Dermatology researchers at the University of Oregon recently published two Phase 3 trials of Dupilumab in eczema. Phase 3 trials are the ones that can lead to FDA approval of a new drug. These trials were very successful.
Dupilumab is a human monoclonal antibody against interleukin-4 receptor alpha. Interleukin-4 is a cytokine (inflammatory molecule) that is an important cause of allergic eczema. The studies were done on 1,500 patients with moderate-to-severe eczema that was not responding to topical medications. In one of the trials, patients received injections of Dupilumab weekly, and in the other trial the injections were every two weeks. Both groups showed more than a 75% improvement in their rash compared to placebo. Not only did the rash improve, but there also was great reduction in itching and anxiety/ depression. Finally, quality of life assessments showed marked improvement. In people with moderate-to severe eczema skin rash can cover large parts of the body’s surface. This rash is accompanied by intense, persistent itching which leads to sleep deprivation and symptoms of anxiety and depression. For many people with this measure of eczema, topical therapies just don’t work. The available systemic treatments are often associated with significant toxicity or side effects. Hence, there is a great need for a safe and effective long-term therapy. Dupilumab seems to fit this need. The two main side effects were injection site swelling (8 to 19%) and conjunctivitis (2 to 5%).