The mean decline in body surface area was “consistently stronger” among those on the biologic, “and was significantly different from the placebo group starting from week 8 until the end of study,” which included the 12th week (P = .009), the researchers noted.
In addition, among those on fezakinumab, mean improvements in Investigator Global Assessment scores compared with baseline were stronger and appeared earlier and were significantly different compared with those on placebo at week 16 (P less than .001).
There were two serious adverse events among those in the treatment group: facial cellulitis after a dental procedure and a pregnancy with elective termination, which were considered “most likely unrelated” to treatment. In the fezakinumab group, four patients had upper respiratory tract infections, the most common adverse event.
“This is the first clinical trial investigating IL-22 blockade in patients with AD, and the first to suggest a pathogenic role of IL-22 in any human disease,” the authors concluded.
SOURCE: Guttman-Yassky et al. J Am Acad Dermatol. 78(5);872-81.
Correction, 4/27/17: An earlier version of this article misstated the statistical significance of the primary endpoint.