Medicine at Mount Sinai, New York, NY, USA; 2University of Lübeck, Lübeck, Germany; 3Central Dermatology and Saint Louis University School of Medicine, St Louis, MO, USA; 4Centre de Recherche Dermatologique du Québec Métropolitain, Québec, Canada; 5UCB Pharma, Raleigh, NC, USA; 6UCB Pharma, Monheim, Germany; 7SCIderm Research Institute, Hamburg, and Dermatologikum Berlin, Germany Figure 1. Study design for CZP in PSO phase 3 trials RESULTS • 154 patients in CIMPASI-1/2 and 71 patients in CIMPACT had nail disease at baseline and were randomized to CZP treatment at Week 0. • Patient baseline characteristics are shown in Table 1. • Patients completing 48 weeks of CZP treatment in CIMPASI-1/2 or CIMPACT demonstrated considerable improvement in their nail disease (Figure 2A), and of these: – Over 70% patients achieved mNAPSI 75 (Figure 2B) – Over 65% demonstrated total resolution of their nail disease (Figure 2C). • Similar results were observed between patients with and without self-reported concomitant PsA (Figure 2). Only patients who received the same dose of CZP through Weeks 0–48 are included in these analyses. aPatients received CZP 400 mg loading dose at Weeks 0, 2 and 4 or Weeks 16, 18 and 20. BW: bi-weekly; CZP: certolizumab pegol; ETN: etanercept; LD: loading dose; PASI: Psoriasis Area Severity Index; Q2W: every two weeks; Q4W: every four weeks. Table 1. Demographics and baseline characteristics of CZP-treated patients with nail disease in CIMPASI-1/CIMPASI-2 and CIMPACT Data are reported for patients with nail disease at baseline (mNAPSI >0) treated with CZP (dose combined: CZP 400 mg or 200 mg Q2W following a 400 mg loading dose at Weeks 0, 2, 4) through 48 weeks. BMI: body mass index; BSA: body surface area; CZP: certolizumab pegol; IL: interleukin; mNAPSI: modified Nail Psoriasis Severity Index; PASI: Psoriasis Area Severity Index; PGA: physician's global assessment; PsA: psoriatic arthritis; +PsA/−PsA: patients with PSO with/without self-reported PsA; PSO; plaque psoriasis; Q2W: every two weeks; SD: standard deviation; TNF: tumor necrosis factor. All PSO patients PSO patients +PsA PSO patients −PsA CIMPASI-1/2 (N=154) CIMPACT (N=71) CIMPASI-1/2 (N=37) CIMPACT (N=12) CIMPASI-1/2 (N=117) CIMPACT (N=59) Age, years, mean ± SD 45.9 ± 13.0 43.2 ± 12.4 48.1 ± 13.1 44.9 ± 13.9 45.2 ± 13.0 42.8 ± 12.1 Male, n (%) 112 (72.7) 47 (66.2) 23 (62.2) 6 (50.0) 89 (76.1) 41 (69.5) BMI, kg/m2, mean ± SD 30.6 ± 6.5 28.3 ± 5.0 31.9 ± 7.1 28.0 ± 6.5 30.2 ± 6.2 28.3 ± 4.8 Prior biologic use, n (%) 61 (39.6) 18 (25.4) 16 (43.2) 6 (50.0) 45 (38.5) 12 (20.3) Anti-TNF 39 (25.3) 0 (0.0) 12 (32.4) 0 (0.0) 27 (23.1) 0 (0.0) Anti-IL-17 11 (7.1) 14 (19.7) 3 (8.1) 6 (50.0) 8 (6.8) 8 (13.6) Anti-IL-12/IL-23 8 (5.2) 2 (2.8) 1 (2.7) 0 (0.0) 7 (6.0) 2 (3.4) PSO duration, years, mean ± SD 19.3 ± 12.9 19.1 ± 11.0 20.2 ± 14.1 23.8 ± 15.1 19.0 ± 12.6 18.2 ± 9.9 PASI, mean ± SD 19.8 ± 8.1 21.0 ± 7.5 19.4 ± 9.9 17.9 ± 5.6 19.9 ± 7.5 21.6 ± 7.8 BSA affected, %, mean ±SD 24.2 ± 14.3 28.0 ± 16.8 22.7 ± 14.7 22.6 ± 12.2 24.6 ± 14.2 29.1 ± 17.5 PGA, n (%)             3 (moderate) 112 (72.7) 50 (70.4) 27 (73.0) 11 (91.7) 85 (72.6) 39 (66.1) 4 (severe) 42 (27.3) 21 (29.6) 10 (27.0) 1 (8.3) 32 (27.4) 20 (33.9) mNAPSI, mean ± SD 5.2 ± 3.0 4.6 ± 2.7 5.9 ± 3.1 5.7 ± 2.3 5.0 ± 2.9 4.4 ± 2.8 A) CIMPASI-1 and CIMPASI-2 B) CIMPACT Figure 2. Week 48 nail disease outcomes in PSO patients with and without PsA treated with CZP in CIMPASI-1/CIMPASI-2 and CIMPACT Observed case data are reported for all patients with PSO who had nail disease at baseline (mNAPSI >0) treated with CZP (dose combined: CZP 400 mg or 200 mg Q2W following a 400 mg loading dose at Weeks 0, 2, 4) through 48 weeks in CIMPASI-1/2 and CIMPACT, and for the subpopulations of patients with and without self-reported PsA (+PsA/−PsA). CZP: certolizumab pegol; mNAPSI: modified Nail Psoriasis Severity Index; mNAPSI 75: ≥75% improvement in mNAPSI; PsA: psoriatic arthritis; PSO; plaque psoriasis. 0 48 Re-randomization 16 4032Week Initial treatment period (double-blinded) Maintenance period (double-blinded)