IL-13Rα1

Real-world findings showed that subgroup of patients treated with Adtralza ® (tralokinumab) / Adbry ® (tralokinumab-ldrm) and with head and neck (H&N) atopic dermatitis (AD) at baseline reported presence of AD in that area in 52.1% of patients after nine months of treatment. 1 As part of one of LEO Pharma’s most extensive scientific programs at EADV to date, the late-breaking presentation examined interim data from the real-world TRACE study of adult AD patients who have been prescribed Adtralza/Adbry for up to nine months. 1 Additional posters presented interim results of the TRACE study on effectiveness of Adtralza/Adbry treatment through various physician and patient reported outcomes such as improvements in Eczema Area and Severity Index (EASI), Investigator Global Assessment (IGA), itch, sleep disturbance and quality of life. 2,3 BALLERUP, Denmark--(BUSINESS WIRE)-- NOT FOR UK USE – NOT INTENDED FOR UK MEDIA LEO Pharma A/S, a global leader in medical dermatology, today presented nine-month interim data from the TRACE study, showing that Adtralza ® (tralokinumab) / Adbry ® (tralokinumab-ldrm) reduced the severity of moderate-to-severe atopic dermatitis (AD) in the head and neck region of the body (H&N). Results were shared through one of LEO Pharma’s five late-breaking oral presentations at the 33 rd European Academy of Dermatology and Venereology (EADV) Congress in Amsterdam. 1 TRACE is an international, prospective, single-cohort study of adult patients with AD who were prescribed Adtralza / Adbry. At the data cut-off for this interim analysis, the following number of patients were included in the full analysis set (FAS): baseline (n=824), three months (n=668), six months (n=331), and nine months (n=143). The late-breaker analysis included patients who had AD involvement on the face, scalp, and/or neck (head and neck area) at baseline (79.5%, 655/824). 1-3 In patients with H&N AD at baseline, the percentage of patients still reporting AD in the H&N area decreased to 67.2% (363/540) at three months and 52.1% (62/119) at nine months. Similar decreases were seen in dupilumab-naïve (50%, 42/84) and dupilumab-experienced (57.1%, 20/35) patients at nine months. 1 Among patients with baseline H&N AD, the percentage of patients with an Investigator’s Global Assessment score of 0 (clear) or 1 (almost clear) (IGA 0/1) increased from 1.4% (9/650) at baseline to 33.6% (172/512) at three months, 48.4% (121/250) at six months, and 57.4% (58/101) at nine months of treatment with Adtralza. 1 “Atopic dermatitis often affects multiple regions of the body but can be exceptionally burdensome and difficult to treat in the head and neck,” said Kreesten Meldgaard Madsen, Chief Development Officer, LEO Pharma. “We are particularly encouraged to see treatment with Adtralza / Adbry leading to such positive real-world outcomes in a challenging region of the body, regardless of previous biologic treatment.” "Presenting this data on Adtralza / Adbry at EADV underscores our commitment to advancing treatment options for atopic dermatitis,” said Alexander Egeberg, Head of Global Medical Affairs, LEO Pharma. “The positive outcomes observed in the TRACE study not only highlight the real-world results of Adtralza/Adbry but also reinforce LEO Pharma’s dedication to addressing the diverse needs of patients. With five late-breakers at this conference, we are proud to showcase our extensive scientific program and the significant strides we are making in dermatology.” Alongside the late-breaking data, two poster presentations used interim TRACE data to show improvements in patient-reported symptoms of itch and physician-assessed Eczema Area and Severity Index (EASI). Patients reported that nine months of treatment with Adtralza / Adbry improved symptoms of itch, with the mean Peak Pruritus Numeric Rating Scale (PP-NRS, where 0 = “no itch” and 10 = “worst itch imaginable”) improving from 6.3 at baseline (n=484) to 3.3 at 9 months (n=65). A physician-assessed outcome measure showed the mean Eczema Area and Severity Index (EASI) improved from 20.1 at baseline (n=631) to 3.6 at 9 months (n=88). 2,3 Separately to data shared from the TRACE study, a poster was shared from the ECZTEND open-label extension trial in AD patients aged 65 and over. In this vulnerable population, reporting of adverse events (AEs) remained consistent with existing data after up to 4.5 years of treatment, while the long-term efficacy pro sustained improvements in AD consistent with the larger trial population. 4 About TRACE TRACE is a prospective, non-interventional, international, single-cohort study of adult patients with AD who were prescribed tralokinumab according to national approved labels. Patients were enrolled between November 2021 and July 2023 and followed for one year. At data cut-off (October 15th, 2023) for the interim analysis, the following number of patients were included in the full analysis set (FAS): baseline (n=824), 3 months (n=668), 6 months (n=331), and 9 months (n=143). 1-3 About the ECZTEND - Long-Term Extension (LTE) Trial ECZTEND (Long-term Extension Trial in Subjects With Atopic Dermatitis Who Participated in Previous Tralokinumab Trials) is an ongoing Phase 3, long-term, five-year, open-label, single-arm extension trial to evaluate the safety and efficacy of Adtralza in patients with atopic dermatitis who participated in the previous Adtralza monotherapy trials (ECZTRA 1 and ECZTRA 2), the combination therapy Adtralza plus TCS trial (ECZTRA 3), the Drug-drug interaction (DDI) trial (ECZTRA 4), the vaccine trial (ECZTRA 5), the adolescent trial (ECZTRA 6), the oral cyclosporine A trial (ECZTRA 7), the combination therapy Adtralza plus TCS trial in Japanese subjects (ECZTRA 8), and the Adtralza monotherapy skin barrier function trial (TraSki). Patients were permitted to enter ECZTEND after completion of the parent trial regardless of their treatment response or whether they were treated with Adtralza or placebo. 5,6 About Atopic Dermatitis Atopic dermatitis is a chronic, inflammatory skin disease characterized by intense itch and eczematous lesions. 7 Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation. 8 Type 2 cytokines, including IL-13, play an important role in the key aspects of atopic dermatitis pathophysiology. 7,8 Excessive IL-22 production is also known to contribute to the pathogenesis of AD. 9 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. 7,8 Adtralza/Adbry specifically binds to the IL-13 cytokine, thereby inhibiting interaction with the IL-13 receptor α1 and α2 subunits (IL-13Rα1 and IL-13Rα2). 10 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. INDICATION AND IMPORTANT SAFETY INFORMATION What is ADBRY? ADBRY ® (tralokinumab-ldrm) injection is a prescription medicine used to treat people 12 years of age and older with moderate-to-severe atopic dermatitis (eczema) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. ADBRY can be used with or without topical corticosteroids. It is not known if ADBRY is safe and effective in children under 12 years of age. Do not use ADBRY if you are allergic to tralokinumab or to any of its ingredients. What should I discuss with my healthcare provider before starting ADBRY? Tell your healthcare provider about all your medical conditions, including if you: have eye problems. have a parasitic (helminth) infection. are scheduled to receive any vaccinations. You should not receive a “live vaccine” if you are treated with ADBRY. are pregnant or plan to become pregnant. It is not known whether ADBRY will harm your unborn baby. There is a pregnancy exposure registry for women who use ADBRY during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. You or your healthcare provider can get information and enroll you in this registry by calling 1-877-311-8972 or visiting . are breastfeeding or plan to breastfeed. It is not known whether ADBRY passes into your breast milk and if it can harm your baby. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. How should I use ADBRY? See the detailed “Instructions for Use” that comes with ADBRY for information on how to prepare and inject ADBRY and how to properly store and throw away (dispose of) used ADBRY prefilled syringes and autoinjectors. Use ADBRY exactly as prescribed by your healthcare provider. Your healthcare provider will tell you how much ADBRY to inject and when to inject it. ADBRY comes as a single-dose prefilled syringe with needle guard or as an autoinjector. ADBRY is given as an injection under the skin (subcutaneous injection). If your healthcare provider decides that you or a caregiver can give the injections of ADBRY, you or your caregiver should receive training on the right way to prepare and inject ADBRY. Do not try to inject ADBRY until you have been shown the right way by your healthcare provider. In children 12 years of age and older, it is recommended that ADBRY be given by or under supervision of an adult. If you miss a dose, inject the missed dose as soon as possible, then continue with your next dose at your regular scheduled time. If you inject too much ADBRY than prescribed, call your healthcare provider or call Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away. Your healthcare provider may prescribe other medicines to use with ADBRY. Use the other prescribed medicines exactly as your healthcare provider tells you to. What are the possible side effects of ADBRY? ADBRY can cause serious side effects including: Allergic reactions (hypersensitivity), including a severe reaction known as anaphylaxis. Stop using ADBRY and tell your healthcare provider or get emergency help right away if you get any of the following symptoms: breathing problems itching skin rash swelling of the face, mouth, and tongue fainting, dizziness, feeling lightheaded (low blood pressure) hives Eye problems. Tell your healthcare provider if you have any new or worsening eye problems, including eye pain or changes in vision. The most common side effects of ADBRY include: upper respiratory tract infections Eye and eyelid inflammation, including redness, swelling, and itching Injection site reactions High count of a certain white blood cell (eosinophilia) These are not all the possible side effects of ADBRY. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Please click here for full U.S. Prescribing Information, including Patient Information and Instructions for Use. 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 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. Late Breaking News Session. D3T01.3. 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. E-poster 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. E-poster Presentation. P0690. 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. E-poster Presentation. P0479. Blauvelt A, Langley RG, Lacour JP, et al. Long-term 2-year safety and efficacy of tralokinumab in adults with moderate-to-severe atopic dermatitis: Interim analysis of the ECZTEND open-label extension trial. J Am Acad Dermatol. 2022;87(4):815-824. ClinicalTrials.gov. National Library of Medicine (U.S.). Long-term Extension Trial in Subjects With Atopic Dermatitis Who Participated in Previous Tralokinumab Trials – ECZTEND. Identifier: NCT03587805. . 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. Popovic B, 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; 429:208-19. MAT-76324 September 2024 Contacts Melissa Borland LEO Pharma, Senior Manager Communications, North America 647.241.1475 MQBCA@leo-pharma.com Jes Broe Frederiksen LEO Pharma, Senior Manager, Global Product and Data Communications Tel: +45 53 60 59 48 Email: jebfe@leo-pharma.com

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. 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Eli Lilly recently announced that the U.S. Food and Drug Administration (FDA) has officially approved its IL-13 inhibitor Ebglyss (lebrikizumab). For the treatment of patients with moderate to severe atopic dermatitis (AD) whose condition has not been effectively controlled despite attempts at topical drug therapy. This approval covers adult and adolescent patients, with a specific age range of 12 years and older and a weight of at least 40 kg. Ebglyss (Lebrikizumab) is a highly affinity monoclonal antibody that specifically binds to IL-13, a key cytokine. In this way, Ebglyss is able to effectively prevent IL-13 from forming heterodimer complexes with its receptors IL-13Rα1 and IL-4Rα, thus blocking subsequent signaling processes. This inhibition significantly mitigated the biological effects of IL-13, which plays a crucial role in atopic dermatitis by driving the type 2 inflammatory response in the skin. This inflammatory response can lead to a range of problems, including impaired skin barrier function, itching, thickening of the skin, and infection. The targeted mechanism of action of Ebglyss, combined with its demonstrated short - and long-term efficacy and safety in clinical trials, makes it a strong choice for patients with moderate to severe atopic dermatitis who do not respond to local treatment. In addition, the monthly maintenance dose of Ebglyss provides great convenience for patients, making the treatment process more manageable and acceptable. This approval undoubtedly brings new hope to these patients and adds a new highlight for Eli Lilly in the field of dermatology treatment.