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. 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. 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. The following is a guide to the UCB-sponsored data presentations at
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
Oral presentation: Monday, November 14, 9:15am – 9:25am (ET)
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.
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
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
e-Poster: Monday, November 14, 1:00pm – 3:00pm (ET)
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
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
e-Poster: Monday, November 14, 1:00pm – 3:00pm (ET)
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
Ignite Talk: Monday, November 14, 2:35pm – 2:40pm (ET)
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
Oral presentation: Saturday, November 12, 5:00pm – 5:10pm (ET)
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
Ignite Talk: Sunday, November 13, 9:10am – 9:15am (ET)
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
Ignite Talk: Sunday, November 13, 9:00am – 9:05am (ET)
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
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
e-Poster: Saturday, November 12, 1:00pm – 3:00pm (ET)
M. Rudwaleit, F. van den Bosch, H. Marzo-Ortega, V. Navarro-Compán, R. Tham, T. Kumke, L. Bauer, M. Kim, L. Gensler
Oral presentation: Saturday, November 12, 4:45pm – 4:55pm (ET)
P.C. Robinson, W.P. Maksymowych, L. Gensler, M. Rudwaleit, B. Hoepken, L. Bauer, T. Kumke, M. Kim, A. Deodhar
e-Poster: Saturday, November 12, 1:00pm – 3:00pm (ET)
X. Baraliakos, P. Machado, L. Bauer, B. Hoepken, M. Kim, T. Kumke, R. Tham, M. Rudwaleit
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 indicated for the treatment of moderate-to-severe plaque psoriasis (PSO) in adults who are candidates for systemic therapy or phototherapy. IMPORTANT SAFETY INFORMATION about CIMZIA in the U.S. 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. 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. 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. 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. 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. 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. Do not use CIMZIA in combination with other biological DMARDS. 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. Patients on CIMZIA should not receive live or live-attenuated vaccines. 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. For further information, contact UCB:
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 8,600 people in approximately 40 countries, the company generated revenue of €5.8 billion in 2021. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news. Forward looking statements
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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 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. 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.