The study is based on Phase 3 clinical trials using baricitinib, a Janus kinase (JAK) inhibitor, to treat alopecia areata, an often-disfiguring skin disease characterized by rapid loss of scalp hair, and sometimes eyebrows and eyelashes.
Phase 3 clinical trials are the final testing hurdle before a new treatment can be considered for U.S. Food and Drug Administration (FDA) approval.
“This is so exciting, because the data clearly show how effective baricitinib is,” said Dr. Brett King, an associate professor of dermatology at the Yale School of Medicine and lead author of the new study, published March 26 in the New England Journal of Medicine. “These large, controlled trials tell us that we can alleviate some of the suffering from this awful disease.”
Before and after images for participants who received 36 weeks of treatment for alopecia areata with baricitinib.
Alopecia areata is an autoimmune disorder in which the body’s immune system attacks hair follicles. More than 200,000 new cases emerge each year in the United States. Although alopecia areata can develop in patients of any age, it typically occurs in people under the age of 40.
There is currently no FDA-approved treatment for the disease.
For the new study, King and his colleagues conducted two large, randomized trials involving a total of 1,200 people. The participants were adults with severe alopecia areata, who had lost at least half of their scalp hair; many had lost all of their scalp hair.