FDA Approves Alopecia Drug That Restores Hair Growth in Many Patients

The disease can vary in severity, but for some it can be life-changing – a complete loss of body hair, including eyelashes and eyebrows, even nose hair and hair in the ears. And until recently, there was no treatment available for people with alopecia areata to regrow hair.

But on Monday, the Food and Drug Administration approved baricitinib, a drug from Eli Lilly that regrows hair by blocking the immune system from attacking hair follicles. Two other companies, Pfizer and Concert Pharmaceuticals, are close behind with similar drugs known as JAK inhibitors. The drugs are already on the market to treat rheumatoid arthritis and other autoimmune diseases. FDA approval is important for insurance coverage for these expensive drugs, which have a list price of nearly $2,500 per month.

The drug Lilly was studied in two studies sponsored by the company and published last month in the New England Journal of Medicine, involving 1,200 patients with severe alopecia areata. Almost 40 percent who took the drug had complete or near-complete hair regrowth after 36 weeks. After a year, almost half of the patients had their hair back.

dr Brett King, a professor of dermatology at Yale University, was the lead investigator for the two Lilly studies and also leads studies sponsored by the other companies. He said he’s optimistic the success rate for the drugs will improve. Manufacturers may be able to improve JAK inhibitors for alopecia areata. And if all three companies have drugs on the market, patients who don’t respond to one company’s drug could respond to one of the others.

The patients in the Lilly study experienced relatively mild side effects, including a small increased risk of acne, urinary tract infections, and other infections. These side effects were easily manageable or improved without treatment.

The results of the Lilly study “are impressive,” wrote Dr. Andrew Messenger from the University of Sheffield and Matthew Harries from the University of Manchester in an accompanying editorial. They added that the results “represent the first published Phase 3 trials for a treatment of this condition.”

More than 300,000 Americans are living with severe alopecia areata, according to the FDA. The impact of the disease is hard to overstate, said Dr. King.

In most people with alopecia areata, the disease manifests as one or more small bald patches on the head. But those with severe cases have something far worse. You may notice small bald spots on their head one day. Three months or even three weeks later, they no longer have hair on their bodies.

dr King is commended by colleagues for stimulating interest in using JAK inhibitors to treat alopecia areata. He said it all started when he noticed three abstracts presented at medical conventions in 2012 and 2013. The studies led by Dr. Raphael Clynes and Dr. Columbia University’s Angela Christiano involved mice but showed that JAK inhibitors could reverse alopecia areata.

Shortly thereafter, a 25-year-old man named Kyle came to see Dr. King. He had almost no hair and his head and body had large, red, scaly plaques of psoriasis.

“I looked at him and said, ‘You have alopecia areata,'” said Dr. King.

Kyle noticed he had severe hair loss when he was at a dance in high school and wore a hat. He went into the bathroom, took off his hat and to his horror found a large amount of hair in the hat.

“This is a Twilight Zone episode,” said Dr. King.

He looked at Kyle and said, “If you want to try something wild that’s never been done before, there’s a drug that’s approved for rheumatoid arthritis and is being developed for psoriasis. There is some evidence in mice that it might work.”

Kyle agreed to take tofacitinib, a Pfizer JAK inhibitor similar to the drug Lilly. Eight months later he had his hair back.

after dr King published a report on Kyle, other dermatologists began trying JAK inhibitors.

Among them was Dr. Maryanne Makredes Senna, director of the Hair Loss Center of Excellence at Beth Israel Lahey Health in Massachusetts.

She would get insurers to cover the drugs, and sometimes she was successful.

“It’s nice to see the amazing effect,” said Dr. Senna, who has received consulting fees from Eli Lilly and Pfizer. “They come in with no hair and completely withdraw from life. Your eyes are downcast. They come back and they say, ‘I got my life back. I have my self back.’”

dr Natasha Atanaskova Mesinkovska, scientific director of the National Alopecia Areata Foundation and dermatology professor at the University of California, Irvine, helped drug companies find patients for their studies. She, too, was impressed with the results in those who responded to the medication.

Severe hair loss not only “robs a person of their identity,” it’s “a medical issue,” she said, adding that when people lose hair in their noses and ears, it affects allergies and hearing.

Christian Daniels, 27, a data center technician who lives in Peoria, Illinois, said hair loss also affected his eyes. Without eyelashes, dust would get into his eyes and irritate them so much that he started putting petroleum jelly on his eyelids.

Mr. Daniels’ hair fell out when he was 25. Within a month all his body hair was gone.

Covid-19 is “a blessing in disguise,” he said, because he can work from home.

“I felt like my life had been put on hold,” he said. “I felt like the only thing that mattered was how I got my hair back.”

He found the Lilly processes by “googling and googling”.

Now, he said, “it’s almost like it never happened,” though he still has flashbacks at times when he looks in a mirror and remembers his hairless self.

dr Brittany Craiglow, a dermatologist in private practice in Fairfield, Connecticut, who worked with Dr. King is married, said severe alopecia areata is particularly difficult for children.

One patient, Cassidy Mackwell of Canton, Massachusetts, lost her hair when she was 8 years old. When adults saw her, they assumed she had cancer.

“People would come up to Cassidy when we were having dinner at a restaurant,” said her mother, Melissa Mackwell. Some would even try to pay for their meals. “They hugged her and said, ‘I’m so sorry. Fight on.'”

one of dr Craiglow’s patient, Brooke Nelson, who lives in Belleville, NJ, lost all of her long blonde hair when she was in first grade. Brooke was so embarrassed about her hair loss that her mother, Danielle Nelson, homeschooled her.

She took Brooke to medical center after medical center, doctor after doctor, but to no avail. “I would have given up my house, gave up everything, if that meant giving Brooke her hair back,” Ms Nelson said.

Ms. Nelson was ready to take Brooke to China for stem cell therapy when she met Dr. Craiglow, who gave Brooke a JAK inhibitor. Her hair grew back.

“It was a miracle,” said Ms. Nelson.

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