Tralokinumab

BALLERUP, Denmark--(BUSINESS WIRE)--In the first nine months of 2025, LEO Pharma continued its robust revenue growth, with significantly improved profitability and free cash flow. As expected, growth accelerated in the third quarter, with the global rollout of Anzupgo® gaining further momentum after its September launch in the U.S. The 2025 financial outlook is updated to reflect the addition of Spevigo® to the portfolio, reinforcing LEO Pharma’s commitment to advancing innovation and expanding access to care. Highlights LEO Pharma’s revenue increased by 7% to DKK 10,064 million, and by 8% at constant exchange rates (CER), entirely driven by organic growth. The revenue growth was led by North America (+27% at CER), with Europe (+2% at CER) and Rest of World (+6% at CER) also contributing to the overall growth. Revenue from the Dermatology portfolio grew by 9% (CER), driven by the Strategic brands Adtralza ® /Adbry ® and Anzupgo ® , which combined had a revenue increase of 41% (CER), in addition to growth of 1% (CER) in the Established brands. Sales in the Critical Care portfolio declined by 1% (CER), affected by a reversal of sales discounts in the same period last year. Operating profit improved significantly, with adjusted EBITDA reaching DKK 2,105 million in 9M 2025, reflecting a margin of 21% (9M 2024: 8%), excluding the STAT6 partnership upfront payment from Gilead Sciences received in January and other non-recurring items. The improvement in adjusted EBITDA was driven by sales growth and reduced operating expenses. Net profit for 9M 2025 was DKK 2,036 million (9M 2024: negative DKK 1,262 million), including non-recurring items. Free cash flow was DKK 1,760 million for 9M 2025 (9M 2024: negative DKK 293 million), and net interest-bearing debt was reduced to DKK 9,423 million (YE 2024: DKK 11,115 million). Excluding M&A, free cash flow was DKK 815 million. In September, Anzupgo® (delgocitinib) cream was launched in the U.S. as the first and only topical pan‑JAK inhibitor for chronic hand eczema (CHE), supported by a more than 50% expansion of LEO Pharma’s U.S. sales force following FDA approval in July 2025. In October, Chinese authorities accepted the NDA filing for Anzupgo® to treat CHE in China. On 30 September, the transaction for Spevigo® (spesolimab) with Boehringer Ingelheim closed, granting LEO Pharma global development and commercialization rights for the first‑in‑class IL‑36R antagonist already approved for generalized pustular psoriasis. Leveraging LEO Pharma’s global dermatology platform, the transaction aims to accelerate and broaden access to Spevigo®, making it a strategic brand, alongside Adtralza®/Adbry® and Anzupgo®. For the 2025 outlook, group revenue growth is now expected to be 8-10% at CER (previously: 7-9%), and the adjusted EBITDA margin is now expected to be 15-17% (previously: 16-18%). The revised outlook reflects the consolidation of Spevigo® including ongoing development costs for the asset. Excluding Spevigo®, the outlook for organic revenue growth of 7-9% is unchanged. "Our momentum continues to build as the global rollout of Anzupgo® accelerates and the Spevigo® brand joins LEO Pharma. With three strategic brands now in our portfolio, we are entering a pivotal chapter in our growth journey – one where we are further investing in our global platform to unlock its full potential and enhance our ability to drive innovation for the benefit of patients worldwide.” CEO Christophe Bourdon. 9M 2025 Financial overview (DKK million) Q3 2025 Q3 2024 Growth 9M 2025 9M 2024 Growth Revenue 3,275 3,057 7% 10,064 9,432 7% Revenue growth at CER 10% 10% N.m. 8% 11% N.m. Adjusted EBITDA 649 181 259% 2,105 780 170% Adjusted EBITDA margin 20% 6% N.m. 21% 8% N.m. Net profit/(loss) for the period 59 (501) N.m. 2,036 (1,262) N.m. About LEO Pharma LEO Pharma is a global leader in medical dermatology. We deliver innovative solutions for skin health, building on a century of experience with breakthrough medicines in healthcare. We are committed to making a fundamental difference in people’s lives, and our broad portfolio of treatments serves close to 100 million patients in over 70 countries annually. Headquartered in Denmark, LEO Pharma has a team of 4,000 people worldwide. LEO Pharma is co-owned by majority shareholder, the LEO Foundation and, since 2021, Nordic Capital. For more information, visit www.leo-pharma.com.

MADISON, N.J.--(BUSINESS WIRE)--LEO Pharma A/S, a global leader in medical dermatology, is advancing the understanding of skin disease and its impact on patients’ lives with the presentation of 46 abstracts at the upcoming 2025 Fall Clinical Dermatology Conference taking place from Oct 23 - 26 in Las Vegas, Nevada. The data span multiple forms of skin disease, including chronic hand eczema (CHE), atopic dermatitis (AD), generalized pustular psoriasis (GPP) and pyoderma gangrenosum (PG). “Fall Clinical Dermatology Conference is an important conference for researchers and clinicians specializing in dermatology, and we’re excited about the wealth of new data we will share at this meeting that can help advance dermatological care for those living with debilitating skin diseases,” said Shannon Schneider, Vice President of North America Medical Affairs for LEO Pharma. “Our deep commitment to advancing science and medicine is reflected in the large volume of new data, which spans a spectrum of dermatologic conditions and offers a more holistic perspective on the patient experience, real-world safety, efficacy, and the health economic impact of our treatments.” Key data to be presented at the 2025 Fall Clinical Dermatology Conference by LEO Pharma include: The first U.S. prevalence data on CHE, based on a survey of more than 10,000 people. The CHECK study includes findings on demographics, disease severity, healthcare resource utilization, and ability to work among CHE patients. 1-5 New health economics and outcomes data that explores the burden of CHE in the U.S. and analyzes the potential financial impact of ANZUPGO ® (delgocitinib) cream on a U.S. Commercial Health plan. 7-10 Real-world ADBRY ® (tralokinumab-ldrm) data, evaluating the safety and effectiveness of up to 12 months of treatment for patients with moderate to severe AD. 21-27 New findings examining the burden of GPP in the U.S., as well as the effect of treatments such as SPEVIGO ® (spesolimab). 35-37 At the 2025 Fall Clinical Dermatology Conference, LEO Pharma will unveil its first data presentations on GPP and SPEVIGO since acquiring the product from Boehringer Ingelheim. SPEVIGO is now the third asset in LEO Pharma’s global portfolio. The company’s full roster of presentations at the 2025 Fall Clinical Dermatology Conference can be found in the table below.1-46 Title Author Presentation details Delgocitinib and Chronic Hand Eczema (CHE) CHE treatment burden: Results from a survey of dermatology healthcare professionals Raj Chovatiya Poster presentation Demographics, clinical, and treatment characteristics of patients with moderate-to-severe CHE in the United States – a retrospective claims analysis April Armstrong Poster presentation Demographics and clinical characteristics of CHE patients – results from the CHECK study in the United States Eric Simpson Poster presentation Prevalence of self-reported physician diagnosis of CHE in adults: A cross-sectional study of more than 10,000 participants in the general population – Results from the CHECK study in the United States Raj Chovatiya Poster presentation Self-reported disease severity, symptoms, and treatment of CHE – results from the CHECK study in the United States Raj Chovatiya Poster presentation Healthcare resource utilization and financial burden among patients with CHE – results from the CHECK study in the United States Raj Chovatiya Poster presentation The impact of CHE on occupation, work productivity, and activity impairment – results from the CHECK study in the United States Eric Simpson Poster presentation Hand eczema workers’ compensation claims: Real-World Data Analysis in the United States Richard Brook Poster presentation Cost-per-responder analysis of delgocitinib topical cream versus dupilumab subcutaneous injection for moderate to severe atopic hand eczema in the United States Sanjeev Balu Poster presentation Budget impact analysis of delgocitinib for moderate-to-severe chronic hand eczema in the United States Jianni Singh-Landa Poster presentation Delgocitinib cream has negligible systemic exposure in patients with maximal use of delgocitinib cream for the treatment of CHE Melinda Gooderham Poster presentation “Super-response” following treatment with delgocitinib cream 20 mg/g in a subgroup of patients with moderate to severe CHE April Armstrong Poster presentation Patient reported outcomes and symptom improvements across subtypes of Chronic Hand Eczema: outcomes from the Phase 3 DELTA-1 and DELTA-2 trials Robert Bissonnette Poster presentation Delgocitinib cream improves pain and health-related quality of life in patients with CHE with severe pain Robert Bissonnette Poster presentation Matching-adjusted indirect comparison of the efficacy at week 12 of Delgocitinib and topical PUVA in the treatment of severe CHE April Armstrong Poster presentation Treatment with delgocitinib cream is associated with a reduction of Staphylococcus aureus density and pain in patients with mild to severe CHE Tove Agner Poster presentation Aetiological subtypes of moderate to severe CHE: Signs, symptoms and localisations - results from the RWEAL study Maria Concetta Fargnoli Poster presentation Patient perspectives in moderate-to-severe chronic hand eczema: Understanding patient experience and factors influencing treatment preference through in-depth qualitative patient interviews in the US April Armstrong Poster presentation DELTA TEEN Phase 3 trial: Efficacy and safety of Delgocitinib cream in adolescents with moderate to severe CHE Sonja Molin Poster presentation Safety of delgocitinib cream in adult patients with mild to severe CHE: pooled analysis of five phase 2b and phase 3 trials Robert Bissonnette Poster presentation Tralokinumab Reduced dosing frequency with tralokinumab provides sustained improvements in symptoms and quality of life up to 1 year in adults with moderate-to-severe AD April Armstrong Poster presentation Real-world effectiveness of up to 12-months tralokinumab treatment in adults with AD who previously failed dupilumab or Janus kinase inhibitors April Armstrong Poster presentation Safety and adverse events of special interest in 825 adults with atopic dermatitis receiving up to 12 months of tralokinumab treatment in a real-world setting Cory Rubin Poster presentation Real-world safety and effectiveness of up to 12-months tralokinumab treatment in adults with AD who discontinued dupilumab due to conjunctivitis April Armstrong Poster presentation Tralokinumab improves patient-reported outcomes in adults with moderate-to-severe AD in the United States: real-world data from a 52-week assessment Peter Lio Poster presentation Estimated conjunctivitis-related healthcare cost savings with increased tralokinumab use versus other biologics among patients with moderate-severe AD in the United States Sanjeev Balu Poster presentation Treatment-free disease control after tralokinumab in patients with moderate-to-severe AD Andrew Blauvelt Poster presentation Pharmacokinetics (PK) and safety of tralokinumab in children (aged 6 to <12 years) with moderate-to-severe AD: an interim analysis of the TRAPEDS 1 phase 2 trial Michael Cork Poster presentation Long-term efficacy with tralokinumab in patients with moderate-to-severe AD: final results from the 5-year ECZTEND study Andrew Blauvelt Poster presentation Effectiveness and safety of 12-months tralokinumab treatment in 824 adults with AD: Final real-world data from the prospective, non-interventional, international, single-cohort TRACE study April Armstrong Poster presentation Patient-reported outcomes evaluations of 12-months tralokinumab treatment in 824 adults with AD: Real-world data from the prospective, non-interventional, international, single-cohort TRACE study Ahmed Ameen Poster presentation Effectiveness of 12-months tralokinumab treatment in 654 adults with AD with head & neck area involvement: Final real-world data from the prospective, non-interventional, international, single-cohort TRACE study Marni Wiseman Poster presentation Initial “Super Response” to Tralokinumab Leads to stable long-term response in patients with moderate-to-severe AD: Responder and predictor analysis from the ECZTRA 3 & ECZTEND Trials Andrew Blauvelt Poster presentation Spesolimab and Generalized Pustular Psoriasis (GPP) EFFISAYIL OBSERVE: A real-world descriptive study of patients with GPP in the USA Mark Lebwohl Poster presentation Understanding the chronicity of GPP and the effect of treatment: a structured review Joseph Merola Poster presentation Spesolimab improves quality of life in GPP as measured by proportion of patients with Dermatology Life Quality Index (DLQI) scores of 0 or 1 and reduction in pain severity over time: Results from the EFFISAYIL® 2 trial Tina Bhutani Poster presentation Spesolimab for the treatment of generalized pustular psoriasis flares: Preliminary analysis of the EFFISAYIL REP study Siew Eng Choon Poster presentation GPP: A systematic literature review of mortality and comorbidity data Mark Lebwohl Poster presentation GPP control is limited on traditional small-molecule therapy as measured by the GPP Physician Global Assessment (GPPGA) and Dermatology Life Quality Index (DLQI): Baseline data from the Effisayil® 2 trial Arash Mostaghimi Poster presentation Spesolimab improves Generalized Pustular Psoriasis Physicians Global Assessment (GPPGA), affected body surface area (BSA), and quality of life (QoL) in GPP: EFFISAYIL® 2 trial analyses Bruce Strober Poster presentation Flare burden in GPP: analysis of pre-trial historical experience of patients enrolled in EFFISAYIL® 2 Milan Anadkat Poster presentation Long-term management of chronic GPP with subcutaneous spesolimab: A case report Angad Chadha Poster presentation Spesolimab impact on health status among patients with GPP measured by EQ-5D-5L: Results from the EFFISAYIL® 2 trial Matthias Augustin Poster presentation The impact of spesolimab on health-related quality of life (HRQoL) measured by the short form-36 (SF-36) among patients with GPP: Results from the EFFISAYIL® 2 trial Alice Gottlieb Poster presentation Pyoderma Gangrenosum (PG) The emotional impact of PG: Real-world experience of the PG patient journey Afsaneh Alavi Poster presentation Randomized Phase 3 trial of spesolimab in patients with ulcerative pyoderma gangrenosum: A study protocol Mark Lebwohl Poster presentation 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.47 HE is one of the most common skin disorders of the hands and in a substantial number of patients, it can develop into a chronic condition.48 CHE affects approximately one in ten adults worldwide.49,50 It is a fluctuating disease characterized by itch and pain, and patients may experience signs such as erythema, scaling, lichenification, hyperkeratosis, vesicles, edema, and fissures on hands and wrists.47 The pathophysiology is characterized by skin barrier dysfunction, inflammation of the skin, and alterations of the skin microbiome.49 CHE has been shown to cause psychological and functional burdens that impact patient quality of life,51,52 with approximately 70% of individuals who live with severe CHE admitting to problems in performing everyday activities.53 Furthermore, careers and earning potential have also been shown to be impacted by the burden of living with CHE.54 About Atopic Dermatitis Atopic dermatitis (AD) is a chronic, inflammatory skin disease characterized by intense itch and eczematous lesions.55 AD is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.56 Type 2 cytokines, including IL-13, play an important role in the key aspects of AD pathophysiology.55,56 Excessive IL-22 production is also known to contribute to the pathogenesis of AD.57 About Generalized Pustular Psoriasis Generalized pustular psoriasis (GPP) is a chronic, heterogeneous, neutrophilic inflammatory disease associated with skin and systemic symptoms that is distinct from plaque psoriasis. GPP is recognized as a separate clinical entity from other forms of psoriasis, with the IL-36 pathway being a key driver of GPP and triggering response to treatment.58,59 GPP can become life-threatening (mortality rates ranging from 2% to 16%) due to severe complications, such as multisystem organ failure and sepsis requiring urgent hospital care; many GPP patients also suffer from various comorbidities, which contribute to the ongoing burden for the patient and healthcare systems.60,61 GPP symptoms appear unpredictable and present on a continuum, which greatly impacts a patient’s quality of life, and may cause fear and anxiety over the disease course, as well as long-term impacts on quality of life related to work/school, emotional health, social activities, and finances.61,62 About ANZUPGO® (delgocitinib) Cream ANZUPGO® (delgocitinib) cream is currently FDA-approved in the U.S. as the first and only topical pan-JAK treatment for chronic hand eczema (CHE). Use of ANZUPGO in combination with other JAK inhibitors or potent immunosuppressants is not recommended.63 ANZUPGO cream is also approved in the European Union, United Kingdom, Switzerland, United Arab Emirates and Canada under the brand name ANZUPGO for the treatment of moderate-to-severe chronic hand eczema (CHE) in adults for whom topical corticosteroids are inadequate or not advisable. ANZUPGO cream is also under investigation in other markets. ANZUPGO cream is a topical pan-Janus kinase (JAK) inhibitor for the treatment of moderate-to-severe CHE in adults. It inhibits the activation of JAK-STAT signaling, which plays a key role in the pathogenesis of CHE.64 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 for topical use in dermatological indications worldwide, excluding Japan, where JT retains rights. INDICATION AND IMPORTANT SAFETY INFORMATION FOR ANZUPGO® (DELGOCITINIB) CREAM What is ANZUPGO? ANZUPGO is a prescription medicine used on the skin (topical) to treat moderate to severe chronic hand eczema (CHE) in adults who are not well-controlled with or cannot use topical corticosteroids. The use of ANZUPGO along with other JAK inhibitors or strong immunosuppressants is not recommended. IMPORTANT SAFETY INFORMATION ANZUPGO is for use on the skin (topical use) only. Do not use ANZUPGO in or on your eyes, mouth, or vagina. What is the most important information I should know about ANZUPGO? ANZUPGO may cause serious side effects, including: Serious Infections: ANZUPGO may increase your risk of infections. ANZUPGO contains delgocitinib. Delgocitinib belongs to a class of medicines called Janus kinase (JAK) inhibitors. JAK inhibitors are medicines that affect your immune system. JAK inhibitors can lower the ability of your immune system to fight infections. Some people have had serious infections while taking JAK inhibitors by mouth or applying on the skin, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have been hospitalized or died from these infections. ANZUPGO should not be used in people with an active, serious infection. You should not start using ANZUPGO if you have any kind of infection unless your healthcare provider tells you it is okay. You may be at a higher risk of developing shingles (herpes zoster) or eczema herpeticum (a blistery, painful skin rash) during treatment with ANZUPGO. Before starting ANZUPGO, tell your healthcare provider if you: are being treated for an infection or have an infection that does not go away or that keeps coming back have TB or have been in close contact with someone with TB have had shingles (herpes zoster) have had hepatitis B or C think you have an infection or have symptoms of an infection such as fever, sweating, or chills; muscle aches; cough or shortness of breath; blood in your phlegm; weight loss; warm, red, or painful skin or sores on your body; diarrhea or stomach pain; burning when you urinate or urinating more often than usual; and/or feeling very tired After starting ANZUPGO, call your healthcare provider right away if you have any symptoms of an infection. ANZUPGO can make you more likely to get infections or make worse any infections that you have. If you get a serious infection, your healthcare provider may stop your treatment with ANZUPGO until your infection is controlled. Non-melanoma skin cancer. ANZUPGO may increase your risk of certain non-melanoma skin cancers. Your healthcare provider will regularly check your skin during your treatment with ANZUPGO. Avoid sunlamps and limit the amount of time you spend in the sunlight. Wear protective clothing when you are in the sun, and use a broad-spectrum sunscreen Tell your healthcare provider if you have ever had any type of cancer Potential risks from Janus kinase (JAK) inhibition. It is not known whether using ANZUPGO has the same risks as taking oral or other topical JAK inhibitors. Increased risk of death (all causes) has happened in people who were 50 years of age and older with at least one heart disease (cardiovascular) risk factor who were taking a JAK inhibitor used to treat rheumatoid arthritis (RA) compared to people taking another medicine in a class of medicines called TNF blockers. ANZUPGO is not for use in people with RA. Oral or other topical JAK inhibitors have also caused increased cholesterol. Before using ANZUPGO, tell your healthcare provider about all your medical conditions, including if you: have an infection have recently received or are scheduled to receive a vaccine. People who use ANZUPGO should not receive live vaccines right before starting, during treatment, or right after treatment with ANZUPGO are pregnant or plan to become pregnant. It is not known if ANZUPGO will harm your unborn baby are breastfeeding or plan to breastfeed. It is not known if ANZUPGO passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with ANZUPGO. If you use ANZUPGO while breastfeeding, avoid touching the nipple and surrounding area right away after applying ANZUPGO to your hands and wrists Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. What are the most common side effects of ANZUPGO? application site reactions, including pain, tingling, itching, and redness; bacterial skin infections, including finger cellulitis and nail infections; and low white blood cells These are not all of the possible side effects of ANZUPGO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Please see full Prescribing Information and Medication Guide. About ADBRY® (tralokinumab-ldrm) / ADTRALZA® (tralokinumab) ADBRY® (tralokinumab-ldrm), which is marketed outside of the U.S. under the tradename ADTRALZA® (tralokinumab), 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.65 Tralokinumab-ldrm specifically binds to the IL-13 cytokine, thereby inhibiting interaction with the IL-13 receptor α1 and α2 subunits (IL-13Rα1 and IL-13Rα2).66 Tralokinumab-ldrm 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, South Korea, the U.S., and Saudi Arabia. Tralokinumab-ldrm is approved for use in adults with moderate to severe AD in Switzerland and Japan. INDICATION AND IMPORTANT SAFETY INFORMATION FOR ADBRY® (TRALOKINUMAB-LDRM) 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 https://mothertobaby.org/ongoing-study/adbry-tralokinumab/ . 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? 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 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 SPEVIGO® (spesolimab) SPEVIGO® (spesolimab) is a humanized, selective antibody that specifically blocks the activation of the IL-36R, a signalling pathway within the immune system shown to be involved in the pathogenesis of several autoinflammatory diseases, including GPP. It is the first targeted therapy for the treatment of GPP and has been evaluated in the largest clinical program specifically for the treatment of patients with GPP.67-69 INDICATION AND IMPORTANT SAFETY INFORMATION FOR SPEVIGO® (SPESOLIMAB) INDICATION SPEVIGO is indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age or older and weighing at least 40 kg. CONTRAINDICATIONS SPEVIGO is contraindicated in patients with severe or life-threatening hypersensitivity to spesolimab-sbzo or to any of the excipients in SPEVIGO. Reported hypersensitivity reactions have included drug reaction with eosinophilia and systemic symptoms (DRESS). WARNINGS AND PRECAUTIONS Infections: SPEVIGO may increase the risk of infections. In patients with a chronic infection or a history of recurrent infection, consider the potential risks and expected clinical benefits of treatment prior to prescribing SPEVIGO. Treatment with SPEVIGO is not recommended in patients with any clinically important active infection until the infection resolves or is adequately treated. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur during or after treatment with SPEVIGO. If a patient develops a clinically important active infection, discontinue SPEVIGO therapy until the infection resolves or is adequately treated. Risk of Tuberculosis: Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with SPEVIGO. Avoid use of SPEVIGO in patients with active TB infection. Consider initiating anti-TB therapy prior to initiating SPEVIGO in patients with latent TB or a history of TB in whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during and after SPEVIGO treatment. Hypersensitivity and Infusion-Related Reactions: SPEVIGO-associated hypersensitivity reactions may include immediate reactions, such as anaphylaxis, and delayed reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS). Drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported in clinical trials with spesolimab-sbzo in subjects with GPP. If a patient develops signs of anaphylaxis or other serious hypersensitivity, discontinue SPEVIGO immediately and initiate appropriate treatment. If a patient develops mild or moderate hypersensitivity during an intravenous infusion or other infusion-related reactions, stop SPEVIGO infusion and consider appropriate medical therapy (eg, systemic antihistamines and/or corticosteroids). Upon resolution of the reaction, the infusion may be restarted at a slower infusion rate with gradual increase to complete the infusion. Vaccinations: Prior to initiating SPEVIGO for treatment of GPP, complete all age-appropriate vaccinations according to current immunization guidelines. Avoid use of live vaccines in patients during and for at least 16 weeks after treatment with SPEVIGO. No specific studies have been conducted in SPEVIGO-treated patients who have recently received live viral or live bacterial vaccines. ADVERSE REACTIONS Intravenous SPEVIGO for Treatment of GPP Flare (Study Effisayil-1): Most common adverse reactions reported in ≥5% of patients treated with SPEVIGO in the clinical trial were asthenia and fatigue, nausea and vomiting, headache, pruritus and prurigo, infusion site hematoma and bruising, and urinary tract infection (UTI). Specific Adverse Reactions Infections : The most frequent adverse reactions that occurred in subjects treated with intravenous SPEVIGO were infections. During the 1-week placebo-controlled period in Study Effisayil-1, infections were reported in 14% of subjects treated with SPEVIGO compared with 6% of subjects treated with placebo. Serious infection (UTI) was reported in 1 subject (3%) in the SPEVIGO group and no subjects in the placebo group. Infections observed through Week 1 in Study Effisayil-1 in subjects treated with SPEVIGO were mild (29%) to moderate (71%). Drug Reaction With Eosinophilia and Systemic Symptoms (DRESS) : Two cases of DRESS were reported in Study Effisayil-1 in subjects with GPP who were treated with intravenous SPEVIGO. RegiSCAR DRESS validation scoring (with the following categories: “no,” “possible,” “probable,” or “definite” DRESS) was applied to the reported cases. Reported cases were assessed as “no DRESS” and “possible DRESS.” Subcutaneous SPEVIGO for Treatment of GPP When Not Experiencing a Flare (Study Effisayil-2): Regarding the exposure-adjusted incidence rates for subjects on randomized treatment prior to receiving rescue treatment for flare or completing trial without a flare, the rate per 100-patient years for injection site reaction (including erythema, pain, swelling, induration, urticaria, and warmth at the injection site) was 31.6 for the subcutaneous SPEVIGO cohort (600 mg loading dose followed by 300 mg every 4 weeks) vs 12.7 for the placebo cohort. The rate per 100-patient years for UTI was 18 for SPEVIGO vs 0 for placebo. The rate per 100-patient years for pruritus was 8.8 for SPEVIGO vs 0 for placebo. The rate per 100-patient years for arthralgia was 13.3 for SPEVIGO vs 6 for the placebo cohort. There were 3 subjects who discontinued subcutaneous SPEVIGO due to treatment-emergent adverse events of psoriasis compared to no subjects in the placebo cohort who discontinued placebo for any treatment-emergent adverse event. Safety in Study Effisayil-2 After Flare: In Effisayil-2, subjects who experienced a GPP flare and received at least one dose of an open-label single intravenous 900 mg dose of SPEVIGO were treated with open-label subcutaneous SPEVIGO 300 mg. These subjects (n=19) received subcutaneous dosing at every 12 weeks, which could have been increased to every 4 weeks based on GPPPGA total score or pustulation subscore increased by ≥1 from any previous open-label maintenance visit. The reported safety profile of open-label subcutaneous SPEVIGO use after treatment of GPP flare with open-label intravenous SPEVIGO use was consistent with the safety profiles of use of SPEVIGO from Trial Effisayil-1 and randomized controlled data from Trial Effisayil-2. Clinical Development of Spesolimab-sbzo Guillain-Barre Syndrome (GBS): Among approximately 835 subjects exposed to spesolimab-sbzo during clinical development, GBS was reported in 3 subjects who received various doses of spesolimab-sbzo via various methods of administration in clinical trials for unapproved indications. SPECIFIC POPULATIONS Pediatric Use: The safety and effectiveness of SPEVIGO for the treatment of GPP have been established in pediatric patients 12 years of age and older and weighing at least 40 kg. Use of SPEVIGO for this indication is supported by data from a randomized, placebo-controlled study, which included 6 pediatric subjects 14 to 17 years of age with a history of GPP treated with subcutaneous SPEVIGO (Study Effisayil-2), and evidence from an adequate and well-controlled study of intravenous SPEVIGO in adults with GPP (Study Effisayil-1), with additional pharmacokinetic analyses showing similar drug exposure levels in adults and pediatric subjects 12 years of age and older and weighing 40 kg or more. The safety and effectiveness of SPEVIGO in pediatric patients younger than 12 years of age or in pediatric patients weighing less than 40 kg have not been established. Please see SPEVIGO Prescribing Information, including Medication Guide. About LEO Pharma LEO Pharma is a global leader in medical dermatology. We deliver innovative solutions for skin health, building on a century of experience with breakthrough medicines in healthcare. We are committed to making a fundamental difference in people’s lives, and our broad portfolio of treatments serves close to 100 million patients in over 70 countries annually. Headquartered in Denmark, LEO Pharma has a team of 4,000 people worldwide. LEO Pharma is co-owned by majority shareholder the LEO Foundation and, since 2021, Nordic Capital. For more information, visit www.leo-pharma.com. References Simpson E, Balu S, Bin Sawad A, et al. Demographics and Clinical Characteristics of Chronic Hand Eczema patients – Results from the CHECK study in the United States. Presented at the Fall Clinical Dermatology Conference 2025. Las Vegas, Nevada. 23-26 Oct. Poster Presentation. Chovatiya R, Balu S, Bin Sawad A, et al. Prevalence of self-reported physician diagnosis of Chronic Hand Eczema in adults: A cross-sectional study of more than 10,000 participants in the general population – Results from the CHECK study in the United States. 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Matching-Adjusted Indirect Comparison of the Efficacy at week 12 of Delgocitinib and topical PUVA in the treatment of Severe CHE. Presented at the Fall Clinical Dermatology Conference 2025. Las Vegas, Nevada. 23-26 Oct. Poster Presentation. Agner T, Aytan-Aktug D, Greig J, et al. Treatment with delgocitinib cream is associated with a reduction of Staphylococcus aureus density and pain in patients with mild to severe Chronic Hand Eczema. Presented at the Fall Clinical Dermatology Conference 2025. Las Vegas, Nevada. 23-26 Oct. Poster Presentation. Concetta Fargnoli M, Molin S, Bewley A, et al. Aetiological subtypes of moderate to severe CHE: Signs, symptoms and localisations - Results from the RWEAL study. Presented at the Fall Clinical Dermatology Conference 2025. Las Vegas, Nevada. 23-26 Oct. Poster Presentation. Armstrong AW, Bin Sawad A, Hazra NC, et al. 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Real-world safety and effectiveness of up to 12-months tralokinumab treatment in adults with atopic dermatitis who discontinued dupilumab due to conjunctivitis. Presented at the Fall Clinical Dermatology Conference 2025. Las Vegas, Nevada. 23-26 Oct. Poster Presentation. Lio P, Balu S, Rene C, et al. Tralokinumab improves patient-reported outcomes in adults with moderate-to-severe atopic dermatitis in the United States: real-world data from a 52-week assessment. Presented at the Fall Clinical Dermatology Conference 2025. Las Vegas, Nevada. 23-26 Oct. Poster Presentation. Balu S, Maitland J, Gauthier-Loiselle M, et al. Estimated conjunctivitis-related healthcare cost savings with increased tralokinumab use versus other biologics among patients with moderate-severe atopic dermatitis in the United States. Presented at the Fall Clinical Dermatology Conference 2025. Las Vegas, Nevada. 23-26 Oct. Poster Presentation. Blauvelt A, Bhutani T, Ehst B, et al. Treatment-free disease control after tralokinumab in patients with moderate-to-severe atopic dermatitis. Presented at the Fall Clinical Dermatology Conference 2025. Las Vegas, Nevada. 23-26 Oct. Poster Presentation. Cork M, de Graaf M, Baselga Torres E, et al. Pharmacokinetics (PK) and safety of tralokinumab in children (aged 6 to <12 years) with moderate-to-severe atopic dermatitis: an interim analysis of the TRAPEDS 1 phase 2 trial. Presented at the Fall Clinical Dermatology Conference 2025. Las Vegas, Nevada. 23-26 Oct. Poster Presentation. Blauvelt A, Chih-Ho Hong H, Katoh N, et al. Long-term efficacy with tralokinumab in patients with moderate-to-severe atopic dermatitis: final results from the 5-year ECZTEND study. Presented at the Fall Clinical Dermatology Conference 2025. Las Vegas, Nevada. 23-26 Oct. Poster Presentation. Armstrong AW, Ferrucci S, Pereyra Rodriguez JJ, et al. Effectiveness and safety of 12-months tralokinumab treatment in 824 adults with atopic dermatitis: Final real-world data from the prospective, non-interventional, international, single-cohort TRACE study. Presented at the Fall Clinical Dermatology Conference 2025. Las Vegas, Nevada. 23-26 Oct. Poster Presentation. Ameen A, Becherel PA, Rubin C, et al. Patient-reported outcomes evaluations of 12-months tralokinumab treatment in 824 adults with atopic dermatitis: Real-world data from the prospective, non-interventional, international, single-cohort TRACE study. Presented at the Fall Clinical Dermatology Conference 2025. Las Vegas, Nevada. 23-26 Oct. Poster Presentation. Wiseman M, Albreiki F, Pink A, et al. Effectiveness of 12-months tralokinumab treatment in 654 adults with atopic dermatitis with head & neck area involvement: Final real-world data from the prospective, non-interventional, international, single-cohort TRACE study. 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Bhutani T, Hsiao JL, Ferris L, et al. Spesolimab improves quality of life in generalized pustular psoriasis (GPP) as measured by proportion of patients with Dermatology Life Quality Index (DLQI) scores of 0 or 1 and reduction in pain severity over time: Results from the EFFISAYIL ® 2 trial. Presented at the Fall Clinical Dermatology Conference 2025. Las Vegas, Nevada. 23-26 Oct. Poster Presentation. Choon SE, Burden AD, Strober B, et al. Spesolimab for the treatment of generalized pustular psoriasis flares: Preliminary analysis of the EFFISAYIL REP study. Presented at the Fall Clinical Dermatology Conference 2025. Las Vegas, Nevada. 23-26 Oct. Poster Presentation. Lebwohl MG, Strober B, Choon SE, et al. Generalized pustular psoriasis: A systematic literature review of mortality and comorbidity data. Presented at the Fall Clinical Dermatology Conference 2025. Las Vegas, Nevada. 23-26 Oct. Poster Presentation. Mostaghimi AM, Merola SF, Gottlieb AB, et al. Generalized pustular psoriasis (GPP) control is limited on traditional small-molecule therapy as measured by the GPP Physician Global Assessment (GPPGA) and Dermatology Life Quality Index (DLQI): Baseline data from the Effisayil ® 2 trial. Presented at the Fall Clinical Dermatology Conference 2025. Las Vegas, Nevada. 23-26 Oct. Poster Presentation. Strober BE, Merola JF, Gottlieb AB, et al. Spesolimab improves Generalized Pustular Psoriasis Physicians Global Assessment (GPPGA), affected body surface area (BSA), and quality of life (QoL) in generalized pustular psoriasis (GPP): EFFISAYIL ® 2 trial analyses. Presented at the Fall Clinical Dermatology Conference 2025. Las Vegas, Nevada. 23-26 Oct. Poster Presentation. Anadkat MJ, Thaci D, Lebwohl MG, et al. Flare burden in generalized pustular psoriasis (GPP): analysis of pre-trial historical experience of patients enrolled in EFFISAYIL ® 2. Presented at the Fall Clinical Dermatology Conference 2025. Las Vegas, Nevada. 23-26 Oct. 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