UCB Reinforces Commitment to Rheumatology With 15 Abstracts Including New Late-Breaking Data at ACR Convergence 2022
UCB is set to present 15 abstracts at ACR Convergence 2022 in Philadelphia from November 10-14, focusing on its rheumatology portfolio. Notably, the presentation includes late-breaking 52-week data for bimekizumab in treating psoriatic arthritis and axial spondyloarthritis. This data will be shared through four oral presentations and eight e-posters, underscoring UCB's dedication to advancing treatment standards. Bimekizumab is still under investigation and not yet approved by the FDA. CIMZIA® data will also be presented, highlighting its use in active axial spondyloarthritis.
- Presentation of late-breaking 52-week data for bimekizumab highlights progress in treatment for psoriatic arthritis and axial spondyloarthritis.
- UCB's commitment to innovative research is demonstrated through the extensive data presentation at ACR Convergence 2022.
- Bimekizumab is still investigational and not FDA-approved, which raises concerns about market readiness.
- The product's efficacy and safety are yet to be established, leading to uncertainty in patient outcomes.
- 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 and ATLANTA, Nov. 8, 2022 /PRNewswire/ -- 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).
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."
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.
- 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 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)
- 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)
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
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
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
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
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.
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.
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.6 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 therapy.7,8 The 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
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
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.
- 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.
CIMZIA® is a registered trademark of the UCB Group of Companies.
©2022 UCB, Inc., Smyrna, GA 30080. All rights reserved.
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FAQ
When will UCB present new data on bimekizumab at ACR Convergence 2022?
What are the key highlights of UCB's data on bimekizumab for psoriatic arthritis?
Is bimekizumab approved for use in the U.S.?
What data will UCB present regarding CIMZIA® at ACR Convergence 2022?
What is the significance of the 52-week data for bimekizumab?
