Safety data show Adbry well tolerated in treatment of moderate to severe atopic dermatitis
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The results of pooled safety data for Adbry showed positive effects in the prolonged treatment of moderate to severe atopic dermatitis, according to a study.
Adbry (tralokinumab, LEO Pharma) is the only FDA-approved biologic that specifically binds to and inhibits the interleukin (IL)-13 cytokine, one of the drivers of atopic dermatitis.
“We know that moderate to severe atopic dermatitis is not a 16-week disease. It’s often a 16-year or a lifetime disease, so we need data to make us comfortable with chronic treatment,” Eric L. Simpson, MD, MCR, Frances J. Storrs Medical Dermatology Professor and director of the OHSU Dermatology Clinical Research Center School of Medicine at Oregon Health & Science University, told Healio. “We’ve found that, with tralokinumab, the blockade of IL-13 cytokine is an extremely safe option for long term therapy for moderate to severe atopic dermatitis.”
Published in the British Journal of Dermatology, the analysis pooled data from five randomized, double-blind, placebo-controlled trials — three pivotal phase 3 trials, a phase 2 trial and a phase 2b trial.
In total, the studies randomly assigned 2,285 patients to tralokinumab (n = 1,605) or placebo (n = 680). During the 16-week initial treatment period, the frequencies of any adverse events were 65.7% for tralokinumab and 67.2% for placebo. Serious adverse events were reported in 2.1% of the tralokinumab groups and 2.8% of the placebo groups.
The most common adverse events reported more frequently with tralokinumab compared with placebo included viral upper respiratory tract infection (15.7% vs. 12.2%), upper respiratory tract infection (5.6% vs. 4.8%), conjunctivitis (5.4% vs. 1.9%) and injection-site reaction (3.5% vs. 0.3%).
Those treated with tralokinumab vs. placebo saw lower rates of skin infections requiring systemic treatment (2.6% vs. 5.5%), eczema herpeticum (0.3% vs. 1.5%), opportunistic infections (3.4% vs. 4.9%) and serious infections (0.4% vs 1.1%).
Tralokinumab outperformed placebo in safety over time with no significant changes in adverse events.
“The adverse event rate in the long term is lower than the short term. And so, your rates of adverse events do not increase over time. In fact, they reduce significantly,” Simpson said. “You could make the claim that Adbry is a safer drug with more prolonged treatment.”
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