Clinically meaningful improvements observed with BIMZELX over one year of treatment were maintained up to two years (Week 96)
At Week 96, over eight in 10 patients treated with BIMZELX achieved HiSCR50, over seven in 10 achieved HiSCR75, and over four in 10 achieved HiSCR100*
Approximately one in three patients treated with BIMZELX reported minimal or no impact of the disease on their health-related quality of life over two years*
ATLANTA, Sept. 27, 2024 /PRNewswire/ -- UCB, a global biopharmaceutical company, today announced the first presentation of two-year data from the Phase 3 studies, BE HEARD I and BE HEARD II, and their open-label extension, evaluating the efficacy and safety of BIMZELX® (bimekizumab-bkzx), an interleukin (IL)-17A and IL-17F inhibitor, in adults with moderate-to-severe hidradenitis suppurativa (HS).1 These new data are presented today as a late-breaking platform presentation at the 33rd European Academy of Dermatology and Venereology (EADV) Congress in Amsterdam, the Netherlands, September 25–28, 2024.
(PRNewsfoto/UCB, Inc.)
Results showed that the clinically meaningful improvements observed with BIMZELX treatment at one year were maintained over two years.1* At Week 96, 85.4 percent (n=381/446) of patients treated with BIMZELX achieved HS Clinical Response 50 (HiSCR50). The more stringent endpoints, HiSCR75 and HiSCR100, were achieved by 77.1 percent (n=344/446) and 44.2 percent (n=197/446) of patients, respectively.1* Improvements in the severity of disease, reductions in draining tunnel count, and improvements in health-related quality of life were also maintained over two years.1* BIMZELX was generally well tolerated and no new safety signals were observed.1
"Hidradenitis suppurativa is a chronic, relapsing, and painful inflammatory skin disease that significantly impacts patients' quality of life. The bimekizumab data presented at EADV 2024 showed maintained improvements in clinical response, symptoms, severity, and quality of life over two years. These findings are particularly encouraging given the need for new treatment options that offer sustained relief for patients," said Professor Christos C. Zouboulis, President of the European Hidradenitis Suppurativa Foundation (EHSF) e.V., 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.
"In moderate to severe hidradenitis suppurativa, healthcare professionals and patients value long-term data when they are making treatment decisions. We are proud to present, for the first time, the bimekizumab two-year results at EADV 2024," said Fiona du Monceau, Executive Vice President, Head of Patient Evidence, UCB. "These longer-term data build on the 48-week results, demonstrating maintained response over two years, which is highly relevant for the hidradenitis suppurativa community."
* Observed Case
Summary of the BIMZELX two-year data in moderate-to-severe HS presented at EADV 2024:
Patients who completed Week 48 in BE HEARD I and BE HEARD II could enroll in the open-label extension study and received BIMZELX every two weeks (Q2W) or every four weeks (Q4W) based on ≥90 percent HiSCR averaged from Weeks 36, 40, and 44. Results are shared for the BIMZELX total patient group.
HS Clinical Response:
HiSCR50 was achieved by 79.9 percent (n=444/556) of BIMZELX patients at Week 48 and 85.4 percent (n=381/446) at Week 96.1*
HiSCR75 was achieved by 64.0 percent (n=356/556) of BIMZELX patients at Week 48 and 77.1 percent (n=344/446) at Week 96.1*
HiSCR90 was achieved by 42.3 percent (n=235/556) of BIMZELX patients at Week 48 and 57.6 percent (n=257/446) at Week 96.1*
HiSCR100 was achieved by 30.2 percent (n=168/556) of BIMZELX patients at Week 48 and 44.2 percent (n=197/446) at Week 96.1*
International HS Severity Score System (IHS4): Patients treated with BIMZELX saw a decrease in the severity of their HS symptoms as measured by the IHS4 score.1* The mean IHS4 score at baseline was 35.6±31.5 among BIMZELX patients.1* The percent change from baseline in IHS4 score at Week 48 among BIMZELX patients was maintained through Week 96 (-70.3±39.6 and -79.8±28.1 at Week 48 and Week 96, respectively).1*
Draining tunnel (DT) count: The mean DTs at baseline was 3.8±4.3 among BIMZELX patients.1* The percent change from baseline in draining tunnel count at Week 48 among BIMZELX patients was maintained through Week 96 (–57.5 ±72.9 and –73.7±45.7 percent, at Week 48 and Week 96, respectively).1*
Health-related quality of life: The proportion of BIMZELX patients who achieved Dermatology Life Quality Index (DLQI) 0/1 at Week 48 was maintained through Week 96. The Mean DLQI Total at baseline was 11.0±6.8 among bimekizumab patients. Approximately one in three patients reported minimal or no impact of the disease on their health-related quality of life over two years (27.4 percent [n=151/155] and 33.9 percent [n=149/439] at Week 48 and Week 96, respectively).1*
BIMZELX was generally well-tolerated over two years with no new safety signals observed. Over two years, 917/995 patients who received ≥1 dose of BIMZELX experienced a treatment-emergent adverse event (TEAE). Serious TEAEs were reported in 122 patients.1 Over two years, the most common TEAEs (exposure adjusted incidence rates) were hidradenitis (20.5), coronavirus infection (15.3), and oral candidiasis (10.5).1
Notes to Editors: * Observed Case
About Hidradenitis Suppurativa
Hidradenitis suppurativa (HS) is a chronic, painful, and debilitating inflammatory skin disease that is associated with systemic manifestations.2,3 The main symptoms are nodules, abscesses, and pus-discharging draining tunnels (or sinus tracts leading out of the skin) which typically occur in the armpits, groin and buttocks.2,3 People with HS experience flare-ups of the disease as well as severe pain, which can have a major impact on quality of life.2,3 HS develops in early adulthood and affects approximately one percent of the population in most studied countries.2,3
About BE HEARD I/BE HEARD II and the Open-Label Extension Study
The efficacy and safety profile of BIMZELX were evaluated in adult patients with moderate-to-severe hidradenitis suppurativa (HS) in two multicenter, randomized, double-blind, placebo-controlled Phase 3 studies (BE HEARD I and BE HEARD II).4 The two studies had a combined enrollment of 1,014 participants.4 In each study, patients were randomized 2:2:2:1 (initial [16-week]/maintenance [32-weeks]) to BIMZELX 320 mg every two weeks (Q2W/Q2W), every four weeks (Q4W/Q4W), or a combination (BIMZELX 320 mg every two weeks to Week 16 then every 4 weeks to Week 48 [Q2W/Q4W] or placebo to Week 16 then BIMZELX 320 mg every two weeks to Week 48 [PBO/Q2W]).1 Patients who completed Week 48 could enroll in the open-label extension.1 Of 1,014 total patients, 556 patients randomized at baseline to BIMZELX in BE HEARD I and II completed Week 48 and entered the open-label extension study; 446 patients in the open-label extension study completed Week 96.1 The primary endpoint in both trials was HiSCR50 at Week 16.4 A key secondary endpoint was HiSCR75 at Week 16.4 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.4
About BIMZELX (bimekizumab-bkzx)
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 Elevated levels of IL-17A and IL-17F are found in lesional psoriatic skin.5
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.5 BIMZELX is not approved in the U.S. for the treatment of moderate-to-severe hidradenitis suppurativa (HS). In the U.S., the efficacy and safety profile of BIMZELX in HS have not been established.
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.
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
Zouboulis C, Garg A, Sayed C, et al. Bimekizumab efficacy and safety through 2 years in patients with hidradenitis suppurativa: Results from the phase 3 BE HEARD I&II trials and open-label extension BE HEARD EXT. Abstract at EADV 2024. Amsterdam, Netherlands.
Kimball AB, Jemec GBE, Sayed CJ, et al. Efficacy and safety of bimekizumab in patients with moderate-to-severe hidradenitis suppurativa (BE HEARD I and BE HEARD II): two 48‑week, randomised, double‑blind, placebo‑controlled, multicentre phase 3 trials. Lancet. 2024;403(10443):2504-19.
