UCB Showcases Key Rheumatology Data at ACR Convergence 2021

Rhea-AI Summary

On November 5, 2021, UCB presented significant data on its investigational drugs, bimekizumab and CIMZIA, during the ACR Convergence 2021 virtual congress. Eleven abstracts showcased findings, with a focus on bimekizumab's potential in psoriatic arthritis and ankylosing spondylitis. The data indicated long-term safety and efficacy, maintaining clinical outcomes over three years. CIMZIA’s three-year results for nr-axSpA were also highlighted, showing no new safety signals. Bimekizumab is currently under FDA review for treating moderate to severe plaque psoriasis.

Positive

• Bimekizumab shows potential for long-term safety and efficacy in treating ankylosing spondylitis, with results maintained over three years.
• CIMZIA demonstrated long-term improvement in clinical outcomes for patients with non-radiographic axial spondyloarthritis without new safety signals.
• UCB is actively participating in advancing treatments in rheumatology, reaffirming its commitment to addressing unmet patient needs.

Negative

• Bimekizumab's efficacy and safety are not yet established for any indication in the U.S., pending FDA review.

ATLANTA, Nov. 5, 2021 /PRNewswire/ -- UCB, a global biopharmaceutical company, today announced new data on its investigational IL-17A and IL-17F inhibitor, bimekizumab, and its TNF inhibitor, CIMZIA^® (certolizumab pegol). Eleven abstracts are being presented at the ACR Convergence 2021 virtual congress on November 3-9, 2021, reinforcing UCB's ongoing commitment to developing treatments that address unmet patient needs.

UCB is investigating bimekizumab in psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA), including ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA), among other therapy areas, as part of a robust clinical program. Bimekizumab is currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe plaque psoriasis in adults, and its efficacy and safety have not been established for any indication in the U.S.

"We are pleased to have the opportunity to share data across our strong immunology clinical programs at ACR Convergence 2021 and beyond," said Jeffrey Stark, MD, Head of Immunology Medical Affairs U.S., UCB. "Our bimekizumab data support the selective inhibition of IL-17F in addition to IL-17A in the treatment of ankylosing spondylitis and psoriatic arthritis, and demonstrate the potential of bimekizumab to provide durable clinical responses over three years for people living with these severe, chronic conditions."

Bimekizumab Data Highlights

An oral presentation will highlight three-year bimekizumab data in AS from the Phase 2b BE AGILE study and its open-label extension (OLE).¹ Data show the long-term safety profile of bimekizumab in patients with AS was in line with previous observations, and clinical outcomes were maintained and consistent over three years of treatment.^1,2,3 In addition to the oral presentation, UCB is presenting two e-posters; one that will report three-year interim health-related quality of life data in patients with active AS from the Phase 2b BE AGILE study and its OLE, and a second that evaluates the impact of the COVID-19 pandemic on disease activity and health-related quality of life in patients from the BE AGILE OLE study.^2,3

Two e-posters will also report bimekizumab data in active PsA from the Phase 2b dose-ranging study BE ACTIVE and its OLE.^4,5 Data reported include the impact up to three years on patient reported outcome measures, and long-term efficacy and safety in the overall bimekizumab population and tumor necrosis factor inhibitor (TNFi)-naïve population.^4,5

CIMZIA certolizumab pegol) Data Highlights

UCB will also present six e-posters detailing CIMZIA data, including the first release of three-year results from the C-axSpAnd pivotal Phase 3 study evaluating the long-term safety and efficacy of CIMZIA in nr-axSpA.^{6,7,8,9,10,11} The analysis reports safety and clinical outcomes in nr-axSpA patients who entered the C-axSpAnd open-label safety follow-up extension (SFE) study. Data show CIMZIA improved signs and symptoms of nr-axSpA for up to three years, and there were no new safety signals.

Building on CIMZIA efficacy in nr-axSpA, a new analysis from this patient population in the C-OPTIMISE study shows that over a year of CIMZIA treatment, clinically relevant responses are achieved in MRI positive patients regardless of their C-reactive protein (CRP) levels. Two e-posters also demonstrate that achieving higher thresholds of disease control with CIMZIA helps reduce the burden on work productivity for people living with axSpA and PsA.^7,11

Following is a guide to the UCB-sponsored data presentations:

Bimekizumab Oral Presentation
Bimekizumab Long-Term Safety and Efficacy in Patients with Ankylosing Spondylitis: Interim Results After 3 Years of Treatment in an Ongoing Phase 2b Study
L. S. Gensler, A. Deodhar, D. van der Heijde, D. Poddubnyy, A. J. Kivitz, M. Dougados, N. de Peyrecave, M. Oortgiesen, T. Vaux, C. Fleurinck, X. Baraliakos (Abstract #0491 – Saturday, Nov. 6; 2:45-2:55pm ET)

Bimekizumab e-Posters:
Bimekizumab Shows Sustained and Meaningful Long-Term Improvements in Health-Related Quality of Life in Ankylosing Spondylitis: Interim Results After 3 Years of Treatment in an Ongoing Phase 2b Study
A. Deodhar, M. Dougados, K. Gaffney, R. Sengupta, M. Magrey, N. de Peyrecave, M. Oortgiesen, T. Vaux, C. Fleurinck, V. Taieb, C. de la Loge, X. Baraliakos (Abstract #0922 – Sunday, Nov. 7; 8:30-10:30am ET)

Minimal Impact of the COVID-19 Pandemic on Patient-Reported Disease Activity and Health-Related Quality of Life in Patients with Ankylosing Spondylitis Receiving Bimekizumab: Post Hoc Analyses from a Phase 2b Study
P. C. Robinson, P. M. Machado, N. Haroon, L. S. Gensler, J. D. Reveille, V. Taieb, T. Vaux, C. Fleurinck, M. Oortgiesen, N. de Peyrecave, A. Deodhar (Abstract #0923 – Sunday, Nov. 7; 8:30-10:30am ET)

Bimekizumab in Patients with Psoriatic Arthritis: 3-Year Results for Overall and Tumor Necrosis Factor Inhibitor (TNFi)-Naïve Populations from a Phase 2b Open-Label Extension Study
P. J. Mease, A. Deodhar, J. F. Merola, I. B. McInnes, D. Assudani, R. Bajracharya, J. Coarse,⁶ B. Ink, G. Schett (Abstract #1338 – Monday, Nov. 8; 8:30-10:30am ET)

Sustained Improvement in Physical Function, Disease Impact and Health­Related Quality of Life in Patients with Psoriatic Arthritis Treated with Bimekizumab: 3-Year Results from a Phase 2b Open-Label Extension Study
L. Gossec, A. Asahina, A. B. Gottlieb, L. C. Coates, B. Ink, D. Assudani, J. Coarse, S. Hellot, J. Eells, P. J. Mease (Abstract #1350 - Monday, Nov. 8; 8:30-10:30am ET)

CIMZIA e-Posters:

Achievement of Stringent Thresholds of Disease Control is Associated with Reduced Burden on Work and Household Productivity in Patients with Axial Spondyloarthritis
M. Rudwaleit, P. M. Machado, L. S. Gensler, V. Taieb, N. de Peyrecave, B. Hoepken, D. van der Heijde (abstract #0362 – Saturday, Nov. 6; 8:30-10:30am ET)

Long-Term Safety and Efficacy of Certolizumab Pegol in Patients with Active Non–Radiographic Axial Spondyloarthritis: 3-Year Results from a Phase 3 Multicenter Study
D. van der Heijde, L. S. Gensler, W. P. Maksymowych, R. Landewé, M. Rudwaleit, L. Bauer, B,. Hoepken, T. Kumke, M. Kim, A. Deodhar (Abstract #0913 – Sunday, Nov. 7; 8:30-10:30am ET)

Response to Certolizumab Pegol in Patients with Non-Radiographic Axial Spondyloarthritis by Baseline C-Reactive Protein Cut-Offs: Post-Hoc Analysis from a Phase 3 Multicenter Study
P. C. Robinson, S. Hall, B. Hoepken, L. Bauer, E. Demas, M. Kim, A. Deodhar (Abstract #0914 – Sunday, Nov. 7; 8:30-10:30am ET)

Disease Activity and Inflammation in Axial Spondyloarthritis Patients Who Did Not Experience Flares Following Certolizumab Pegol Withdrawal, Dose Reduction or Dose Continuation
L. S. Gensler, X. Baraliakos, L. Bauer, B. Hoepken, T. Kumke, M. Kim, R. Landewé (Abstract #0916 – Sunday, Nov. 7; 8:30-10:30am ET)

Reduced Burden on Paid and Household Work Productivity with Stringent Thresholds of Disease Control: Further Results from Long-Term Certolizumab Pegol Treatment in Patients with Psoriatic Arthritis
W. Tillett, L. C. Coates, S. Kiri, V. Taieb, P. J. Mease (Abstract #1826 – Tuesday, Nov. 9; 8:30-10:30am ET)

Other UCB e-Posters:
Development of a Deep Learning Algorithm for the Detection of Sacroiliitis on MRI in Patients with Active Axial Spondyloarthritis
J. Nicolaes, P. M. Machado, X. Baraliakos, M. Santosh, A. Carnell, N. de Peyrecave, A. N. Bennett (Abstract #0157 – Saturday, Nov. 6; 8:30-10:30am ET)

About bimekizumab

Bimekizumab is an investigational humanized monoclonal IgG1 antibody that selectively and directly inhibits both IL-17A and IL-17F, two key cytokines driving inflammatory processes.¹² IL-17F has overlapping biology with IL-17A and drives inflammation independently of IL-17A.^{13,14,15,16,17} Selective inhibition of IL-17F in addition to IL-17A suppresses inflammation to a greater extent than IL-17A inhibition alone.^12,17 

Bimekizumab is currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe plaque psoriasis in adults, and its efficacy and safety have not been established for any indication in the U.S.

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 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.

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 the treatment of moderate to severe plaque psoriasis (PSO) in adults who are candidates for systemic therapy or phototherapy. 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.

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 8,400 people in nearly 40 countries, the company generated revenue of €5.3 billion in 2020. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCBUSA.

Forward looking statements UCB

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.

For further information, UCB:

Immunology Communications, U.S. Nicole Herga U.S. Immunology Communications, UCB T +1.404.226.7591 nicole.herga@ucb.com

Investor Relations Antje Witte, Investor Relations, UCB T +32.2.559.94.14 antje.witte@ucb.com

¹ Gensler LS, Deodhar A, van der Heijde D, et al. Bimekizumab Long-Term Safety and Efficacy in Patients with Ankylosing Spondylitis: Interim Results After 3 Years of Treatment in an Ongoing Phase 2b Study [abstract]. In: American College of Rheumatology Convergence; 2021 Nov 3-9; ACR; 2021. Abstract nr 491

² Deodhar A, Dougados M, Gaffney K, et al. Bimekizumab Shows Sustained and Meaningful Long-Term Improvements in Health-Related Quality of Life in Ankylosing Spondylitis: Interim Results After 3 Years of Treatment in an Ongoing Phase 2b Study [abstract]. In: American College of Rheumatology Convergence; 2021 Nov 3-9; ACR; 2021. Abstract nr 922

³ Robinson PC, Machado PM, Haroon N, et al. Minimal Impact of the COVID-19 Pandemic on Patient-Reported Disease Activity and Health-Related Quality of Life in Patients with Ankylosing Spondylitis Receiving Bimekizumab: Post Hoc Analyses from a Phase 2b Study [abstract]. In: American College of Rheumatology Convergence; 2021 Nov 3-9; ACR; 2021. Abstract nr 923

⁴ Mease PJ, Dedhar A, Merola JF, et al. Bimekizumab in Patients with Psoriatic Arthritis: 3-Year Results for Overall and Tumor Necrosis Factor Inhibitor (TNFi)-Naïve Populations from a Phase 2b Open-Label Extension Study [abstract]. In: American College of Rheumatology Convergence; 2021 Nov 3-9; ACR; 2021. Abstract nr 1338

⁵ Gossec L, Asahina AB, Gottlieb LC, et al. Sustained Improvement in Physical Function, Disease Impact and Health­Related Quality of Life in Patients with Psoriatic Arthritis Treated with Bimekizumab: 3-Year Results from a Phase 2b Open-Label Extension Study [abstract]. In: American College of Rheumatology Convergence; 2021 Nov 3-9; ACR; 2021. Abstract nr 1350

⁶ Nicolaes J, Machado PM, Baraliakos X, et al. Development of a Deep Learning Algorithm for the Detection of Sacroiliitis on MRI in Patients with Active Axial Spondyloarthritis [abstract]. In: American College of Rheumatology Convergence; 2021 Nov 3-9; ACR; 2021. Abstract nr 157

⁷ Rudwaleit M, Machado PM, Gensler LS, et al. Achievement of Stringent Thresholds of Disease Control is Associated with Reduced Burden on Work and Household Productivity in Patients with Axial Spondyloarthritis [abstract]. In: American College of Rheumatology Convergence; 2021 Nov 3-9; ACR; 2021. Abstract nr 362

⁸ van der Heijde D, Gensler LS, Maksymowych WP, et al. Long-Term Safety and Efficacy of Certolizumab Pegol in Patients with Active Non–Radiographic Axial Spondyloarthritis: 3-Year Results from a Phase 3 Multicenter Study [abstract]. In: American College of Rheumatology Convergence; 2021 Nov 3-9; ACR; 2021. Abstract nr 913

⁹ Robinson PC, Hall S, Hoepken B, et al. Response to Certolizumab Pegol in Patients with Non-Radiographic Axial Spondyloarthritis by Baseline C-Reactive Protein Cut-Offs: Post-Hoc Analysis from a Phase 3 Multicenter Study [abstract]. In: American College of Rheumatology Convergence; 2021 Nov 3-9; ACR; 2021. Abstract nr 914

¹⁰ Gensler LS, Baraliakos X, Bauer L, et al. Disease Activity and Inflammation in Axial Spondyloarthritis Patients Who Did Not Experience Flares Following Certolizumab Pegol Withdrawal, Dose Reduction or Dose Continuation [abstract]. In: American College of Rheumatology Convergence; 2021 Nov 3-9; ACR; 2021. Abstract nr 916

¹¹ Tillett W, Coates LC, Kiri S, et al. Reduced Burden on Paid and Household Work Productivity with Stringent Thresholds of Disease Control: Further Results from Long-Term Certolizumab Pegol Treatment in Patients with Psoriatic Arthritis [abstract]. In: American College of Rheumatology Convergence; 2021 Nov 3-9; ACR; 2021. Abstract nr 1826

¹² 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.

¹³ Yang XO, Chang SH, Park H, et al. Regulation of inflammatory responses by IL-17F. J Exp Med. 2008;205(5):1063–1075.

¹⁴ Hymowitz SG, Filvaroff EH, Yin JP, et al. IL-17s adopt a cystine knot fold: structure and activity of a novel cytokine, IL-17F, and implications for receptor binding. EMBO J. 2001;20(19):5332–5341.

¹⁵ van Baarsen LG, Lebre MC, van der Coelen D, et al. Heterogeneous expression pattern of interleukin 17A (IL-17A), IL-17F and their receptors in synovium of rheumatoid arthritis, psoriatic arthritis and osteoarthritis: possible explanation for nonresponse to anti-IL-17 therapy? Arthritis Res Ther. 2014;16(4):426.

¹⁶ 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(2):213.

¹⁷ 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 randomised placebo-controlled clinical trial that IL-17F contributes to human chronic tissue inflammation. Ann Rheum Dis. 2018;77(4):523-532.

 

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SOURCE UCB, Inc.

FAQ

What were the key findings from UCB's ACR Convergence 2021 presentation on bimekizumab and CIMZIA?

UCB presented data showing bimekizumab's long-term safety and efficacy in ankylosing spondylitis, along with CIMZIA's effectiveness in non-radiographic axial spondyloarthritis, with no new safety signals reported.

Is bimekizumab approved for use in the U.S.?

Bimekizumab is currently under review by the U.S. FDA for treating moderate to severe plaque psoriasis.

What does the new data from UCB suggest about CIMZIA's effectiveness?

The new data suggest that CIMZIA improves signs and symptoms in patients with non-radiographic axial spondyloarthritis for up to three years.

What are the implications of the new UCB data for investors holding UCBJY stock?

The positive data on bimekizumab and CIMZIA may enhance investor confidence in UCB's pipeline, potentially boosting the stock performance of UCBJY.

When was the ACR Convergence 2021 congress held where UCB presented its data?

The ACR Convergence 2021 congress was held from November 3-9, 2021.