Dermatologists, who recently celebrated the US Food and Drug Administration’s (FDA’s) approval of the world’s first oral systemic treatment for adults with severe alopecia areata (AA), are now looking ahead to the practicalities of getting the drug to eligible patients.
On June 13, the FDA approved baricitinib, a Janus kinase (JAK) inhibitor (Olumiant, Lilly), for severe AA, and two other options may not be far behind. Pfizer and Concert Pharmaceuticals have JAK inhibitors in late-stage development for AA. JAK inhibitors, including baricitinib, are already on the market for treating rheumatoid arthritis (RA) and other autoimmune diseases.
Meanwhile, dermatologists have been fielding calls from hopeful patients and sorting out who should get the treatment, how to advise patients on risks and benefits, and what tests should be used before and after starting treatment.
Uptake for new systemic drugs, such as biologics, can be slow in dermatology, notes Adam Friedman, MD, Professor and Chair of Dermatology, George Washington University School of Medicine & Health Sciences, Washington, DC, as some doctors like to stick with what they know.
He told Medscape Medical News that he hopes that uptake for baricitinib is quicker, as it is the only approved oral systemic treatment for patients with severe alopecia areata, which affects about 300,000 people a year in the United States. Other treatments, including steroid injections in the scalp, have lacked efficacy and convenience.
Beyond the physical effects, the mental toll of patchy hair clumps and missing brows and lashes can be devastating for patients with alopecia areata.
Fielding Patient Inquiries
Word of the FDA approval spread fast, and calls and emails are coming into dermatologists’ offices and clinics from interested patients.
Physicians should be ready for patients with any kind of hair loss, not just severe alopecia areata, to ask about the drug, Friedman said. Some patients contacting him don’t fit the indication, which he says, “highlights how disabling hair loss” is for people, considering that, in general, “people see this and think it is for them.”
Baricitinib is not a new drug, but a drug with a new indication. It had already been approved for treating moderate-to-severe RA in patients who have had an inadequate response to one or more TNF blockers, and for treating COVID-19 in certain hospitalized adults.
Patients may ask about the boxed warning in the baricitinib label about the increased risk for serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis.
Natasha A. Mesinkovska, MD, PhD, an investigator in the clinical trials that led to FDA approval of baricitinib and the chief scientific officer at the National Alopecia Areata Foundation, told Medscape Medical News that several aspects of the label are important to point out.
One is that the warning is for all the JAK inhibitors used to treat RA and other inflammatory conditions, not just baricitinib. Also, the warning is based mostly on data on patients with RA who, she notes, have substantial comorbidities and have been taking toxic immunosuppressive medications. The RA population is also typically many years older than the alopecia areata population.
“Whether the warnings apply to the alopecia areata patients is as yet unclear,” says Mesinkovska, who is also an associate professor of dermatology at the University of California, Irvine.
Patients are also asking about how well it works.
In one of the two trials that led up to the FDA approval, which enrolled patients with at least 50% scalp hair loss for over 6 months, 22% of the patients who received 2 mg of baricitinib and 35% of those who received 4 mg saw adequate hair coverage (at least 80%) at week 36 compared with 5% on placebo. In the second trial, 17% of those who received 2 mg and 32% who received 4 mg saw adequate hair coverage compared with 3% on placebo.
Common side effects associated with baricitinib, according to the FDA, are lower respiratory tract infections, headache, acne, high cholesterol, increased creatinine phosphokinase, urinary tract infection, liver enzyme elevations, folliculitis, fatigue, nausea, genital yeast infections, anemia, neutropenia, abdominal pain, herpes zoster (shingles), and weight gain.
Mesinkovska says that the risk-benefit discussions with patients should also include potential benefits beyond hair regrowth on the scalp. Loss of hair in the ears and nose can affect hearing and allergies, she said.
“About 30% to 50% with alopecia areata, depending on age group or part of the world, will have allergies,” she says.
Patients should also know that baricitinib will need to be taken “for a very long time,” Mesinkovska notes. It’s possible that could be forever and that stopping the medication at any point may result in hair falling out again, she says, but duration will vary from case to case.
The good news, she says, is that it has been well tolerated. “We give a lot of medications for acne like doxycycline and other antibiotics and people have more stomach problems and angst with those than with [baricitinib],” she says.
Regrowth Takes Time
Benjamin Ungar, MD, a dermatologist at the Alopecia Center of Excellence at Mount Sinai in New York City, told Medscape Medical News that an important message for patients is that hair regrowth takes time. For some other skin conditions, patients start treatment and see almost instant improvement.
“That is not the case for alopecia areata,” he said. “The expectation is that it will take months for regrowth in general.”
He said he hasn’t started prescribing baricitinib yet, but he plans to do so soon.
“Obviously, I’ll have conversations with patients about it, but it’s a medication I’m going to be using, definitely. I have no reservations,” Ungar says.
After initial testing, physicians may find that some patients might not be ideal candidates, he adds. People with liver disease, a history of blood clots, abnormal blood counts, or low neutrophils are among those who may not be the best candidates for baricitinib, he says.
For most with severe alopecia areata, though, baricitinib provides hope, he says.
“Treatment options have been not readily available, often inaccessible, ineffective, often dangerous,” he says. “There’s a treatment now that can be accessed, generally is safe and i[s] effective for many people.”
Be Up Front With Patients About the Unknown
Additionally, it’s important to tell patients what is not yet known, the experts interviewed say.
“Alopecia areata is a chronic disease. We don’t have long-term data on the patient population yet,” Friedman said.
Also unknown is how easy it will be for physicians to get insurance to reimburse for baricitinib, which, at the end of June, was priced at about $5,000 a month for the 4-mg dose. FDA approval was important in that regard. Previously, some claims had been rejected for drugs used off-label for AA.
“We dermatologists know how much it affects patients,” Mesinkovska says. “As long as we stick by what we know and convey to insurers how much it affects people’s lives, they should cover it.”
She said that another unknown is what other drugs can be taken with baricitinib. In clinical trials, it was used alone, she says. Currently, concomitant use of other immune suppressants — such as methotrexate or prednisone — is not recommended. But it remains to be seen what other medications will be safe to use at the same time as more long-term data are available, she says.
Lynne J. Goldberg, MD, professor of dermatology, pathology, and laboratory medicine, Boston University School of Medicine, and director, Hair Clinic, Boston Medical Center, Massachusetts, told Medscape Medical News that she received a slew of emails from patients asking about baricitinib, but most of them did not have alopecia areata and were not candidates for this treatment.
She said that nurses in her clinic have been instructed on what to tell patients about which patients the drug is meant to treat, side effects, and benefits.
Access Won’t be Immediate
Goldberg says the drug’s approval does not mean immediate access. The patient has to come in, discuss the treatment, and get lab tests first. “It’s not a casual drug. This is a potent immunosuppressant drug. You need lab tests and once you start it you need blood tests every three months to stay on it.”
She said those tests may vary by physician, but people will generally need a standard blood count and a comprehensive metabolic panel and lipid panel. “There’s nothing esoteric,” she says.
“You don’t want to reactivate something,” she notes.
But, Goldberg adds, the benefits for all who have been either living with only patches of hair or no hair or who put on a wig or hat every day are “life changing.”
Mesinkovska is on the advisory boards and runs trials for Eli Lilly, Pfizer, and Concert Pharmaceuticals. Friedman, Goldberg, and Ungar report no relevant financial relationships.
Marcia Frellick is a freelance journalist based in Chicago. She has previously written for the Chicago Tribune, Science News, and Nurse.com, and was an editor at the Chicago Sun-Times, the Cincinnati Enquirer, and the St. Cloud (Minnesota) Times. Follow her on Twitter at @mfrellick.