July 19, 2022 – For many people with severe alopecia, who have lived with baldness, or with sparsely hairy scalps, or with missing eyebrows or eyelashes, the future has a new look.

“There’s this incredible momentum,” Brett King, MD, associate professor of dermatology at Yale University School of Medicine in New Haven, CT, said during a recent webinar hosted by the National Alopecia Areata Foundation. .

First oral treatment recently approved

Much of this momentum comes from the first FDA-approved systemic drug for severe alopecia areata. (Severe illness is characterized by at least 50% hair loss.)

The drug, made by Eli Lilly, is called baricitinib, which is part of the class of Janus kinase (JAK) inhibitors. Two other JAK inhibitors for the disease (one from Pfizer and another from Concert Pharmaceuticals) are showing promising results in phase III clinical trials and also might not be far from being approved, he said.

Baricitinib was approved last month by the FDA, and patients will soon be able to get it by prescription.

It had previously been approved for patients with rheumatoid arthritis. It was then tested in clinical trials with patients with alopecia areata who had at least 50% hair loss.

King is a pioneer in the use of JAK inhibitors in the treatment of disease, and he has conducted several clinical trials to test their effectiveness.

With alopecia areata, which affects up to nearly 7 million people in the United States each year, the body attacks its own hair follicles, for reasons that are only just beginning to be understood. JAK inhibitors can help interrupt this cycle.

What hasn’t worked in clinical trials are topical JAK inhibitors, King says, although some patients referred to him spend as much as $400 a month on these treatments.

“It’s terrible,” he said. “There are no data indicating that topical JAK inhibitors are effective for severe alopecia areata.”

Treatments won’t work for everyone

King said oral JAK inhibitors don’t work for everyone with severe hair loss, and there are few answers as to why.

“One of the reasons why some people don’t succeed is that their hair loss has been severe for too long. And we believe that approaching 10 years or more often, not always, often leads to a poor prognosis,” said he declared.

“It’s an important thing for everyone to hear,” he said. “We don’t want severe hair loss to last too long before we treat it. To keep hair follicles viable.
Bringing attention to the seriousness of the disease to insurers and others has been difficult because for some it is just hair loss. But patients and their healthcare teams know the extent of the psychological toll.

Behind the Oscars slap

If you haven’t heard of alopecia areata, you probably heard of “the slap” at this year’s Oscars. At the origin of the controversy was the host, Chris Rock, making a joke about Will Smith’s wife, Jada Pinkett Smith, who has a smooth scalp. The joke got Smith out of his seat and onto the stage. Jada Pinkett Smith opened up about her struggles with alopecia areata in recent years.

Will Smith’s response alludes to the depths of emotion and frustration and often depression and anxiety that can accompany illness.

Until June, treatments were limited to steroid injections into the scalp, which were mainly used for mild alopecia areata, but sometimes for more serious conditions. It could involve dozens of needle sticks into the hairless patches, which were painful and ineffective, King said.

Other options for severe illness were systemic corticosteroids, but their effectiveness varies, he said.

Now patients have heard about the approved oral treatment and have called and emailed dermatologists.

“Several people have contacted me about this. People are aware of this approval and they are interested. This is a great unmet need to treat this condition,” says Benjamin Ungar, MD, dermatologist at the Mount Sinai Alopecia Center of Excellence in New York, of baricitinib.

Regrowth takes time

Ungar says it’s important to manage expectations when it comes to hair regrowth. With other inflammatory skin conditions, new medications may start working immediately.

“That’s not the case for alopecia areata,” he says, noting that seeing regrowth with baricitinib could take months.

Additionally, it is expected that “based on the studies we have seen, treatment will need to be continued to maintain response,” he notes. If you stop the treatment, the hair will probably fall out again.

Natasha A. Mesinkovska, MD, researcher at clinical tests which led to baricitinib’s approval by the FDA and the chief scientific officer of the National Alopecia Areata Foundation, said patients with the disease may benefit more from baricitinib for other issues they face, such as arthritis or allergies, which may respond to JAK inhibitors.

“About 30% to 50% of people with alopecia areata, depending on age group or part of the world, will have allergies, which can be helped” with baricitinib, she says.

Patients taking baricitinib will need to visit their dermatologist’s office approximately every 3 months after starting the drug for monitoring tests.

The risks and benefits will be different for each patient, she says.

Patients should speak with their dermatologist about all risks and the black box warning on the drug. The main warnings listed are an increased risk of serious infection, death, cancer and major cardiovascular events such as heart attacks and blood clots.

“I can tell you that these events happen at an extremely low rate in clinical trials,” King said.

He pointed out that all JAK inhibitors have the black box warning, whether used in gastroenterology, rheumatology or dermatology.

Still, it’s important to discuss your own possible risks and benefits with your dermatologist when deciding whether to take baricitinib, he said.

Some common questions

Lisa Anderson, director of research for the National Alopecia Areata Foundation, said more than 600 questions were sent to the foundation before and during the webinar.

Below are a few that King responded to during the webinar, edited for length and clarity:

Can I get a prescription from a GP?

1. A dermatologist must give the prescription because serious skin diseases must be treated by a specialist. A dermatologist will better understand the risks and benefits for each patient and how to monitor progress.

What if your dermatologist doesn’t know about the new approved treatment or doesn’t plan to use it?

1. Defend yourself. If getting your hair back is important to you, ask to be referred to someone who is willing to add the medicine to your care. If someone tells you that you don’t qualify for the drug, they owe you at least a reason.

Now that baricitinib has been approved, do you recommend replacing tofacitinib with this drug, which has been used off-label to treat alopecia areata?

1. This should be discussed with your dermatologist. This is a reasonable request because insurance reimbursement is so often denied for tofacitinib. But there’s no data on the change, so weigh the pros and cons with your dermatologist. Baricitinib will likely be covered by insurance due to FDA approval.

Should I take JAK inhibitors during pregnancy?

A: No. And not when you are breastfeeding either.

King described the future in light of the first FDA-approved treatment and the promise of more soon: “Really, we’re going from an endless story of nothing to something, but that’s still the first step. These are huge advances. »