UCB to share first presentations of BIMZELX® (bimekizumab-bkzx) two-year data in axial spondyloarthritis and psoriatic arthritis at EULAR 2024

• Patients with non-radiographic axial spondyloarthritis (nr-axSpA) and those with ankylosing spondylitis (AS) treated with BIMZELX showed sustained and consistent clinical and patient-reported outcomes up to two years
• Late-breaking data revealed that >90 percent of patients with AS treated with BIMZELX showed no spinal radiographic progression over two years, as defined by modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) change from baseline <2
• Patients with psoriatic arthritis (PsA) treated with BIMZELX who were new to biologics, and those with prior inadequate response or intolerance to tumor necrosis factor inhibitors (TNFi-IR), showed sustained and consistent minimal disease activity (MDA) up to two years

ATLANTA, June 12, 2024 /PRNewswire/ -- UCB, a global biopharmaceutical company, today announced the first presentation of two-year data from the Phase 3 studies, BE MOBILE 1 and BE MOBILE 2, and the open-label extension (OLE), BE MOVING, evaluating BIMZELX, an interleukin (IL)-17A and IL-17F inhibitor, in the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA) and ankylosing spondylitis (AS), also known as radiographic axial spondyloarthritis. The impact of BIMZELX treatment on two-year radiographic progression in the spine of patients with AS will also be presented in a late-breaking oral presentation. In addition, the first two-year BIMZELX data in psoriatic arthritis (PsA) from the Phase 3 studies, BE OPTIMAL and BE COMPLETE, and the open-label extension, BE VITAL, are also announced today. These data are presented at the European Congress of Rheumatology, EULAR 2024, in Vienna, Austria, June 12–15.^1,2,3,4

In the U.S., BIMZELX is approved for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.⁵ BIMZELX is not approved in the U.S. for the treatment of PsA, nr-axSpA, and AS. In the U.S., the efficacy and safety of BIMZELX in the treatment of PsA, nr-axSpA, and AS have not been established, and these are investigational indications.

“The bimekizumab new two-year data in axial spondyloarthritis and psoriatic arthritis presented at EULAR 2024 reinforce our belief in bimekizumab to provide long-term robust and sustained outcomes for patients with psoriatic arthritis and for patients across the full spectrum of axial spondyloarthritis,” said Emmanuel Caeymaex, Executive Vice President, Head of Patient Impact, Chief Commercial Officer, UCB. “We are particularly excited to share new late-breaking data that highlights our commitment to demonstrate the long-term benefit of bimekizumab on disease progression in radiographic axial spondyloarthritis.”

“The bimekizumab data in axial spondyloarthritis presented at EULAR 2024 showed that non-radiographic and radiographic axSpA patients achieved sustained suppression of inflammation over two years, and reported sustained improvements in symptoms which have a substantial impact on daily living including spinal pain, morning stiffness and fatigue,” said Xenofon Baraliakos, Professor of Internal Medicine and Rheumatology, Ruhr-University Bochum, Bochum, Germany. “One of the long-term treatment goals in axSpA is the prevention of structural progression. Late-breaking data also shared at the congress showed that the majority of radiographic axial spondyloarthritis patients treated with bimekizumab had no spinal radiographic progression over two years.”

“Minimal disease activity and remission are key treatment targets in the treatment of psoriatic arthritis,” said Laura Coates, Associate Professor, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, UK. “New two-year data presented at EULAR 2024 showed that approximately 50% of patients treated with bimekizumab achieved sustained minimal disease activity and remission over two years. Improvements were observed across all patient-reported and most clinical components of minimal disease activity, with robust improvements in joint and skin outcomes.”

Across the spectrum of axSpA, approximately one in two patients treated with BIMZELX over two years achieved and maintained a 40 percent or greater improvement in signs and symptoms of axSpA, Assessment of SpondyloArthritis international Society (ASAS40).^1† At two years, approximately six in ten patients with either nr-axSpA or AS achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) low disease activity (ASDAS <2.1) and three in ten achieved a state of inactive disease (ASDAS <1.3).^1‡ Late-breaking data revealed that patients with AS treated with BIMZELX showed minimal spinal radiographic progression at two years, and there was a high proportion of non-progressors, including in those with baseline spinal damage. Furthermore, one-year results and post hoc analyses from BE MOBILE 1 and BE MOBILE 2 showed that treatment with BIMZELX substantially improved magnetic resonance imaging (MRI) inflammation, reduced erosions and increased backfill and fat in the sacroiliac joints of patients with nr-axSpA and AS, which may suggest evidence of tissue repair.⁶

In PsA, approximately one in two patients treated with BIMZELX who were new to biologics, and those with prior inadequate response or intolerance to tumor necrosis factor inhibitors (TNFi-IR) showed sustained achievement of minimal disease activity (MDA) over two years. Patients also achieved sustained remission up to two years as measured by the Disease Activity Index for Psoriatic Arthritis (DAPSA) remission (REM) or low disease activity (LDA) (REM≤4; REM+LDA≤14) responses and DAPSA change from baseline.⁴

Highlights from the BIMZELX two-year data in axSpA presented at EULAR 2024:

• ASAS40: At Week 104, 49.2 percent of patients with nr-axSpA (n=254) and 53.9 percent (n=332) of patients with AS treated with BIMZELX achieved ASAS40.^1†
• Low Disease Activity: At Week 104, 61.2 percent of patients with nr-axSpA (n=254) and 63.4 percent of patients with AS (n=332) treated with BIMZELX achieved low disease activity (ASDAS<2.1).^1‡
• Inactive Disease: At Week 104, 31.6 percent of patients with nr-axSpA (n=254) and 31.3 percent^‡ of patients with AS (n=332) achieved inactive disease (ASDAS <1.3).^1‡
• Radiographic Progression: At Week 104, the majority of patients with AS (157/190) treated with BIMZELX had no spinal radiographic progression as defined by mSASSS Change from Baseline (CfB) =0. The proportion of non-progressors was 85.3 percent (162/190), as defined by mSASSS CfB ≤0.5. The proportion of non-progressors was 92.1 percent (175/190), as defined by mSASSS CfB <2, which included 83.1 percent (69/83) of the patients who had existing structural damage (mSASSS ≥2) at baseline.²
• Patient-Reported Outcomes: Treatment with BIMZELX demonstrated consistently sustained improvements in spinal pain, morning stiffness, and fatigue in patients with nr-axSpA and AS over two years, as reported by patients.³
• Safety Profile: The safety profile of BIMZELX in axSpA over two years was consistent with previous studies with no new safety signals observed.¹ To Week 104, 89.5 percent (514/574) of patients with axSpA had ≥1 treatment-emergent adverse event (TEAE) on BIMZELX.¹ The most frequent TEAEs by exposure-adjusted incidence rate per 100 patient-years were SARS-CoV-2 infection (COVID-19; 13.2), nasopharyngitis (10.2), and upper respiratory tract infection (6.0).¹

Highlights from the BIMZELX two-year data in PsA presented at EULAR 2024:

• Minimal Disease Activity & Remission: At Week 104, 52.4 percent of biologic-naïve patients with PsA treated with BIMZELX (n=431) and 49.8 percent of biologic-naïve patients with PsA who switched from placebo to BIMZELX (n=281) at Week 16 achieved MDA.^4† In patients in the adalimumab reference arm who switched to BIMZELX at Week 52, the MDA response at Week 52 was sustained to Week 104. At Week 88, 46.1 percent of TNFi-IR patients with PsA treated with BIMZELX (n=267) and 36.8 percent of TNFi-IR patients with PsA who switched from placebo to BIMZELX (n=133) at Week 16 achieved MDA.^4† Trends were similar at Week 104/88 for achievement of DAPSA remission and low disease activity.⁴

Notes to editors:

^†Non-Responder Imputation
^‡Multiple Imputation

About Axial Spondyloarthritis
Axial Spondyloarthritis, which includes both nr-axSpA and 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 1.4 percent of adults.^8,9 Approximately half of all patients with axSpA have 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 AS 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 bimekizumab-bkzx in the treatment of nr-axSpA and AS, respectively.¹⁰ The primary endpoint in both studies was Assessment of SpondyloArthritis International Society 40 percent (ASAS40) response at Week 16.¹⁰ BE MOBILE 1 and BE MOBILE 2 comprised a 16-week double-blind treatment period followed by a 36-week maintenance period.¹⁰ In BE MOBILE 1 and BE MOBILE 2, patients were randomized to bimekizumab-bkzx (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).¹⁰ Patients initially randomized to placebo were switched to bimekizumab-bkzx (160 mg Q4W) at Week 16.¹⁰ At Week 52, those who completed either study were eligible to be enrolled into BE MOVING.^1,2 Of 254 patients with nr-axSpA and 332 patients with AS originally randomized to bimekizumab-bkzx or placebo in BE MOBILE 1 and 2, respectively, 494 patients entered BE MOVING at Week 52.^1,2 By July 2023, 456 patients completed Week 104 (nr-axSpA n=189; AS n=267).^1,2

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 and 6 percent to 41 percent of patients with psoriasis.¹¹ Symptoms include 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).¹²

About BE OPTIMAL and BE COMPLETE
BE OPTIMAL and BE COMPLETE were two Phase 3 studies evaluating the efficacy and safety of bimekizumab-bkzx in the treatment of PsA.^13,14 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 (non-responder imputation).^13,14 BE OPTIMAL (bDMARD-naïve) and BE COMPLETE (TNFi–IR) assessed subcutaneous bimekizumab-bkzx 160 mg every four weeks (Q4W) in patients with PsA; both studies were placebo–controlled to Week 16, after which placebo patients switched to bimekizumab-bkzx.^13,14 BE OPTIMAL included a reference arm (adalimumab 40 mg Q2W); adalimumab patients switched to bimekizumab-bkzx at Week 52 with no washout between treatments. BE OPTIMAL Week 52 and BE COMPLETE Week 16 completers were eligible for BE VITAL open-label extension.⁴ From BE OPTIMAL 83.3 percent of patients (n=710/852) and from BE COMPLETE 82.5 percent (n=330/400) completed Week 104 and Week 88, respectively.⁴ Outcomes are reported to Week 88 for BE COMPLETE because 18 (4.5%) had not yet attended their Week 100 visit.⁴

About bimekizumab-bkzx
Bimekizumab is a humanized IgG1 monoclonal antibody that selectively binds to IL-17A, IL-17F and IL-17AF cytokines, blocking their interaction with the IL-17RA/IL-17RC receptor complex.⁵

Please see Important Safety Information below and full U.S. prescribing information at http://www.ucb-usa.com/Innovation/Products/BIMZELX.

BIMZELX U.S. IMPORTANT SAFETY INFORMATION⁵

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 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, advise 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. 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 adverse reactions (≥1 percent) are upper respiratory infections, oral candidiasis, headache, injection site reactions, tinea infections, gastroenteritis, Herpes Simplex Infections, acne, folliculitis, other Candida infections, and fatigue.

For further information, contact UCB:

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

U.S. 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 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: @UCB_usa.

Forward looking statements
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: 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. 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

1. Baraliakos X, Deodhar A, van der Heijde D, et al. Long-term sustained efficacy and safety of bimekizumab across the full spectrum of axial spondyloarthritis: 2-year results from two Phase 3 studies. Abstract at EULAR 2024, Vienna, Austria.
2. Baraliakos X, Ramiro S, Maksymowych WP, et al. Minimal spinal radiographic progression in patients with radiographic axial spondyloarthirits over two years of bimekizumab treatment: results from a Phase 3 open-label extension study. Late-breaking presentation at EULAR 2024, Vienna, Austria.
3. Marzo-Ortega H, Mease P, Dougados M, et al. Sustained improvements with bimekizumab in patient-reported symptoms of axial spondyloarthritis: 2-year results from two phase 3 studies. Abstract at EULAR 2024, Vienna, Austria.
4. Coates L, Kristensen L, Ogdie A, et al. Bimekizumab-treated patients with active psoriatic arthritis showed sustained achievement of minimal disease activity and remission: up to 2-year results from two phase 3 studies. Abstract at EULAR 2024, Vienna, Austria.
5. BIMZELX [prescribing information]. Smyrna, GA: UCB, Inc.
6. Maksymowych W, Ramiro S, Poddubnyy D, et al. Impact of bimekizumab on MRI inflammatory and structural lesions in the sacroiliac joints of patients with axial spondyloarthritis: 52-week results and post hoc analyses from the BE MOBILE 1 and 2 phase 3 studies. Abstract at EULAR 2024, Vienna, Austria.
7. Deodhar A. Understanding Axial Spondyloarthritis: A Primer for Managed Care. Am J Manag Care. 2019;25:S319-S330.
8. Reveille JD, Witter JP, Weisman MH. Prevalence of axial spondyloarthritis in the United States: estimates from a cross-sectional survey. Arthritis Care Res (Hoboken). 2012;64:905-10.
9. 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;16:392.
10. 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;83:199–213.
11. Ogdie A, Weiss P. The Epidemiology of Psoriatic Arthritis. Rheum Dis Clin North Am. 2015;41:545-68.
12. Mease PJ, Armstrong AW. Managing patients with psoriatic disease: the diagnosis and pharmacologic treatment of psoriatic arthritis in patients with psoriasis. Drugs. 2014;74:423–41.
13. Ritchlin CT, Coates LC, McInnes IB, 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;82:1404–14.
14. Coates LC, Landewé R, McInnes IB, et al. Bimekizumab treatment in patients with active psoriatic arthritis and prior inadequate response to tumour necrosis factor inhibitors: 52-week safety and efficacy from the phase III BE COMPLETE study and its open-label extension BE VITAL. RMD Open. 2024;10:e003855. doi:10.1136/rmdopen-2023-003855.

BIMZELX^® is a registered trademark of the UCB Group of Companies.
©2024 UCB, Inc., Smyrna, GA 30080. All rights reserved.
Date of preparation: June 2024
US-BK-2400873

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