Tralokinumab

Tralokinumab is a human monoclonal IgG4 antibody that, unlike Dupilumab, binds specifically to the interleukin-13 cytokine (IL-13). IL-13 plays an essential role in the pathogenesis of atopic dermatitis and bronchial asthma. Blocking IL-13 inhibits the interaction with the receptor and prevents the subsequent downstream IL-13 signal transmission. The therapeutic success with tralokinumab in atopic dermatitis (but not in asthma) supports the hypothesis that blocking the cytokine IL-13 alone is sufficient to improve the symptoms of atopic dermatitis.

Asthma: Tralokinumab was primarily developed for the treatment of severe, uncontrolled asthma. Here, the efficacy and safety of tralokinumab could not be adequately demonstrated. Further testing in this condition was therefore discontinued (Panettieri RA Jr et al 2018).

Atopic dermatitis: In contrast, tralokinumab rapidly and persistently relieved symptoms of atopic dermatitis in a phase II study (Wollenberg A et al. 2019). Tralokinumab was shown to have good effects both as monotherapy and in combination with topical corticosteroids in adults with moderate-to-severe atopic dermatitis.

In June 2018, a phase IIb study was published that illustrated that the monoclonal antibody tralokinumab successfully relieved symptoms in patients with moderate-to-severe AD. This study also evaluated the effect of tralokinumab on health-related quality of life compared to placebo in 52 adult patients. Patients treated with the antibody showed statistically significant and clinically relevant improvements compared with placebo in nearly all aspects of health-related quality of life from week 12 (Silverberg J et al. 2018).

Tralokinumab has been approved for the treatment of moderate-to-severe atopic dermatitis in adults since June 2021.

Tralokinumab (Adtralza®⁾ has been approved since 2022 for patients 12 years of age and older with moderate-to-severe atopic dermatitis (AD).

1. Panettieri RA Jr et al (2018) Tralokinumab for the treatment of severe, uncontrolled asthma: the ATMOSPHERE clinical development program. Immunotherapy 10: 473-490.
2. Panettieri RA Jr et al (2018) Tralokinumab for severe, uncontrolled asthma (STRATOS 1 and STRATOS 2): two randomised, double-blind, placebo-controlled, phase 3 clinical trials. Lancet Respir Med 6:511-525.
3. Parker JM et al (2018) A phase 2 randomized controlled trial of tralokinumab in subjects with idiopathic pulmonary fibrosis. Am J Respir Crit Care Med 197:94-103.
4. Russell RJ et al (2018) MESOS study investigators. Effect of tralokinumab, an interleukin-13 neutralising monoclonal antibody, on eosinophilic airway inflammation in uncontrolled moderate-to-severe asthma (MESOS): a multicentre, double-blind, randomised, placebo-controlled phase 2 trial. Lancet Respir Med 6: 499-510.
5. Silverberg J et al: Treatment with tralokinumab improves healthrelated quality of life in adult patients with moderate to severe atopic dermatitis: results from a phase 2b, randomized, double-blind, placebo-controlled study. EADV 2018; Abstract P0281.
6. Wollenberg A et al (2019) Treatment of atopic dermatitis with tralokinumab, an anti-IL-13 mAb. J Allergy Clin Immunol 143:135-141.
7. Wollenberg A et al.(2022) European guideline (EuroGuiDerm) on atopic eczema: part I - systemic therapy. J Eur Acad Dermatol Venereol 36:1409-1431.
8. Professional information Adtralza®, as of October 2022, LEO Pharma.