UCB Presents New 4-year Data for BIMZELX® (bimekizumab-bkzx) in Moderate-to-Severe Plaque Psoriasis at EADV 2024

News provided by

Sep 25, 2024, 07:00 ET

Responder analyses demonstrated that approximately nine out of 10 patients treated with BIMZELX who achieved PASI90 at Year 1, and over seven out of 10 patients who achieved complete skin clearance (PASI100) at Year 1, maintained this response to Year 4
Switching adalimumab, secukinumab, or ustekinumab PASI90 non-responders to BIMZELX led to most patients (over 70 percent) rapidly achieving and maintaining PASI90 for up to four years, and a large proportion (over 40 percent) achieved complete skin clearance based on a post-hoc analysis

ATLANTA, Sept. 25, 2024 /PRNewswire/ -- UCB, a global biopharmaceutical company, today announced the presentation of new four-year data in patients with moderate-to-severe plaque psoriasis treated with BIMZELX^® (bimekizumab-bkzx), an interleukin (IL)-17A and IL-17F inhibitor. These post-hoc analyses include maintenance of response through four years in BIMZELX patients who achieved near-complete or complete skin clearance after one year, and the clinical response up to four years in patients switching to BIMZELX following an inadequate response to either adalimumab, ustekinumab, or secukinumab.^1,2 These data are presented at the 33^rd European Academy of Dermatology and Venereology (EADV) Congress in Amsterdam, the Netherlands, September 25–28, 2024. In addition, the design and rationale behind the exploratory, multicenter, open-label Phase 3b BIMZELX study, BE UNIQUE, that is exploring the fast onset, high level, and durability of clinical and molecular responses in patients with psoriatic disease are also shared.³

"Given the chronic nature of psoriasis, it is critically important to evaluate long-term response of treatments. Achieving completely clear skin is a key goal for people living with moderate-to-severe plaque psoriasis, and results presented at EADV 2024 showed that over 7 out of 10 patients who achieved complete skin clearance after one year maintained this response at four years," said Professor Richard Warren, Northern Care Alliance NHS Foundation Trust and The University of Manchester, United Kingdom.

"The four-year data presented at EADV 2024 demonstrate maintenance of complete skin clearance for patients continuing treatment with bimekizumab," said Fiona du Monceau, Executive Vice President, Head of Patient Evidence, UCB. "We are also proud to share the design of BE UNIQUE, a Phase 3b study investigating whether the durability of clinical response with bimekizumab is associated with molecular and cellular changes in skin, blood, and joints of patients with psoriatic disease."

Highlights from the BIMZELX abstracts presented at EADV 2024:

Maintenance of response from end of pivotal trials through four years (post-hoc analysis): Data were pooled from the 52-week BE VIVID and 56-week BE SURE and BE READY pivotal Phase 3 trials, and their open-label extension (OLE), BE BRIGHT.¹ Included patients were randomized to BIMZELX 320 mg every four weeks (Q4W) to Week 16, then BIMZELX Q4W or every eight weeks (Q8W) until OLE entry.¹ Data are reported here for the combined BIMZELX dose group.¹

Of the 771 patients forming this group, 89.6 percent (n=691) and 75.1 percent (n=579) were PASI90 and PASI100 responders at Year 1, respectively.^1†
Of the PASI90 responders at Year 1, 87.9 percent maintained PASI90 response at Year 4.^1‡
Of the PASI100 responders at Year 1, 74.2 percent maintained PASI100 response at Year 4.^1‡

Four-year analysis of patients switching after inadequate response to adalimumab, ustekinumab, and secukinumab (post-hoc analysis): Included patients from the 56-week BE SURE (BIMZELX versus adalimumab) and 52-week BE VIVID (BIMZELX versus ustekinumab) who then entered the BE BRIGHT OLE, and also patients from the 48-week BE RADIANT (BIMZELX versus secukinumab) who then entered its OLE.² All patients received BIMZELX Q8W from OLE Week 16/48 (BE RADIANT/BE BRIGHT) or the next scheduled visit.²

Of patients randomized to receive adalimumab at baseline who entered the OLE, 41.9 percent (n=54/129) did not have a PASI90 response at the time of switch to BIMZELX (Week 24).^2*
- Following switch from adalimumab and after 176 weeks of BIMZELX, 92.2 percent achieved PASI90 and 74.4 achieved PASI100.^2‡
Of patients randomized to receive ustekinumab at baseline who entered the OLE, 33.3 percent (n=44/132) did not achieve PASI90 at the time of switch to BIMZELX (Week 52).^2*
- Following switch from ustekinumab and after 144 weeks of BIMZELX, 82.0 percent achieved PASI90 and 58.8 percent achieved PASI100.^2‡
Of patients randomized to receive secukinumab at baseline who entered the OLE, 18.5 percent (n=58/314) did not achieve PASI90 at the time of switch to BIMZELX (Week 48).^2*
- Following switch from secukinumab and after 96 weeks of BIMZELX, 71.7 percent achieved PASI90 and 39.8 percent achieved PASI100.^2‡

Design and rationale behind the Phase 3b BE UNIQUE study: BE UNIQUE is an ongoing multicenter Phase 3b study designed to investigate molecular and cellular changes associated with BIMZELX responses in patients with psoriasis and psoriatic arthritis.³ The primary objective is to assess change in gene expression score on skin biopsies, using preselected genes based on BIMZELX's mechanism of action and psoriatic disease pathways.³

UCB previously shared four-year safety data on BIMZELX for the treatment of moderate-to-severe plaque psoriasis. Data showed that treatment-emergent adverse events were consistent with longer BIMZELX exposure, with no new safety signals.

Notes to Editors:
^†Non-Responder Imputation
^‡ Modified Non-Responder Imputation
* Observed Case

About Plaque Psoriasis
Psoriasis is a common, chronic inflammatory disease with primary involvement of the skin.⁴ This skin condition affects men and women of all ages and ethnicities.⁵ Psoriasis signs and symptoms can vary but may include red patches of skin covered with silvery-white scales; dry, cracked skin that may bleed; and thickened, pitted, or ridged nails.⁴Psoriasis affects nearly three percent of the total population, or about 125 million people worldwide.⁶

About BIMZELX (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.⁷ Elevated levels of IL-17A and IL-17F are found in lesional psoriatic skin.⁷

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, adults with active psoriatic arthritis, adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation, and adults with active ankylosing spondylitis.⁷

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

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 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 (≥ 1%) adverse reactions in plaque psoriasis 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 infections.

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 (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: @UCBUSA.

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

Gordon KB, Cather J, Pariser D, et al. Bimekizumab maintenance of response from the end of pivotal trials through 4 years: Results in patients with moderate to severe plaque psoriasis from BE BRIGHT. Abstract at EADV 2024, Amsterdam, the Netherlands.
Kokolakis G, Han G, Pariser G, et al. Bimekizumab long-term efficacy in patients with moderate to severe plaque psoriasis after switching from adalimumab, ustekinumab, or secukinumab: Results from up to 4 years of total treatment from BE BRIGHT and BE RADIANT. Abstract at EADV 2024, Amsterdam, the Netherlands.
Gudjonsson J, Merola J, Warren R, et al. Bimekizumab: Exploring the fast onset, high level, and durability of clinical and molecular responses in patients with psoriatic disease – Design and rationale behind the exploratory, multicentre, open-label phase 3b BE UNIQUE study. Abstract at EADV 2024, Amsterdam, the Netherlands.
Griffiths C, Armstrong A, Gudjonsson J, et al. Psoriasis. Lancet. 2021;397(10281):1301–15.
Parisi R, Iskandar I, Kontopantelis E, et al. National, regional, and worldwide epidemiology of psoriasis: systematic analysis and modelling study. BMJ. 2020;369:m1590.doi:10.1136/bmj.m1590.
Griffiths CEM, van der Walt JM, Ashcroft DM, et al. The global state of psoriasis disease epidemiology: a workshop report. Br J Dermatol. 2017;177(1):e4-e7.
BIMZELX^® (bimekizumab-bkzx) U.S. Prescribing Information. https://www.ucb-usa.com/Innovation/Products/BIMZELX. Accessed September 2024.