Romosozumab-AQQG

Sustained symptom relief in patients with psoriatic arthritis: Achievement of the stringent ACR50 endpoint was sustained at three years by 53.2% and 55.2% of patients with psoriatic arthritis (PsA) naïve to biologics or who had an inadequate response to, or were intolerant of, tumor necrosis factor inhibitors, respectively†* Lasting improvements in physical function across the full spectrum of patients with axial spondyloarthritis: ASAS40, a composite endpoint, was sustained at three years by 60.4% and 60.1% of patients with non-radiographic axial spondyloarthritis (nr-axSpA) and ankylosing spondylitis (AS), respectively¥* Long-term inflammation control through three years: New data demonstrated consistent sustainability of efficacy across stringent clinical endpoints in PsA, nr-axSpA, and AS, showing potential to improve long-term outcomes and prevent structural damage Dual inhibition: BIMZELX® is the first and only approved medicine designed to selectively inhibit interleukin 17A (IL-17A) in addition to interleukin 17F (IL-17F) ATLANTA, June 11, 2025 /PRNewswire/ -- UCB, a global biopharmaceutical company, today announced new three-year data from Phase 3 trials, and their open-label extensions, investigating BIMZELX® (bimekizumab-bkzx) in adults with active psoriatic arthritis (PsA) and active axial spondyloarthritis (axSpA), which includes both non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation and ankylosing spondylitits (AS). BIMZELX, a dual inhibitor of IL-17A and IL-17F,1 demonstrated sustained control of inflammation and deep efficacy in patients living with PsA and axSpA,2-5 chronic inflammatory diseases with considerable impact on physical and emotional wellbeing.6-7 Sustained symptom relief in patients with active psoriatic arthritis "A primary treatment goal in psoriatic arthritis is sustained control of inflammation to help prevent long-term, irreversible structural damage and to improve quality of life," said Professor Laure Gossec,‡ from the Sorbonne University Hospital, Paris, France. "These bimekizumab data are notable for their consistency across treatment-naïve and experienced patients, with elimination of swollen joints in nearly sixty percent of patients and approximately half reaching minimal disease activity (MDA) at three years – both strong clinical responses that suggest real control of inflammation in PsA." In patients with active PsA, regardless of prior treatment experience, results from BE OPTIMAL, BE COMPLETE, and their open-label extension, BE VITAL, showed that BIMZELX delivered sustained efficacy across multiple stringent clinical endpoints for up to three years.2-3 At three years, 59.5% and 59.1% of bDMARD-naïve and TNFi-IR patients, respectively, achieved elimination of swollen joints (SJC=0).†*2-3 Complete skin clearance, measured by Psoriasis Area and Severity Index [PASI]100, was sustained to three years by 61.9% and 67.5% of bDMARD-naïve and TNFi-IR patients, respectively.†*2-3 MDA, a comprehensive and clinically meaningful endpoint, was sustained to three years by 52.9% and 48.8% of bDMARD-naïve and TNFi-IR patients, respectively.†*2-3 Improvements in physical function across the full spectrum of patients with axial spondyloarthritis "Long-term data, showing that patients living with axSpA can maintain high levels of clinical response, are invaluable for informed treatment decisions. It's particularly compelling to see sustained responses with bimekizumab treatment at three years with stringent outcome measures like ASAS40 and low disease activity," said Professor Xenofon Baraliakos,‡ from the Rheumazentrum Ruhrgebiet Herne, Ruhr University Bochum, Bochum, Germany. "These endpoints are key indicators of durable inflammation control in axSpA, and achieving this level of sustained disease management is likely to have a profound impact on patients' daily lives." Across patients with nr-axSpA and AS, data from two Phase 3 studies, BE MOBILE 1 and 2, and their combined open-label extension, BE MOVING, BIMZELX treatment demonstrated sustained clinical responses up to three years.4 Achievement of ASAS40 was sustained to three years by 60.4% and 60.1% of nr-axSpA and AS patients, respectively*, while 61.8% and 59.9% of nr-axSpA and AS patients, respectively, maintained Axial Spondyloarthritis Disease Activity Score (ASDAS) low disease activity (LDA <2.1) through three years.¥±4 Long-term inflammation control in patients with PsA and axSpA "Psoriatic arthritis and axial spondyloarthritis are serious, chronic inflammatory diseases that can have a great impact in the daily lives of patients and their families. The data presented at EULAR reinforce the role of bimekizumab to deliver deep, consistent, and sustained outcomes across a spectrum of PsA and axSpA," said Donatello Crocetta, Chief Medical Officer, UCB. "These data, alongside our other EULAR data presentations of dapirolizumab pegol§ in systemic lupus erythematosus and romosozumab in osteoporosis, reflect UCB's commitment to offering differentiated, science-driven solutions that meet the diverse and evolving needs of people living with rheumatic diseases." Across the three-year clinical trial data for PsA and axSpA, BIMZELX was generally well-tolerated and no new safety signals were observed.2-4 The most common treatment-emergent adverse events (TEAEs) over three years for both PsA and axSpA in these studies were SARS-CoV-2 (COVID-19) infection, nasopharyngitis, and upper respiratory tract infection.2-4 UCB will present 14 abstracts on PsA and axSpA at EULAR 2025 in Barcelona, Spain, June 11-14, and will complement other presentations from UCB in systemic lupus erythematosus and osteoporosis. These data, together with a dedication to advancing clinical research – including the ongoing head-to-head Phase 3b BE BOLD trial in psoriatic arthritis – underscore UCB's ambition to be a leader in rheumatology, commitment to advancing innovation, and focus on providing meaningful solutions across the spectrum of rheumatic diseases. †PsA data reported from BE OPTIMAL, BE COMPLETE, and their open-label extension (OLE), BE VITAL, for patients in the BKZ Total group (PBO/BKZ patients and BKZ-randomized patients). BE OPTIMAL (bDMARD-naïve) Week 52 and BE COMPLETE (TNFi-IR) Week 16 completers were eligible for the BE VITAL open-label extension.2-3 *mNRI: Modified non-responder imputation (binary). All visits following discontinuation due to adverse events or lack of efficacy were treated as non-response, other reasons for missing data were calculated using multiple imputation (MI).2-4 ¥axSpA trials BE MOBILE 1 (nr-axSpA) and BE MOBILE 2 (AS) each comprised a 16-week, double-blind, placebo-controlled period and a 36-week maintenance period. All patients received subcutaneous BKZ 160 mg every 4 weeks (Q4W) from Week 16.4 At Week 52, eligible patients could enter the OLE, BE MOVING.4 Of 586 randomized patients (nr-axSpA: 254; AS: 332), 494 (84.3%) patients entered the OLE at Week 52.4 Data presented include patients originally randomized to placebo; all patients were treated with BKZ 160 mg Q4W from Week 16.4 ±Multiple imputation (MI). ‡co-author. §Dapirolizumab pegol is an investigational drug and is not approved for use in systemic lupus erythematosus by any regulatory authority worldwide. Notes to Editors: ACR50: A 50% or greater improvement from baseline in American College of Rheumatology response criteria, including at least a 50% improvement in tender and swollen joint counts as well as 50% improvement in three additional criteria (physician global, patient global, patient pain, function, and CRP/erythrocyte sedimentation rate).8 This represents a stringent efficacy outcome in PsA9-10 ASAS40: Assessment of SpondyloArthritis International Society 40%, a composite endpoint covering a core set of domains that should be assessed in axSpA patients.11 This core set of domains includes physical function, morning stiffness, patient global assessment, and pain.11 In order to meet an ASAS40 response, three of the four domains should improve by at least 40% and a minimum of two units on a scale of 0 to 10. In the remaining domain, there should be no worsening of 20% and a minimum of 1 unit, on a 0 to 10 scale.11 TNFi-inadequate response (TNFi-IR): Patients with PsA who experience prior inadequate response or intolerance to tumor necrosis factor inhibitors3 bDMARD-naïve: Patients who had not previously taken a biologic disease-modifying antirheumatic drug (bDMARD)2 About Psoriatic Arthritis Psoriatic arthritis is a serious, highly heterogeneous, chronic, systemic inflammatory condition affecting both the joints and skin with a prevalence of 0.02 percent to 0.25 percent of the population.12 Psoriatic arthritis affects approximately 30 percent of people living with psoriasis.13 It manifests as joint pain and stiffness, skin plaques, swollen toes and fingers (dactylitis), and inflammation of the sites where tendons or ligaments insert into the bone (enthesitis).14 The burden on those living with PsA extends beyond physical discomfort to reduced quality of life, with comorbidities including hypertension, cardiovascular disease, and depression.6 In PsA, uncontrolled active disease can lead to long-term, irreversible structural damage.15 About BE OPTIMAL and BE COMPLETE BE OPTIMAL and BE COMPLETE were two Phase 3 studies evaluating the efficacy and safety of BIMZELX in the treatment of psoriatic arthritis.16 The primary endpoint in both studies was the proportion of patients reaching 50% or greater improvement in American College of Rheumatology criteria (ACR50) at Week 16.16 BE OPTIMAL (bDMARD-naïve) and BE COMPLETE (TNFi-IR) assessed subcutaneous BIMZELX 160 mg every four weeks (Q4W) in patients with PsA; both studies were placebo-controlled to Week 16, after which placebo patients switched to BIMZELX.16 BE OPTIMAL Week 52 and BE COMPLETE Week 16 completers were eligible for BE VITAL open-label extension.16 About Axial Spondyloarthritis Axial spondyloarthritis (axSpA), which includes both non-radiographic axSpA (nr-axSpA) and ankylosing spondylitis (AS), is a chronic, immune-mediated, inflammatory disease.7 nr-axSpA is defined clinically by the absence of definitive x-ray evidence of structural damage to the sacroiliac joints.7 axSpA is a painful condition that primarily affects the spine and the joints linking the pelvis and lower spine (sacroiliac joints).7 The leading symptom of axSpA in a majority of patients is inflammatory back pain that improves with exercise, but not with rest.7 Other common clinical features frequently include anterior uveitis, enthesitis, peripheral arthritis, psoriasis, inflammatory bowel disease, and dactylitis.7 The overall prevalence of axSpA is 0.3 percent to 1.3 percent of adults.17-18 Approximately half of all patients with axSpA are patients with nr-axSpA.7 axSpA onset usually occurs before the age of 45.7 Approximately 10 to 40 percent of patients with nr-axSpA progress to ankylosing spondylitis over 2 to 10 years.7 About BE MOBILE 1 and BE MOBILE 2 BE MOBILE 1 and BE MOBILE 2 were two Phase 3 studies evaluating the efficacy and safety of BIMZELX in the treatment of nr-axSpA and AS, respectively.19 The primary endpoint in both studies was the Assessment of SpondyloArthritis international Society 40 percent (ASAS40) response at Week 16.19 BE MOBILE 1 and BE MOBILE 2 comprised a 16-week double-blind treatment period followed by a 36-week maintenance period.19 In BE MOBILE 1 and BE MOBILE 2, patients were randomized to BIMZELX (160 mg Q4W; n=128 for BE MOBILE 1 and n=221 for BE MOBILE 2) or to placebo (n=126 for BE MOBILE 1 and n=111 for BE MOBILE 2).19 Patients initially randomized to placebo were switched to BIMZELX (160 mg Q4W) at Week 16.19 BE MOBILE 1 and BE MOBILE 2 Week 52 completers were eligible for BE MOVING open-label extension.20 About BIMZELX® (bimekizumab-bkzx) BIMZELX 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.1 IL-17A and IL-17F are key contributors of chronic inflammation and damage across multiple tissues, with IL-17F increasing over time.1,21-23 IL-17F is over-expressed in skin and highly elevated in the serum of patients with psoriasis (PSO), psoriatic arthritis (PsA), non-radiographic axial spondyloarthritis (nr-axSpA), ankylosing spondylitis (AS), and hidradenitis suppurativa (HS).1,21-24 The approved indications for BIMZELX in the U.S. are:1 Plaque psoriasis: BIMZELX is approved for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy Psoriatic arthritis: BIMZELX is indicated for the treatment of adult patients with active psoriatic arthritis Non-radiographic axial spondyloarthritis: BIMZELX is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation Ankylosing spondylitis: BIMZELX is indicated for the treatment of adult patients with active ankylosing spondylitis Hidradenitis suppurativa: BIMZELX is indicated for the treatment of adult patients with moderate-to-severe hidradenitis suppurativa BIMZELX U.S. IMPORTANT SAFETY INFORMATION IMPORTANT SAFETY INFORMATION Suicidal Ideation and Behavior BIMZELX (bimekizumab-bkzx) may increase the risk of suicidal ideation and behavior (SI/B). A causal association between treatment with BIMZELX and increased risk of SI/B has not been definitively established. Prescribers should weigh the potential risks and benefits before using BIMZELX in patients with a history of severe depression or SI/B. Advise monitoring for the emergence or worsening of depression, suicidal ideation, or other mood changes. If such changes occur, instruct to promptly seek medical attention, refer to a mental health professional as appropriate, and re-evaluate the risks and benefits of continuing treatment. Infections BIMZELX may increase the risk of infections, including serious infections. Do not initiate treatment with BIMZELX in patients with any clinically important active infection until the infection resolves or is adequately treated. In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing BIMZELX. Instruct patients to seek medical advice if signs or symptoms suggestive of clinically important infection occur. If a patient develops such an infection or is not responding to standard therapy, monitor the patient closely and do not administer BIMZELX until the infection resolves. Tuberculosis Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with BIMZELX. Avoid the use of BIMZELX in patients with active TB infection. Initiate treatment of latent TB prior to administering BIMZELX. Consider anti-TB therapy prior to initiation of BIMZELX in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Closely monitor patients for signs and symptoms of active TB during and after treatment. Liver Biochemical Abnormalities Elevated serum transaminases were reported in clinical trials with BIMZELX. Test liver enzymes, alkaline phosphatase, and bilirubin at baseline, periodically during treatment with BIMZELX, and according to routine patient management. If treatment-related increases in liver enzymes occur and drug-induced liver injury is suspected, interrupt BIMZELX until a diagnosis of liver injury is excluded. Permanently discontinue use of BIMZELX in patients with causally associated combined elevations of transaminases and bilirubin. Avoid use of BIMZELX in patients with acute liver disease or cirrhosis. Inflammatory Bowel Disease Cases of inflammatory bowel disease (IBD) have been reported in patients treated with IL-17 inhibitors, including BIMZELX. Avoid use of BIMZELX in patients with active IBD. During BIMZELX treatment, monitor patients for signs and symptoms of IBD and discontinue treatment if new onset or worsening of signs and symptoms occurs. Immunizations Prior to initiating therapy with BIMZELX, complete all age-appropriate vaccinations according to current immunization guidelines. Avoid the use of live vaccines in patients treated with BIMZELX. Most Common Adverse Reactions Most common (≥ 1%) adverse reactions in plaque psoriasis and hidradenitis suppurativa include upper respiratory tract infections, oral candidiasis, headache, injection site reactions, tinea infections, gastroenteritis, herpes simplex infections, acne, folliculitis, other candida infections, and fatigue. Most common (≥ 2%) adverse reactions in psoriatic arthritis include upper respiratory tract infections, oral candidiasis, headache, diarrhea, and urinary tract infections. Most common (≥ 2%) adverse reactions in non-radiographic axial spondyloarthritis include upper respiratory tract infections, oral candidiasis, headache, diarrhea, cough, fatigue, musculoskeletal pain, myalgia, tonsillitis, transaminase increase, and urinary tract infections. Most common (≥ 2%) adverse reactions in ankylosing spondylitis include upper respiratory tract infections, oral candidiasis, headache, diarrhea, injection site pain, rash, and vulvovaginal mycotic infection. Please see Important Safety Information below and full U.S. Prescribing Information at . For further information, contact UCB: Investor Relations Antje Witte T +32.2.559.94.14 email: [email protected] Brand Communications Nicole Herga T +1.773.960.5349 email: [email protected] About UCB UCB, Brussels, Belgium () 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 9,000 people in approximately 40 countries, the company generated revenue of €5.3 billion in 2023. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCBUSA. 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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. 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. References BIMZELX® (bimekizumab-bkzx) U.S. Prescribing Information. . Accessed June 2025. Gossec L, Coates L, McInnes I, et al. Bimekizumab, a dual inhibitor of IL-17A and IL 17F, demonstrated long-term safety and efficacy biologic DMARD naïve patients with active psoriatic arthritis: final 3-year results from the Phase 3 BE OPTIMAL study and its open label extension [abstract]. EULAR 2025. POS1294. McInnes I, Merola J, Coates L, et al. Dual inhibition of IL-17A and IL-17F with bimekizumab demonstrated long-term safety and efficacy in patients with active psoriatic arthritis and prior inadequate response to tumor necrosis factor inhibitors: final 3-year results from the Phase 3 BE COMPLETE study and its open-label extension [abstract]. EULAR 2025. POS0105. Baraliakos X, Deodhar A, van der Heijde D, et al. Bimekizumab demonstrated sustained efficacy and safety across the full spectrum of axial spondyloarthritis: 3-year results from two Phase 3 studies and their open-label extension [abstract]. EULAR 2025. POS0788. Navarro-Compán V, Kiltz U, Mease P, et al. Sustained improvements with bimekizumab in pain, morning stiffness, fatigue, physical function and health-related quality of life in patients with axial spondyloarthritis: 3-year results from two Phase 3 studies [abstract]. EULAR 2025. #POS0921. Lee S, Mendelsohn A, Sarnes E. The burden of psoriatic arthritis: A literature review from a global health systems perspective. P T. 2010;35(12):680–89. Deodhar A. Understanding Axial Spondyloarthritis: A Primer for Managed Care. Am J Manag Care. 2019;25:S319–30. Gladman DD, Mease PJ, Healy P, et al. Outcome measures in psoriatic arthritis. J Rheumatol. 2007;34(5):1159-66. Ritchlin C, Coates L, McInnes I, et al. Bimekizumab treatment in biologic DMARD-naïve patients with active psoriatic arthritis: 52-week efficacy and safety results from the phase III, randomised, placebo-controlled, active reference BE OPTIMAL study. Ann Rheum Dis. 2023:82(11);1404–14. Kerschbaumer A, Smolen JS, Ferreira RJO, et al. Efficacy and safety of pharmacological treatment of psoriatic arthritis: a systematic literature research informing the 2023 update of the EULAR recommendations for the management of psoriatic arthritis. Ann Rheum Dis. 2024;83(6):760-774. doi: 10.1136/ard-2024-225534. Landewé R, van Tubergen A. Clinical Tools to Assess and Monitor Spondyloarthritis. Curr Rheumatol Rep. 2015:17(7);47. Ogdie A, Weiss P. The Epidemiology of Psoriatic Arthritis. Rheum Dis Clin North Am. 2015:41(4);545–68. Mease PJ, Gladman DD, Papp KA, et al. Prevalence of rheumatologist-diagnosed psoriatic arthritis in patients with psoriasis in European/North American dermatology clinics. J Am Acad Dermatol. 2013;69(5):729-735. doi: 10.1016/j.jaad.2013.07.023. Mease P, Armstrong A. Managing patients with psoriatic disease: the diagnosis and pharmacologic treatment of psoriatic arthritis in patients with psoriasis. Drugs. 2014:74(4);423–41. Kwok T, Sutton M, Cook R, et al. Musculoskeletal Surgery in Psoriatic Arthritis: Prevalence and Risk Factors. J Rheumatol. 2023:50(4);497–503. Mease PJ, Merola JF, Tanaka Y, et al. Safety and Efficacy of Bimekizumab in Patients with Psoriatic Arthritis: 2-Year Results from Two Phase 3 Studies. Rheumatol Ther. 2024;11(5):1363-1382. doi: 10.1007/s40744-024-00708-8. Reveille J, Witter J, Weisman M. Prevalence of axial spondylarthritis in the United States: estimates from a cross-sectional survey. Arthritis Care Res (Hoboken). 2012:64(6);905–10. Hamilton L, Macgregor A, Toms A, et al. The prevalence of axial spondyloarthritis in the UK: a cross-sectional cohort study. BMC Musculoskelet Disord. 2015:10(16);392. Baraliakos X, Deodhar A, van der Heijde D, et al. Bimekizumab treatment in patients with active axial spondyloarthritis: 52-week efficacy and safety from the randomised parallel phase 3 BE MOBILE 1 and BE MOBILE 2 studies. Ann Rheum Dis. 2024:83(2);199–213. Baraliakos X, Deodhar A, van der Heijde D, et al. Long-term safety and efficacy of bimekizumab in axial spondyloarthritis: 2-year results from two phase 3 studies. Rheumatology (Oxford). 2025;64(6):3534-3546. doi: 10.1093/rheumatology/keaf009. 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;77:523–32. Gordon KB, Foley P, Krueger JG, et al. Bimekizumab efficacy and safety in moderate-to-severe plaque psoriasis (BE READY): a multicentre, double-blind, placebo-controlled, randomized withdrawal phase 3 trial. Lancet. 2021;397(10273):475-486. Reich K, Papp KA, Blauvelt A, et al. Bimekizumab versus ustekinumab for the treatment of moderate-to-severe plaque psoriasis (BE VIVID): efficacy and safety from a 52-week, multicentre, double-blind, active comparator and placebo controlled phase 3 trial. Lancet. 2021;397(10273):487-498. Rumberger BE, Boarder EL, Owens SL, et al. Transcriptomic analysis of hidradenitis suppurativa skin suggests roles for multiple inflammatory pathways in disease pathogenesis. Inflamm Res. 2020;69(10):967-973. US-BK-2500704 Date of preparation: June 2025 BIMZELX® is a registered trademark of the UCB Group of Companies ©2025 UCB, Inc., Smyrna, GA 30080, All rights reserved. SOURCE UCB WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED