Regeneron and Sanofi's AD Drug Dupilumab Performs Well in Phase III Studies
Dupilumab improves the signs and symptoms of atopic dermatitis including pruritus, anxiety/depression symptoms, and quality of life, according to two Phase III clinical trials published in the New England Journal of Medicine in conjunction with a presentation at the European Academy of Dermatology and Venereology in Vienna, Austria.
Dupilumab is currently under clinical development. 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.
In the studies, dupilumab alleviated the skin lesions and intense itching that were previously untreatable with standard medications and often impacted large areas of a trial participant's body and 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,” says study author Eric Simpson, M.D., M.C.R., director of the clinical studies unit in Portland's Oregon Health & Science University's dermatology department. "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.”
About the SOLO Trials
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. Dupilumab-treated participants also experienced significant reductions in measures of anxiety and depression, two common conditions that can accompany the disease.
Larger trials of longer duration are needed to assess the effectiveness and safety of long-term treatment with dupilumab, and these studies are underway, the study authors note.
Dupilumab side effects 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.
The Phase III trials were fully funded by Sanofi and Regeneron Pharmaceuticals.