July 19, 2022 – For many people with severe alopecia areata, who have lived with baldness, or with scalps only sparsely dotted with hair, or with missing eyebrows or lashes, the future has a new look.
“There’s this unbelievable momentum,” Brett King, MD, an associate professor of dermatology at the 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 that momentum comes from the first systemic medication approved by the FDA for severe alopecia areata. (Severe disease is marked by at least 50% hair loss.)
The medication, made by Eli Lilly, is called baricitinib, part of the Janus kinase (JAK) inhibitor class. Two other JAK inhibitors for the condition (one from Pfizer and another from Concert Pharmaceuticals) are seeing promising results in phase III of clinical trials and may not be far from approval as well, he said.
Baricitinib was approved last month by the FDA, and patients will be able to get it soon with a prescription.
It had been approved previously for rheumatoid arthritis patients. It was then tested in clinical trials with alopecia areata patients who had at least 50% hair loss.
King is a pioneer in the use of JAK inhibitors in treating the condition, and he has led multiple clinical trials to test their effectiveness.
With alopecia areata, which affects up to nearly 7 million people in the U.S. each year, the body attacks its own hair follicles, for reasons just beginning to be understood. JAK inhibitors can help interrupt that cycle.
What hasn’t worked in clinical trials is topical JAK inhibitors, King says, though some patients who are referred to him spend up to $400 month on those treatments.
“It’s terrible,” he said. “There is no data that says that topical JAK inhibitors are effective for severe alopecia areata.”
Treatments Won’t Work for Everyone
King said that oral JAK inhibitors don’t work for everyone with severe hair loss, and answers are few as to why that is.
“One of the reasons some people don't succeed is because their hair loss has been severe for too long. And we think that approaching 10 years or longer often, not always, often carries a poor prognosis,” he said.
“This is an important thing for everybody to hear,” he said. “We don't want severe hair loss to go on for too long before we treat it. So that the hair follicles remain viable.”
Drawing attention to the seriousness of the disease from insurers and others has been difficult because to some, it’s just hair loss. But patients and their health care teams know the extent of the psychological toll.
Behind the Oscars Slap
If you haven’t heard of alopecia areata, you likely have heard of “the slap” at this year’s Oscars ceremony. At the root 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 brought Smith out of his seat and up on the stage. Jada Pinkett Smith has been vocal about her struggles with alopecia areata in recent years.
Will Smith’s response hints at the depths of emotion and frustration and often depression and anxiety that can come with the disease.
Until June, treatments were limited to steroid shots in the scalp, which was mostly used for mild alopecia areata, but sometimes for more severe disease. It could involve dozens of needle sticks in the hairless patches, which were painful and not very effective, King said.
The other options for severe disease were systemic corticosteroids, but they vary in effectiveness, he said.
Now, patients have heard the news about the approved oral treatment and have been calling and emailing dermatologists.
“I’ve had several people reach out about it. People are aware of this approval and they’re interested. It’s a big unmet need for treating this condition,” Benjamin Ungar, MD, a dermatologist with the Alopecia Center of Excellence at Mount Sinai in New York City, says about baricitinib.
Regrowth Takes Time
Ungar says that managing expectations for hair regrowth is important. With other inflammatory skin conditions, new drugs may start working right away.
“That is not the case for alopecia areata,” he says, noting that seeing regrowth with baricitinib could take months.
Also, the expectation is that “based on the studies we’ve seen, the treatment needs to be continued to maintain the response,” he notes. If you stop the treatment, the hair will likely fall out again.
Natasha A. Mesinkovska, MD, an investigator in the clinical trials that led to FDA approval of baricitinib and the chief scientific officer at the National Alopecia Areata Foundation, said that patients with the condition may get added benefit from baricitinib for other issues they are dealing with, such arthritis or allergies, that may respond to JAK inhibitors.
“About 30% to 50% with alopecia areata, depending on age group or part of the world, will have allergies, which may be helped” with baricitinib, she says.
Patients on baricitinib will need to come into their dermatologist’s office about every 3 months after they start taking the drug for monitoring tests.
The risks and benefits will be different for each patient, she says.
Patients should talk with their dermatologist about all the risks and about the black box warning on the medication. The main warnings listed are 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 exceedingly 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, research director 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 answered during the webinar, edited for length and clarity:
Can you get a prescription from a general practitioner?
- A dermatologist should give the prescription because severe skin disease should be managed by a specialist. A dermatologist will better understand the risks and benefits for individual patients and how to monitor progress.
What if your dermatologist isn’t familiar with the new approved treatment or doesn’t plan to use it?
- Advocate for yourself. If getting your hair back is important to you, ask for a referral to someone who is open to adding the drug to your care. If someone tells you that you don’t qualify for the medication, they at least owe you a reason why.
Now that baricitinib has been approved, do you recommend switching to that medication from tofacitinib, which has been used off-label to treat alopecia areata?
- That needs to be a discussion with your dermatologist. That s a reasonable request because insurance reimbursement is so often denied for tofacitinib. But there is no data on switching, so weigh pros and cons with your dermatologist. Baricitinib will likely be covered by insurance because of the FDA approval.
Should you take JAK inhibitors when you’re pregnant?
A: No. And not when you’re breastfeeding either.
King described the future in light of the first FDA-approved treatment and the promise of more soon: “Truly, we're going from an endless history of nothing to something, but it's still the first step. These are enormous advancements.”