UCB Showcases Strength of the Expanding Dermatology Portfolio at the 31st EADV Congress

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UCB, Inc.

Sep 01, 2022, 10:00 ET

  • 20 abstracts highlight research in key disease areas including psoriasis and psoriatic arthritis
  • New three-year data to be presented on bimekizumab in the treatment of moderate to severe plaque psoriasis

BRUSSELS and ATLANTA, Sept. 1, 2022 /PRNewswire/ -- UCB, a global biopharmaceutical company, today announced that it will present 20 abstracts across its dermatology portfolio at the 31st European Academy of Dermatology and Venereology (EADV) Congress in Milan, Italy, September 7-10. The abstracts, accepted for poster presentation, underscore UCB's commitment to delivering innovative solutions that aim to address the unmet needs of people living with dermatological diseases.

"We are proud to present new data from our expanding dermatology portfolio at the 31st EADV Congress. At UCB, our ambition is to transform the lives of people living with severe diseases such as psoriasis and psoriatic arthritis, and the strength of scientific data at this year's congress reaffirms our long-standing commitment to raising standards of care," said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S., UCB.

Key data to be presented on UCB's investigational product bimekizumab include new results from the BE BRIGHT open-label extension study evaluating maintenance of response with bimekizumab through three years in patients with moderate to severe plaque psoriasis who responded at week 16 during Phase 3 clinical studies. New analysis of pooled safety data from up to three years of treatment with bimekizumab in the treatment of moderate to severe plaque psoriasis across Phase 2 and 3 clinical trials will also be presented. Bimekizumab is an investigational product; its efficacy and safety have not been established for any indication in the U.S. and it is not approved by the U.S. Food and Drug Administration (FDA).

For CIMZIA® (certolizumab pegol), data to be presented include three-year data from three Phase 3 trials evaluating the association of patient-reported outcomes (Dermatology Life Quality Index, DLQI 0/1) with relative skin clearance improvements (Psoriasis Area and Severity Index, PASI) in subgroups of adult patients with moderate to severe plaque psoriasis.

The following is a guide to the UCB-sponsored data presentations at the 31st EADV Congress:

Bimekizumab e-Posters: Psoriasis

  • Bimekizumab maintenance of response through three years in patients with moderate to severe plaque psoriasis who responded at Week 16: Results from the BE BRIGHT open-label extension
    B. Strober, Y. Tada, U. Mrowietz, M. Lebwohl, P. Foley, R.G. Langley, J. Barker, M. Wang, V. Vanvoorden, B. Szilagyi, V. Ciaravino, C. Paul
    #P1491

  • Bimekizumab safety in patients with moderate to severe plaque psoriasis: Analysis of pooled data from up to three years of treatment in Phase 2 and 3 clinical trials
    K.B. Gordon, R.G. Langley, R.B. Warren, Y. Okubo, D. Rosmarin, M. Lebwohl, L. Peterson, C. Madden, D. de Cuyper, N. Nunez Gomez, D. Thaçi 
    #P1569

  • Bimekizumab versus secukinumab in plaque psoriasis: Cumulative clinical and health related quality of life benefit through 2 years of the BE RADIANT Phase 3b trial and open label extension
    M. Lebwohl, P. Brunner, J. Soung, K. Ghoreschi, J. Weisman, L. Peterson, B. Szilagyi, F. Staelens, V. Ciaravino, WH. Boehncke
    #P1561

  • Bimekizumab efficacy through 96 weeks in patients with moderate to severe plaque psoriasis: patient-reported outcomes from the BE RADIANT Phase 3b trial
    G. Kokolakis, R.G. Langley, A.B. Gottlieb, M. Augustin, N. Magnolo, B. Elewski, R. Vender, A. López Ferrer, R. Warham, S. Wiegratz, V. Ciaravino, S.R. Feldman
    #P1595

  • Bimekizumab efficacy and safety through two years in patients with moderate psoriasis: Analysis of pooled data from five Phase 3/3b clinical trials
    A. Blauvelt, L. Stein Gold, M. Gooderham, B. Strober, A. Pinter, J.M. Carrascosa, P. Gisondi, J. Bleier, C. Madden, D. Deherder, N. Nunez Gomez, R.B. Warren
    #1573

  • Bimekizumab efficacy in high-impact areas for patients with moderate to severe plaque psoriasis: Pooled results through two years from the BE SURE and BE RADIANT Phase 3 trials
    J.F. Merola, A.B. Gottlieb, A. Morita, J.M. Carrascosa, B. Elewski, N. Tilt, S. Wiegratz, K. Wixted, U. Mrowietz
    #P1467   

  • Bimekizumab efficacy and safety through three years in patients with moderate to severe plaque psoriasis: Long-term results from the BE SURE randomised controlled trial and the BE BRIGHT open-label extension
    D. Thaçi, R. Vender, M. de Rie, C. Conrad, J. Soung, B. Strober, M. Wang, N. Cross, D. Deherder, N. Nunez Gomez, A.B. Gottlieb
    #P1572

  • Bimekizumab efficacy over two years in patients with moderate to severe plaque psoriasis with scalp and nail involvement who switched from adalimumab, ustekinumab, or secukinumab: Results from the BE SURE, BE VIVID, BE BRIGHT, and BE RADIANT Phase 3/3b trials
    R.B. Warren, B. Strober, A. Pinter, A. Blauvelt, M. Sebastian, L. Davis, V. Vanvoorden, S. Wiegratz, M. Gooderham   
    #P1478

  • A network meta-analysis of cumulative clinical benefit of anti-IL biologics for the treatment of moderate to severe psoriasis over 48–52 weeks
    R.B. Warren, A. Armstrong, M. Lebwohl, K. Gordon, C. Leonardi, N. Nunez Gomez, V. Taieb, S. Vermeersch, S. Kiri, A. Körber
    #P1571

  • Both IL-17RA and IL-17RC receptor complexes are required for IL-17A- and IL-17F-driven inflammation
    A. Maroof, A. Manghera, S. Shaw
    #P1562

  • Single-cell sequencing of freshly isolated cells from lesional and peri-lesional skin to explore cellular origins of IL-17 isoforms in psoriasis
    A. Skelton, K. Pappelbaum, X. Li, V. Oji, A. Tsianakas, M. Page, M. Bertolini, S. Shaw, A. Maroof #P1563   

Bimekizumab e-Posters: Psoriatic Arthritis

  • Efficacy and safety of bimekizumab in patients with active psoriatic arthritis and inadequate response to tumour necrosis factor inhibitors: 16-week results from BE COMPLETE, a Phase 3, randomised, double-blind placebo-controlled study
    R.B. Warren, A. Asahina, P. Gisondi, L.E. Kristensen, D. McGonagle, P.J. Mease, J.F. Merola, B. Strober, D. Thaçi, B. Ink, D. Assudani, R. Bajracharya, J. Coarse, A.B. Gottlieb
    #P0479

  • Efficacy and safety of bimekizumab in bDMARD-naïve patients with psoriatic arthritis: 24-week results from BE OPTIMAL, a Phase 3, multicentre, randomised, placebo-controlled, active reference study
    J.F. Merola, A. Asahina, F. Behrens, A.B. Gottlieb, M. Lebwohl, D. McGonagle, P.J. Mease, L. Puig, W.H. Boehncke, B. Ink, D. Assudani, R. Bajracharya, J. Coarse, P. Gisondi
    #P0480   

Bimekizumab e-Posters: Axial Spondyloarthritis

  • Bimekizumab in patients with active non-radiographic axial spondyloarthritis and active ankylosing spondylitis: 24-week efficacy and safety from the BE MOBILE Phase 3 studies
    D. Thaçi, X. Baraliakos, J.F. Merola, D. Poddubnyy, F. van den Bosch, M. Oortgiesen, C. Fleurinck, A.M. Ellis, T. Vaux, J. Shepherd-Smith, A. Marten, D. van der Heijde
    #P0477   

CIMZIA e-Posters: Psoriasis

  • Stable plasma concentration of certolizumab pegol is associated with clinical improvement among patients with moderate to severe plaque psoriasis: Data from CIMPASI-1 and CIMPASI-2
    L. Puig, P. Gisondi, A. Pinter, J.M. López Pinto, I.D. Pousa, J. Sidhu, N. Tilt, M. Lebwohl
    #P1570

  • Association of DLQI 0/1 with relative PASI improvements in subgroups of patients with moderate to severe plaque psoriasis treated with certolizumab pegol: Three-year results from three Phase 3 trials (CIMPASI-1, CIMPASI-2, and CIMPACT)
    S. McBride, J. Węgłowska, P. Wolf, P. Foley, F. Fierens, N. Tilt, C. de la Loge, B. Elewski
    #P1492

  • Certolizumab pegol for psoriasis in routine clinical practice (CIMREAL): Patient characteristics and interim results
    R.B. Warren, E. Lazaridou, D. Vidal Sarro, O. Vanhooteghem, G. Fabbrocini, L. Bianchi, M. Perrussel, H. Kadima, T. Kumke, J. Hee, M. Bari, F. Fierens, B. Korge
    #P1621

  • Certolizumab pegol for psoriasis in routine clinical practice (CIMREAL): Interim results in women of child-bearing potential
    K. Asadullah, M. Concetta Fargnoli, C. De Simone, T. Boyé, T. Hillary, A. Machovcova, A. Makrygeorgou, K. Papp, M. Bari, T. Kumke, I.D. Pousa, F. Fierens, Á. Flórez, E. Papadavid 
    #P1623    

Disease State e-Posters: Psoriasis

  • Treatment preferences in young bio-naïve patients with moderate to severe psoriasis – preliminary results from a mixed-method study across the Nordic countries
    G.L. Mortensen, F. Balieva, L. Catton, B. Wilson Claréus, K. Danielsen, F. Fierens, L. Iversen, L. Koulu, R. Pasternack, A. Osmancevic, L. Skov
    #P1529

  • Practical tools to manage women with psoriasis: From dermatologists to dermatologists
    A. Dattola, M.M. Constantin, I.D. Pousa, Á. González-Cantero, T. Hillary, C.E. Kleyn, N. Magnolo 
    #P1535   

Notes to editors:

About bimekizumab

Bimekizumab is a humanized monoclonal IgG1 antibody that is designed to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F), two key cytokines driving inflammatory processes.1

In August 2021, bimekizumab was approved in the European Union (EU)/European Economic Area (EEA) and in Great Britain, for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy2, 3 In January 2022, bimekizumab received marketing authorization in Japan for the treatment of plaque psoriasis, generalized pustular psoriasis and psoriatic erythroderma in patients who are not sufficiently responding to existing treatments.4 In February and March 2022, bimekizumab was approved in Canada and Australia, respectively, for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.5,6

Bimekizumab is an investigational product; its efficacy and safety have not been established for any indication in the U.S. and it is not approved by the U.S. Food and Drug Administration (FDA).

About CIMZIA® in the U.S.
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 moderate to severe plaque psoriasis (PSO) in adults who are candidates for systemic therapy or phototherapy.

CIMZIA is also indicated for the treatment of adults with moderately to severely active rheumatoid arthritis (RA), adults with active psoriatic arthritis (PsA), adults with active ankylosing spondylitis (AS), and adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation.

In addition, CIMZIA is indicated for reducing signs and symptoms of Crohn's disease (CD) 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.

IMPORTANT SAFETY INFORMATION about CIMZIA in the U.S.

CONTRAINDICATIONS

CIMZIA is contraindicated in patients with a history of hypersensitivity reaction to certolizumab pegol or to any of the excipients. Reactions have included angioedema, anaphylaxis, serum sickness, and urticaria.

SERIOUS INFECTIONS
Patients treated with CIMZIA are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. 

Discontinue CIMZIA if a patient develops a serious infection or sepsis.

Reported infections include:

  • Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before CIMZIA use and during therapy. Initiate treatment for latent TB prior to CIMZIA use.
  • Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.
  • Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria. 

Carefully consider the risks and benefits of treatment with CIMZIA prior to initiating therapy in the following patients: with chronic or recurrent infection; who have been exposed to TB;  with a history of opportunistic infection; who resided in or traveled in regions where mycoses are endemic; with underlying conditions that may predispose them to infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with CIMZIA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

  • Do not start CIMZIA during an active infection, including localized infections.
  • Patients older than 65 years, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants may be at greater risk of infection.
  • If an infection develops, monitor carefully and initiate appropriate therapy.

MALIGNANCY
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which CIMZIA is a member. CIMZIA is not indicated for use in pediatric patients.

  • Consider the risks and benefits of CIMZIA treatment prior to initiating or continuing therapy in a patient with known malignancy.
  • In clinical trials, more cases of malignancies were observed among CIMZIA-treated patients compared to control patients.
  • In CIMZIA clinical trials, there was an approximately 2-fold higher rate of lymphoma than expected in the general U.S. population. Patients with rheumatoid arthritis, particularly those with highly active disease, are at a higher risk of lymphoma than the general population.
  • Malignancies, some fatal, have been reported among children, adolescents, and young adults being treated with TNF blockers. Approximately half of the cases were lymphoma, while the rest were other types of malignancies, including rare types associated with immunosuppression and malignancies not usually seen in this patient population.
  • Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including CIMZIA. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn's disease or ulcerative colitis, and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. Carefully assess the risks and benefits of treating with CIMZIA in these patient types.
  • Cases of acute and chronic leukemia were reported with TNF blocker use.

HEART FAILURE

  • Worsening and new onset congestive heart failure (CHF) has been reported with TNF blockers. Exercise caution and monitor carefully.

HYPERSENSITIVITY

  • Angioedema, anaphylaxis, dyspnea, hypotension, rash, serum sickness, and urticaria have been reported following CIMZIA administration. If a serious allergic reaction occurs, stop CIMZIA and institute appropriate therapy. The needle shield inside the removable cap of the CIMZIA prefilled syringe contains a plastic derivative of natural rubber latex which may cause an allergic reaction in individuals sensitive to latex.

HEPATITIS B VIRUS REACTIVATION

  • Use of TNF blockers, including CIMZIA, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases have been fatal.
  • Test patients for HBV infection before initiating treatment with CIMZIA.
  • Exercise caution in patients who are carriers of HBV and monitor them before and during CIMZIA treatment.
  • Discontinue CIMZIA and begin antiviral therapy in patients who develop HBV reactivation. Exercise caution when resuming CIMZIA after HBV treatment.

NEUROLOGIC REACTIONS

  • TNF blockers, including CIMZIA, have been associated with rare cases of new onset or exacerbation of central nervous system and peripheral demyelinating diseases, including multiple sclerosis, seizure disorder, optic neuritis, peripheral neuropathy, and Guillain-Barré syndrome.

HEMATOLOGIC REACTIONS

  • Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia has been infrequently reported with CIMZIA.
  • Consider stopping CIMZIA if significant hematologic abnormalities occur.

DRUG INTERACTIONS

  • Do not use CIMZIA in combination with other biological DMARDS.

AUTOIMMUNITY

  • Treatment with CIMZIA may result in the formation of autoantibodies and, rarely, in development of a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop.

IMMUNIZATIONS

  • Patients on CIMZIA should not receive live or live-attenuated vaccines.

ADVERSE REACTIONS

  • The most common adverse reactions in CIMZIA clinical trials (≥8%) were: upper respiratory infections (18%), rash (9%), and urinary tract infections (8%).

For full prescribing information, please visit
https://www.ucb.com/_up/ucb_com_products/documents/Cimzia_09_11_2019_en.pdf 

CIMZIA® is a registered trademark of the UCB Group of Companies. 

For further information, contact UCB:

Investor Relations
Antje Witte
T +32.2.559.94.14 
Email: [email protected] 

U.S. Immunology Communications
Nicole Herga
T +1.404.226.7591
Email: [email protected]

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 approximately 8,600 people in approximately 40 countries, the company generated revenue of €5.8 billion in 2021. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news.

Forward looking statements
This press release may contain forward-looking statements including, without limitation, statements containing the words "believes", "anticipates", "expects", "intends", "plans", "seeks", "estimates", "may", "will", "continue" and similar expressions. These forward-looking statements are based on current plans, estimates and beliefs of management. All statements, other than statements of historical facts, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, arbitration, political, regulatory or clinical results or practices and other such estimates and results. By their nature, such forward-looking statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and assumptions which might cause the actual results, financial condition, performance or achievements of UCB, or industry results, to differ materially from those that may be expressed or implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: the global spread and impact of COVID-19, changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms or within expected timing, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, product liability claims, challenges to patent protection for products or product candidates, competition from other products including biosimilars, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in tax laws or the administration of such laws, and hiring and retention of its employees. There is no guarantee that new product candidates will be discovered or identified in the pipeline, will progress to product approval or that new indications for existing products will be developed and approved. Movement from concept to commercial product is uncertain; preclinical results do not guarantee safety and efficacy of product candidates in humans. So far, the complexity of the human body cannot be reproduced in computer models, cell culture systems or animal models. The length of the timing to complete clinical trials and to get regulatory approval for product marketing has varied in the past and UCB expects similar unpredictability going forward. Products or potential products, which are the subject of partnerships, joint ventures or licensing collaborations may be subject to differences disputes between the partners or may prove to be not as safe, effective or commercially successful as UCB may have believed at the start of such partnership. UCB's efforts to acquire other products or companies and to integrate the operations of such acquired companies may not be as successful as UCB may have believed at the moment of acquisition. Also, UCB or others could discover safety, side effects or manufacturing problems with its products and/or devices after they are marketed. The discovery of significant problems with a product similar to one of UCB's products that implicate an entire class of products may have a material adverse effect on sales of the entire class of affected products. Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment, including pricing pressure, political and public scrutiny, customer and prescriber patterns or practices, and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement activities and outcomes. Finally, a breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of UCB's data and systems.

Given these uncertainties, you should not place undue reliance on any of such forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labelling in any market, or at any particular time, nor can there be any guarantee that such products will be or will continue to be commercially successful in the future.

UCB is providing this information, including forward-looking statements, only as of the date of this press release and it does not reflect any potential impact from the evolving COVID-19 pandemic, unless indicated otherwise. UCB is following the worldwide developments diligently to assess the financial significance of this pandemic to UCB. UCB expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report or reflect any change in its forward-looking statements with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless such statement is required pursuant to applicable laws and regulations.

Additionally, information contained in this document shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any offer, solicitation or sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction. 

References

  1. 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.
  2. BIMZELX® (bimekizumab) EU Summary of Product Characteristics, March 2022. https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf. Last accessed August 2022.
  3. BIMZELX® (bimekizumab) GB Summary of Product Characteristics. https://www.medicines.org.uk/emc/product/12834; https://www.medicines.org.uk/emc/product/12833 Last accessed: August 2022.
  4. Pharmaceuticals and Medical Devices Agency. Available at: https://www.pmda.go.jp/english/review-services/reviews/approved-information/drugs/0001.html Last accessed: August 2022.
  5. BIMZELX (bimekizumab) Canada Product Monograph. Available at: https://pdf.hres.ca/dpd_pm/00064702.PDF Last accessed: August 2022.
  6. BIMZELX (bimekizumab) Australia. Available at: https://www.tga.gov.au/apm-summary/bimzelx. Last accessed August 2022.

SOURCE UCB, Inc.

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