NICE publishes FAD recommending the use of Adtralza®▼(tralokinumab)

• The National Institute for Health and Care Excellence (NICE) has approved tralokinumab, a biologic which inhibits the IL-13 cytokine, a driver of atopic dermatitis, for adult patients with moderate-to-severe atopic dermatitis that is suitable for systemic treatment, only if the disease has not responded to at least one systemic immunosuppressant, or these are not suitable. ^1,2,3
• Following a multiple technology appraisal (MTA), NICE has published a Final Appraisal Document (FAD) simultaneously approving tralokinumab, upadacitinib and abrocitinib for reimbursement following use within NHS England and Wales, based upon both cost-effectiveness and a demonstration of positive patient outcomes.³
• Four phase III studies (ECZTRA 1, 2, 3 and 7) demonstrated superiority of tralokinumab in improving signs and symptoms of atopic dermatitis at 16 weeks when compared with placebo, as monotherapy or in combination with topical corticosteroids in patients with moderate-to-severe atopic dermatitis who are candidates for systemic therapy. ^4,5,6

Hurley, Berks, UK, 29 JUNE, 2022 – LEO Pharma welcomes the news that the National Institute for Health and Care Excellence (NICE) has issued a positive Final Appraisal Document (FAD) which recommends tralokinumab, upadacitinib and abrocitinib for use within NHS England and Wales. NICE recommended these options for the treatment of moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic treatment, only if the disease has not responded to at least one systemic immunosuppressant, or these are not suitable. ³

This comes at a critical time when atopic dermatitis affects approximately 3.5% of adults across Europe. ⁷ Research from earlier this year found that those living with atopic dermatitis in the UK would be willing to trade 37% of their remaining life span in order to achieve better health. ⁸

Tralokinumab is the first high affinity, a human monoclonal antibody developed to specifically bind to and inhibit the IL-13 cytokine in adult patients with uncontrolled moderate-to-severe atopic dermatitis who are candidates for systemic therapy. ^1,2 Tralokinumab is available in a 150 mg/mL prefilled syringe for subcutaneous injection with an initial dose of 600 mg followed by 300 mg every other week. ⁹ Tralokinumab can be used with or without topical corticosteroids (TCS).⁹

“NICE’s decision to recommend tralokinumab is an important step for those living with moderate-to-severe atopic dermatitis. We are delighted that this recommendation will give those living with the condition in England and Wales access to a new treatment option. This approval represents the latest innovation from LEO Pharma as we continue to support people living with skin conditions. Thank you to all the LEO Pharma employees and our partners, as well as the clinicians and patient organisations who have worked so hard to support this process for patients,” shared Sarah Kleinpeter, Vice President and General Manager of UK and Ireland at LEO Pharma.

“Atopic dermatitis patients often have individual, complex needs. This recommendation offers significant new treatment options for atopic dermatitis patients and is an essential step in improving patient experience and quality of life in England and Wales,” said Professor Anthony Bewley, Consultant Dermatologist, Barts Health NHS Trust.

“The NICE recommendation of tralokinumab is a hugely encouraging milestone for those living with atopic dermatitis and is another important step towards expanding the choices and options patients have for accessing an effective treatment for their condition”, commented Andrew Proctor, Chief Executive of the National Eczema Society.

The evidence supporting the efficacy and safety of tralokinumab comes from four randomised, multicenter, double-blind, placebo-controlled, phase III studies: ECZTRA 1, ECZTRA 2, ECZTRA 3 in patients with moderate-to-severe atopic dermatitis and ECZTRA 7 in patients with severe disease.^4,5,6

Tralokinumab was approved by the European Commission (EC) for adults with moderate-to-severe atopic dermatitis who are candidates for systemic therapy in Europe and by the Medicines & Healthcare products Regulatory Agency (MHRA) 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. Tralokinumab is also approved for use in Canada, the United Arab Emirates and was approved by the U.S. Food and Drug Administration (FDA), in December, 2021. In January 2022, the Scottish Medicines Consortium (SMC) accepted tralokinumab for use within NHS Scotland.

Notes to editors

About the pivotal ECZTRA 1, 2, 3 and ECZTRA 7 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 tralokinumab (300 mg) as monotherapy in adults with moderate-to-severe atopic dermatitis who were candidates for systemic therapy. Primary endpoints were Investigator's Global Assessment (IGA) score of 0 or 1 at week 16 and ≥ 75% improvement in Eczema Area and Severity Index (EASI-75) at week 16.⁴

ECZTRA 3 (ECZema TRAlokinumab trial No. 3) was a double-blind, randomised, placebo-controlled, multinational 32-week trial, which included 380 adult patients, to evaluate the safety and efficacy of tralokinumab (300 mg) in combination with TCS in adults with moderate-to-severe atopic dermatitis who are candidates for systemic therapy. Primary endpoints were IGA score of 0 (clear) or 1 (almost clear) and EASI 75 at week 16.⁵

ECZTRA 7 (ECZema TRAlokinumab trial No. 4) was a double-blind, randomised, placebo controlled, multinational 26-week trial, which included 277 adult patients to demonstrate that tralokinumab in combination with topical corticosteroids (TCS) is superior to placebo in combination with TCS in treating severe AD in subjects who are not adequately controlled with or have contraindications to oral cyclosporine A (CSA). The primary endpoint was a 75% improvement in EASI 75 at week 16 (64.2% vs 50.5%; difference [95% confidence interval] 14.1% [2.5-25.7]; P=0.018).6

About atopic dermatitis

Atopic dermatitis is a chronic, inflammatory, skin disease characterised by intense itch and eczematous lesions. ¹⁰ Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation. ¹¹ Type 2 cytokines, including IL-13, play a central role in the key aspects of atopic dermatitis pathophysiology. ²

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

About NICE The National Institute for Health and Care Excellence (NICE) is an independent organisation set up by the Government to tackle the variation in availability and quality of healthcare in the NHS. NICE is funded by and accountable to the Department of Health and Social Care. NICE provide technology appraisals, clinical guidance and quality standards on treatments and care. This consists of recommendations on how to best identify, refer, diagnose, treat and manage patients based on the best evidence available. NICE is internationally recognised for its scientific robustness and the quality and accuracy of its recommendations. https://www.nice.org.uk/about

Contacts

Kate Barwise-Ennis

Senior Internal and External Engagement Manager

LEO Pharma

+44 7880 740096

kabar@leo-pharma.com

Sam Coldicutt 

Senior Account Manager

WE Communication

+44 20 7632 3838

scoldicutt@we-worldwide.com

References

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2. Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020; 75:54–62.
3. National Institute for Health and Care Excellence. Final Appraisal Document – abrocitinib, tralokinumab and upadacitinib for treating moderate to severe atopic dermatitis. June 2022.
4. Wollenberg A, et al. Tralokinumab for moderate‐to‐severe atopic dermatitis: results from two 52‐ week, randomized, double‐blind, multicentre, placebo‐controlled phase III trials (ECZTRA 1 and ECZTRA 2). Br J Dermatol. 2021; 437–449.
5. Silverberg JI, et al. Tralokinumab plus topical corticosteroids for the treatment of moderate‐to‐ severe atopic dermatitis: results from the double‐blind, randomized, multicentre, placebo‐controlled phase III ECZTRA 3 trial. Br J Dermatol. 2021; 450– 463.
6. Gutermuth J, et al. Tralokinumab plus topical corticosteroids in adults with severe atopic dermatitis and inadequate response to or intolerance of ciclosporin A: a placebo‐controlled, randomized, phase III clinical trial (ECZTRA 7). Br Journal of Dermatol. 2021.
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9. SmPC Guidance. Adtralza® (tralokinumab) 2021, Available at: https://www.ema.europa.eu/en/documents/product-information/adtralza-epar-product[1]information_en.pdf
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