Spesolimab

MADISON, N.J.--(BUSINESS WIRE)--LEO Pharma A/S, a global leader in medical dermatology, today announced it will present 17 scientific posters at the 2026 American Academy of Dermatology (AAD) Annual Meeting (March 27-31, Denver, Colorado), highlighting new real-world and clinical data across its medical dermatology portfolio and pipeline for inflammatory skin diseases. Key data to be presented by LEO Pharma at AAD 2026 include: ADBRY ® (tralokinumab) 12‑month real‑world data from the TRACE study evaluating the safety and effectiveness of ADBRY among patients with atopic dermatitis (AD), including analyses in patients with hand and foot involvement and patients with skin of color. 1-3 ANZUPGO ® (delgocitinib) data evaluating outcomes with ANZUPGO cream 20 mg/g in adults with moderate-to-severe chronic hand eczema (CHE), including results across patients with and without prior systemic therapy exposure, further characterizing treatment response in this difficult-to-treat population. 4 SPEVIGO ® (spesolimab) long-term data from the EFFISAYIL program evaluating intravenous and subcutaneous SPEVIGO for treatment of GPP flares and characterizing baseline non‑flaring disease phenotype. 5-7 “We’re proud to present LEO Pharma’s largest body of research to date at the AAD Annual Meeting, highlighting new real-world and clinical insights across Atopic Dermatitis, Generalized Pustular Psoriasis and Chronic Hand Eczema,” said Sophie Lamle, EVP, Development at LEO Pharma. “Together, these findings reflect continued advancements in the understanding and management of chronic dermatologic diseases and underscore our ambition to help address critical treatment gaps for patients.” The company’s full roster of presentations at the 2026 AAD Annual Meeting is listed below.1-17 AAD 2026 Scientific Abstracts Presented by LEO Pharma Author Format & Timing Tralokinumab – Atopic Dermatitis Real-world effectiveness of 12 months tralokinumab treatment in patients with skin of color and moderate to severe Atopic Dermatitis: Final data from the prospective, noninterventional, international TRACE study Armstrong AW, Rubin C, Jarell A, et al. Online ePoster with an Oral Poster Presentation March 27, 2026 2:05 - 2:10 PM MT Real-world effectiveness of 12 months tralokinumab in 495 adult Atopic Dermatitis patients with hand and feet involvement: Final data from the prospective, non-interventional, international TRACE study Armstrong AW, Rodriguez A, Jarell A, et al. Online ePoster with an Oral Poster Presentation March 28, 2026 3:45 - 3:50 PM MT Minimal disease activity with 12 months of tralokinumab treatment in adults with Atopic Dermatitis: Real-world data from the prospective, non-interventional, international, TRACE study Pink A, Pezzolo E, Jarell A, et al. Online ePoster Spesolimab – Generalized Pustular Psoriasis Intravenous spesolimab for (re)treatment of Generalized Pustular Psoriasis flares in patients receiving subcutaneous spesolimab: Results from the 5‑year, open‑label EFFISAYIL® ON extension study Gordon K, Navarini A, Choon SE, et al. Online ePoster Long‑term (≥3‑year) efficacy of subcutaneous spesolimab treatment for prevention of flares in patients with Generalized Pustular Psoriasis: Results from the EFFISAYIL® program Gudjonsson J, Navarini A, Langley R, et al. Online ePoster Characterization of Generalized Pustular Psoriasis (GPP) severity via individual GPP Physician Global Assessment (GPPGA) components during a non-flaring period: Baseline data from EFFISAYIL® 2 Lebwohl MG, Morita A, Mostaghimi A, et al. Online ePoster Delgocitinib – Chronic Hand Eczema Delgocitinib cream 20 mg/g for moderate to severe Chronic Hand Eczema: outcomes over 16 weeks by prior systemic therapy exposure Bissonnette R, Schliemann S, Worm M, et al. Online ePoster with an Oral Presentation March 28, 2026 8:50 - 8:55 AM MT Patient-perceived factors associated with Chronic Hand Eczema–Results from the CHECK study in the United States Simpson E, Balu S, Bin Sawad A, et al. Online ePoster with an Oral Presentation March 28, 2026 2:45 - 2:50 PM MT Sustained Health-Related Quality of Life improvements with Delgocitinib 20 mg/g Cream in Chronic Hand Eczema - Results from the Phase 3 Open-Label Extension DELTA 3 Trial Armstrong AW, Stein Gold L, Bauer A, et al. Online ePoster Health-related quality of life in people with Chronic Hand Eczema - Results from the CHECK study in the United States Chovatiya R, Balu S, Bin Sawad A, et al. Online ePoster The DELTA TEEN Phase 3 trial: systemic exposure and safety profile of delgocitinib cream in adolescents with moderate to severe Chronic Hand Eczema Molin S, Baselga E, Navarro‑Triviño FJ, et al. Online ePoster Pyoderma Gangrenosum Prevalence of comorbidities in patients with Pyoderma Gangrenosum (PG) in the U.S. Mostaghimi A, Dini V, Bohn RL, et al. Online ePoster with​ an Oral Presentation​ March 29, 2026 1:00 - 1:05 PM MT Mortality and adverse outcomes in patients with Pyoderma Gangrenosum (PG) in the U.S. Mostaghimi A, Hall C, Bohn RL, et al. Online ePoster with​ an Oral Presentation​ March 29, 2026 2:20 - 2:25 PM MT Patient perspectives on the signs, symptoms and impacts of Pyoderma Gangrenosum (PG): A qualitative study Mostaghimi A, Jha RK, Nokela M, et al. Online ePoster Psoriasis Cost Effectiveness Analysis of Biological Drugs Targeting IL-17 Pathway in Plaque Psoriasis from the Perspective of the Brazilian Private Healthcare System Muzy G, Magalhaes AMF, Colli LG, et al. Online ePoster with an Oral Presentation March 27, 2026 10:05 - 10:10 AM MT Systemic Immune-Inflammation Index (SII) and systemic inflammation response index (SIRI) trend in Psoriatic patients treated with brodalumab: A real-life pilot study Mastorino L, Dapavo P, Cangialosi L, et al. Online ePoster with an Oral Presentation Epithelial-Derived IL-17C and IL-17E as Psoriatic Inflammation Amplifiers and Targets​ Muzy G, Magalhaes AMF, Vargas ALBSJ, et al. Online ePoster About Atopic Dermatitis Atopic Dermatitis (AD) is a chronic, inflammatory skin disease characterized by intense itch and eczematous lesions.18 AD is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.19 Type 2 cytokines, including IL-13, play an important role in the key aspects of AD pathophysiology.18-19 Excessive IL-22 production is also known to contribute to the pathogenesis of AD.20 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.21,22 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.23,24 GPP symptoms appear unpredictably 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.24,25 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.26 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.27 CHE affects approximately one in ten adults in the U.S.28 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 the hands and wrists.26 The pathophysiology is characterized by skin barrier dysfunction, inflammation of the skin, and alterations of the skin microbiome.29 CHE has been shown to cause psychological and functional burdens that impact patient quality of life.30,31 Individuals living with CHE experience substantial impairment in daily activities, with an average activity impairment of more than 40%.32 Furthermore, careers and earning potential have also been shown to be impacted by the burden of living with CHE.33 About ADBRY® (tralokinumab)/ADTRALZA® (tralokinumab) ADBRY® (tralokinumab), 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.34,35 Tralokinumab specifically binds to the IL-13 cytokine, thereby inhibiting interaction with the IL-13 receptor α1 and α2 subunits (IL-13Rα1 and IL-13Rα2).36 Tralokinumab 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 is approved for use in adults with moderate- to-severe AD in Switzerland and Japan. INDICATION AND IMPORTANT SAFETY INFORMATION FOR ADBRY® (TRALOKINUMAB) What is ADBRY? ADBRY ® (tralokinumab) 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 signaling pathway within the immune system shown to be involved in the pathogenesis of several autoinflammatory diseases, including GPP.37 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.38-40 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 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 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 (e.g., 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 Guillain-Barre Syndrome (GBS): Among approximately 835 subjects exposed to spesolimab during clinical development, GBS was reported in 3 subjects who received various doses of spesolimab 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 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.41 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.41,42 In 2014, LEO Pharma obtained the exclusive rights to develop and commercialize delgocitinib for topical use in dermatological indications worldwide, excluding Japan, where Shionogi & Co., Ltd. owns the 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. Nonmelanoma 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 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. LEO Pharma is co-owned by majority shareholder the LEO Foundation and, since 2021, Nordic Capital. Headquartered in Denmark, LEO Pharma has a team of 4,000 people worldwide. Together, we reach far beyond the skin. For more information, visit www.leo-pharma.com. References Armstrong AW, Rubin C, Jarell A, et al. Real-world effectiveness of 12 months tralokinumab treatment in patients with skin of color and moderate-to-severe atopic dermatitis: final data from the prospective, non-interventional, international TRACE study. Presented at the 2026 American Academy of Dermatology Annual Meeting; March 27-31, 2026; Denver, CO. Poster ID: 77199. Oral Poster Presentation. Armstrong AW, Rodriguez A, Jarell A, et al. Real-world effectiveness of 12 months tralokinumab in 495 adult patients with atopic dermatitis and hand and foot involvement: final data from the prospective, non-interventional, international TRACE study. Presented at the 2026 American Academy of Dermatology Annual Meeting; March 27-31, 2026; Denver, CO. Poster ID: 77138. Oral Poster Presentation. Pink A, Pezzolo E, Jarell A, et al. Minimal disease activity with 12 months of tralokinumab treatment in adults with atopic dermatitis: real-world data from the prospective, non-interventional, international TRACE study. Presented at the 2026 American Academy of Dermatology Annual Meeting; March 27-31, 2026; Denver, CO. Poster ID: 74527. Online ePoster. Bissonnette R, Schliemann S, Worm M, et al. Delgocitinib cream 20 mg/g for moderate to severe chronic hand eczema: outcomes over 16 weeks by prior systemic therapy exposure. Presented at the 2026 American Academy of Dermatology Annual Meeting; March 27-31, 2026; Denver, CO. Poster ID: 72824. Oral Poster Presentation. Gordon K, Navarini A, Choon SE, et al. Intravenous spesolimab for (re)treatment of generalized pustular psoriasis flares in patients receiving subcutaneous spesolimab: results from the 5-year, open-label EFFISAYIL ® ON extension study. Presented at the 2026 American Academy of Dermatology Annual Meeting; March 27-31, 2026; Denver, CO. Poster ID: 73676. Online ePoster. Gudjonsson J, Navarini A, Langley R, et al. Long-term (≥3-year) efficacy of subcutaneous spesolimab treatment for prevention of flares in patients with generalized pustular psoriasis: results from the EFFISAYIL ® program. Presented at the 2026 American Academy of Dermatology Annual Meeting; March 27-31, 2026; Denver, CO. Poster ID: 72814. Online ePoster. Lebwohl MG, Morita A, Mostaghimi A, et al. Characterization of Generalized Pustular Psoriasis (GPP) severity via individual GPP Physician Global Assessment (GPPGA) components during a non-flaring period: Baseline data from EFFISAYIL® 2. Presented at the 2026 American Academy of Dermatology Annual Meeting; March 27-31, 2026; Denver, CO. Online ePoster. Simpson E, Balu S, Bin Sawad A, et al. Patient-perceived factors associated with chronic hand eczema–results from the CHECK study in the United States. Presented at the 2026 American Academy of Dermatology Annual Meeting; March 27-31, 2026; Denver, CO. Poster ID: 74846. Oral Poster Presentation. Armstrong AW, Stein Gold L, Bauer A, et al. Sustained health-related quality of life improvements with delgocitinib 20 mg/g cream in chronic hand eczema: results from the phase 3 open-label extension DELTA 3 trial. Presented at the 2026 American Academy of Dermatology Annual Meeting; March 27-31, 2026; Denver, CO. Poster ID: 72213. Online ePoster. Chovatiya R, Balu S, Bin Sawad A, et al. Health-related quality of life in people with chronic hand eczema: results from the CHECK study in the United States. Presented at the 2026 American Academy of Dermatology Annual Meeting; March 27-31, 2026; Denver, CO. Poster ID: 74798. Online ePoster. Molin S, Baselga E, Navarro-Triviño FJ, et al. The DELTA TEEN phase 3 trial: systemic exposure and safety profile of delgocitinib cream in adolescents with moderate to severe chronic hand eczema. Presented at the 2026 American Academy of Dermatology Annual Meeting; March 27-31, 2026; Denver, CO. Poster ID: 73148. Online ePoster. Mostaghimi A, Dini V, Bohn RL, et al. Prevalence of comorbidities in patients with pyoderma gangrenosum in the United States. Presented at the 2026 American Academy of Dermatology Annual Meeting; March 27-31, 2026; Denver, CO. Poster ID: 73202. Oral Poster Presentation. Mostaghimi A, Hall C, Bohn RL, et al. Mortality and adverse outcomes in patients with pyoderma gangrenosum in the United States. Presented at the 2026 American Academy of Dermatology Annual Meeting; March 27-31, 2026; Denver, CO. Poster ID: 75161. Oral Poster Presentation. Mostaghimi A, Jha RK, Nokela M, et al. Patient perspectives on the signs, symptoms and impacts of pyoderma gangrenosum: a qualitative study. Presented at the 2026 American Academy of Dermatology Annual Meeting; March 27-31, 2026; Denver, CO. Poster ID: 75154. Online ePoster. Muzy G, Magalhaes AMF, Colli LG, et al. Cost-effectiveness analysis of biological drugs targeting the IL-17 pathway in plaque psoriasis from the perspective of the Brazilian private healthcare system. Presented at the 2026 American Academy of Dermatology Annual Meeting; March 27-31, 2026; Denver, CO. Poster ID: 74858. Oral Poster Presentation. Mastorino L, Dapavo P, Cangialosi L, et al. Systemic immune-inflammation index and systemic inflammation response index trends in psoriatic patients treated with brodalumab: a real-life pilot study. Presented at the 2026 American Academy of Dermatology Annual Meeting; March 27-31, 2026; Denver, CO. Oral Poster Presentation. Muzy G, Magalhaes AMF, Vargas ALBSJ, et al. Epithelial-derived IL-17C and IL-17E as psoriatic inflammation amplifiers and therapeutic targets. Presented at the 2026 American Academy of Dermatology Annual Meeting; March 27-31, 2026; Denver, CO. Poster ID: 77358. Online ePoster. Weidinger S, Novak N. Atopic dermatitis. Lancet . 2016;387(10023):1109-1122. 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点击关注『免皮前研』，跟踪最新免疫性皮肤病动态 全文共3031字，全文阅读时间约15分钟 随着人们对银屑病的认知不断加深，小分子靶向药与新疗法正不断突破，而近两年国产创新药的集中获批更为国内银屑病患者带来了一批新药、好药、高性价比药。 今天我们就来盘点一下今年银屑病患者能用哪些药，还有哪些新药正在研发路上↓↓ PART.01 生物制剂 01 已获批用于中重度斑块状银屑病治疗的生物制剂 TNF-α抑制剂： 包括依那西普、英夫利昔单抗、阿达木单抗，均已在国内获批用于银屑病治疗。而戈利木单抗在国内仅获批银屑病关节炎适应症。培赛利珠单抗在国内仅获批类风湿关节炎，未获批银屑病适应症。 IL-12/23抑制剂： 包括乌司奴单抗和依若奇单抗、Icotrokinra。依若奇单抗于2025年4月18日获批，是国产首个IL-12/IL-23双靶向单抗，商品名爱达罗，维持期一年仅需4针，是目前给药频次最低的生物制剂之一。Icotrokinra（商品名：Icotyde）于今年3月18日获得FDA批准上市，用于治疗12岁及以上青少年和成人的中重度斑块状银屑病（PsO）。Icotrokinra是首个可精准阻断 IL-23 受体的靶向口服肽类药物，每日晨起用水送服一次即可。 IL-17A抑制剂： 包括安沐奇塔单抗、司库奇尤单抗、依奇珠单抗、赛立奇单抗和夫那奇珠单抗。夫那奇珠单抗于2024年8月获批；赛立奇单抗于2024年9月获批，二者为国内首批上市的自主研发IL-17A抑制剂，填补了国产IL-17A抑制剂的空白。安沐奇塔单抗，也是国产创新药，于2026 年 2 月 13 日获批上市，可用于治疗适合系统治疗或光疗的中度至重度斑块状银屑病成人患者。除了银屑病外，安沐奇塔单抗针对强直性脊柱炎、放射学阴性中轴型脊柱关节炎的III期临床正在开展，未来有望覆盖更多自免疾病患者。 IL-23p19抑制剂： 包括古塞奇尤单抗、替瑞奇珠单抗、匹康奇拜单抗和利生奇珠单抗。匹康奇拜单抗于2025年11月28日获批，是国内首个自研IL-23p19单抗，商品名信美悦；利生奇珠单抗于2023年在国内获批银屑病适应症。 IL-17A/F抑制剂： 比奇珠单抗全球首个且唯一同时获批 nr-axSpA及 AS 的 IL-17A&F 双靶点生物制剂，可100%抑制 IL-17A&F 炎症通。它于2024年7月19日在国内获批强直性脊柱炎适应症，银屑病适应症于2025年5月申报，尚未获批。 IL-36受体抑制剂： 佩索利单抗于2022年12月14日在中国获批，商品名圣利卓，用于成人泛发性脓疱型银屑病的治疗。 02 国内自主研发生物制剂进展 赛立奇单抗——全人源IL-17A抑制剂，于2024年9月12日获批用于中重度斑块状银屑病。夫那奇珠单抗同为IL-17A抑制剂，于2024年8月获批。 匹康奇拜单抗——国内首个自研IL-23p19单抗，于2025年11月28日获批，商品名信美悦。 依若奇单抗——首个国产IL-12/IL-23双靶向单抗，于2025年4月18日获批，商品名爱达罗。 03 国内外在研生物制剂 古莫奇单抗--针对IL-17A靶点，新药上市申请已获受理，52周PASI 90应答率超90%，显示出持久的皮损清除能力。 依泽吉贝普——IL-17A抑制剂，80mg每2周一次的给药方案在12周时PASI 90应答率最高，且疗效可持续长达3年，为长期治疗提供了有力数据支持。 SAR441566——口服TNF抑制剂，目前处于Ⅱ期临床评估阶段。 JNJ-77242113——口服IL-23受体拮抗肽，已进入Ⅲ期临床，其Ⅱb期数据显示100mg每日两次组的PASI 75率达79%，展现出口服给药的显著潜力。该药物即Icotrokinra，Ⅲ期ICONIC-TOTAL研究正在进行。 DC-853——口服IL-17抑制剂，于2024年10月进入Ⅱ期临床试验。该药是DC-806的迭代分子，由礼来公司在前者基础上优化开发，具有更强的效力和代谢稳定性。原DC-806项目已不再推进。 PART.02 JAK抑制剂 01 已获批药物 氘可来昔替尼——首个获批用于中重度斑块状银屑病的口服选择性TYK2抑制剂，于2023年10月在中国获批，与传统JAK抑制剂相比显著降低了免疫相关不良反应风险。 托法替尼（tofacitinib）——可有效抑制JAK1和JAK3的活性，阻断多种炎性细胞因子的信号转导。既有研究表明托法替尼对类风湿关节炎、溃疡性结肠炎、银屑病等多种炎症相关疾病有良好的治疗效应。已在我国获批用于治疗银屑病关节炎。 02 临床开发阶段的JAK/TYK2抑制剂 Zasocitinib（TAK-279）——一种口服TYK2抑制剂，Ⅲ期临床试验已成功完成。2025年12月公布的积极结果显示，第16周时约58%患者达到PASI 90，约33%达到PASI 100，疗效显著且安全性良好。 ESK-001——高选择性TYK2抑制剂，Ⅱ期临床试验已完成，40mg每日两次组12周PASI 75应答率达64%，耐受性良好，目前Ⅲ期试验正在进行中。 VTX958——针对TYK2靶点，但由于疗效未达预期，Ventyx公司于2024年宣布停止该项目的开发。 Ropsacitinib（PF-06826647）——是一种TYK2抑制剂，其Ⅱb期临床试验已于2022年完成。该药物后续针对银屑病的开发状态尚不明确，目前研发重点已转向化脓性汗腺炎和溃疡性结肠炎等适应症。 PART.03 磷酸二酯酶4（PDE4）抑制剂 阿普米司特——首个获批用于中重度斑块状银屑病及银屑病关节炎的口服PDE4抑制剂，开创了口服小分子药物治疗的新时代。 国产PDE4抑制剂莫米司特——于2025年10月获批上市，为首款国产PDE4抑制剂，为中重度斑块状银屑病患者提供了新的口服治疗选择。 Orismilast——新型选择性口服PDE4抑制剂，对PDE4B和PDE4D亚型具有更强的选择性，目前Ⅱ期临床试验已完成。 Mufemilast（emay005）——口服PDE4抑制剂，60mg每日两次的给药方案针对中重度银屑病的Ⅱ期试验已完成，16周PASI 75应答率为53.6%。 ME3183——正在开发的口服PDE4抑制剂，在Ⅱa期试验中治疗结果明显优于安慰剂，显示出良好的治疗潜力。 PART.04 外用药物 罗氟司特——PDE4抑制剂，其泡沫剂型具有更好的渗透性和更易清洁的特性，在斑块状银屑病治疗中显示出良好的安全性与耐受性。罗氟司特0.3%泡沫剂于2025年5月获FDA批准用于12岁及以上斑块状银屑病。 本维莫德乳膏——在12周治疗中tPGA≤1清除率高达88.5%，已在美国及日本获批用于成人斑块状银屑病，目前正处于儿童适应证的Ⅲ期临床试验阶段。 新型递送技术如纳米颗粒与微针可提升药物生物利用度，为局部治疗开辟新途径。热休克蛋白90抑制剂RGRN-305也显示出局部治疗潜力。 局部JAK抑制剂Brepocitinib在Ⅱb期临床试验中未达到主要疗效终点，可能因银屑病皮损皮肤屏障功能障碍影响药物渗透所致，提示局部给药需要克服特殊的药代动力学挑战。 PART.05 电刺激疗法 无电池可穿戴式多组分充药电子微针（mD-eMN）系统，通过电激活皮肤细胞并增强药物渗透显著缓解银屑病症状。该技术为前沿研究，尚未进入临床应用。利用人工智能的先进技术有望显著促进银屑病电刺激疗法的发展。 PART.06 干细胞治疗 造血干细胞移植与间充质干细胞（含脐带源及脂肪源MSC）已用于银屑病治疗，为难治性病例提供了新的治疗思路。扩展阅读：银屑病未来还能这样治？间充质干细胞了解一下！ 干细胞治疗的安全性和长期疗效尚需通过建立全球标准和进一步研究加以明确。 MSC来源的外泌体在Ⅰ期和Ⅱ期临床研究中，皮肤红斑、浸润、鳞屑均显著改善，显示出无细胞治疗的独特优势。扩展阅读：国际新研究汇总：外泌体贴片治银屑病，红斑、鳞屑明显改善 未来展望 如今银屑病治疗药物迎来创新药集中爆发与治疗模式全面升级的好春光，已形成以生物制剂为核心、口服小分子为补充、外用药物持续优化的多层次治疗体系。 生物制剂覆盖 TNF-α、IL-12/23、IL-17、IL-23 等主流靶点，多款国产自研单抗相继获批，填补多项国内空白，给药便捷性与疗效大幅提升；JAK/TYK2、PDE4 等口服靶向药不断迭代，安全性更优且国产替代加速推进。外用剂型、电刺激、干细胞及外泌体等前沿疗法也在积极探索，为难治性病例提供新方向。 国产药物崛起与新型疗法突破，更持续为患者带来更多高效、安全、便捷的治疗选择。 主要参考资料： 戴敏,蒋裕雄,史玉玲.2023年至2024年银屑病诊治进展[J/OL].诊断学理论与实践,1-12[2026-03-07].https://doi.org/10.16150/j.1671-2870.2025.06.004. 【免责声明】 信息性质：本文内容为健康知识科普，仅基于公开信息进行整理与分享。文章内容不属于医疗诊断、治疗建议或专业医学意见，不可替代专业医疗建议。 信息准确性：我们力求内容准确，但医学知识更新迅速，不保证信息的绝对准确性与完整性，若有疏漏欢迎指正。 版权声明：尊重原创与版权。如内容涉嫌侵权，请提供证明与我们联系，我们将及时处理。