For patients with moderate-to-severe atopic dermatitis, tralokinumab is well tolerated, according to research published in the December issue of the British Journal of Dermatology .

Eric L. Simpson, M.D., from the Oregon Health & Science University in Portland, and colleagues characterized the safety profile of tralokinumab for the treatment of moderate-to-severe atopic dermatitis in pooled analyses of phase II and phase III placebo-controlled clinical trials.

A total of 2,285 patients were randomly assigned in the initial treatment periods up to 16 weeks (1,605 and 680 to tralokinumab and placebo, respectively). The researchers found that for tralokinumab and placebo, the frequencies of any adverse event were 65.7 and 67.2 percent, respectively. Per 100 patient-years of exposure (ep100PYE), the corresponding rates were 640 and 678 events. Serious adverse events occurred in 2.1 and 2.8 percent of those receiving tralokinumab and placebo, respectively (7.4 and 11.9 ep100PYE). Viral upper respiratory tract infection, upper respiratory tract infection, conjunctivitis, and injection-site reactions were the most common adverse events occurring at a higher frequency and rate with tralokinumab versus placebo. No increase in adverse events was seen with continued maintenance and open-label treatment, including rates of common or serious adverse events or those leading to drug discontinuation.

"This analysis from a large pool of patients exposed to tralokinumab for an extended period of time reaffirms the safety profile of tralokinumab, as it was well tolerated both in combination with topical corticosteroids and as monotherapy with long-term use up to 52 weeks for moderate-to-severe atopic dermatitis," the authors write.

Several authors disclosed financial ties to pharmaceutical companies, including Leo Pharma, which manufactures tralokinumab.

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