Presented at Fall Clinical Dermatology | Las Vegas, Nevada | October 18–21, 2018. Previously presented at EADV 2018 100 80 60 40 20 0 4440363228242016 48 Week R e sp o n d e r ra te ( % ) 86.1% 98.0% Durability of Response in Patients with Chronic Plaque Psoriasis Treated with Certolizumab Pegol over 48 Weeks: Pooled Results from Ongoing Phase 3, Multicenter, Randomized, Placebo-Controlled Studies (CIMPASI-1, CIMPASI-2 and CIMPACT) M. Augustin,1 J. Węgłowska,2 M. Lebwohl,3 C. Paul,4 V. Piguet,5,6,7 H. Sofen,8 A. Blauvelt,9 L. Peterson,10 R. Rolleri,10 K. Reich,11 D. Thaçi,12 C. Leonardi,13 Y. Poulin,14 C. Arendt,15 A. B. Gottlieb16 1Institute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany; 2Niepubliczny Zakład Opieki Zdrowotnej multiMedica, Wrocław, Poland; 3Icahn School of Medicine at Mount Sinai, New York, NY; 4Paul Sabatier University, Toulouse, France; 5Cardiff University and University Hospital of Wales, Cardiff, UK; 6Division of Dermatology, Department of Medicine, University of Toronto, Toronto, Canada; 7Division of Dermatology, Women’s College Hospital, Toronto, Canada; 8David Geffen School of Medicine at UCLA, Los Angeles, CA; 9Oregon Medical Research Center, Portland, OR; 10UCB Pharma, Raleigh, NC; 11SCIderm Research Institute, Hamburg, and Dermatologikum Berlin, Germany; 12University Hospital of Schleswig-Holstein Campus Lübeck, Lübeck, Germany; 13Central Dermatology and Saint Louis University School of Medicine, St Louis, MO; 14Centre de Recherche Dermatologique du Québec Métropolitain, Québec, Canada; 15UCB Pharma, Brussels, Belgium; 16Department of Dermatology, New York Medical College at Metropolitan Hospital, New York, NY OBJECTIVE • To assess the durability of the initial clinical response to certolizumab pegol in patients with moderate to severe plaque psoriasis over 48 weeks in phase 3 trials. BACKGROUND • Plaque psoriasis (PSO) is an immune-mediated, inflammatory disease. • Treatment options include topicals, phototherapy or systemic medications (including biologics). However, loss of response can occur over time.1 • Certolizumab pegol (CZP) is a unique Fc-free, PEGylated, anti- tumor necrosis factor biologic, approved by both the FDA and EMA for the treatment of moderate to severe PSO.2,3 • In phase 3 trials, CZP has demonstrated significant improvements in the signs and symptoms of PSO, and a safety profile consistent with the class.4,5 • We assessed durability of the initial Week 16 response to CZP over a further 32 weeks of treatment. METHODS Study Design • Data were pooled from three ongoing CZP phase 3 trials in adults with PSO: CIMPASI-1 (NCT02326298), CIMPASI-2 (NCT02326272) and CIMPACT (NCT02346240) (Figure 1). • This analysis includes only patients who achieved a ≥75% reduction from baseline in Psoriasis Area Severity Index (PASI 75) at Week 16, and continued on the same CZP dose during the maintenance period. Patients • ≥18 years of age with PSO for ≥6 months with PASI ≥12, ≥10% body surface area affected and 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; history of primary failure to any biologic or secondary failure to >1 biologic; erythrodermic, guttate or generalized PSO types; history of current, chronic or recurrent viral, bacterial or fungal infections. Study Assessments • PASI 75 and PASI 90 (≥90% reduction) responder rates were assessed through Weeks 16–48 in patients who achieved PASI 75 at Week 16. • PASI 90 responder rates were additionally assessed through Weeks 16–48 in patients who achieved PASI 90 at Week 16. CONCLUSIONS • The response to CZP was durable, with high response rates maintained through Week 48. • CZP provides an effective, long-term treatment option for patients with moderate to severe PSO. SUMMARY After 48 weeks of treatment with certolizumab pegol... CZP 200 mgCZP 400 mgCZP 200 mg CZP 400 mg Week 16 PASI 75 responders Week 16 PASI 90 responders 80% still reported PASI 90 still reported PASI 75 still reported PASI 75 still reported PASI 90 98%86% 89% These data show that CZP provides an e�ective, long-term treatment option for patients with moderate to severe psoriasis. 1 Fab’ Certolizumab pegol Figure 1. Study design for CZP in PSO phase 3 trials BW: twice per week; CZP: certolizumab pegol; ETN: etanercept; LD: CZP 400 mg loading dose at Weeks 0, 2 and 4 or Weeks 16, 18 and 20; PASI: Psoriasis Area Severity Index; Q2W: every two weeks; Q4W: every four weeks. B) CIMPACT A) CIMPASI-1 and CIMPASI-2 CZP 200 mg Q2Wa (N=173) CZP 400 mg Q2W (N=180) Age, years, mean (SD) 44.8 (13.0) 44.7 (13.0) Male, n (%) 117 (67.6) 114 (63.3) BMI, kg/m2, mean (SD) 30.9 (7.7) 29.6 (6.5) Prior biologic use, n (%) 52 (30.1) 55 (30.6) Anti-TNF 32 (18.5) 27 (15.0) Anti-IL-17 17 (9.8) 14 (7.8) Anti-IL-12/IL-23 1 (0.6) 11 (6.1) PSO duration, years, mean (SD) 18.1 (12.7) 17.7 (11.9) PASI, mean (SD) 19.9 (7.9) 19.8 (6.8) BSA affected, %, mean (SD) 24.3 (16.0) 24.4 (13.4) PGA score, n (%) 3 (moderate) 121 (69.9) 128 (71.1) 4 (severe) 52 (30.1) 52 (28.9) aCZP 200 mg Q2W patients received CZP 400 mg at Weeks 0, 2 and 4. BMI: body mass index; BSA: body surface area; CZP: certolizumab pegol; IL: interleukin; PASI: Psoriasis Area Severity Index; PGA: physician’s global assessment; SD: standard deviation; TNF: tumor necrosis factor. Table 1. Demographics and baseline characteristics CZP 200 mg Q2W (N=173)a CZP 400 mg Q2W (N=180) Figure 2. PASI response through Weeks 16–48 in Week 16 PASI 75 responders MCMC imputation. aCZP 200 mg Q2W patients received loading dose of CZP 400 mg at Weeks 0, 2 and 4. CZP: certolizumab pegol; MCMC: Markov Chain Monte Carlo; NRI: non-responder imputation; PASI: Psoriasis Area Severity Index; Q2W: every two weeks. A) PASI 75 B) PASI 90 Figure 3. PASI 90 response through Weeks 16–48 in Week 16 PASI 90 responders CZP 200 mg Q2W CZP 400 mg Q2W Week 48 MCMC, % 80.1 89.0 NRI, % 75.0 84.5 100 80 60 40 20 0 4440363228242016 48 Week R e sp o n d e r ra te ( % ) 80.1% 89.0%100 80 60 40 20 0 4440363228242016 48 Week R e sp o n d e r ra te ( % ) 64.7% 57.8% 77.4% 64.4% 0 Initial treatment period (Double-blind) Maintenance period (Double-blind) 48 Re-randomization 16 4032Week Initial treatment period (Double-blind) Maintenance period (Double-blind)