UCB Reinforces Commitment to Rheumatology With 15 Abstracts Including New Late-Breaking Data at ACR Convergence 2022

Nov 08

This Press Release is Intended for Media and Investor Stakeholders Only

Late-breaking 52-week data on investigational bimekizumab in the treatment of adults with active psoriatic arthritis and active axial spondyloarthritis to be presented
New data on CIMZIA® (certolizumab pegol) and bimekizumab underscore UCB’s commitment to innovative research in rheumatology

Brussels/Atlanta, November 8, 2022 (12:00 PM ET) – UCB, a global biopharmaceutical company, today announced that it will present 15 abstracts across its rheumatology portfolio at ACR Convergence 2022 to be held in Philadelphia, November 10–14, 2022. The abstracts, including two with late-breaking data, have been accepted as four oral presentations, eight e-posters, and three “Ignite Talks,” which are five-minute in-person presentations focused on the highest-ranked posters at the meeting.

“The breadth of new data we are presenting at ACR Convergence 2022, including the first presentation of bimekizumab 52-week data in psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis, underscore our commitment to address unmet patient needs and to raise standards of care,” said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S., UCB.

UCB is investigating bimekizumab in psoriatic arthritis (PsA), non-radiographic axial spondyloarthritis (nr-axSpA), and ankylosing spondylitis (AS). 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).

Bimekizumab data highlights
Data evaluating bimekizumab in the treatment of PsA and across the spectrum of axSpA will be shared across three oral presentations, three “Ignite Talks,” and six e-posters.

One oral presentation and one “Ignite Talk,” will detail late-breaking 52-week data from the bimekizumab studies. The oral presentation will present results from the Phase 3 BE OPTIMAL study evaluating bimekizumab in patients with active PsA who were biologic naïve. The “Ignite Talk” will share data from the Phase 3 BE MOBILE 1 and BE MOBILE 2 studies evaluating bimekizumab in the treatment of nr-axSpA and AS, respectively.

A second oral presentation will share data from the Phase 3 BE COMPLETE study, evaluating bimekizumab in the treatment of active PsA in patients with a previous inadequate response or intolerance to tumor necrosis factor inhibitors (TNFi-IR). A third oral presentation will share 24-week data from the Phase 3 BE MOBILE 1 study evaluating bimekizumab in nr-axSpA.

In addition, 24-week data from the BE MOBILE 2 study evaluating bimekizumab in the treatment of AS and key patient reported outcomes from the Phase 3 BE MOBILE 1 and BE MOBILE 2 studies will be presented in two “Ignite Talks.”

CIMZIA® (certolizumab pegol) data highlights
Data evaluating certolizumab pegol in the treatment of active axSpA will also be shared across one oral presentation and two e-posters. The oral presentation will detail an exploratory analysis that aims to evaluate the relationship between objective signs of inflammation and clinical outcomes following 12 weeks of certolizumab pegol treatment in patients with active axSpA.

The following is a guide to the UCB-sponsored data presentations at
ACR Convergence 2022:

Bimekizumab abstracts: Psoriatic Arthritis

Bimekizumab Treatment in Biologic DMARD-Naïve Patients with Active Psoriatic Arthritis: 52-Week Efficacy and Safety Results from a Phase 3, Randomized, Placebo-Controlled, Active Reference Study
C. Ritchlin, L. C. Coates, I. McInnes, P. J. Mease, J. Merola, Y. Tanaka, A. Asahina, L. Gossec, A. Gottlieb, D. Thaçi, B. Ink, D. Assudani, R. Bajracharya, V. Shende, J. Coarse, R. Landewé
#L02
Oral presentation: Monday, November 14, 9:15am – 9:25am (ET)
Bimekizumab Treatment in Patients with Active Psoriatic Arthritis and Inadequate Response to Tumor Necrosis Factor Inhibitors: 16-week Efficacy and Safety from a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study
J. Merola, R. Landewé, I.B. McInnes, P.J. Mease, C. Ritchlin, Y. Tanaka, A. Asahina, F. Behrens, D. Gladman, L. Gossec, R. Warren, B. Ink, D. Assudani, R. Bajracharya, J. Coarse, L. Coates.
#1599
Oral presentation: Sunday, November 13, 3:30pm – 3:40pm (ET)
Bimekizumab Treatment Improves Health-Related Quality of Life in Biologic DMARD-Naïve and TNFi-IR Patients with Active PsA: Pooled 16-Week Results From Two Phase 3 Randomized, Placebo-Controlled Studies
D. Gladman, L.E. Kristensen, D. Thaçi, P. Gisondi, L. Gossec, M.E. Husni, A. Gottlieb, H. Dobashi, B. Ink, D. Assudani, R. Bajracharya, J. Coarse, J. Lambert, W. Tillett
#2122
e-Poster: Monday, November 14, 1:00pm – 3:00pm (ET)
Bimekizumab Improvements in Efficacy on Disease Activity Assessed via Composite Endpoints in Biologic DMARD-naïve and TNFi-IR Patients with Active PsA: Pooled 16-Week Results from Phase 3 Randomized, Placebo-Controlled Studies
P.J. Mease, L. Coates, R. Landewé, I.B. McInnes, C. Ritchlin, T. Atsumi, F. Behrens, D. Gladman, L. Gossec, P. Nash, B. Ink, D. Assudani, R. Bajracharya, J. Coarse, A.R. Prickett, A.B. Gottlieb
# 2117
e-Poster: Monday, November 14, 1:00pm – 3:00pm (ET)
Bimekizumab Treatment Results in Improvements in Fatigue and Pain in Biologic DMARD-Naïve or TNFi-IR Patients with Active Psoriatic Arthritis: Pooled 16-Week Results from Two Phase 3 Randomized, Placebo-Controlled Studies
M.E. Husni, P.J. Mease, J. Merola, F. Behrens, E.G. Favalli, D. McGonagle, W. Tillett, S. Tsuji, B. Ink, D. Assudani, R. Bajracharya, J. Coarse, J. Lambert, L. Gossec
#2119
e-Poster: Monday, November 14, 1:00pm – 3:00pm (ET)
Achieving Increasingly Stringent Clinical Disease Control Criteria is Associated with Greater Improvements in Patient-Centric Measures of Physical Function and Pain in Patients with Active PsA: 16-Week Results from Two Phase 3 Randomized, Placebo-Controlled Studies
J. Walsh, L. Coates, P.J. Mease, J. Merola, P. Nash, A. Ogdie, W. Tillett, P. Gisondi, B. Ink, D. Assudani, R. Bajracharya, J. Lambert, V. Taieb, D. Willems, L.E. Kristensen
#2118
e-Poster: Monday, November 14, 1:00pm – 3:00pm (ET)

Bimekizumab abstracts: Axial Spondyloarthritis

Bimekizumab Maintains Improvements in Efficacy Endpoints and Has a Consistent Safety Profile Through 52 Weeks in Patients with Non-Radiographic Axial Spondyloarthritis and Ankylosing Spondylitis: Results from Two Parallel Phase 3 Studies
X. Baraliakos, A. Deodhar, D. van der Heijde, M. Magrey, W. Maksymowych, T. Tomita, H. Xu, M. Oortgiesen, U. Massow, C. Fleurinck, A. M. Ellis, T. Vaux, J. Shepherd-Smith, A. Marten, L. S. Gensler
#L14
Ignite Talk: Monday, November 14, 2:35pm – 2:40pm (ET)
Bimekizumab Improves Signs and Symptoms, Including Inflammation, in Patients with Active Non-Radiographic Axial Spondyloarthritis: 24-Week Efficacy & Safety from a Phase 3, Multicenter, Randomized, Placebo-Controlled Study
A. Deodhar, D. van der Heijde, L. Gensler, H. Xu, K. Gaffney, H. Dobashi, W.P. Maksymowych, M. Rudwaleit, M. Magrey, D. Elewaut, M. Oortgiesen, C. Fleurinck, N. de Peyrecave, A. Ellis, T. Vaux, J. Shepherd-Smith, X. Baraliakos
#0544
Oral presentation: Saturday, November 12, 5:00pm – 5:10pm (ET)
Bimekizumab Improves Signs and Symptoms, Including Inflammation, in Patients with Active Ankylosing Spondylitis: 24-Week Efficacy & Safety From a Phase 3, Multicenter, Randomized, Placebo Controlled Study
D. van der Heijde, X. Baraliakos, M. Dougados, M. Brown, D. Poddubnyy, F. van den Bosch, N. Haroon, H. Xu, T. Tomita, L. Gensler, M. Oortgiesen, C. Fleurinck, N. de Peyrecave, T. Vaux, A Marten, A. Deodhar
#0411
Ignite Talk: Sunday, November 13, 9:10am – 9:15am (ET)
Bimekizumab Improves Key Patient Reported Symptoms of Axial Spondyloarthritis Including Spinal Pain and Fatigue: Results from Two Phase 3 Studies
P.J. Mease, A. Deodhar, M. Dougados, M. Dubreuil, M. Magrey, H. Marzo-Ortega, M. Rudwaleit, C. de la Loge, A. Ellis, C. Fleurinck, M. Oortgiesen, V. Taieb, L. Gensler
#0409
Ignite Talk: Sunday, November 13, 9:00am – 9:05am (ET)
Bimekizumab Improves Physical Function and Health-Related Quality of Life in Patients with Axial Spondyloarthritis: Results From Two Phase 3 Studies
M. Dubreuil, K. Gaffney, L. Gensler, J. Kay, V. Navarro-Compán, C. de la Loge, A. Ellis, C. Fleurinck, M. Oortgiesen, V. Taieb, A. Deodhar
#0412
e-Poster: Saturday, November 12, 1:00pm – 3:00pm (ET)
Achieving Increasingly Stringent Clinical Response Criteria & Lower Levels of Disease Activity Is Associated With Greater Improvements in Physical Function and HRQoL in Patients With Active Axial Spondyloarthritis: 16-Week Results From Two Phase 3 Randomized, Placebo-Controlled Studies
M. Magrey, A. Deodhar, P.J. Mease, V. Navarro-Compán, S. Ramiro, M. Rudwaleit, C. de la Loge, C. Fleurinck, V. Taieb, M.F. Mørup, M. Oortgiesen, J. Kay
#0410
e-Poster: Saturday, November 12, 1:00pm – 3:00pm (ET)

CIMZIA® (certolizumab pegol) abstracts: Axial Spondyloarthritis

An Exploratory Analysis of the Potential Disconnect Between Objective Inflammatory Response and Clinical Response following Certolizumab Pegol Treatment in Patients with Active Axial Spondyloarthritis
M. Rudwaleit, F. van den Bosch, H. Marzo-Ortega, V. Navarro-Compán, R. Tham, T. Kumke, L. Bauer, M. Kim, L. Gensler
#0543
Oral presentation: Saturday, November 12, 4:45pm – 4:55pm (ET)
Long-Term Clinical Outcomes of Certolizumab Pegol Treatment in Patients with Active Non‑Radiographic Axial Spondyloarthritis Stratified by Baseline MRI and C-Reactive Protein Status
P.C. Robinson, W.P. Maksymowych, L. Gensler, M. Rudwaleit, B. Hoepken, L. Bauer, T. Kumke, M. Kim, A. Deodhar
#0408
e-Poster: Saturday, November 12, 1:00pm – 3:00pm (ET)
Comparison of Established and New, Preliminarily Proposed ASAS Cut-Offs for Inflammatory MRI Lesions in the Sacroiliac Joints of Axial Spondyloarthritis Patients and Implications for Recruitment in Clinical Studies
X. Baraliakos, P. Machado, L. Bauer, B. Hoepken, M. Kim, T. Kumke, R. Tham, M. Rudwaleit
#1010
e-Poster: Sunday, November 13, 9:00am – 10:30am (ET)

Abstracts to be presented at ACR Convergence 2022 are available at ACR Convergence 2022 Archives - ACR Meeting Abstracts (acrabstracts.org)

Notes to editors:
About BE OPTIMAL
BE OPTIMAL was a randomized, multicenter, double-blind, placebo-controlled, active reference (adalimumab), parallel-group, Phase 3 study designed to evaluate the efficacy and safety of bimekizumab in the treatment of adult patients with active psoriatic arthritis, who are biologic disease-modifying anti-rheumatic drug naïve. For additional details on the study, visit BE OPTIMAL on clinicaltrials.gov.¹

About BE COMPLETE
BE COMPLETE was a randomized, multicenter, double-blind, placebo-controlled, parallel-group, Phase 3 study designed to evaluate the efficacy and safety of bimekizumab in adults with active psoriatic arthritis and an inadequate response to tumor necrosis factor-alpha inhibitors (TNFαi). All enrolled study participants had a history of inadequate response (lack of efficacy after at least three months of therapy at an approved dose) or intolerance to treatment with one or two TNFαi for either psoriatic arthritis or psoriasis. For additional details on the study, visit BE COMPLETE on clinicaltrials.gov.²

About BE MOBILE 1
BE MOBILE 1 was a randomized, multicenter, double-blind, placebo-controlled, parallel-group, Phase 3 study designed to evaluate the efficacy and safety of bimekizumab in the treatment of adult patients with active nr-axSpA. For additional details on the study, visit BE MOBILE 1 on clinicaltrials.gov.³

About BE MOBILE 2
BE MOBILE 2 was a randomized, multicenter, double-blind, placebo-controlled, parallel-group, Phase 3 study designed to evaluate the efficacy and safety of bimekizumab in the treatment of adult patients with active AS. For additional details on the study, visit BE MOBILE 2 on clinicaltrials.gov.⁴

About CIMZIA® in the U.S.⁵
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 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.

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

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.

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.⁶In 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 therapy.^7,8The label information may differ in other countries. Please check local prescribing information.

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 further information, contact UCB:

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

U.S. Immunology Communications
Nicole Herga
T +1.773.960.5349
Email: nicole.herga@ucb.com

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.

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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.

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References

A Study to Test the Efficacy and Safety of Bimekizumab in the Treatment of Subjects with Active Psoriatic Arthritis (BE OPTIMAL). ClinicalTrials.gov. Available from: https://www.clinicaltrials.gov/ct2/show/NCT03895203?term=BE+OPTIMAL&draw=2&rank=1 Last accessed: November 2022.
A Study to Evaluate the Efficacy and Safety of Bimekizumab in the Treatment of Subjects with Active Psoriatic Arthritis (BE COMPLETE). ClinicalTrials.gov. Available from: https://www.clinicaltrials.gov/ct2/show/NCT03896581 Last accessed: November 2022.
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects with Active Non-radiographic Axial Spondyloarthritis (BE MOBILE 1). ClinicalTrials.gov. Available from: https://clinicaltrials.gov/ct2/show/NCT03928704 Last accessed: November 2022.
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects with Active Ankylosing Spondylitis (BE MOBILE 2). ClinicalTrials.gov. Available from: https://www.clinicaltrials.gov/ct2/show/NCT03928743 Last accessed: November 2022.
CIMZIA (certolizumab pegol) US Prescribing Information. Available at: Cimzia_09_11_2019_en.pdf (ucb.com) Last accessed: November 2022.
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.
BIMZELX® (bimekizumab) EU Summary of Product Characteristics, March 2022. Available at: https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf. Last accessed: November 2022.
BIMZELX® (bimekizumab) GB Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/12834/smpc#gref. Last accessed: November 2022.

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