The biologic dupilumab had a breakthrough designation when it received FDA approval earlier this year.
Use of dupilumab was associated with a 46% reduction in skin infections among patients with moderate-to-severe atopic dermatitis (AD), compared with placebo, according to a meta-analysis published this week in the Journal of the American Academy of Dermatology.
The analysis was a review of 8 randomized controlled trials that involved 2706 patients, with follow-up times that ranged from 4 to 52 weeks. Researchers Patrick Fleming, MD, MSc, and Aaron M. Drucker, MD, ScM, wrote that it was not clear what mechanism led to the reduction in skin infections, “but it is likely related to improvement in AD severity.”
Dupilumab, sold as Dupixent, received “breakthrough” designation before it was approved by FDA earlier this year. It is intended for patients who whose condition has not improved with use of topical treatments, or who are not advised to take these treatments. Dupilumab, a biologic, works on 2 interleukins that are believed to trigger AD by binding to their cell receptors to calm the inflammatory response and reduce the symptoms.
Because AD is a chronic condition, patients are advised to remain on the drug. The regimen requires 2 subcutaneous injections a month, compared with skin care regimens for severe AD that could take up to an hour a day. In clinical trials, 70% of patients taking dupilumab saw some improvement and 37% showed clearing or near-clearing of skin lesions.
The authors of the new meta-analysis wrote that the findings suggest the markedly lower rates of skin infection were due to the improvement of AD activity, “rather than a specific effect of dupilumab.”
“Examining patient-level data on AD severity and skin infections in the dupilumab RCTs would help provide further insights into this relationship,” they wrote.
When lesions fail to clear, patients can experience a complication called eczema herpeticum, a rare, but serious, infection caused by herpes simplex viruses that can lead to death. It requires treatment with antiviral medications. It is caused when those who have an open AD lesion come into skin-to-skin contact with someone carrying the virus.
The authors of the meta-analysis write that the interleukins active in AD can cause the herpes simplex virus to spread; thus, taking dupilumab with its interleukin blockers “may have specific antiviral effects.” However, the effect of the drug on other herpes infections is less clear, and the authors did not find an association between dupilumab and an overall reduction in herpes virus infections.
Fleming P, Drucker AM. Risk of infection in patients with atopic dermatitis treated with dupilumab: a meta-analysis in randomized controlled trials [published online October 4, 2017]. J Am Acad Dermatol. 2017; doi: 10.1016/j.jaad.2017.09.052.