The National Institute for Health and Care Excellence (NICE) has issued a positive Final Appraisal Document (FAD) recommending Adtralza®▼(tralokinumab) for use within NHS England and Wales.
The recommendation is 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
Sarah Kleinpeter, Vice President and General Manager of UK and Ireland at LEO Pharma said: “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.”
Professor Anthony Bewley, Consultant Dermatologist, Barts Health NHS Trust said: “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.”
Andrew Proctor, Chief Executive of the National Eczema Society said: “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.”
- Popovic B, et al. Structural Characterization reveals mechanism of IL-13-neutralising monoclonal antibody tralokinumab as inhibition of binding to IL-13Rα1 and IL-13Rα2. J Mol Biol. 2017 Jan 20;429(2):208-219.
- Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020; 75:54–62.
- National Institute for Health and Care Excellence. Final Appraisal Document – abrocitinib, tralokinumab and upadacitinib for treating moderate to severe atopic dermatitis. June 2022.
- 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.
- 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.
- 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.
- Barbarot, S., Auziere, S., Gadkari, A., Girolomoni, G., Puig, L., Simpson, E., Margolis, D., Bruin‐Weller, M. and Eckert, L., 2018. Epidemiology of atopic dermatitis in adults: Results from an international survey. Allergy, 73(6), pp.1284- 1293.
- Global Patient Initiative for Improved Eczema Care Dashboard 2022, Available at: https://www.improveeczemacare.com/dashboard
- SmPC Guidance. Adtralza® (tralokinumab) 2021, Available at: https://www.ema.europa.eu/en/documents/product-information/adtralza-epar-productinformation_en.pdf