Safety of tralokinumab for the treatment of atopic dermatitis

Tralokinumab is a new biologic drug, known as a monoclonal antibody. This is a manufactured antibody designed to block a speciﬁc section of the immune system, which in this case is a substance called interleukin-13. This interleukin plays a key role in causing the inﬂammation involved in atopic dermatitis. This study was designed to assess the safety and side-effects recorded in clinical trials of this drug in adults with moderate or sev-ere atopic dermatitis. The study examined the results from 2285 patients (1605 patients on tralokinumab, and 680 patients on placebo, which looked like the drug being tested but did not contain any medicine) who were treated for up to 16 weeks at cen-tres around the world. The occurrences of any type of adverse event (side-effect) were 66% and 67% for those receiving tralokinumab and placebo, respectively, and of these 2% and 3% were rated as serious. The most common side-effects were upper (nose and throat) and lower (chest and lungs) respiratory infections, redness and dis-comfort at the injection site, and conjunctivitis. These occurred slightly more commonly in the patients receiving tralokinumab. In contrast, skin infections that required oral antibiotics or antiviral medicines were seen less frequently in those treated with tralokinumab. These outcomes did not change if treatment was prolonged for up to 1 year. Overall, the study ﬁndings suggest that the new drug, tralokinumab, is well tolerated and safe for the treatment of atopic dermatitis for periods of up to 1 year.