LEO Pharma Presents Late-breaking Tralokinumab Data at EADV 2024 for Moderate-to-Severe Atopic Dermatitis (AD) in the Difficult-to-Treat Head and Neck Region

GLOBAL RELEASE 

NOT FOR UK USE – NOT INTENDED FOR UK MEDIA 

BALLERUP, Denmark, 27 September 2024 – 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 33rd 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 profile showed sustained improvements in AD consistent with the larger trial population.⁴ 

*ENDS* 

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 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? 

• 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 

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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. https://clinicaltrials.gov/ct2/show/NCT03587805. 

7. Weidinger S, Novak N. Atopic dermatitis. Lancet. 2016;387(10023):1109-1122. 

8. Boguniewicz M, Leung DY. Atopic dermatitis: a disease of altered skin barrier and immune dysregulation. Immunol Rev. 2011;242(1):233-246.

9. Dudakov JA, Hanash AM, van den Brink MR. Interleukin-22: immunobiology and pathology. Annu Rev Immunol. 2015;33:747-785. 

10. 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