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Tralokinumab in Atopic Dermatitis: A Profile of Its Use

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Abstract

Tralokinumab (tralokinumab-ldrm) [Adbry™ (USA); Adtralza® (EU)], a human IgG4 monoclonal antibody that binds specifically to interleukin (IL)-13, is an effective and generally well tolerated treatment option for adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy. In pivotal phase III trials, subcutaneous tralokinumab improved the clinical signs and symptoms of atopic dermatitis as well as quality of life (QOL). In ECZTRA 1 and 2, tralokinumab monotherapy was superior to placebo in the first 16 weeks of treatment, with improvements in pruritus and sleep scores seen as early as week 1. Many patients who met the criteria for clinical response at week 16 maintained this response at week 52. Tralokinumab was also more effective than placebo when used in combination with ‘as needed’ topical corticosteroids (TCS) in ECZTRA 3 and 7; most tralokinumab recipients used no or very little amounts of TCS. In an open-label extension trial, tralokinumab provided consistent symptom control over the longer term (up to 2 years). The majority of adverse events with tralokinumab, including injection-site reactions and conjunctivitis, were of mild to moderate severity. The tolerability profile of tralokinumab longer term was consistent with that in the phase III trials.

Plain Language Summary

Atopic dermatitis is an ongoing inflammatory skin condition that causes dryness, itching and redness. Standard first-line treatments include moisturizers and medical ointments that are applied directly to the skin. However, topical treatments often fail to adequately control symptoms in patients with moderate to severe disease. More recently, biological therapies have been developed that target the different inflammatory proteins involved in atopic dermatitis. Tralokinumab [Adbry™ (USA); Adtralza® (EU)] is a human monoclonal antibody that targets IL-13, a key protein involved in driving the signs and symptoms of atopic dermatitis. When given alone or together with topical corticosteroids, subcutaneous tralokinumab improves the signs and symptoms of atopic dermatitis in adults with moderate to severe disease and provides consistent long-term disease control. Patients treated with tralokinumab also report improvements in health-related quality of life. Adverse events seen with tralokinumab are generally mild or moderate in severity. Thus, subcutaneous tralokinumab offers a new effective and generally well-tolerated treatment option for adults with moderate to severe atopic dermatitis who require systemic therapy.

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Acknowledgments

The article was updated from Drugs 2021;81:1657–63 [39] and was reviewed by: R. Chovatiya, Department of Dermatology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA; S. R. Feldman, Department of Dermatology, Pathology & Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, NC, USA; M. Gooderham, SKiN Centre for Dermatology, Peterborough, ON, Canada; P. Y. Ong, University of Southern California Keck School of Medicine, Division of Clinical Immunology and Allergy, Children's Hospital Los Angeles, Los Angeles, CA, USA. During the peer review process, the marketing authorization holder of tralokinumab was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.

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    Hannah A. Blair

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Correspondence to Hannah A. Blair.

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Hannah Blair is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.

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Blair, H.A. Tralokinumab in Atopic Dermatitis: A Profile of Its Use. Clin Drug Investig 42, 365–374 (2022). https://doi.org/10.1007/s40261-022-01135-9

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