UCB showcases wealth of new psoriasis research at EADV 2019
DATA to be presented at EADV 2019 will further confirm the durability of CIMZIA® (certolizumab pegol) treatment in moderate-to-severe plaque psoriasis, including new three-year efficacy data and new positive 60-week outcomes data from Phase 2 studies that underscore the potential of bimekizumab to improve scalp and nail psoriasis and health-related quality of life in psoriasis patients.
In total, UCB will present nine abstracts at the meeting, demonstrating the company’s ongoing commitment to improving the lives of people with psoriasis and psoriatic arthritis
UCB, a global biopharmaceutical company, today announced new data on the use of the Fc-free anti-TNF treatment, CIMZIA® (certolizumab pegol), in psoriasis and psoriatic arthritis (PsA) will be presented at the 28th European Academy of Dermatology and Venereology congress (EADV) in Madrid, October 9-13, 2019. Data include three-year outcomes in psoriasisi and four-year results in PsA from the open-label extension studies of CIMZIA.ii Additionally, the company will share 60-week resultsiii,iv from the Phase 2 clinical development program of the company’s pipeline molecule bimekizumab – a novel humanized monoclonal IgG1 antibody that potently and selectively neutralizes both IL-17A and IL-17F cytokines, thought to be key drivers of psoriasis.v
Emmanuel Caeymaex, Head of Immunology and Executive Vice President, Immunology Patient Value Unit, UCB, said: “Results presented at EADV 2019 will reinforce and support the durability profile of CIMZIA efficacy in the treatment of both psoriasis and psoriatic arthritis, and provide further evidence as to the exciting potential of bimekizumab in psoriasis. Patients with psoriasis deserve rapid and sustainable treatment results. The data we will share in Madrid show our commitment to delivering against these key patient needs.”
Reflecting UCB’s efforts to better understand the impact of psoriasis on patients, and the unique needs of women, UCB will present new results from a sample of almost 90,000 respondents of the World Psoriasis Happiness Surveys. These findings highlight gender as a strong predictor of psychological and social well-being in people living with psoriasis and PsA, more so than geographies. The analysis illustrates how psoriasis and PsA can negatively affect women more than men when it comes to life satisfaction, loneliness, mood and selfesteem. Worse life satisfaction, stress, loneliness and isolation were felt most in young women with psoriasis.vi
New CIMZIA three-year efficacy data in plaque psoriasis from a pooled analysis of the completed CIMPASI-1 and CIMPASI-2 open-label extension Phase 3 studies will be presented as an oral presentation at EADV 2019;i CIMZIA’s safety profile remains consistent with previously reported data.i Additional pooled results from these trials include CIMZIA 48-week sustained efficacy data in psoriasis of the head and neck, areas where disease manifestations can cause high degrees of emotional distress, particularly for female patients.vii A posthoc analysis of the four-year RAPID-PsA study will also be highlighted, showing durability of response of CIMZIA in PsA.ii The ongoing focus on researching the long-term efficacy and safety of CIMZIA demonstrates how UCB continues its ongoing commitment to improving the lives of people with psoriasis.
New 60-week data on novel investigational molecule bimekizumab, from the BE ABLE Phase 2 clinical development program, will be shared in an oral presentation. The findings show rapid and sustained improvements in quality of life (as measured by the Dermatology Life Quality Index), which positively associate with clinical outcomes in patients with moderate-to-severe plaque psoriasis.iii Positive scalp and nail disease outcomes at 60 weeks will also be presented, further supporting bimekizumab’s potential.iv
The safety and efficacy of bimekizumab have not been established, and it is not approved by any regulatory authority worldwide.
i Gordon K, et al. Certolizumab Pegol for Treatment of Plaque Psoriasis: Pooled Three-Year Efficacy Outcomes from the Intent-to-Treat Population of Two Phase 3 Trials (CIMPASI-1 and CIMPASI-2). Abstract to be presented at EADV 2019, 9-13 October, Madrid Spain.
ii Gottlieb A, et al. Durability of Response in Patients with Psoriatic Arthritis Treated with Certolizumab Pegol over 216 Weeks: PostHoc Analyses from the RAPID-PsA Study. Abstract to be presented at EADV 2019, 9-13 October, Madrid Spain.
iii Papp K, et al. Bimekizumab provides rapid and sustained improvements in quality of life that correlate with clinical outcomes in patients with moderate to severe plaque psoriasis: 60-week results from a randomised, double-blinded, Phase 2b extension study. Abstract to be presented at EADV 2019, 9-13 October, Madrid Spain.iv Blauvelt A, et al. Bimekizumab provides rapid and sustained improvements in scalp and nail outcomes in patients with moderate-tosevere plaque psoriasis: 60 week results from a randomised, double-blinded, Phase 2b extension study. Abstract to be presented at EADV 2019, 9-13 October, Madrid Spain. v Glatt S, Baeten D, Baker T, et al. Dual IL-17A and IL-17F neutralisation by bimekizumab in psoriatic arthritis: evidence from preclinical experiments and a randomized placebo-controlled clinical trial that IL-17F contributes to human chronic tissue inflammation. Ann Rheum Dis. 2018;77:523-532. vi McBride S, et al. Gender Differences in the Impact of Psoriasis: Results from the World Psoriasis Happiness Surveys. Abstract to be presented at EADV 2019, 9-13 October, Madrid Spain.
vii van de Kerkhof P, et al. Efficacy of Certolizumab Pegol for Psoriasis of the Head and Neck in Two Phase 3 Clinical Trials: CIMPASI-1 and CIMPASI-2. Abstract to be presented at EADV 2019, 9-13 October, Madrid Spain. viii Glatt S, Helmer E, Haier B, et al. First-in-human randomized study of bimekizumab, a humanized monoclonal antibody and selective dual inhibitor of IL-17A and IL-17F, in mild psoriasis. Br J Clin Pharmacol. 2017;83(5):991-1001. ix Papp K, Merola J, Gottlieb A, Griffiths C, Cross N, Peterson L, Cioffi C, Blauvelt A. Dual neutralization of both interleukin 17A and interleukin 17F with bimekizumab in patients with psoriasis: Results from BE ABLE 1, a 12-week randomized, double-blinded, placebocontrolled phase 2b trial. J Am Acad Dermatol. 2018;79(2):277-286.e10. x Shah M, Maroof A, Al-Hosni R, Gikas P, Gozzard N, Shaw S, Roberts S. Bimekizumab Blocks T Cell-Mediated Osteogenic Differentiation of Periosteal Stem Cells: Coupling Pathological Bone Formation to IL-17A and IL-17F Signaling [abstract]. Arthritis Rheumatol. 2017;69(suppl 10).
xi Maroof A, Okoye R, Smallie T, et al. Bimekizumab dual inhibition of IL-17A and IL-17F provides evidence of IL-17F contribution to chronic inflammation in disease-relevant cells. Ann Rheum Dis. 2017;76(suppl.2):213-213.