NEW PHASE THREE DATA
In March 2017, the U.S. Food and Drug Administration (FDA) approved dupilumab injection, with or without topical corticosteroids, for the treatment of adults with moderate to severe eczema atopic dermatitis when topical therapies don’t provide adequate control or are inadvisable.
That approval was based in part on safety and efficacy data from three placebo-controlled clinical trials including a total of 2,119 adult participants with moderate to severe AD that was not adequately controlled by topical medication.
Similar to what was seen in those previous trials, the phase three study presented at EADV (known as CAFÉ) show that dupilumab with topical corticosteroids significantly improved overall measures of disease severity, including lesions, itch, quality of life measures and symptoms of anxiety and depression, with a safety profile consistent with what was previously observed for this agent.
The primary endpoint in the CAFÉ study was the proportion of patients achieving a 75% or greater improvement in Eczema Area and Severity Index (EASI-75) score at 16 weeks from baseline. Investigators reported that 59% of patients receiving dupilumab plus TCS achieved EASI-75, compared with 30% of patients receiving placebo plus TCS (P < 0.0001). Secondarily, they found that the mean percent change improvement in EASI was 78% and 80%, respectively, for patients receiving dupilumab weekly and every 2 weeks, respectively, compared with 47% in the placebo arm (P < 0.0001).
The proportion of patients reporting an adverse event was similar among dupilumab and placebo treatment arms, according to Dr. Thaçi. Conjunctivitis was more frequent in patients who received dupilumab with TCS, with 16% and 28% reported in the dupilumab weekly and every 2 weeks groups, versus 11% for the placebo arm.
“Dupilumab and cyclosporine A have not been evaluated in a head-to-head trial, so we cannot compare their safety profiles objectively,” Dr. Thaçi said. “However, with dupilumab we do not observe serious or severe infections, no liver or kidney nephrotoxicity, and no limitation of treatment due to comorbidities and concomitant medication. All of these are known side effects of CSA, which limits the use of CsA in a real world population.”