IL-17RA

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 33rd 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.4 Psoriasis 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 . 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 () 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. . Accessed September 2024. US-BK-2401208 Date of preparation: September 2024 BIMZELX® is a registered trademark of the UCB Group of Companies. ©2024 UCB, Inc., Smyrna, GA 30080. All rights reserved. SOURCE UCB WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

BALLERUP, Denmark--( BUSINESS WIRE )-- NOT FOR UK USE – NOT INTENDED FOR UK MEDIA LEO Pharma A/S, a global leader in medical dermatology, will present new clinical and real-world data from across its portfolio of products at the upcoming 33 rd European Academy of Dermatology and Venereology (EADV) Congress. The event will be held from the 25 th to the 28 th of September in Amsterdam, Netherlands, where LEO Pharma will present 5 coveted late-breaking presentations in addition to 23 scientific posters for a range of skin conditions, forming the largest collection of data LEO Pharma has ever shared at the EADV congress. 1-28 “ It is extraordinary to witness the breadth and variety of LEO Pharma’s scientific contribution at this year’s EADV Congress. It is a record-breaking presence for us – and we cannot wait to share this ground-breaking data with the medical dermatology community ,” said Christophe Bourdon, CEO of LEO Pharma. The first late-breaking presentation for Anzupgo ® (delgocitinib) cream will provide data from the 24-week DELTA FORCE trial that compared the efficacy and safety of topical delgocitinib cream with oral alitretinoin capsules in adults with severe CHE. 1 An additional late-breaking oral presentation will provide data from the matching-adjusted indirect comparison (MAIC) of the efficacy of delgocitinib and dupilumab in the treatment of moderate to severe atopic hand eczema. 25 The third delgocitinib cream late-breaking presentation will provide information on biomarker and efficacy data from the randomized vehicle-controlled clinical trial with delgocitinib cream in patients with frontal fibrosing alopecia. 26 A late-breaking presentation will also be presented for Adtralza/Adbry, highlighting the interim real-world effectiveness results of tralokinumab in adult patients with head and neck atopic dermatitis after up to 9 months of treatment in the TRACE real world evidence (RWE) study. 27 Finally, a late-breaking presentation for temtokibart will also be presented, comparing clinical and molecular responses in the targeting of IL-22RA1 with temtokibart vs dupilumab in patients with moderate to severe atopic dermatitis. 28 " The 2024 EADV Congress marks a pivotal moment for LEO Pharma as we unveil a wealth of new data," said Kreesten Meldgaard Madsen, Chief Development Officer, LEO Pharma. " Our presentations at EADV showcase our most comprehensive research portfolio to date, underscoring our unwavering commitment to developing innovative dermatological therapies and helping to bring new hope to patients grappling with challenging skin conditions." The company’s full roster at the 2024 EADV Congress, encompassing new research, encore abstracts, and 3 symposiums, 1-28 includes: Anzupgo ® (delgocitinib) cream DELTA FORCE trial: A 24-week head-to-head phase 3 trial comparing the efficacy and safety of topical delgocitinib cream with oral alitretinoin capsules in adults with severe chronic hand eczema Author: Ana Maria Giménez-Arnau Presentation ID: D1T01.1F LB presentation: Wednesday, 25 Sep, 15:30 - 15:45 Location: Auditorium Matching-adjusted indirect comparison of the efficacy of delgocitinib and dupilumab in the treatment of moderate to severe atopic hand eczema Author: David Cohen Presentation ID: D3T01.4B LB presentation: Friday, 27 Sep, 16:15 - 16:30 Location: Auditorium Randomized vehicle-controlled clinical trial with the topical JAK inhibitor delgocitinib in patients with frontal fibrosing alopecia demonstrates biomarker and clinical efficacy Author: Maryanne Makredes Senna Presentation ID: D3T01.4F LB presentation: Friday, 27 Sep, 17:15 - 17:30 Location: Auditorium Treatment response of delgocitinib cream according to Chronic Hand Eczema (CHE) subtypes in adults with moderate to severe CHE: results from the Phase 3 DELTA 1, DELTA 2, and DELTA 3 trials Author: Robert Bissonnette Presentation ID: FC07.04 Oral presentation: Friday, 27 Sep, 14:45 - 14:55 Location: G104-G105 Topical pan-JAK inhibition with delgocitinib restores the molecular signature of lesional skin in patients with Chronic Hand Eczema Author: Sonja Molin Poster ID: P0572 ePoster presentation Health-related quality of life in people with Chronic Hand Eczema - Findings from the multi-national CHECK study Author: Anthony Bewley Poster ID: P3443 ePoster presentation Clinical trial exit interviews in patients with moderate to severe Chronic Hand Eczema: perspectives on disease burden and its impact on quality of life from participants in the phase 3 DELTA 1 trial Author: Padma Mohandas Poster ID: P0532 ePoster presentation Patient characteristics and comorbidities in moderate-to-severe CHE: Results from the RWEAL study Author: Maria Concetta Fargnoli Poster ID: P2559 ePoster presentation The multifactorial and heterogenous nature of Chronic Hand Eczema in clinical practice: Results from the RWEAL study Author: Maria Concetta Fargnoli Poster ID: P0608 ePoster presentation Delgocitinib cream reduces itch and pain in adults with moderate to severe Chronic Hand Eczema: pooled analyses of the Phase 3 DELTA 1 and 2 trials Author: Andrea Bauer Poster ID: P0564 ePoster presentation Efficacy and safety of delgocitinib cream in adults with moderate to severe Chronic Hand Eczema: pooled results of the Phase 3 DELTA 1 and 2 trials Author: Marie Louise Schuttelaar Poster ID: P0569 ePoster presentation Systemic exposure and safety profile of delgocitinib cream in adults with moderate to severe Chronic Hand Eczema in the Phase 3 DELTA 2 trial Author: Melinda Gooderham Poster ID: P0581 ePoster presentation Long-term safety and efficacy of delgocitinib cream for up to 36 weeks in adults with Chronic Hand Eczema: results of the Phase 3 open-label extension DELTA 3 trial Author: Sonja Molin Poster ID: P0565 ePoster presentation Association and impact of Chronic Hand Eczema on occupational and household/leisure activities– results from the multinational CHECK study Author: Marie Noelle Crepy Poster ID: P1076 ePoster presentation Prevalence of Chronic Hand Eczema in adults: A cross-sectional multi-national study of over 60,000 respondents in the general population Author: Christian Apfelbacher Poster ID: P1901 ePoster presentation Treatment patterns in moderate to severe Chronic Hand Eczema - Results from the multinational RWEAL medical chart review Author: Ana Maria Giménez-Arnau Poster ID: P3568 ePoster presentation Self-reported disease severity and treatment of Chronic Hand Eczema from the CHECK study - A multinational study in six countries Author: Sonja Molin Poster ID: P3526 ePoster presentation Adtralza ® (tralokinumab)/Adbry ® (tralokinumab-ldrm) Real-world effectiveness of tralokinumab in adults with atopic dermatitis: Interim data on improvements in patients with head and neck atopic dermatitis after up to 9 months of treatment in the TRACE study Author: April Armstrong Presentation ID: D3T01.3C LB presentation: Friday, 27 Sep, 14:45 - 15:00 Location: Auditorium Real-world effectiveness of tralokinumab in adults with atopic dermatitis: Interim data on improvements in physician-assessed disease severity after up to 9 months of follow-up in the TRACE study Author: Elena Pezzolo Poster ID: P0689 ePoster presentation Real-world effectiveness of tralokinumab in adults with atopic dermatitis: Interim data on improvements in patient-reported outcomes after up to 9 months of follow-up in the TRACE study Author: Antonio Costanzo Poster ID: P0690 ePoster presentation Long-term safety and efficacy of tralokinumab in patients 65 years or older with moderate-to-severe atopic dermatitis Author: Andrew Blauvelt Poster ID: P0479 ePoster presentation Improvement of the head and neck regions with continuous tralokinumab treatment for up to 4 years in adults with moderate-to-severe atopic dermatitis Author: Raj Chovatiya Poster ID: P0595 ePoster presentation Tralokinumab formulated as a pre-filled pen was efficacious and well-tolerated in adults and adolescents with moderate-to-severe atopic dermatitis Author: Jennifer Soung Poster ID: P0574 ePoster presentation Stability of long-term therapeutic responses to tralokinumab in adults with moderate-to-severe atopic dermatitis Author: Andrew Blauvelt Poster ID: P0596 ePoster presentation Kyntheum ® (brodalumab) Observational study to assess the real-life descriptive effectiveness in patients with moderate to severe plaque psoriasis treated with Brodalumab stratified by patients with BMI>30 and patients with BMI ≤ 30. The BROACTIVE Study. 2 years - results. Author: Juan Escalas Poster ID: P3205 ePoster presentation Long-term management outcome assessment of adult patients with moderate-to-severe plaque psoriasis treated with brodalumab in Greece: The ReSOLVE study. Author: Pantelis Panagakis Poster ID: P3102 ePoster presentation Temtokibart Targeting IL-22RA1 with temtokibart in patients with moderate to severe atopic dermatitis induces fast clinical and molecular responses, distinct from dupilumab Author: Christine Bangert Presentation ID: D2T01.3A LB presentation: Thursday, 26 Sep, 14:15 - 14:30 Location: Auditorium Individual responses to IL-22RA1 inhibition in Asian patients with moderate-to-severe atopic dermatitis in Phase 1 and 2a clinical trials Author: Diamant Thaçi Poster ID: P0691 ePoster presentation In addition to the abstracts and poster presentations, LEO Pharma will also present 3 symposiums at the meeting: A New Era in Atopic Dermatitis Speakers: Prof. Melinda Gooderham, Prof. April Armstrong and Prof. Marjolein de Bruin-Weller 17:45–19:15 CEST on Thursday the 26th of September in Room 7.1, RAI Amsterdam Plaque psoriasis and obesity — a double burden for patients? Speakers: Prof. Dr med. Khusru Asadullah and Dr Matteo Megna 11:15-12:00 CEST on Thursday the 26th of September in Amtrium 1, Hall 4, RAI Amsterdam Chronic Hand Eczema Breaking the Silent Conversation Speakers: Prof. Swen Malte John, Prof. April Armstrong, Dr Marie-Louise Schuttelaar 13:00-14:00 CEST on Friday the 27 th of September in Room 7.3, RAI Amsterdam. About Chronic Hand Eczema Chronic hand eczema (CHE) is defined as hand eczema (HE) that lasts for more than three months or relapses twice or more within a year. 29,30 CHE is one the most common skin disorder of the hands with a prevalence rate of approximately 4.7%. 31 In a substantial number of patients, HE can develop into a chronic condition. 32 CHE is a fluctuating disorder characterized by itch and pain, and patients may experience signs such as erythema, scaling, lichenification, hyperkeratosis, vesicles, edema, and fissures on hands and wrists. 33 CHE has been shown to cause psychological and functional burdens that impact patient quality of life, 34 with approximately 70% of individuals who live with severe CHE admitting to problems in performing everyday activities, and suffering disruption in their daily life due to the condition. 35 Furthermore, careers and earning potential have also been shown to be impacted by the burden of living with CHE. 36 About Atopic Dermatitis Atopic dermatitis is a chronic, inflammatory skin disease characterized by intense itch and eczematous lesions. 37 Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation. 38 Type 2 cytokines, including IL-13, play an important role in the key aspects of atopic dermatitis pathophysiology. 37,38 Excessive IL-22 production is also known to contribute to the pathogenesis of AD. 39 About Psoriasis Psoriasis is a chronic, systemic inflammatory disease that primarily affects the skin in 125 million people worldwide. 40,41 Psoriasis is the result of skin barrier cell proliferation and the activation of cytokines (a family of proteins involved in immune responses) that cause inflammation. 42 About 80% to 90% of patients are affected by plaque psoriasis, the most common clinical form of psoriasis. 43 The symptoms of plaque psoriasis are itchy or painful raised scaly and inflamed plaques. Plaques may appear anywhere on the body, but often appear on the scalp, knees, elbows and torso. 43 About Anzupgo ® (delgocitinib) cream Anzupgo ® (delgocitinib) cream 20 mg/g is a topical pan-Janus kinase (JAK) inhibitor for the treatment of moderate to severe CHE. It inhibits the activation of JAK-STAT signaling, which plays a key role in the pathogenesis of CHE. 44 The pathophysiology is characterized by skin barrier dysfunction, inflammation of the skin, and alterations of the skin microbiome. 45 Anzupgo is currently approved in the European Union for the treatment of moderate to severe chronic hand eczema (CHE) in adults for whom topical corticosteroids are inadequate or inappropriate. In 2014, LEO Pharma A/S and Japan Tobacco Inc. (JT) entered into a license agreement in which LEO Pharma gained exclusive rights to develop and commercialize delgocitinib cream for topical use in dermatological indications worldwide, excluding Japan, where JT retains rights. About Adtralza ® (tralokinumab) / Adbry ® (tralokinumab-ldrm) Adtralza ® (tralokinumab), which is marketed under the tradename Adbry ® in the U.S., is a high-affinity fully human monoclonal antibody developed to bind to and inhibit the interleukin IL-13 cytokine, which plays a role in the immune and inflammatory processes underlying atopic dermatitis signs and symptoms. 38,46 Adtralza ® specifically binds to the IL-13 cytokine, thereby inhibiting interaction with the IL-13 receptor α1 and α2 subunits (IL-13Rα1 and IL-13Rα2). 47 Adtralza ® is approved for the treatment of moderate to severe AD in adult and adolescent patients 12 years and older in the European Union, Canada, Great Britain, the United Arab Emirates, and South Korea. Adtralza ® is approved for use in adults with moderate to severe AD in the U.S., Switzerland, Saudi Arabia, and Japan. About Kyntheum ® (brodalumab) Kyntheum ® (brodalumab) is a recombinant fully human monoclonal immunoglobulin IgG2 antibody that binds with high affinity to human IL-17RA and blocks the biological activities of the pro-inflammatory cytokines IL-17A, IL-17F, IL-17A/F heterodimer, IL-17C and IL-17E (also known as IL-25), resulting in inhibition of the inflammation and clinical symptoms associated with psoriasis. IL-17RA is a protein expressed on the cell surface and is a required component of receptor complexes utilized by multiple IL-17 family cytokines. IL-17 family cytokine levels have been reported to be increased in psoriasis. IL-17A, IL-17F and IL-17A/F heterodimer have pleiotropic activities including the induction of pro-inflammatory mediators such as IL-6, GROα, and G-CSF from epithelial cells, endothelial cells and fibroblasts that promote tissue inflammation. IL-17C has been shown to induce similar responses as IL-17A and IL-17F in keratinocytes. Blocking IL-17RA inhibits IL-17 cytokine-induced responses resulting in normalization of inflammation in the skin. 48 Kyntheum ® is indicated in the European Union, Great Britain, the United Arab Emirates, and Brazil for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy. About temtokibart Temtokibart (LEO 138559) is an investigational monoclonal antibody that targets the IL-22RA1 receptor subunit, currently in Phase 2 development for the potential treatment of moderate to severe atopic dermatitis. 49 It blocks the IL-22RA1 subunit and thereby inhibits the effects of the IL-22 cytokine, and potentially also to some extent the effects of IL-20 and IL-24. 49 Temtokibart does not bind to the IL-22 cytokine itself. 49 LEO Pharma has obtained a worldwide exclusive license to develop and commercialize temtokibart from argenx. About LEO Pharma LEO Pharma is a global company dedicated to advancing the standard of care for the benefit of people with skin conditions, their families and society. Founded in 1908 and majority owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, and today, the company offers a wide range of therapies for all disease severities. LEO Pharma is headquartered in Denmark with a global team of 4,200 people, serving millions of patients across the world. In 2023, the company generated net sales of DKK 11.4 billion. References Giménez-Arnau AM, Pinter A, Sondermann W et al. DELTA FORCE trial: A 24-week head-to-head phase 3 trial comparing the efficacy and safety of topical delgocitinib cream with oral alitretinoin capsules in adults with severe chronic hand eczema. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. Oral Presentation. D1T01.1F. Bisonnette R, Schliemann S, Gooderham M, et al. Treatment response of delgocitinib cream according to Chronic Hand Eczema (CHE) subtypes in adults with moderate to severe CHE: results from the Phase 3 DELTA 1, DELTA 2, and DELTA 3 trials. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. Oral Presentation. FC07.04 Giménez-Arnau AM, Bewley A, Molin S, et al. Patient characteristics and comorbidities in moderate-to-severe CHE: Results from the RWEAL study. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P2559 Fargnoli MN, Molin S, Bewley A, et al. The multifactorial and heterogenous nature of Chronic Hand Eczema in clinical practice: Results from the RWEAL study. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P0608. Worm M, Jiang L, Litman T, et al. Topical pan-JAK inhibition with delgocitinib restores the molecular signature of lesional skin in patients with Chronic Hand. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. Oral Presentation. P0572. Bewley A, Molin S, Crepy MN, et al. Health-related quality of life in people with Chronic Hand Eczema - Findings from the multi-national CHECK study. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P3443. Mohandas P, Devani AR, Baranowski K, et al. Clinical trial exit interviews in patients with moderate to severe Chronic Hand Eczema: perspectives on disease burden and its impact on quality of life from participants in the phase 3 DELTA 1 trial. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P0532. Pezzolo E, Cork M, Beecker J, et al. Real-world effectiveness of tralokinumab in adults with atopic dermatitis: Interim data on improvements in physician-assessed disease severity after up to 9 months of follow-up in the TRACE study. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P0689. Costanzo A, Becherel PA, Serra E, et al. Real-world effectiveness of tralokinumab in adults with atopic dermatitis: Interim data on improvements in patient-reported outcomes after up to 9 months of follow-up in the TRACE study. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P0690. Escalas J, Armesto S, Abalde T, et al. Observational study to assess the real-life descriptive effectiveness in patients with moderate to severe plaque psoriasis treated with Brodalumab stratified by patients with BMI>30 and patients with BMI ≤ 30. The BROACTIVE Study. 2 years - results. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P3205. Panagakis P, Chasapi V, Kalapothakou K, et al. Long-term management outcome assessment of adult patients with moderate-to-severe plaque psoriasis treated with brodalumab in Greece: The ReSOLVE study. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P3102. Thaçi D, Bangert C, Laquer V, et al. Individual responses to IL-22RA1 inhibition in Asian patients with moderate-to-severe atopic dermatitis in Phase 1 and 2a clinical trials. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P0691. Blauvelt A, Merola J, Carrascosa JM, et al. Long-term safety and efficacy of tralokinumab in patients 65 years or older with moderate-to-severe atopic dermatitis. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P0479. Bauer A, Schuttelaar ML, Baranowski K, et al. Delgocitinib cream reduces itch and pain in adults with moderate to severe Chronic Hand Eczema: pooled analyses of the Phase 3 DELTA 1 and 2 trials. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P0564. Schuttelaar ML, Bisonnette R, Worm M, et al. Efficacy and of delgocitinib cream in adults with moderate to severe Chronic Hand Eczema: pooled results of the Phase 3 DELTA 1 and 2 trials. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P0569. Gooderham M, Thaçi D, Damgaard T, et al. Systemic exposure and safety profile of delgocitinib cream in adults with moderate to severe Chronic Hand Eczema in the Phase 3 DELTA 2 trial. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P0581. Molin S, Gooderham M, Bisonnette R, et al. Long-term safety and efficacy of delgocitinib cream for up to 36 weeks in adults with Chronic Hand Eczema: results of the Phase 3 open-label extension DELTA 3 trial. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P0565. Crepy MN, Molin S, Giménez-Arnau AM, et al. Association and impact of Chronic Hand Eczema on occupational and household/leisure activities– results from the multinational CHECK study. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P1076. Apfelbacher C, Bewley A, Molin S, et al. Prevalence of Chronic Hand Eczema in adults: A cross-sectional multi-national study of over 60,000 respondents in the general population. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P1901. Giménez-Arnau AM, Bewley A, Apfelbacher C et al. Treatment patterns in moderate to severe Chronic Hand Eczema - Results from the multinational RWEAL medical chart review. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P3568. Molin S, Fargnoli MN, Crepy MN, et al. Self-reported disease severity and treatment of Chronic Hand Eczema from the CHECK study - A multinational study in six countries. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P3526 . Chovatiya R, Wollenberg A, Ribero S, et al. Improvement of the head and neck regions with continuous tralokinumab treatment for up to 4 years in adults with moderate-to-severe atopic dermatitis. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P0595. Soung J, Laquer V, Zirwas M, et al. Tralokinumab formulated as a pre-filled pen was efficacious and well-tolerated in adults and adolescents with moderate-to-severe atopic dermatitis. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P0574. Blauvelt A, Hong HC, Peris K, et al. Stability of long-term therapeutic responses to tralokinumab in adults with moderate-to-severe atopic dermatitis. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P0596. Cohen D, Bewley A, Wollenberg A, et al. Matching-adjusted indirect comparison of the efficacy of delgocitinib and dupilumab in the treatment of moderate to severe atopic hand eczema. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. Oral Presentation.D3T01.4B. Senna MM, Soerensen OE, Nielsen AB et al. Randomized vehicle-controlled clinical trial with the topical JAK inhibitor delgocitinib in patients with frontal fibrosing alopecia demonstrates biomarker and clinical efficacy. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. Oral Presentation. D3T01.4F. Armstrong A, Ameen A, Bagel J et al. Real-world effectiveness of tralokinumab in adults with atopic dermatitis: Interim data on improvements in patients with head and neck atopic dermatitis after up to 9 months of treatment in the TRACE study. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. Oral Presentation. D3T01.3C Bangert C, Berdyshev E, Alkon N et al. Targeting IL-22RA1 with temtokibart in patients with moderate to severe atopic dermatitis induces fast clinical and molecular responses, distinct from dupilumab. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. Oral Presentation. D2T01.3A. Lynde C, Guenther L, Diepgen TL, et al. Canadian hand dermatitis management guidelines. J Cutan Med Surg. 2010;14(6):267-284. Erratum in: J Cutan Med Surg. 2011 Nov-Dec;15(6):360. Diepgen TL, et al. Guidelines for diagnosis, prevention and treatment of hand eczema. J Dtsch Dermatol Ges. 2015 Jan;13(1):e1–22. Apfelbacher C, Bewley A, Molin S, et al. Prevalence of Chronic Hand Eczema in adults: A cross-sectional multi-national study of 60,000 respondents in the general population. Presented at the 2024 European Society of Contact Dermatitis (ESCD) congress; September 04-07 2024; Dresden, Germany. Poster presentation #3 Bissonnette R, et al. Redefining treatment options in chronic hand eczema (CHE). JEADV . 2010;24;1–20. Thyssen JP, Silverberg JI, Guttman-Yassky E. Chronic hand eczema understanding has ramifications on clinical management. J Eur Acad Dermatol Venereol. 2020;34(8):e429-e430. Grant L, Seiding Larsen L, Burrows K, et al. Development of a Conceptual Model of Chronic Hand Eczema (CHE) Based on Qualitative Interviews with Patients and Expert Dermatologists. Adv Ther. 2020;37(2):692-706. Cortesi PA, Scalone L, Belisari A, et al. Cost and quality of life in patients with severe chronic hand eczema refractory to standard therapy with topical potent corticosteroids. Contact Dermatitis. 2014;70(3):158-168. Voorberg AN, Loman L, Schuttelaar MLA. Prevalence and Severity of Hand Eczema in the Dutch General Population: A Cross-sectional, Questionnaire Study within the Lifelines Cohort Study. Acta Derm Venereol. 2022;102:adv00626. Weidinger S, Novak N. Atopic dermatitis. Lancet. 2016;387(10023):1109-1122. Boguniewicz M, Leung DY. Atopic dermatitis: a disease of altered skin barrier and immune dysregulation. Immunol Rev. 2011;242(1):233-246. Dudakov JA, Hanash AM, van den Brink MR. Interleukin-22: immunobiology and pathology. Annu Rev Immunol . 2015;33:747-785. Menter A, Korman NJ, Elmets CA, Feldman SR, Gelfand JM, Gordon KB, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis. Section 3. Guidelines of care for the management and treatment of psoriasis with topical therapies. J Am Acad Dermatol 2009; 60: 643-659. Psoriasis Statistics. National Psoriasis Foundation website. https://www.psoriasis.org/content/statistics . Accessed September, 2024. Hawkes JE, Chan TC, Krueger JG. Psoriasis pathogenesis and the development of novel targeted immune therapies. J Allergy Clin Immunol. 2017;140(3):645-653. Plaque Psoriasis. National Psoriasis Foundation website. https://www.psoriasis.org/plaque/ . Updated September 2020. Accessed August 16, 2024. Dubin C, Del Duca E, Guttman-Yassky E. Drugs for the Treatment of Chronic Hand Eczema: Successes and Key Challenges. Ther Clin Risk Manag. 2020;16:1319-1332. Erratum in: Ther Clin Risk Manag. 2021 Mar 18;17:233. Lee GR, Maarouf M, Hendricks AK, Lee DE, Shi VY. Current and emerging therapies for hand eczema. Dermatol Ther. 2019;32(3):e12840. Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy . 2020; 75:54-62. Popovic B, Breed J, Rees DG, et al. Structural Characterisation Reveals Mechanism of IL-13-Neutralising Monoclonal Antibody Tralokinumab as Inhibition of Binding to IL-13Rα1 and IL-13Rα2. J Mol Biol. 2017;429(2):208-219. Electronic Medicines Compendium. SmPC. Kyntheum (brodalumab). 10 Jan 2023. https://www.ema.europa.eu/en/documents/product-information/kyntheum-epar-product-information_en.pdf Accessed September, 2024. Thaçi D, et al. Efficacy and safety of IL-22R inhibition in patients with moderate-to-severe atopic dermatitis: results from a phase 2a monotherapy trial. Presented at the 2023 American Academy of Dermatology Annual Meeting; March 17–21 2023; New Orleans, LA. MAT-76322 September 2024

BRUSSELS, Belgium I September 23, 2024 I UCB, a global biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved BIMZELX ® (bimekizumab-bkzx) for the treatment of adults with active psoriatic arthritis (PsA), adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, and adults with active ankylosing spondylitis (AS). 1 Bimekizumab-bkzx is the first approved treatment for these three indications that is designed to selectively inhibit two key cytokines driving inflammatory processes – interleukin 17A (IL-17A) and interleukin 17F (IL-17F). 1 These newly approved indications follow the first U.S. approval for BIMZELX ® in October 2023 for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. 1 “The approval of BIMZELX in the U.S. across three new indications – active psoriatic arthritis, active non-radiographic axSpA with objective signs of inflammation, and active ankylosing spondylitis – highlights the clinical benefit of dual inhibition of both IL-17A and IL-17F for patients, and provides an opportunity for more people living with chronic inflammatory diseases to achieve meaningful outcomes,” said Emmanuel Caeymaex, Executive Vice President, Head of Patient Impact and Chief Commercial Officer, UCB. “In psoriatic arthritis and across the spectrum of axSpA, clinical study results and real-world experience outside the U.S. have highlighted that BIMZELX can help patients achieve high thresholds of clinical response that are rapid in onset and sustained up to two years.” The FDA recommended dosage of bimekizumab for adult patients with active PsA, active nr-axSpA with objective signs of inflammation, and active AS is 160 mg by subcutaneous injection every four weeks. 1 For PsA patients with co-existent moderate to severe plaque psoriasis, the dosage and administration is the same as for patients with moderate to severe plaque psoriasis. 1 BIMZELX is currently available for eligible patients. Bimekizumab-bkzx for the treatment of adults with active psoriatic arthritis “In Phase 3 clinical studies, the clinically meaningful and consistent clinical response in patients who had a previous inadequate response to TNF inhibitors, and in patients who were new to biologics, suggest that bimekizumab-bkzx has the potential to be an important new treatment option in our armamentarium for adults with psoriatic arthritis,” said Joseph F. Merola, MD, MMSc, Professor, Dermatologist, Rheumatologist, and Investigator, BE OPTIMAL and BE COMPLETE. “The approval of bimekizumab-bkzx for the treatment of active psoriatic arthritis provides a new, differentiated treatment option for the rheumatology and dermatology communities.” The approval of bimekizumab-bkzx for adult patients with active PsA is supported by data from the Phase 3 BE OPTIMAL and BE COMPLETE studies, in which bimekizumab-bkzx met the primary endpoint of American College of Rheumatology 50 (ACR50) response at Week 16 versus placebo, and all ranked secondary endpoints. 2,3 Consistent results were seen across both biologic-naïve and TNF inhibitor inadequate-responder (TNFi-IR) populations. 2,3 Clinical responses achieved at Week 16 were sustained to Week 52 in BE OPTIMAL and in BE COMPLETE, and its open-label extension, as assessed by ACR50 (primary endpoint), Psoriasis Area and Severity Index 90 (PASI90, ranked secondary endpoint), minimal disease activity (MDA; ranked secondary endpoint) and PASI100, i.e., complete skin clearance (other endpoint). 4,5 “Psoriatic arthritis can severely impact a person’s quality of life. With joint pain and stiffness, daily activities can become burdensome. New treatment options are always a welcome addition, and they offer some renewed hope for relief from the symptoms and health impacts of PsA,” said Leah M. Howard, J.D., the President and CEO of the National Psoriasis Foundation, U.S. Bimekizumab-bkzx for the treatment of adults with active nr-axSpA and active AS “In the Phase 3 clinical studies, patients treated with bimekizumab-bkzx saw improvements in signs and symptoms and key measures of disease activity at Week 16 which were sustained to one year and consistent across patients with non-radiographic axial spondyloarthritis and ankylosing spondylitis,” said Atul Deodhar, MD, Professor of Medicine and Medical Director of rheumatology clinics at the Division of Arthritis & Rheumatic Diseases, Oregon Health & Science University, Portland, Oregon, U.S. “The U.S. rheumatology community welcomes the approval of bimekizumab-bkzx for use across the entire spectrum of axial spondyloarthritis, especially given that there are few options approved currently to treat both non-radiographic axial spondyloarthritis and ankylosing spondylitis.” The approvals of bimekizumab-bkzx for adult patients with active nr-axSpA with objective signs of inflammation, and active AS are supported by data from the Phase 3 BE MOBILE 1 and BE MOBILE 2 studies, respectively. 6,7 In both studies, bimekizumab-bkzx met the primary endpoint of Assessment of SpondyloArthritis international Society 40 (ASAS40) response at Week 16 compared with placebo, and all ranked secondary endpoints. 6,7 ASAS40 responses were consistent across TNFi-naïve and TNFi-inadequate responder patients. 6,7 Clinical responses achieved at Week 16 were sustained in both patients with nr-axSpA and AS to Week 52 as assessed by ASAS40, ranked secondary and other endpoints. 6,7 “People living with non-radiographic axial spondyloarthritis and ankylosing spondylitis experience pain, stiffness and fatigue that can limit their daily activities, ability to work, and quality of life,” said Seth Ginsberg, Co-Founder and President, Global Health Living Foundation and CreakyJoints, U.S. “A new treatment option offers the opportunity for more patients to reach their treatment goals.” Notes to Editors: 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. 8 PsA affects approximately 30 percent of people living with psoriasis. 9 Symptoms include joint pain and stiffness, skin plaques, swollen toes and fingers (dactylitis), inflammation of the sites where tendons or ligaments insert into the bone (enthesitis), and inflammatory axial involvement. 10 About BE OPTIMAL and BE COMPLETE 2,3,4,5 Bimekizumab-bkzx (160 mg every four weeks) was evaluated in adult patients with active psoriatic arthritis (PsA) in two Phase 3 multicentre, randomized, double-blind, placebo-controlled studies (BE OPTIMAL and BE COMPLETE). The BE OPTIMAL study evaluated 852 patients not previously exposed to any biologic disease-modifying anti-rheumatic drug (bDMARD-naïve) for the treatment of PsA. The BE COMPLETE study evaluated 400 patients with an inadequate response or intolerance to treatment with one or two tumour necrosis factor alpha inhibitors (TNFi-IR) for the treatment of PsA. Key findings from the Phase 3 Clinical Development Program: In PsA, the most common (≥ 2 percent) adverse reactions with bimekizumab-bkzx are upper respiratory tract infections, oral candidiasis, headache, diarrhea and urinary tract infection. 1 About Axial Spondyloarthritis Axial spondyloarthritis (axSpA), which includes both non-radiographic axSpA (nr-axSpA) and ankylosing spondylitis (AS), also known as radiographic axSpA (r-axSpA), is a chronic, immune-mediated, inflammatory disease. 11 Non-radiographic-axSpA (nr-axSpA) is defined clinically by the absence of definitive x-ray evidence of structural damage to the sacroiliac joints. 11 axSpA is a painful condition that primarily affects the spine and the joints linking the pelvis and lower spine (sacroiliac joints). 11 The leading symptom of axSpA in a majority of patients is inflammatory back pain that improves with exercise, but not with rest. 11 Other common clinical features frequently include anterior uveitis, enthesitis, peripheral arthritis, psoriasis, inflammatory bowel disease, and dactylitis. 11 The overall prevalence of axSpA is up to 1.4 percent of adults. 12,13 Approximately half of all patients with axSpA are patients with nr-axSpA. 11 Axial spondyloarthritis onset usually occurs before the age of 45. 11 Approximately 10 to 40 percent of patients with nr-axSpA progress to ankylosing spondylitis over 2 to 10 years. 11 About BE MOBILE 1 and BE MOBILE 2 6,7 The efficacy and safety of bimekizumab, 160 mg every four weeks, were evaluated in two Phase 3 multicenter, randomized, double-blind, placebo-controlled studies, one in non-radiographic axSpA (nr-axSpA; BE MOBILE 1) and one in ankylosing spondylitis (AS; BE MOBILE 2). The BE MOBILE 1 and BE MOBILE 2 studies evaluated 254 and 332 patients, respectively. Key findings from the Phase 3 BE MOBILE 1 and BE MOBILE 2 studies: In nr-axSpA, the most common (≥ 2 percent) adverse reactions with bimekizumab-bkzx are upper respiratory tract infections, oral candidiasis, headache, diarrhea, cough, fatigue, musculoskeletal pain, myalgia, tonsilitis, transaminase increase and urinary tract infection. 1 In AS, the most common (≥ 2 percent) adverse reactions with bimekizumab-bkzx are upper respiratory tract infections, oral candidiasis, headache, diarrhea, injection site pain, rash and vulvovaginal mycotic infection. 1 About BIMZELX in the U.S. (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. 1 Elevated levels  of IL-17A and IL-17F are found in lesional psoriatic skin. 1 Please see Important Safety Information below and full U.S. Prescribing Information at www.UCB-USA.com/Innovation/Products/BIMZELX . About BIMZELX ® ▼(bimekizumab) in the European Union/European Economic Area The approved indications for bimekizumab▼ in the EU are: 14 The label information may differ in other countries where approved. Please check local Prescribing Information. BIMZELX ® ▼(bimekizumab) EU/EEA Important Safety Information The most frequently reported adverse reactions with bimekizumab were upper respiratory tract infections (14.5%, 14.6%, 16.3%, 8.8% in plaque psoriasis, psoriatic arthritis, axial spondyloarthritis (axSpA) and hidradenitis suppurativa, respectively) and oral candidiasis (7.3%, 2.3%, 3.7%, 5.6% in PSO, PsA, axSpA and HS, respectively). Common adverse reactions (≥1/100 to <1/10) were oral candidiasis, tinea infections, ear infections, herpes simplex infections, oropharyngeal candidiasis, gastroenteritis, folliculitis, vulvovaginal mycotic infection (including vulvovaginal candidiasis), headache, rash, dermatitis and eczema, acne, injection site reactions, fatigue. Elderly may be more likely to experience certain adverse reactions such as oral candidiasis, dermatitis and eczema when using bimekizumab. Bimekizumab is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients and in patients with clinically important active infections (e.g. active tuberculosis). Bimekizumab may increase the risk of infections. Treatment with bimekizumab must not be initiated in patients with any clinically important active infection. Patients treated with bimekizumab should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur. If a patient develops an infection the patient should be carefully monitored. If the infection becomes serious or is not responding to standard therapy, treatment should be discontinued until the infection resolves. Prior to initiating treatment with bimekizumab, patients should be evaluated for tuberculosis (TB) infection. Bimekizumab should not be given in patients with active TB. Patients receiving bimekizumab should be monitored for signs and symptoms of active TB. Cases of new or exacerbations of inflammatory bowel disease have been reported with bimekizumab. Bimekizumab is not recommended in patients with inflammatory bowel disease. If a patient develops signs and symptoms of inflammatory bowel disease or experiences an exacerbation of pre-existing inflammatory bowel disease, bimekizumab should be discontinued and appropriate medical management should be initiated. Serious hypersensitivity reactions including anaphylactic reactions have been observed with IL-17 inhibitors. If a serious hypersensitivity reaction occurs, administration of bimekizumab should be discontinued immediately and appropriate therapy initiated. Live vaccines should not be given in patients treated with bimekizumab. Please consult the Summary of Product Characteristics in relation to other side effects, full safety and Prescribing Information. European SmPC date of revision: August 2024. https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf . Last accessed: September 2024. ▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. 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_news. References SOURCE: UCB