Phase 3 Data Analysis Presented at EADV 2023 Showed Bimekizumab Achieved High Thresholds of Clinical Response in Hidradenitis Suppurativa
Bimekizumab treatment resulted in clinically meaningful improvements in HiSCR50 and the more stringent endpoints HiSCR75, HiSCR90 and HiSCR100 vs. placebo at Week 16, with improvements increasing for patients remaining in the study through Week 48
Over 8 in 10 patients treated with bimekizumab who achieved a HiSCR50 response after 16 weeks maintained response to Week 48
ATLANTA, Oct. 12, 2023 /PRNewswire/ -- UCB, a global biopharmaceutical company, today announced the first analyses of pooled data from the two Phase 3 bimekizumab studies (BE HEARD I and BE HEARD II) in moderate-to-severe hidradenitis suppurativa (HS).1,2,3,4 These analyses are among bimekizumab data in HS presented this week across three oral presentations and several posters at the 2023 European Academy of Dermatology and Venereology (EADV) Congress in Berlin, Germany, October 11–14.
"Patients with hidradenitis suppurativa live with one of the most burdensome chronic systemic skin diseases. There is a compelling need for new treatment options that can offer high and durable clinical response," said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S., UCB. "Data presented at EADV showed that over 48 weeks many patients treated with bimekizumab achieved high thresholds of response. These findings suggest that inhibition of IL-17F in addition to IL-17A represents a promising treatment approach in moderate-to-severe hidradenitis suppurativa."
"The bimekizumab Phase 3 clinical trial program in hidradenitis suppurativa included the more stringent clinical outcomes of HiSCR75, HiSCR90 and HiSCR100 in addition to the standard HiSCR50. In these studies, bimekizumab demonstrated clinical meaningful improvements for these outcomes over placebo at Week 16, with improvements increasing for patients remaining in the studies through Week 48. In addition, improvements in disease severity were seen over time, with the majority of patients with severe hidradenitis suppurativa at baseline shifting to mild-to-moderate disease according to the IHS4 dynamic classification system," said Professor Christos C. Zouboulis, President of the European Hidradenitis Suppurativa Foundation, Director of the Departments of Dermatology, Venereology, Allergology and Immunology, Städtisches Klinikum Dessau, and Founding Professor of Dermatology and Venereology at the Brandenburg Medical School, Germany.
The safety and efficacy of bimekizumab in HS have not been established, and it is not approved for use in HS by any regulatory authority worldwide. In the U.S., the efficacy and safety of bimekizumab have not been established for any indication and it is not approved by the U.S. Food and Drug Administration.
Data were pooled from the BE HEARD I and II studies, which included an initial (Weeks 0–16) and maintenance treatment period (Weeks 16–48).1,2,3,4 Adult patients (N=1,014) were randomized 2:2:2:1 (initial/maintenance) to receive, either bimekizumab 320 mg every two weeks (Q2W) /Q2W (n=288); bimekizumab Q2W/every four weeks (Q4W); n=292; bimekizumab Q4W/Q4W (n=288) or placebo/bimekizumab Q2W (n=146).1,2,3,4
Highlights from the pooled data analysis (BE HEARD I and BE HEARD II)
Bimekizumab-treated patients showed higher response rates in the primary endpoint (HiSCR50) at Week 16 vs. placebo (58 percent Q2W/Q2W, 55.9 percent Q2W/Q4W, 56.1 percent Q4W/Q4W vs. 33.4 percent for placebo).†1 Improvements increased for patients through Week 48 with almost 8 in 10 achieving HiSCR50.‡1 At Week 48, the response in patients who switched from placebo to bimekizumab at Week 16 approached that reached by patients on bimekizumab from baseline (70.5 percent [n=74/105]). ‡1
A similar trend was seen in the more stringent HiSCR75 and HiSCR90 endpoints through Week 48.‡1,5,6 Bimekizumab-treated patients had improved responses at Week 48 with approximately 6 in 10 patients achieving HiSCR75.‡1 Analysis of the most stringent endpoint, HiSCR100, showed numerically higher responses in bimekizumab patients vs. placebo at Week 16, and improved responses at Week 48 with approximately 3 out of 10 patients achieving HiSCR100. Patients who switched from placebo to bimekizumab at Week 16 demonstrated a similar trend in HiSCR100 rates at Week 48.‡1
Across all bimekizumab treatment groups, over 8 out of 10 patients who achieved HiSCR50 at Week 16 (n=160 Q2W/Q2W; n=155 Q2W/Q4W; n=152 Q4W/Q4W), maintained the response through Week 48.‡¥2 In addition, across all bimekizumab treatment groups, more than 8 out of 10 patients who achieved an abscess and inflammatory nodule (AN) count of 0,1 or 2 at Week 16 (n=104 Q2W/Q2W, n=99 Q2W/Q4W; n=87 Q4W/Q4W) maintained this response to Week 48.‡¥2
According to the International Hidradenitis Suppurativa Severity Score System (IHS4), at baseline, 83.7–88.4 percent of the enrolled patients across bimekizumab dosing regimens had severe HS.3 A post hoc analysis showed that at Week 16 higher proportions of bimekizumab-treated patients had mild HS vs. placebo (24.6–27.2 percent vs. 15.3 percent).3 Similar trends were observed for patients with HS (25.8–28.0 percent vs. 17.1 percent).3 Improvements in IHS4 categories were sustained over time across bimekizumab groups. At Week 48, 37.3–40.1 percent had mild HS and 23.8–25.3 percent had moderate HS.3
Analyses showed that regardless of weight and body mass index category, a higher proportion of patients treated with bimekizumab vs. placebo achieved clinical response at Week 16 (HiSCR50, HiSCR75 and HiSCR90) with increasing levels of response between Week 16 and Week 48.4
The safety profile of bimekizumab across BE HEARD I and BE HEARD II was consistent with previous studies with no new safety signals observed.1 The most frequently reported TEAEs in 995 patients receiving ≥1 dose of bimekizumab were hidradenitis (18.7 percent), oral candidiasis (11.2 percent), and coronavirus infection (10.8 percent).1 Serious treatment emergent adverse events were reported in 7.0 percent Q4W/Q4W, 4.5 percent Q2W/Q4W and 8.1 percent Q2W/Q2W patients.1
Notes to editors:
†Modified non-responder imputation
‡Observed Case
¥ Last Observation Carried Over
About Hidradenitis Suppurativa (HS)
Hidradenitis suppurativa (HS) is a chronic, recurring, painful, and debilitating inflammatory skin disease.7,8 The main symptoms are nodules, abscesses, and pus-discharging fistulas (channels leading out of the skin), which typically occur in the armpits, groin, and buttocks.7,8 People with HS experience flare-ups of the disease as well as severe pain, which can have a major impact on quality of life.7,8
HS most commonly develops in early adulthood and affects approximately one percent of the population in most studied countries.7,8 Approximately one-third of people with HS have a family history of HS, and lifestyle factors such as smoking and obesity can also play a crucial role in the clinical course of HS.7,8
The symptoms of pain, discharge, and scarring are not only a physical burden. People with HS also experience stigma: worrying about or directly experiencing negative attitudes and reactions from society in response to their symptoms.9 These feelings can lead to embarrassment, social isolation, low self-esteem, and sexual life impairment, and impact all areas of life, including interpersonal relationships, education, and work.10
About BE HEARD I and BE HEARD II
BE HEARD I and BE HEARD II are randomized, double-blind, placebo-controlled, parallel group, multicenter, Phase 3 studies designed to evaluate the efficacy and safety of bimekizumab in adults with moderate-to-severe hidradenitis suppurativa (HS).5,6 The two studies had a combined enrollment of 1,014 participants with a diagnosis of moderate-to-severe HS.5,6 The primary endpoint in both studies was HiSCR50 at Week 16.5,6 A key secondary endpoint was HiSCR75 at Week 16.5,6 HiSCR50 and HiSCR75 are defined as at least either a 50 or 75 percent reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count.5,6
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.11 In the U.S., the efficacy and safety of bimekizumab have not been established for any indication 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. 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 8,700 people in approximately 40 countries, the company generated revenue of €5.5 billion in 2022. 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
Zouboulis C, Gottlieb A, Forman S, et al. Bimekizumab efficacy and safety in patients with moderate to severe hidradenitis suppurativa: Analysis of pooled data from BE HEARD I and II phase 3, randomised, double-blind, placebo-controlled, multicentre studies. Oral presentation at EADV 2023, Berlin, Germany.
Ingram JR, Porter M, Chovatiya R, et al. Bimekizumab response maintenance to 48 weeks in patients with moderate to severe hidradenitis suppurativa: Pooled responder analysis from the phase 3, double-blind, placebo-controlled, randomised clinical trials BE HEARD I and II. Poster presentation at EADV 2023, Berlin, Germany.
Zouboulis C, Kirby JS, Tzellos T, et al. IHS4 outcomes with bimekizumab in patients with moderate to severe hidradenitis suppurativa: Pooled results from the BE HEARD I and II phase 3 trials. Oral presentation at EADV 2023, Berlin, Germany.
Garg A, Lev-Tov H, Naik HB, et al. Bimekizumab efficacy across weight and BMI based subgroups in patients with moderate to severe hidradenitis suppurativa: 48–week pooled results from the randomised, double-blind, placebo–controlled, multicentre BE HEARD I and II phase 3 trials. Oral presentation at EADV 2023, Berlin, Germany.
ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa (BE HEARD I). Available at: https://clinicaltrials.gov/ct2/show/NCT04242446?term=be+heard&draw=2&rank=1. Last accessed: October 2023.
ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa (BE HEARD II). Available at: https://classic.clinicaltrials.gov/ct2/show/NCT04242498. Last accessed: October 2023.
Jemec GBE. Clinical practice. Hidradenitis suppurativa. N Engl J Med. 2012;366(2):158–64.
Sabat R, Jemec GBE, Matusiak L, et al. Hidradenitis suppurativa. Nat Rev Dis Primers. 2020;6(1):18.
Koumaki D, Efthymiou O, Bozi E, et al. Perspectives on Perceived Stigma and Self-Stigma In Patients With Hidradenitis Suppurativa. Clin Cosmet Investig Dermatol. 2019;12:785–90.
Kokolakis G, Wolk K, Schneider-Burrus S, et al. Delayed Diagnosis of Hidradenitis Suppurativa and Its Effect on Patients and Healthcare System. Dermatology. 2020;236(5):421–30.
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.
View original content to download multimedia:https://www.prnewswire.com/news-releases/phase-3-data-analysis-presented-at-eadv-2023-showed-bimekizumab-achieved-high-thresholds-of-clinical-response-in-hidradenitis-suppurativa-301955218.html
SOURCE UCB
