LEO Pharma presents new Adtralza®▼ (tralokinumab) data following long-term continuous treatment at EADV 30th Congress

LEO Pharma presents new Adtralza^®▼ (tralokinumab) data following long-term continuous treatment at EADV 30^th Congress

• Interim analysis of ECZTEND, an open-label extension trial, demonstrated sustained improvements in extent and severity of atopic dermatitis after two years of continuous treatment, with a 92.7% median EASI improvement from parent trial baseline (n=126)¹
• Patients also reported improvements in itch severity and sleep interference¹ 

BALLERUP, Denmark; HURLEY, Berks, UK, and DUBLIN, IE, 30 SEPTEMBER, 2021 – LEO Pharma A/S, a global leader in medical dermatology, today announced results showing that after two years of continuous treatment with Adtralza, adult patients with moderate-to-severe atopic dermatitis maintained improvements in signs and symptoms, itch severity and sleep interference.¹ Findings were shared as an oral presentation during the European Academy of Dermatology and Venereology (EADV) Congress 2021.

The interim analysis investigated continued treatment with Adtralza as well as the ability to regain response after pausing and reinitiating Adtralza.¹

“Atopic dermatitis is a debilitating disease that can cause severe itch and discomfort for decades. As clinicians, we’re always looking for additional long-term treatment options that could offer consistent results over time for our patients,” said Andrew Blauvelt, MD, MBA, President of Oregon Medical Research Center in Portland, Oregon, and lead investigator for ECZTEND. “The data being presented at EADV are very encouraging because they showed that patients treated with Adtralza maintained improvements in signs and symptoms of atopic dermatitis over several years.”

Long-term efficacy outcomes were assessed in patients (n=345) who had received two years of treatment with Adtralza, including the full 52 weeks in the pivotal Phase 3 parent trials (ECZTRA 1 and 2) and 56 weeks in the ECZTEND trial.¹ Patients were split into three cohorts based on the length of time between their last dose of Adtralza in the parent trial and their first dose in ECZTEND. Continuous treatment was defined as ≤5 weeks between the last dose in the parent trial and the first dose in ECZTEND (n=126), interrupted treatment was defined as 6-15 weeks (n=133), and >15 weeks (n=86) was considered a full washout of treatment.¹

Patients who received continuous treatment with Adtralza over two years reported a high level of long-term control in atopic dermatitis signs and symptoms, as demonstrated by a median Eczema Area and Severity Index score (EASI) improvement from parent trial baseline of 92.7%.¹

Maintenance of improvements in patient-reported outcomes, including pruritus (itch) severity and sleep interference, were demonstrated at two years as well. Itch severity and sleep interference were reported using a Numeric Rating Scale (NRS) of 0-10. Patients who received continuous treatment reported improvements in itch severity, with worst weekly NRS score for median pruritus, shifting from severe itch (8.1 out of 10) at parent trial baseline to mild itch (3 out of 10) following two years of treatment.¹ These patients also reported improvement in median sleep interference, from severe sleep interference (7.3 out of 10) at parent trial baseline to mild sleep interference (1 out of 10) in ECZTEND.¹ During the parent trials, patients recorded their daily itch and sleep interference, and weekly averages of scores were used. During ECZTEND, worst itch severity and sleep interference of the previous week were reported.

“The sustained response over two years further adds to the long-term efficacy profile of Adtralza,” said Jörg Möller, Executive Vice President, Global Research and Development, LEO Pharma. “We are proud to offer a treatment that shows sustained response across both clinical and patient-reported measures of atopic dermatitis such as itch reduction and sleep interference, which create a huge burden for patients living with this chronic disease. Understanding the needs of people living with skin diseases is key to bringing new treatment options that improve their lives, thereby fulfilling our purpose of advancing the standard of care in medical dermatology.”

A decline in the median EASI percentage was observed in the washout cohort within the period without treatment. After one year of treatment in the parent trial, results showed a median EASI percent improvement of 86.9% compared to baseline. Following the washout of treatment (>15 weeks), median EASI percent improvement (vs. parent trial baseline) declined to 68.6%. A median EASI percent improvement equivalent to response at one year in the parent trials was regained within 12 weeks from treatment re-initiation with tralokinumab in ECZTEND.¹

The safety of Adtralza treatment was also assessed in this interim analysis and results were consistent with the initial placebo-controlled treatment periods of the parent trials.¹

Additionally, LEO Pharma is presenting a post-hoc analysis that evaluated predictors of maintained response with Adtralza dosing every four weeks as a late-breaking oral presentation.² An interim analysis of COVID-19 cases and SARS-CoV-2 vaccinations during treatment with Adtralza in patients with moderate-to-severe atopic dermatitis enrolled in the ECZTEND trial will also be presented as an e-poster.³

About Adtralza (tralokinumab) 

Adtralza (tralokinumab) is a fully human, high-affinity, monoclonal antibody developed to specifically neutralise IL-13, which plays a key role in the immune process underlying atopic dermatitis signs and symptoms. Adtralza specifically binds to IL-13 with high affinity, thereby preventing interaction with the IL-13 receptor α1 and α2 subunits (IL-13Rα1 and IL-13Rα2).^4,5

Adtralza was approved by the European Commission for adults with moderate-to-severe atopic dermatitis who are candidates for systemic therapy in Europe and by the Medicines & Healthcare products Regulatory Agency in Great Britain, in June 2021. The MHRA and EC decisions are valid in the UK and all European Union Member States, Iceland, Norway, and Liechtenstein. Additional regulatory filings are underway with the U.S. Food and Drug Administration (FDA) and other health authorities worldwide.

About the ECZTEND - Long-Term Extension (LTE) Trial

ECZTEND 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 tralokinumab or placebo.^1,6

About ECZTRA 1 and ECZTRA 2 Trials

ECZTRA 1 and ECZTRA 2 (ECZema TRAlokinumab trials Nos. 1 and 2) were randomised, double-blind, placebo-controlled, multinational 52-week trials, which included 802 and 794 adult patients, respectively, to evaluate the safety and efficacy of Adtralza (300 mg) as monotherapy in adults with moderate-to-severe atopic dermatitis who were candidates for systemic therapy.⁷

About atopic dermatitis

Atopic dermatitis is a chronic, inflammatory, skin disease characterised by intense itch and eczematous lesions.⁸ Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.⁹ Type 2 cytokines, including IL-13, play a central role in the key aspects of atopic dermatitis pathophysiology.⁴

About LEO Pharma

LEO Pharma helps people achieve healthy skin. The company is a leader in medical dermatology with a robust R&D pipeline, a wide range of therapies and a pioneering spirit. 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, setting new standards of care for people with skin conditions. LEO Pharma is headquartered in Denmark with a global team of 6,000 people, serving 93 million patients in 130 countries. In 2020, the company generated net sales of EUR 1,359 million. For more information, please visit www.LEO-Pharma.co.uk

Contacts

Danielle Idone

Communications Business Partner   

LEO Pharma  

+1 973 879 1811 

deius@leo-pharma.com

References

1. Blauvelt et. al. Two-year Maintenance of Response with Tralokinumab in Moderate-to-Severe Atopic Dermatitis: Interim Analysis of the ECZTEND Open-label Extension Trial. European Academy of Dermatology and Venereology (EADV). Sept 29-Oct 2, 2021. On-demand video oral presentation FC01.04.
2. Weidinger et. al. Predictors of maintained response with tralokinumab every four weeks dosing in adults with moderate-to-severe atopic dermatitis. European Academy of Dermatology and Venereology (EADV). Sept 29-Oct 2, 2021. [Abstract # 2948]
3. Langley et. al. Updated on COVID-19 cases and SARS-CoV-2 vaccinations during tralokinumab treatment in moderate-to-severe atopic dermatitis from ECZTEND long-term extension trial. European Academy of Dermatology and Venereology (EADV). Sept 29-Oct 2, 2021. [Abstract # 1763]
4. Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020; 75:54-62.
5. 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.
6. EU Clinical Trials Register. Long-term extension trial in subjects with atopic dermatitis who participated in previous tralokinumab trials – ECZTEND. EudraCT number: 2018-000746-19. https://www.clinicaltrialsregister.eu/ctr-search/trial/2018-000746-19/GB.
7. Wollenberg A, et al. Tralokinumab for moderate‐to‐severe atopic dermatitis: results from two 52‐week, randomised, double‐blind, multicentre, placebo‐controlled phase III trials (ECZTRA 1 and ECZTRA 2). Br J Dermatol. 2021; 437-449.
8. Weidinger S, et al. Atopic dermatitis. Lancet. 2016; 387:1109-1122.
9. Boguniewicz M, et al. Atopic dermatitis: a disease of altered skin barrier and immune dysregulation. Immunol Rev. 2011;242(1):233-46.