Tralokinumab

Author: Prof. Dr. med. Peter Altmeyer

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Last updated on: 29.10.2020

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Definition
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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.

Field of application/use
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Asthma: Tralokinumab was primarily developed for the treatment of severe, uncontrolled asthma. The efficacy and safety of tralokinumab has not been adequately demonstrated. Further testing in this clinical picture was therefore discontinued (Panettieri RA Jr et al. 2018).

Atopic dermatitis: In contrast, tralokinumab rapidly and persistently relieved the symptoms of atopic dermatitis in a phase II study (Wollenberg A et al. 2019). Tralokinumab has shown good efficacy 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 showing that the monoclonal antibody tralokinumab successfully relieved symptoms in patients with moderate to severe AD. This study also investigated 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 over placebo in almost all aspects of health-related quality of life from week 12 onwards (Silverberg J et al. 2018).

Tralokinumab has not yet been approved.

Literature
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  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 the treatment of 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 Study of Tralokinumab in Subjects with Idiopathic Pulmonary Fibrosis. At 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, on anti-IL-13 mAb. J Allergy Clin Immunol 143:135-141.

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Last updated on: 29.10.2020