Dr. Antonella Tosti discusses the FDA’s first drug treatment approved for alopecia areata, JAK inhibitor baricitinib, as well as two JAK inhibitors that have filed with the FDA for the indication.
Antonella Tosti, MD, Fredric Brandt Endowed Professor of Dermatology and Cutaneous Surgery, University of Miami, Miller School of Medicine, Miami, Florida
“This year has been a big year for alopecia areata, both for doctors and patients, because the FDA approved the first medication for the treatment of alopecia areata, baricitinib, a Janus kinase (JAK) inhibitor (Olumiant, Lilly). We finally have one approved treatment. And this is just the beginning because we know that other JAK inhibitors are presently in clinical trials and at least two of them are filing for FDA approval,” said Antonella Tosti, MD, who presented “New Drugs in Alopecia Areata,” during the European Academy of Dermatology and Venereology (EADV) Congress in Milan, Italy.
According to the FDA, baricitinib is indicated for patients with severe alopecia areata, meaning more than 50% of the scalp is involved, said Dr. Tosti.
“Baricitinib also is indicated for alopecia of the eyebrows and eyelashes, which the data show respond to this medication.”
Contraindication Considerations
There are important contraindications to consider before starting treatment with a JAK inhibitor, said Dr. Tosti.
“Main contraindications are infections. We need to check the patient for tuberculosis, hepatitis, [and] HIV. We do not want to start a medication like baricitinib in a patient who already has an infection because it is an immune suppressant.”
Dermatologists should also run a complete blood count (CBC) and metabolic panel to check the liver and kidneys and help to ensure the patient is in good health, she said.
Dosing Details
According to the FDA, the starting dose of baricitinib for the treatment of alopecia areata is 2 mg daily. In some cases, that dose can be increased to 4 mg per day, said Dr. Tosti.
“There is an exception when you can start directly with 4 mg a day, and that is with alopecia totalis and universalis. So, when alopecia involves the whole scalp, and patients have severe alopecia with involvement of eyelashes and eyebrows, then you can start with 4 mg of baricitinib daily.”
The data show that once the patient has hair growth, prescribers can reduce the dose to 2 mg, said Dr. Tosti.
“Not all patients respond. Roughly 40% of patients reach Severity of Alopecia Tool 20, meaning less than 20% of the scalp is involved.”
Unfortunately, according to Dr. Tosti, the only way to maintain results it to continue the drug.
“This is a treatment; not a cure.”
Pipeline JAKs
“There are two JAK inhibitors that are filing for FDA approval to treat alopecia areata. One is a JAK 3 inhibitor called ritlecitinib (Pfizer). The other is a deuterium-modified analog of ruxolitinib [which selectively inhibits JAK 1 and JAK 2 (Concert Pharmaceuticals)]. Those two will probably be approved in the next year.”
Ritlecitinib is also filing for children 12 and older, which is important because there are many adolescent patients with alopecia areata, according to Dr. Tosti.
Black Box Warning
All the JAK inhibitors have an FDA warning about the risk of severe infections and thromboembolic events, as well as elevated cancer and cardiac risks, said Dr. Tosti.
“These are rare but are a possibility, so it’s something you always have to discuss with your patients. These are serious drugs, and you have to explain everything to patients.”
Disclosures: Dr. Tosti is a consultant for Lilly and was a PI in the clinical trial for baricitinib. She also is a consultant for Pfizer and a PI for Concert Pharmaceuticals.
