An alopecia drug receives FDA approval

An alopecia drug receives FDA approval

The disease can vary in severity, but for some it may be life-changing: total loss of body hair, including eyelashes and eyebrows, and even hair on the nose and ears. In addition, until recently, those affected by alopecia areata did not have any treatment to make their hair grow back.

But on Monday, the Food and Drug Administration (FDA) approved baricitinib, a drug made by Eli Lilly that makes hair grow back by blocking the immune system’s attack on hair follicles. Two other companies, Pfizer and Concert Pharmaceuticals, are following her closely with similar drugs known as JAK inhibitors. These drugs are already marketed for the treatment of rheumatoid arthritis and other autoimmune diseases. FDA approval is important for insurance to cover these expensive drugs, which are priced at nearly $ 2,500 a month.

Lilly’s drug was studied in two trials, sponsored by the company and published last month in the New England Journal of Medicine, involving 1,200 patients with severe alopecia areata. Nearly 40 percent of those taking the drug experienced complete or near-complete hair growth after 36 weeks. Within a year, almost half of the patients had recovered their hair.

Brett King, a professor of dermatology at Yale University, was the principal investigator of Lilly’s two trials and also directs trials sponsored by other companies. He was optimistic about improving the success rate of drugs. Manufacturers could improve JAK inhibitors for alopecia areata. And when all three companies have drugs on the market, patients who do not respond to one company’s drug may respond to one of the others.

Patients in Lilly’s study experienced relatively mild side effects, such as a small increase in the risk of acne, urinary tract infections, and other infections. These side effects were easily treatable or improved without treatment.

The results of Lilly’s essay are “impressive,” wrote Andrew Messenger of the University of Sheffield and Matthew Harries of the University of Manchester in an editorial. They added that the results “represent the first published phase 3 trials of any treatment for this disease.”

More than 300,000 Americans suffer from severe alopecia areata, according to the FDA. The impact of the disease is hard to overstate, King said.

For most people with alopecia areata, the disease manifests as one or more small bald spots on the head. But those with severe cases are much worse off. They may notice small bald spots on the head one day and three months or even three weeks later, they have no hair on their body.

His colleagues attribute to King the credit for arousing interest in the use of JAK inhibitors to treat alopecia areata. He says it all started when he looked at three abstracts presented at medical meetings in 2012 and 2013. Studies, led by Raphael Clynes and Angela Christiano of Columbia University, were on mice, but indicated that JAK inhibitors could reverse alopecia areata.

Shortly afterwards, a 25-year-old man named Kyle went to see King for the treatment of psoriasis. He had almost no hair, and his head and body had large, scaly, red plaques of psoriasis.

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

Kyle began to notice that he had severe hair loss when he was at a high school dance and was wearing a hat. He went to the bathroom, took it off, and to his horror found a large amount of hair in his hat.

“It’s an episode of the Unknown Dimension,” King said.

He looked at Kyle and said, “If you want to try something wild that hasn’t been done before, there’s a drug that is approved for rheumatoid arthritis and is being developed for psoriasis. There are indications in mice that it might work. “

Kyle agreed to take tofacitinib, a JAK inhibitor made by Pfizer that is similar to Lilly’s medicine. Eight months later, he had regained his hair.

After King published a report on Kyle, other dermatologists began testing JAK inhibitors.

Maryanne Makredes Senna, director of Beth Israel Lahey Health’s Center for Excellence for Hair Loss in Massachusetts, was one of them.

She was in charge of convincing the insurers to cover the drugs, and sometimes she did.

“It’s great to see the incredible impact,” said Senna, who has received consulting fees from Eli Lilly and Pfizer. “They arrive hairless, completely withdrawn from life. His eyes are downcast. They come back and say, ‘I’ve got my life back. I am myself again. ‘”

Natasha Atanaskova Mesinkovska, scientific director of the National Alopecia Areata Foundation and a professor of dermatology at the University of California at Irvine, helped pharmaceutical companies find patients for their trials. She was also impressed with the results of those who responded to the drugs.

Severe hair loss not only “deprives a person of their identity,” but is “a medical problem,” he said, adding that when people lose hair on their nose and ears, it affects allergies and hearing. .

Christian Daniels, 27, a data center technician living in Peoria, Illinois, said the hair loss also affected his eyes. Without eyelashes, dust entered his eyes and irritated them so much that he began to put Vaseline on his eyelids.

Daniels started to lose his hair when he was 25 years old. Within a month, all the hair on his body was gone.

COVID-19 was “a lucky misfortune,” he said, because he could work from home.

“I felt like my life was on hold,” he said. “I felt like the only thing that mattered was how to get my hair back.”

He found Lilly’s essays “searching and searching on Google.”

Now, he says, “it’s almost like it never happened,” though he still has memories when he looks in a mirror and remembers his hairless days.

Brittany Craiglow, a private practice dermatologist in Fairfield, Connecticut, who is married to King, said severe alopecia areata was especially difficult for children.

One patient, Cassidy Mackwell, of Canton, Massachusetts, lost her hair at the age of eight, and when the adults saw her, they thought she had cancer.

“People used to approach Cassidy when we were at a restaurant having dinner,” said her mother, Melissa Mackwell. Some even tried to pay for their meals. “They hugged her and said, ‘I’m so sorry. Keep fighting. ”

One of Craiglow’s patients, Brooke Nelson, who lives in Belleville, New Jersey, lost all her long blonde hair when she was in first grade. Brooke was so embarrassed by her hair loss that her mother, Danielle Nelson, raised her at home.

He took Brooke to one medical center after another, doctor after doctor, but to no avail. “I would have given up my house, everything, if that meant returning Brooke’s hair,” says Nelson.

Nelson was about to take Brooke to China for stem cell therapy when she found Craiglow, who was given a JAK inhibitor. Her hair grew back.

“It was a miracle,” Nelson said.

Gina Kolata writes about science and medicine. She has twice been a Pulitzer Prize winner and author of six books, including Mercies in Disguise: A Story of Hope, a Family’s Genetic Destiny, and The Science That Saved Them. @ginakolata

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