A drug that blocks the chemical messengers that are overactive in allergic reactions proved effective in clearing or reducing symptoms caused by atopic eczema, based on results from an international Phase III clinical trial led by OHSU in Portland, Oregon.
The study data published Oct. 1 in the New England Journal of Medicine online edition in conjunction with a presentation at the European Academy of Dermatology and Venereology show that dupilumab alleviated the skin lesions and intense itching that were previously untreatable by standard medications and often impacted large areas of a trial participant’s body. In turn, the drug also reduced the sleep deprivation, depression and anxiety participants suffered because of the severity of symptoms.
“We now have a promising new option for patients whose quality of life was severely diminished by their disease,” said Eric Simpson, M.D., M.C.R., director of the clinical studies unit in OHSU’s dermatology department and lead author on the study. “Additional clinical trials are needed to explore whether long-term use of dupilumab is safe, but it represents a potential new approach for our patients who have suffered without good options for far too long.”
For people with moderate-to-severe atopic eczema, existing topical therapies provide limited benefit and systemic treatments, such as steroids, are associated with substantial toxic effects and often, as a result, can’t be used for long periods of time. “There is a large unmet need for effective long-term medications for these patients,” Simpson added.
Dupilumab is a manufactured antibody provided in the form of an injectable drug that blocks abnormal immune system responses that drive diseases such as atopic eczema, atopic dermatitis, asthma and chronic sinusitis with nasal polyps.
The 16-week, randomized Phase III trials tested participants’ responses in three ways and in two groups with 671 participants in the first group and 708 participants in the second. Participants received either: a weekly dose of dupilumab; a dose every other week or placebo injections. All participants enrolled in the trial were aged 18 years or older, had moderate to severe forms of disease that didn’t respond to existing treatments or who were unable to use existing drugs.
In the first study, called SOLO 1, 38 percent of participants, who received the drug every other week saw a clearing or near clearing of skin lesions as did 37 percent who received it weekly. Only 10 percent of participants who only received the placebo also experienced this response. Results were similar in the second group, SOLO 2, with 36 percent of participants who received the treatment every other week, as well as those receiving it weekly, experiencing a complete clearing or near-full response. In the second study, 8 percent of those who received a placebo similarly improved.
In addition, participants experienced significant reduction in itching in the dupilumab-treated groups when compared to placebo - the most troubling symptom for participants. Dupilumab-treated participants also experienced significant reductions in measures of anxiety and depression, two common conditions that can accompany the disease.
Side effects for those who received the drug included reactions at the site of injection and conjunctivitis, or pinkeye; two deaths were reported among participants who were treated with dupilumab that were determined to be not related to the drug. Larger trials of longer duration are needed to assess the effectiveness and safety of long-term treatment with dupilumab, and these studies are underway.
Dupilumab is currently under clinical development and its safety and efficacy have not been fully evaluated by any regulatory authority. The drug’s makers, Regeneron Pharmaceuticals Inc. and Sanofi, announced in late September that the U.S. Food and Drug Administration will conduct a priority review of the treatment for adults.
The Phase III trials were fully funded by Sanofi and Regeneron Pharmaceuticals.
In the interest of ensuring the integrity of our research and as part of our commitment to public transparency, OHSU actively regulates, tracks and manages relationships that our researchers may hold with entities outside of OHSU. In regards to these research projects, Simpson has a financial interest in Regeneron, a sponsor of this research. Review details of OHSU's conflict of interest program to find out more about how we manage these business relationships.