A few weeks ago, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) gave a positive opinion in favor of the drug Olumiant (baricitinib), which is used to treat severe alopecia areata in adults. In this way it became the first specific treatment for this immunological pathology whose effects go far beyond the usual hair loss.
Now, the Food and Drug Administration (FDA) of the United States has also reported that it has decided to approve this drug against patchy baldness based on two clinical trials that have shown the efficacy and safety of this drug. In this way, the first approval of this organism for a systemic treatment against alopecia areata is formalized, that is, a drug that treats the entire body instead of a specific location.
Alopecia areata – commonly known simply as alopecia – is an autoimmune disorder in which the body begins to attack its own hair follicles, causing the hair to loosen from the root and fall out intensely. The drug Olumiant, developed by the pharmaceutical company Eli Lilly and Company, works by inhibiting Janus kinase (JAK), which directly interferes with the pathway that causes inflammation and hair loss.
Up to 80% more hair on the scalp
In the two studies that have looked at the effectiveness and safety of this drug, trial AA-1 and trial AA-2, participants had at least 50% hair loss for more than six months. To test baricitinib, they were divided into groups and given 2 mg of this drug, 4 mg or placebo daily.
The most common side effects after taking Olumiant were headaches, acne, respiratory infections, fatigue, and folliculitis.
Results indicated that at least 80% scalp hair regrowth was achieved in both studies at week 36, a substantial improvement for adult patients with severe alopecia areata. The researchers stated that the combination of Olumiant with other JAK inhibitors, such as cyclosporine, biologic immunomodulators, or other potent immunosuppressants, is not recommended.
As for the side effects after taking this drug, the trials indicated that the most common were headaches, upper respiratory tract infections, acne, high cholesterol, urinary tract infection, increased creatinine phosphokinase enzyme, fatigue, increased of liver enzymes, folliculitis, genital candidiasis, anemia, abdominal pain, weight gain, and shingles.
This drug had previously been approved by the FDA in 2018 as a treatment for some patients with moderate to severe rheumatoid arthritis and was also given the green light as a treatment for COVID-19 in certain hospitalized patients.
.