FDA Approves Arthritis Drug for Hair Regrowth in Alopecia Patients

Alopecia areata often causes people to lose hair in chunks, leaving their head patchy or bald, or rendering eyebrows and eyelashes bare. Getting that hair to regrow can be challenging—existing treatments require patients to regularly visit their dermatologist, deal with painful injections, or risk uncomfortable side effects.

The condition can be “psychologically distressing” for patients, said Melissa Piliang, MD, an alopecia expert and dermatologist at the Cleveland Clinic.

For the first time, the Food and Drug Administration approved a drug last week to systemically treat patients with severe alopecia areata. With a once-a-day pill, patients with substantial hair loss may see hair regrowth within months.

Alopecia areata is an autoimmune condition that interferes with the body’s ability to grow hair. While it most often affects the scalp, some people lose eyelashes, eyebrows, and nose hairs—all of which functionally keep sweat and dirt out of the eyes and nose.

“I think people often have the perception that alopecia areata is more of a cosmetic problem because of the hair loss,” Piliang said. “People think, ‘I’m sure it’s terrible for teenagers.’ I’ll tell you, it is terrible at all ages. I have patients who are in their 70s who are in tears about their alopecia areata. It’s really important that we have safe and effective treatments for our patients.”

The drug, called Olumiant (baricitinib), is already on the market as a treatment for rheumatoid arthritis and other inflammatory diseases.

In clinical trials, one in three patients with severe alopecia who took the drug daily saw hair regrowth. Nearly half of these patients had no scalp hair when the trials started and regained 80% of their hair coverage after six months.

Emma Guttman, MD, PhD, director of the Alopecia Areata Center of Excellence at Mount Sinai Hospital in New York, said the treatment is “very exciting” for the nearly 7 million people in the United States who have or will develop alopecia in their lifetime.

“It opens a new era for alopecia,” Guttman said. “I have many patients who really gave up at some point because there was nothing there. And now, I think the message to patients is ‘you have hope, you have new drugs—one is already approved and others are coming.’ It’s a hopeful message for patients.”

How Baricitinib Works

Most people have what’s called “immune privilege,” which protects certain parts of the body—like hair follicles—from damage from inflammatory immune responses. In people with alopecia, this immune privilege breaks down and white blood cells attack groups of hair follicles, stopping the normal hair growth process.

Baricitinib works by inhibiting a group of enzymes called Janus kinase (JAK) inhibitors. JAKs usually promote inflammation, so interfering with them can keep the immune system from attacking follicles, allowing hair to grow normally.

In 2018, the FDA approved baricitinib for rheumatoid arthritis. Last month, the drug was also approved to treat adults who are hospitalized for COVID-19.

In two randomized, double-blind trials, researchers tracked hair regrowth in people who received 2 milligrams of Olumiant, 4 milligrams of the drug, or a placebo. By six months of starting the medication, more than 35% of the participants who had taken the higher dosage regrew at least 80% of their hair.

Some patients with alopecia may lose all their hair. Regaining even three-quarters of their hair, Piliang said, feels like a success.

To be effective at spurring hair regrowth, baricitinib must be taken every day. In some studies, patients who stopped taking the drugs daily saw hair shedding.

“They work only when you use them—they don't cure the disease,” Piliang said. “Once you start, you’re signing up to continue taking this medication long-term.”

The drug can affect the liver or kidney. And because it’s an immune suppressant, people who use it can be at a higher risk for infections.

A Promising Treatment, But Not a Cure

Researchers have studied biologic drugs that could work against alopecia for years. From that research, JAKs inhibitors stood out as the most promising treatments, Piliang said.

Health providers have prescribed JAKs inhibitors, including baricitinib, off-label for years. But Piliang said these drugs were expensive, and providers often had a hard time getting insurance companies to cover the costs because they weren’t licensed for alopecia.

Olumiant has a list price of $2,500 per month. With the FDA approval, insurance companies may cover more of that cost, and health providers may feel more comfortable prescribing it to their patients with alopecia.

The FDA has only approved the drug for people with severe alopecia. But people who have more limited disease might benefit from it, too, Guttman said. The earlier that an alopecia patient receives treatment, the more likely they are to have sustained hair regrowth.   

“What’s mild to moderate today may be moderate to severe tomorrow. You cannot tell with this disease—it’s unpredictable,” Guttman said.

There are other, non-systemic treatments for alopecia, such as injectable steroids and topical medications. But these options come with side effects and can be challenging to administer.

Guttman said there are other JAK inhibitors in the pipeline for FDA evaluation. If approved, these drugs could increase the number of options for patients with moderate to severe alopecia. And researchers are studying ways to cure the disease so that patients don’t depend on a daily pill to see hair regrowth.

“The wishful thinking is that at some point, we will be able to give patients some drugs for a while and then stop and they will not need to take them again. But we are not there yet,” Guttman said.