A common arthritis drug has shown promise in regrowing hair of patients with alopecia areata, an autoimmune disorder resulting in sudden hair loss for which there is currently no Food and Drug Administration (FDA)-approved treatment.
One in three patients regrew hair in two Phase 3 clinical trials, the results of which are published in The New England Journal of Medicine. The trials’ success will likely prompt the FDA to approve the use of the drug as an alopecia treatment, offering hope to the almost 7 million people in the US who have it.
“Alopecia areata is a crazy journey, marked by chaos, confusion, and profound sadness for many who suffer from it,” Dr Brett King, associate professor of dermatology at the Yale School of Medicine and lead author of the new study, said in a statement.
“These large, controlled trials tell us that we can alleviate some of the suffering from this awful disease.”
Alopecia is an autoimmune condition that causes people to lose some or all of the hair on their scalp and/or body. It can affect people of any gender, ethnicity, and age, although it is most common in people under the age of 40.
While alopecia and arthritis may not seem likely bedfellows, both involve the body’s immune system attacking its own cells. For people with alopecia, it’s their hair follicles that are targeted, leading to rapid hair loss.
The team, from Yale University, were keen to see if this similarity could be exploited to develop a potential treatment for alopecia. Baricitinib is an arthritis drug that inhibits janus kinases (JAK) – a family of proteins that play a crucial role in the control of immune responses.
In two randomized trials, a total of 1,200 people with severe alopecia were given a daily dose of baricitinib (4 milligrams or 2 milligrams) or a placebo. After 36 weeks, one-third of the participants on the higher dose saw hair grow back, while both treatment groups saw an improvement in hair regrowth compared to the placebo.
Hair regrowth was measured using the Severity of Alopecia Tool (SALT), a scale from 0 (no scalp hair loss) to 100 (complete scalp hair loss). All trial participants initially had a score of at least 50, but by the end of the nine months, 35 percent of people on the higher dose and 20 percent of those on the lower dose had a score of 20 or less.
“This is so exciting,” King said. “The data clearly show how effective baricitinib is.”
However, the drug isn’t without side effects. Acne and higher cholesterol levels were reported by some individuals during the trials. Its ability to inhibit a component of the immune system could make those who take it more susceptible to infections.
It is also worth noting that the trials were funded by Eli Lilly, the company that develops baricitinib.
There have been various other drugs that have shown some promise in treating alopecia – an eczema drug and an immunosuppressant, for example – however, none have received FDA approval. Most are best at treating mild cases, and severe cases remain difficult to treat. There is also currently no cure – even after treatment alopecia often comes back – only around 10 percent of alopecia universalis (the most advanced form of alopecia) patients fully recover.
Whether or not baricitinib could be this sought-after cure, which proves effective in the long term, remains to be seen. But the trials are ongoing, meaning its long-term safety and efficacy will continue to be assessed.