Dermatologists, who recently celebrated US Food and Drug Administration (FDA) approval of the world’s first oral systemic treatment for adults with severe alopecia (AA), are now considering the practical aspects of administration of 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 the treatment of rheumatoid arthritis (RA) and other autoimmune diseases.
Meanwhile, dermatologists fielded calls from hopeful patients and worked out who should receive treatment, how to counsel patients about the risks and benefits, and what tests should be used before and after treatment begins.
Adoption of 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, because some physicians like stick to what they know.
He said Medscape Medical News that he hopes the adoption of baricitinib will be faster because it is the only oral systemic treatment approved for patients with severe alopecia, which affects approximately 300,000 people a year in the United States. Other treatments, including scalp injections of steroids, have lacked efficacy and convenience.
Beyond the physical effects, the mental toll of patchy clumps of hair and missing eyebrows and eyelashes can be devastating for patients with alopecia areata.
Respond to patient inquiries
News of the FDA approval has spread quickly, and calls and emails are coming in to dermatologists’ offices and clinics from interested patients.
Doctors should be prepared for patients with any type of hair loss, not just severe alopecia, to ask about the drug, Friedman said. Some patients who contact him do not fit the indication, which he says “highlights how debilitating hair loss is” for people, considering that in general “people see this and think that it’s for them”.
Baricitinib is not a new drug, but a drug with a new indication. It had previously been approved for the treatment of moderate to severe RA in patients who have had an inadequate response to one or more anti-TNFs, and for the treatment of COVID-19 in some hospitalized adults.
Patients may inquire about the boxed warning in the baricitinib label regarding the increased risk of serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis.
Natasha A. Mesinkovska, MD, PhD, researcher in the clinical trials that led to FDA approval of baricitinib and chief scientific officer of the National Alopecia Areata Foundation, said Medscape Medical News that several aspects of etiquette are important to emphasize.
The first is that the warning applies to all JAK inhibitors used to treat rheumatoid arthritis and other inflammatory conditions, not just baricitinib. Additionally, the warning is based primarily on data from RA patients who, she notes, have significant comorbidities and have taken toxic immunosuppressive drugs. The RA population is also generally several years older than the alopecia areata population.
“Whether the warnings apply to patients with alopecia areata is not yet clear,” says Mesinkovska, who is also an associate professor of dermatology at the University of California, Irvine.
Patients also ask if it works well.
In one of two trials that led to FDA approval, which enrolled patients with at least 50% hair loss for more than 6 months, 22% of patients who received 2 mg of baricitinib and 35% of those given 4 mg observed adequate hair coverage (at least 80%) at week 36, compared to 5% on placebo. In the second trial, 17% of those given 2mg and 32% of those given 4mg saw adequate hair coverage, compared to 3% on placebo.
According to the FDA, common side effects associated with baricitinib are lower respiratory tract infections, headache, acne, high cholesterol, increased creatinine phosphokinase, urinary tract infections, enzyme elevations liver disease, folliculitis, fatigue, nausea, genital yeast infections, anemia, neutropenia. , abdominal pain, shingles (shingles) and weight gain.
Mesinkovska says risk-benefit discussions with patients should also include potential benefits beyond hair regrowth on the scalp. Hair loss in the ears and nose can affect hearing and allergies, she said.
“About 30 to 50 percent of people with alopecia, depending on age group or part of the world, will have allergies,” she says.
Patients should also be aware that baricitinib will need to be taken “for a very long time,” Mesinkovska notes. It’s possible that it lasts forever and stopping the drug at any time can cause further hair loss, she says, but how long will vary from case to case.
The good news, she says, is that it was well tolerated. “We give a lot of acne medications like doxycycline and other antibiotics and people have more stomach issues and anxiety with those than with them. [baricitinib],” she says.
Regrowth takes time
Benjamin Ungar, MD, dermatologist at the Mount Sinai Alopecia Center of Excellence in New York, said 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’s not the case for alopecia areata,” he said. “It is expected to take months for regrowth in general.”
He said he hasn’t started prescribing baricitinib yet, but plans to do so soon.
“Obviously I will have conversations with patients about it, but it’s a drug I’m going to use for sure. I have no reservations,” Ungar says.
After initial testing, doctors may find that some patients may 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.
However, for most people with severe alopecia, baricitinib provides hope, he says.
“Treatment options were not readily available, often inaccessible, ineffective, often dangerous,” he says. “There is now an accessible, generally safe treatment and I[s] effective for many people.
Be candid with patients about the unknown
In addition, it is important to tell patients what is not yet known, say the experts interviewed.
“Alopecia areata is a chronic disease. We don’t have long-term patient population data yet,” Friedman said.
It’s also unclear how easy it will be for doctors to get insurance to reimburse baricitinib, which as of late June was priced at around $5,000 a month for the 4mg dose. FDA approval was important in this regard. Previously, some claims had been rejected for drugs used off-label for AA.
“We dermatologists know how much this affects patients,” says Mesinkovska. “As long as we stick to what we know and communicate to insurers how much this affects people’s lives, they should cover it.”
She said another unknown is what other drugs can be taken with baricitinib. In clinical trials, it’s been used on its own, she says. Currently, the concomitant use of other immunosuppressants – such as methotrexate or prednisone – is not recommended. But it remains to be seen what other drugs will be able to be used safely at the same time as longer-term data become 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, said Medscape Medical News that she received a flurry 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 nurses at her clinic have been given instructions on what to tell patients about the patients the drug is supposed to treat, the side effects and the benefits.
Access will not be immediate
Goldberg says drug approval doesn’t mean immediate access. The patient must come in, discuss the treatment and first pass laboratory tests. “It’s not an occasional drug. It’s a strong immunosuppressant. You need lab tests and once you start it you need blood tests every three months to stay on it.”
She said these tests can vary by doctor, but people will generally need a standard blood count and a full metabolic panel and lipid panel. “There’s nothing esoteric about it,” she says.
She said doctors will need to check for infections, including tuberculosis and hepatitis B and C, before prescribing, just as they would before starting to prescribe a biologic drug.
“You don’t want to reactivate something,” she notes.
But, adds Goldberg, the benefits for anyone who has lived with only clumps of hair or no hair or who has put on a wig or hat every day are “life changing.”
Mesinkovska is on the advisory boards and leads trials for Eli Lilly, Pfizer and Concert Pharmaceuticals. Friedman, Goldberg and Ungar report no relevant financial relationships.
Marcia Frellick is a Chicago-based freelance journalist. She has already written for the Chicago Grandstand, Scientific News, and Nurse.com, and was editor at Chicago Sun-Timesthe Cincinnati Applicantand the St Cloud (Minnesota) hours. Follow her on Twitter at @mfrellick.
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