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• A post hoc four-year interim subgroup analysis of the ongoing ECZTEND open-label extension trial assessed whether continuous use of Adtralza provided long-term disease control in adult patients with moderate-to-severe AD.¹
• Evidence of a safety profile consistent with previous study results for Adtralza was further supported by both the above interim ECZTEND results and an integrated analysis of the ECZTEND trial plus seven of the parent trials.^1,2
• Initial findings from the cohort study of patients with atopic dermatitis to evaluate tralokinumab real-world clinical use (TRACE).³

LEO Pharma A/S, a global leader in medical dermatology, today presented new data assessing the long-term safety and efficacy data of continuous treatment with Adtralza® (tralokinumab) over four years for moderate-to-severe atopic dermatitis (AD) in adults. Findings were shared during two oral presentations at the 32nd European Academy of Dermatology and Venereology (EADV) Congress in Berlin.^1,2

A post hoc, interim, subgroup analysis of the ongoing ECZTEND five-year, single-arm, open-label extension trial assessed whether continuous use of Adtralza provided long-term disease control over four years in adult patients with moderate-to-severe AD. The analysis was of participants from ECZTEND who had previously enrolled in the ECZTRA 1 and 2 phase 3 trials. This was the largest, most homogenous group of participants in the ECZTEND trial, with the longest treatment duration.¹

A total of 347 adult patients using Adtralza for up to four years were included in the analysis. At the end of this period, an Investigator's Global Assessment score of 0 (clear) or 1 (almost clear) (IGA 0/1) was observed in 52.6% of patients. At least a 75% reduction in the Eczema Area and Severity Index (EASI-75) was observed in 84.5% of patients, and an EASI-90 in 64.4%. The safety profile was consistent with earlier analyses, with no new safety signals arising with continued Adtralza use over the four-year treatment period.¹

The safety profile for Adtralza was also supported by an additional integrated analysis of the long-term Adtralza use for up to 4.5 years. Again, the pattern of adverse events (AEs) was consistent with the initial placebo-controlled treatment period and with no new safety signals identified. The analysis included 2693 patients (≥12 years) that received tralokinumab (5320 patient years exposure) in seven placebo controlled trials and the ECZTEND trial.²

“Long-term disease control is a critical need for patients with atopic dermatitis,” said Dr. Andrew Blauvelt, Oregon Medical Research Center, Portland, U.S., and International Coordinating Investigator (ICI) of the ECZTEND trial. “These new long-term data demonstrate that treatment with tralokinumab produces sustained responses that offer real benefits to the people living with this debilitating disease over time.”

In addition to the two oral presentations, a poster will be provided on the initial findings from the tralokinumab real-world clinical use (TRACE) cohort study in Germany. The observational, prospective, single-cohort study of adult patients with moderate-to-severe AD aims to better understand the efficacy, safety, and clinical use of Adtralza in daily practice.³

“We are proud to be able to share this latest data for Adtralza,” says Kreesten Meldgaard Madsen, Chief Development Officer, LEO Pharma. “We aim to use this long-term and real-world evidence to build upon Adtralza’s existing foundation of research.”

*Ends*

About atopic dermatitis

Atopic dermatitis is a chronic, inflammatory skin disease characterized by intense itch and eczematous lesions.⁴ Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.⁵ Type 2 cytokines, including IL-13, play an important role in the key aspects of atopic dermatitis pathophysiology.^5,6

About Adtralza^® (tralokinumab)

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.^5,6 Adtralza specifically binds to the IL-13 cytokine, thereby inhibiting interaction with the IL-13 receptor α1 and α2 subunits (IL-13Rα1 and IL-13Rα2).⁷

Adtralza is approved for the treatment of moderate-to-severe AD in adult and adolescent patients 12 years and older who are candidates for systemic therapy in the European Union, Canada, Great Britain, the United Arab Emirates, and South Korea. Adtralza is approved for use in adults with moderate-to-severe AD in the U.S., Switzerland, Saudi Arabia, and Japan.

About 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.^8,9

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 4,700 people, serving millions of patients across the world. In 2022, the company generated net sales of DKK 10.6 billion.

References

1. Blauvelt A, et al. Continuous tralokinumab treatment over 4 years in adults with moderate-to-severe atopic dermatitis provides long-term disease control. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2023. Berlin, Germany. 11– 14 October.
2. Reich K, et al. Safety of tralokinumab for the treatment of atopic dermatitis in patients with up to 4.5 years of treatment: an updated integrated analysis of eight clinical trials. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2023. Berlin, Germany. 11– 14 October.
3. Thaçi D, et al. A global, observational, cohort study of patients with atopic dermatitis to evaluate tralokinumab real-world clinical use (TRACE): baseline characteristics from the first 100 patients in Germany. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2023. Berlin, Germany. 11– 14 October.
4. Weidinger S, et al. Atopic dermatitis. Lancet. 2016;387:1109-1122.
5. Boguniewicz M, et al. Atopic dermatitis: a disease of altered skin barrier and immune dysregulation. Immunol Rev. 2011;242(1):233-46.
6. Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020; 75:54-62.
7. 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.
8. 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.
9. 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.

MAT-68780 October 2023

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