— Oral presentation of Phase 2b findings for bimekizumab in the treatment of moderate-to-severe chronic plaque psoriasis patients will focus on the effects of dual neutralization of both IL-17A and IL-17F
— Three pooled sub-analyses from ongoing, Phase 3 studies CIMPASI-1, CIMPASI-2 and CIMPACT reflect potential versatility of CIMZIA® (certolizumab pegol) in the treatment of psoriasis
— Results from the largest cohort of pregnant women exposed to an anti-TNF for management of a chronic inflammatory disease highlight the value of CIMZIA for this underserved population
BRUSSELS, Belgium I February 16, 2018 I UCB, a global biopharmaceutical company, will be presenting new data on CIMZIA® (certolizumab pegol) and one of UCB’s key pipeline molecules, bimekizumab, at the 2018 American Academy of Dermatology (AAD) Annual Meeting in San Diego, CA (February 16-20, 2018).
“UCB is thrilled to participate in the important scientific exchange at AAD this week and to translate our learnings into improved patient care. We are committed to patients with psoriatic disease, through investment in underserved areas and breakthrough solutions that deliver unique outcomes,” said Emmanuel Caeymaex, Head of Immunology and Executive Vice President at UCB. “As our research at AAD shows, UCB is executing on its Patient Value Strategy to connect the unmet needs of patients with innovative science. People living with psoriasis often face a heavy disease burden and may experience significant physical discomfort. The studies presented this week explore the potential value of CIMZIA for psoriasis patient subpopulations, as well as the development of new approaches to treating inflammation associated with psoriasis, such as the neutralization of both IL-17A and IL-17F with bimekizumab.”
Full efficacy and safety findings from the Phase 2b BE ABLE study on the investigational molecule bimekizumab will highlight the dual neutralization of IL-17A and IL-17F, two key cytokines driving the inflammatory processes, as a novel and effective targeting approach in psoriasis. In July 2017, UCB announced positive topline results from the BE ABLE study demonstrating that 79% of patients achieved at least 90% skin clearance in the psoriasis area and severity index (PASI90) and up to 60% of patients achieved complete skin clearance (PASI100) at week 12.
Additional data highlights include presentations on the treatment effect of CIMZIA in adults with moderate-to-severe chronic plaque psoriasis. Results will be presented from a pooled sub-analysis of the ongoing, Phase 3 studies CIMPASI-1, CIMPASI-2 and CIMPACT, exploring the effect of CIMZIA in psoriasis patients who had been previously exposed to systemic therapy, including biologics. A separate pooled sub-analysis of the three studies analyzes the potential treatment effect across demographic and baseline disease subgroups, including age, gender, weight/BMI, and disease severity. A third sub-analysis explores the treatment effect of CIMZIA in psoriasis patients both with and without self-reported concurrent psoriatic arthritis. CIMZIA is not currently approved by the U.S. Food and Drug Administration or other health authorities to treat psoriasis.
Prospective and retrospective data showcasing the characteristics and outcomes from 1,541 maternal CIMZIA-exposed pregnancies — the largest cohort of pregnant women exposed to an anti-TNF for management of a chronic inflammatory disease — will also be presented this week. Women surveyed in this study were living with psoriatic arthritis, Crohn’s disease, rheumatoid arthritis, and ankylosing spondylitis, among others (excluding psoriasis).
Following is a guide to the UCB-sponsored data presentations:
Presentations on UCB’s Investigational Pipeline:
Bimekizumab
[F061] Dual Neutralization of Interleukin (IL)-17A and IL-17F with Bimekizumab in Moderate-to-severe Psoriasis: Results from a Phase 2b, Randomized, Double-blinded, Placebo-controlled, Dose-ranging Study
Papp, K. A. et al.
- Date/Time: Saturday, February 17 at 1:00 PM – 3:00 PM PT
- Session Information: Late-breaking Research: Clinical Trials – Ballroom 20A
Presentations on Investigational Studies of CIMZIA®:
Psoriasis
[7774] Certolizumab Pegol is Effective for Chronic Plaque Psoriasis Regardless of Previous Exposure to Systemic Therapy: A Pooled Subanalysis of Ongoing, Phase 3 Studies (CIMPASI-1, CIMPASI-2, CIMPACT)
Blauvelt, A. et al.
- Date/Time: Friday, February 16 at 7:00AM PT
- Session Information: ePoster only
[7692] Certolizumab Pegol is Effective for Chronic Plaque Psoriasis Across Patient Subgroups: A Pooled Subanalysis From Ongoing, Phase 3 Studies (CIMPASI-1, CIMPASI-2, CIMPACT)
Reich, K. et al.
- Date/Time: Saturday, February 17 at 4:35 PM – 4:40 PM PT
- Session Information: ePoster Presentation Center 1
[7773] A Pooled Subanalysis of the Efficacy of Certolizumab Pegol in Patients with Self-Reported Psoriatic Arthritis in Ongoing, Phase 3 Psoriasis Studies (CIMPASI-1, CIMPASI-2, CIMPACT)
Gottlieb, A. B. et al.
- Date/Time: Friday, February 16 at 7:00AM PT
- Session Information: ePoster only
Women of Childbearing Age
[7094] Characteristics and Outcomes of Prospectively Reported Pregnancies Exposed to Certolizumab Pegol from a Safety Database
Kimball, A. B. et al.
- Date/Time: Friday, February 16 at 1:10 PM – 1:15PM PT
- Session Information: ePoster Presentation Center 1
About Bimekizumab
Bimekizumab is a novel humanized monoclonal IgG1 antibody that potently and selectively neutralizes both IL-17A and IL-17F, two key cytokines driving inflammatory processes. IL-17A and IL-17F have overlapping pro-inflammatory functions and independently cooperate with other inflammatory mediators to drive chronic inflammation and damage across multiple tissues.
Previous early Phase clinical studies in psoriasis and psoriatic arthritis have suggested that dual neutralization of both IL-17A and IL-17F with bimekizumab may provide a new targeted approach for the treatment of immune-mediated inflammatory diseases. Preclinical results in disease-relevant cells have shown that dual neutralization of both IL-17A and IL-17F reduces skin and joint inflammation, as well as pathological bone formation to an extent greater than inhibition of IL-17A or IL-17F alone.i,ii,iii
UCB is studying bimekizumab in psoriasis, psoriatic arthritis and ankylosing spondylitis. Bimekizumab is not approved by any regulatory authority worldwide.
About Cimzia® In the US
Cimzia® is the only Fc-free, PEGylated anti-TNF (Tumor Necrosis Factor). Cimzia® has a high affinity for human TNF-alpha, selectively neutralizing the pathophysiological effects of TNF-alpha.
Cimzia® is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis, adults with active psoriatic arthritis (PsA), and adults with active ankylosing spondylitis (AS). In addition, it is indicated for reducing signs and symptoms of Crohn’s disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. See important safety information including risk of serious bacterial, viral and fungal infections and tuberculosis below.
About UCB
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 7 500 people in approximately 40 countries, the company generated revenue of € 4.2 billion in 2016. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news
i 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. In Press.
ii 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).
UCB Data on File. July 2017.
iii 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. 201706;76 (suppl.2):213-213.
SOURCE: UCB
Post Views: 46
— Oral presentation of Phase 2b findings for bimekizumab in the treatment of moderate-to-severe chronic plaque psoriasis patients will focus on the effects of dual neutralization of both IL-17A and IL-17F
— Three pooled sub-analyses from ongoing, Phase 3 studies CIMPASI-1, CIMPASI-2 and CIMPACT reflect potential versatility of CIMZIA® (certolizumab pegol) in the treatment of psoriasis
— Results from the largest cohort of pregnant women exposed to an anti-TNF for management of a chronic inflammatory disease highlight the value of CIMZIA for this underserved population
BRUSSELS, Belgium I February 16, 2018 I UCB, a global biopharmaceutical company, will be presenting new data on CIMZIA® (certolizumab pegol) and one of UCB’s key pipeline molecules, bimekizumab, at the 2018 American Academy of Dermatology (AAD) Annual Meeting in San Diego, CA (February 16-20, 2018).
“UCB is thrilled to participate in the important scientific exchange at AAD this week and to translate our learnings into improved patient care. We are committed to patients with psoriatic disease, through investment in underserved areas and breakthrough solutions that deliver unique outcomes,” said Emmanuel Caeymaex, Head of Immunology and Executive Vice President at UCB. “As our research at AAD shows, UCB is executing on its Patient Value Strategy to connect the unmet needs of patients with innovative science. People living with psoriasis often face a heavy disease burden and may experience significant physical discomfort. The studies presented this week explore the potential value of CIMZIA for psoriasis patient subpopulations, as well as the development of new approaches to treating inflammation associated with psoriasis, such as the neutralization of both IL-17A and IL-17F with bimekizumab.”
Full efficacy and safety findings from the Phase 2b BE ABLE study on the investigational molecule bimekizumab will highlight the dual neutralization of IL-17A and IL-17F, two key cytokines driving the inflammatory processes, as a novel and effective targeting approach in psoriasis. In July 2017, UCB announced positive topline results from the BE ABLE study demonstrating that 79% of patients achieved at least 90% skin clearance in the psoriasis area and severity index (PASI90) and up to 60% of patients achieved complete skin clearance (PASI100) at week 12.
Additional data highlights include presentations on the treatment effect of CIMZIA in adults with moderate-to-severe chronic plaque psoriasis. Results will be presented from a pooled sub-analysis of the ongoing, Phase 3 studies CIMPASI-1, CIMPASI-2 and CIMPACT, exploring the effect of CIMZIA in psoriasis patients who had been previously exposed to systemic therapy, including biologics. A separate pooled sub-analysis of the three studies analyzes the potential treatment effect across demographic and baseline disease subgroups, including age, gender, weight/BMI, and disease severity. A third sub-analysis explores the treatment effect of CIMZIA in psoriasis patients both with and without self-reported concurrent psoriatic arthritis. CIMZIA is not currently approved by the U.S. Food and Drug Administration or other health authorities to treat psoriasis.
Prospective and retrospective data showcasing the characteristics and outcomes from 1,541 maternal CIMZIA-exposed pregnancies — the largest cohort of pregnant women exposed to an anti-TNF for management of a chronic inflammatory disease — will also be presented this week. Women surveyed in this study were living with psoriatic arthritis, Crohn’s disease, rheumatoid arthritis, and ankylosing spondylitis, among others (excluding psoriasis).
Following is a guide to the UCB-sponsored data presentations:
Presentations on UCB’s Investigational Pipeline:
Bimekizumab
[F061] Dual Neutralization of Interleukin (IL)-17A and IL-17F with Bimekizumab in Moderate-to-severe Psoriasis: Results from a Phase 2b, Randomized, Double-blinded, Placebo-controlled, Dose-ranging Study
Papp, K. A. et al.
- Date/Time: Saturday, February 17 at 1:00 PM – 3:00 PM PT
- Session Information: Late-breaking Research: Clinical Trials – Ballroom 20A
Presentations on Investigational Studies of CIMZIA®:
Psoriasis
[7774] Certolizumab Pegol is Effective for Chronic Plaque Psoriasis Regardless of Previous Exposure to Systemic Therapy: A Pooled Subanalysis of Ongoing, Phase 3 Studies (CIMPASI-1, CIMPASI-2, CIMPACT)
Blauvelt, A. et al.
- Date/Time: Friday, February 16 at 7:00AM PT
- Session Information: ePoster only
[7692] Certolizumab Pegol is Effective for Chronic Plaque Psoriasis Across Patient Subgroups: A Pooled Subanalysis From Ongoing, Phase 3 Studies (CIMPASI-1, CIMPASI-2, CIMPACT)
Reich, K. et al.
- Date/Time: Saturday, February 17 at 4:35 PM – 4:40 PM PT
- Session Information: ePoster Presentation Center 1
[7773] A Pooled Subanalysis of the Efficacy of Certolizumab Pegol in Patients with Self-Reported Psoriatic Arthritis in Ongoing, Phase 3 Psoriasis Studies (CIMPASI-1, CIMPASI-2, CIMPACT)
Gottlieb, A. B. et al.
- Date/Time: Friday, February 16 at 7:00AM PT
- Session Information: ePoster only
Women of Childbearing Age
[7094] Characteristics and Outcomes of Prospectively Reported Pregnancies Exposed to Certolizumab Pegol from a Safety Database
Kimball, A. B. et al.
- Date/Time: Friday, February 16 at 1:10 PM – 1:15PM PT
- Session Information: ePoster Presentation Center 1
About Bimekizumab
Bimekizumab is a novel humanized monoclonal IgG1 antibody that potently and selectively neutralizes both IL-17A and IL-17F, two key cytokines driving inflammatory processes. IL-17A and IL-17F have overlapping pro-inflammatory functions and independently cooperate with other inflammatory mediators to drive chronic inflammation and damage across multiple tissues.
Previous early Phase clinical studies in psoriasis and psoriatic arthritis have suggested that dual neutralization of both IL-17A and IL-17F with bimekizumab may provide a new targeted approach for the treatment of immune-mediated inflammatory diseases. Preclinical results in disease-relevant cells have shown that dual neutralization of both IL-17A and IL-17F reduces skin and joint inflammation, as well as pathological bone formation to an extent greater than inhibition of IL-17A or IL-17F alone.i,ii,iii
UCB is studying bimekizumab in psoriasis, psoriatic arthritis and ankylosing spondylitis. Bimekizumab is not approved by any regulatory authority worldwide.
About Cimzia® In the US
Cimzia® is the only Fc-free, PEGylated anti-TNF (Tumor Necrosis Factor). Cimzia® has a high affinity for human TNF-alpha, selectively neutralizing the pathophysiological effects of TNF-alpha.
Cimzia® is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis, adults with active psoriatic arthritis (PsA), and adults with active ankylosing spondylitis (AS). In addition, it is indicated for reducing signs and symptoms of Crohn’s disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. See important safety information including risk of serious bacterial, viral and fungal infections and tuberculosis below.
About UCB
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 7 500 people in approximately 40 countries, the company generated revenue of € 4.2 billion in 2016. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news
i 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. In Press.
ii 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).
UCB Data on File. July 2017.
iii 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. 201706;76 (suppl.2):213-213.
SOURCE: UCB
Post Views: 46
