• Eleven abstracts across UCB’s rheumatology portfolio, including investigational bimekizumab and CIMZIA^® (certolizumab pegol), underscore UCB’s dedication to rheumatology
• Long-term three-year data from Phase 2b studies highlight bimekizumab’s potential to improve the lives of people living with ankylosing spondylitis (AS) and psoriatic arthritis (PsA)
• Phase 3 C-axSpAnd open-label safety follow-up extension study shows CIMZIA improved signs and symptoms of non-radiographic axial spondyloarthritis (nr-axSpA) up to three years

Atlanta, Ga. – November 5, 2021 – 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
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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.

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For further information, UCB:

^[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.