The Food and Drug Administration has approved the monoclonal antibody tralokinumab-ldrm (Adbry) for the treatment of moderate to severe atopic dermatitis (a severe form of eczema) in adults whose disease has not been controlled by topical therapies. Tralokinumab-ldrm can be used with or without topical corticosteroids. The drug is administered by subcutaneous injection.

Atopic dermatitis is a chronic allergic reaction characterized by itchy, red, and irritated skin. For reasons still unknown, people with atopic dermatitis have disordered and overactive immune systems that produce inflammation that damages the skin barrier. Atopic dermatitis is associated with elevated levels of immunoglobulin E (IgE). Tralokinumab-ldrm specifically binds to interleukin-13 (IL-13)-a key stimulus of inflammation in atopic dermatitis-and inhibits its action, preventing the release of proinflammatory cytokines, chemokines, and IgE.

The efficacy of tralokinumab-ldrm was assessed in three randomized, double-blind, placebo-controlled trials of 1,934 adults 18 years of age or older with moderate to severe atopic dermatitis not controlled by topical medications. Disease severity was defined as an Investigator Global Assessment (IGA) score of >= 3 in the overall assessment of atopic dermatitis lesions (on a severity scale of 0 to 4), an Eczema Area and Severity Index (EASI) score of >= 16 (on a scale of 0 to 72), and a minimum body surface area involvement of >= 10%. Effectiveness was determined by IGA scores of 0 or 1 (clear or almost clear) or an EASI score improvement of at least 75% at week 16. The drug was administered every other week for the first 16 weeks. At week 16, more patients treated with tralokinumab-ldrm than placebo achieved an IGA score of 0 or 1 (38.9% versus 26.2%) and an EASI score improvement of at least 75% (56% versus 35.7%).1 After 16 weeks, those who had met these end points were rerandomized to receive the drug every two weeks, every four weeks, or to receive placebo for 16 more weeks. Tralokinumab-ldrm continued to have a positive response at week 32.1

The most common adverse effects of treatment are upper respiratory tract infections, conjunctivitis, injection site reactions, and eosinophilia. Keratitis and hypersensitivity reactions, including anaphylaxis and angioedema, are possible. Because of the changes in the immune system from tralokinumab-ldrm, the risk of an infection increases if a live vaccine is given.

Nurses should confirm that the patient is up to date on all vaccines prior to starting tralokinumab-ldrm treatment because live vaccines must be avoided once treatment has begun and safety data are limited on the use of nonlive vaccines in someone treated with tralokinumab-ldrm. As IL-13 promotes excessive mucus secretion and expulsion of parasitic worms, nurses should assess and treat patients for helminth infections prior to starting tralokinumab-ldrm. If a helminth infection occurs during treatment, and the patient does not respond to antihelminth treatment, tralokinumab-ldrm should be discontinued until the infection resolves.

Nurses must teach patients how to administer tralokinumab-ldrm subcutaneously. Although the drug comes in a prefilled syringe, more than one syringe is needed to deliver the prescribed dose. Either two or four injections are required. These injections can be given in the same area (for example, in the left thigh), so long as each is at least one inch apart from the others. Patients should be taught to rotate injection sites.

For complete prescribing information for tralokinumab-ldrm, go to http://www.leo-pharma.us/Files/Billeder/US%20Website%20Product%20PIs/AdbryPI.pdf.

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