The Scottish Medicines Consortium accepts the use of Adtralza®▼(tralokinumab) for adult patients with moderate-to-severe atopic dermatitis who are candidates for systemic therapy
- Tralokinumab is the first approved biologic available to specifically target the IL-13 cytokine only, a driver of atopic dermatitis signs and symptoms, for use within NHS Scotland.,,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, 17 JANUARY, 2022 – The Scottish Medicines Consortium (SMC) has issued advice accepting tralokinumab for use within NHS Scotland for the treatment of moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic therapy.3 The SMC recommendation makes tralokinumab the first and only recommended biologic that specifically targets the IL-13 cytokine alone, a driver of atopic dermatitis signs and symptoms, for use within NHS Scotland.1,2,3
Tralokinumab is the first high affinity, 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.7 Tralokinumab can be used with or without topical corticosteroids (TCS).7
“This moment marks a milestone for LEO Pharma and tralokinumab. The Scottish Medicines Consortium (SMC) decision in the UK clearly underscores the unmet need for people living with atopic dermatitis and the importance of biologic treatment options. Thank you to all the LEO employees who have supported the tralokinumab SMC submission process,” said Sarah Kleinpeter, Vice President and General Manager of UK and Ireland at LEO Pharma.
“The SMC acceptance of tralokinumab is a significant milestone for adults in Scotland living with atopic dermatitis. The condition can cause serious physical discomfort and emotional distress, tralokinumab is an important new treatment option for patients,” said Dr Alison MacDonald, Consultant Dermatologist, Glasgow Royal Infirmary.
The evidence supporting the efficacy and safety of tralokinumab comes from four randomised, multicentre, 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) on the 27th December, 2021.
The full SMC advice can be found below:
ADVICE: following a full submission
Tralokinumab is accepted for restricted use within NHS Scotland.
Indication under review: treatment of moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic therapy.
SMC restriction: as monotherapy or in combination with topical corticosteroids or topical calcineurin inhibitors, in patients who have had an inadequate response to an existing systemic immunosuppressant such as ciclosporin, or in whom such treatment is considered unsuitable.
Four phase III studies demonstrated superiority of tralokinumab in improving signs and symptoms of atopic dermatitis when compared with placebo, as monotherapy or in combination with topical corticosteroids in patients with moderate-to-severe atopic dermatitis.3
This advice applies only in the context of an approved NHS Scotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.
1. 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.
3. Scottish Medicine’s Consortium. Medicines advice. Tralokinumab (Adtralza®▼). 17 January 2022. Available from https://www.scottishmedicines.org.uk/medicines-advice/tralokinumab-adtralza-full-smc2403/ (Accessed January 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.
7. SmPC Guidance. Adtralza® (tralokinumab) 2021, Available at: https://www.ema.europa.eu/en/documents/product-information/adtralza-epar-product-information_en.pdf
8. Weidinger S, Beck LA, Bieber T, Kabashima K, Irvine AD. Atopic dermatitis. Nat Rev Dis Primers. 2018 Jun 21;4(1):1.
- Boguniewicz M, et al. Atopic dermatitis: a disease of altered skin barrier and immune dysregulation. Immunol Rev. 2011; 242(1):233–46.
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