The Lancet Publishes Results from Two Bimekizumab Phase 3 Studies in Psoriatic Arthritis

Rhea-AI Summary

UCB announced the publication of two articles in The Lancet, detailing results from Phase 3 studies BE OPTIMAL and BE COMPLETE on bimekizumab, an investigational treatment for psoriatic arthritis. Both studies met primary and secondary endpoints, with statistically significant improvements in joint symptoms and skin clearance compared to placebo (p<0.0001). Bimekizumab's safety profile remained consistent with previous data. However, it is important to note that bimekizumab has not been approved by the U.S. FDA and its safety and efficacy remain unestablished in the U.S.

Positive

• Both the BE OPTIMAL and BE COMPLETE studies met their primary and secondary endpoints.
• Statistically significant improvements in joint symptoms (ACR50) and skin clearance (PASI 90) were achieved compared to placebo.
• The safety profile of bimekizumab was consistent with prior studies, with no new safety signals observed.

Negative

• Bimekizumab is not approved by the U.S. FDA, and its efficacy and safety are not established in the U.S.

• Two articles report results from the Phase 3 BE OPTIMAL and BE COMPLETE studies evaluating bimekizumab, an investigational, selective inhibitor of IL-17A and IL-17F, in patients with psoriatic arthritis

BRUSSELS and ATLANTA, Dec. 7, 2022 /PRNewswire/ -- UCB, a global biopharmaceutical company, today announced that The Lancet  has published two articles detailing 24-week results from the Phase 3 BE OPTIMAL study and 16-week results from the Phase 3 BE COMPLETE study, evaluating the efficacy and safety of bimekizumab in the treatment of adults with active psoriatic arthritis who were biologic naïve and tumor necrosis factor inhibitor inadequate responders (TNFi-IR), respectively.^1,2

"Publication of two articles in tandem in The Lancet, one of the world's most prestigious peer-reviewed journals, highlights the significance of these Phase 3 bimekizumab studies to the medical community. We look forward to continuing to work with regulatory agencies to make bimekizumab available to people living with psoriatic arthritis as soon as possible," said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of US, UCB.

Data from BE OPTIMAL and BE COMPLETE show that both studies met their primary and all ranked secondary endpoints.^1,2 A significantly higher proportion of patients treated with bimekizumab achieved improvements in joint symptoms at week 16 compared with placebo – as measured by ACR50, the primary endpoint – with a consistent clinical response observed in both biologic-naïve and TNFi-IR populations (p<0.0001 for each). In addition, at week 16, a significantly higher proportion of bimekizumab-treated patients compared with placebo achieved high levels of skin clearance – as measured by PASI 90, a secondary endpoint – with a consistent clinical response in both populations (p<0.0001 for each). The safety profile of bimekizumab was consistent with safety data seen in previous studies with no new observed safety signals.^1,2 

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).

Notes to editors:

About BE OPTIMAL 

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, see article in The Lancet.¹ 

About BE COMPLETE 

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).² 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, see article in The Lancet.²

About Psoriatic Arthritis 

Psoriatic arthritis (PsA) 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.³ 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).⁴

About bimekizumab                                                                                                                        

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.^5,6 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.^6,7  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

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 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: @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: 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. 

References

1. McInnes I.B., Asahina A, Coates L.C. et al. Bimekizumab in patients with psoriatic arthritis, naïve to biologic treatment: a randomised, double-blind, placebo-controlled, phase 3 trial (BE OPTIMAL) The Lancet. 2022. Published online. Available at:  https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)02302-9/fulltext
2. Merola J.F., Landewé R, McInnes I.B. et al. Bimekizumab in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor-α inhibitors: a randomised, double-blind, placebo-controlled, phase 3 trial (BE COMPLETE) The Lancet. 2022. Published online. Available at: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)02303-0/fulltext
3. Ogdie A, Weiss P. The Epidemiology of Psoriatic Arthritis. Rheum Dis Clin North Am. 2015;41(4):545–568.
4. Mease PJ, Armstrong AW. Managing patients with psoriatic disease: The diagnosis and pharmacologic treatment of psoriatic arthritis in patients with psoriasis. Drugs. 2014;74(4):423–441.
5. 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.
6. BIMZELX^® (bimekizumab) EU Summary of Product Characteristics. 
   https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf. Last accessed: December 2022.
7. BIMZELX^® (bimekizumab) GB Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/12834; https://www.medicines.org.uk/emc/product/12833. Last accessed: December 2022.

BIMZELX^® is a registered trademark of the UCB Group of Companies. ©2022 UCB, Inc., Smyrna, GA 30080. All rights reserved. 
US-N-BK-PsA-2200026 
Date of preparation: December 2022

 

View original content to download multimedia:https://www.prnewswire.com/news-releases/the-lancet-publishes-results-from-two-bimekizumab-phase-3-studies-in-psoriatic-arthritis-301696945.html

SOURCE UCB

FAQ

What are the results of the Phase 3 BE OPTIMAL and BE COMPLETE studies on UCB's bimekizumab?

The BE OPTIMAL study showed significant improvements in joint symptoms for biologic-naïve patients, while BE COMPLETE demonstrated efficacy in patients with inadequate response to TNF inhibitors, both achieving primary and secondary endpoints.

What is the significance of the articles published in The Lancet regarding bimekizumab?

The publications highlight the importance of bimekizumab's clinical trials to the medical community and demonstrate its potential benefits for treating psoriatic arthritis.

When can we expect bimekizumab to be available for psoriatic arthritis patients?

UCB is working with regulatory agencies to make bimekizumab available as soon as possible, although it is not yet approved in the U.S.

What are the primary endpoints of the bimekizumab studies?

The primary endpoint was the improvement in joint symptoms measured by ACR50 in the BE OPTIMAL study, and the effectiveness in patients with TNFi inadequate response in the BE COMPLETE study.

Is bimekizumab approved for any other indications?

Yes, bimekizumab is approved in the EU for moderate to severe plaque psoriasis but remains investigational in the U.S. for psoriatic arthritis.