The happy world of an 11-year-old girl began to crumble one summer day in 2015. María Guaita’s hair started falling out all at once, like in some crazy nightmare or horror movie. Without a drug to treat her specific condition, her doctors decided to prescribe corticosteroids that made her put on 45 pounds. The young girl was suddenly bald and overweight, a difficult burden to bear in the often cruel world of teenagers. “It was a very big blow. I was so young and was wondering, ‘Why me? Why did this happen to me?’ I had a very hard time at first,” said Guaita, who just turned 18. The young woman from Cuenca (Spain) later became one of the first patients to be given a breakthrough drug to reverse baldness called baricitinib. After seven cruel years, she has hair again and is back to her normal weight.
María Guaita suffers from alopecia areata, a mysterious disease in which the human body’s defense system attacks the scalp. The condition only affects about 2% of the population at some point in their lives, but is usually manifested in a few coin-sized bald patches. In extreme cases like Guaita’s, all the hair falls out, sometimes in just a few days. Baricitinib helps the body grow the hair back within a few weeks. US regulators approved the drug on June 13, and the European Medicines Agency (EMA) recommended its authorization in May. The European Commission will probably make a final decision on approval by the end of June, according to EMA spokesperson, Stefan de Keersmaecker.
Dermatologist Sergio Vañó, director of the Trichology Unit of the Ramón y Cajal Hospital in Madrid, believes that baricitinib is the start of “a new era.” The drug inhibits JAK proteins that launch ferocious attacks on the scalp. Now that baricitinib (made by pharma giant Eli Lilly and Company) has been approved in the US, similar drugs like Pfizer’s tofacitinib are expected to receive approval as well. “These drugs are revolutionizing treatment of this condition, and will dramatically improve quality of life for these patients,” said Vañó, who treated young María Guaita at the Pedro Jaén Group Clinic in Madrid.
But Vañó cautions that the drug has some drawbacks. “This is not a curative treatment. You can’t take this for six months and be forever cured of alopecia areata. It will only have an effect as long as it is used,” he said. “If a patient stops taking the drug, the condition usually returns. It’s a huge step forward, but it’s not a panacea.”
An expensive treatment
Another drawback of baricitinib is its prohibitive price. The drug was previously approved in Spain to treat rheumatoid arthritis and atopic dermatitis, but it costs about US$990 a month. Nor is it effective in every patient with alopecia areata. Pharmacist Jesús Sierra does the math based on the partial efficacy observed in clinical trials–if for every three patients treated, one patient’s hair is restored, it would cost almost US$38,000 a year to achieve success for a single patient. “Proper patient selection is important–it should only be prescribed for the patients who can benefit the most from the treatment. And negotiate costs with the pharmaceutical company to review current pricing,” said Sierra, who works at the Jerez de la Frontera University Hospital in Cadiz (Spain). In 2021, Eli Lilly and Company earned US$5.25 billion in revenue.
Sergio Vañó dispelled some other misconceptions. “The European Commission’s approval of this drug doesn’t mean that Spain’s national health system will cover the cost. The Ministry of Health has to first assess whether it will cover this drug and in which cases. This process could take a year or longer. Right now, we’re not able to automatically prescribe baricitinib. It would have to be requested individually [from the national health system] and most likely they’ll say no.”
Vañó explains that alopecia areata is not just an aesthetic problem. “Imagine losing every single hair on your body overnight. That completely changes your self-image, and stigmatizes you. People ask if you have cancer, and can have societal and workplace impacts. I have had young female patients here with this problem, and some have attempted suicide,” said Vañó. The most severe forms of the disease are often associated with psychiatric problems, such as anxiety and depression. “Patients also have functional problems. Since they have no eyelashes, they run a greater risk of have corneal erosion. It can be uncomfortable to play sports because sweat gets in their eyes. They also have more nose and ear infections because they have no hair in those areas,” said Vañó.
Dermatologist Joan Ferrando, an honorary professor at the University of Barcelona, says that baricitinib should only be administered under strict medical supervision. “People shouldn’t think that everything will be easy with baricitinib. It has side effects–it can weaken defenses, lead to infections, activate dormant tuberculosis, and may also lead to a higher incidence of lymphomas or cerebral infarctions,” said Ferrando. Sergio Vañó notes that the most common side effects are mild respiratory infections, acne, and a higher risk of getting shingles. “It’s a very safe drug. Getting your hair back improves your quality of life and self-esteem, which compensates for the potential side effects.”
Vañó estimates that 0.05% of the population may suffer from severe alopecia areata, about 25,000 people in Spain. “I think the high cost will limit the use of the drug to these severe cases,” he said. Vañó predicts that the price of baricitinib will drop to around US$525 per month. María Guaita’s mother, Paloma Torrecilla, remembers the “ordeal” that her daughter went through during adolescence, suffering hundreds of useless drug injections in her scalp. She hopes that Spain’s national health system will cover the cost of baricitinib for the most serious cases. “María is now starting to feel well. It’s amazing how much hair can change a person–it’s a transformation,” said Torrecilla.
María Guaita exhibits an extraordinary maturity when talking about her illness, and would like to see government funding for drugs to treat alopecia areata. “Since the number of cases is low, it seems viable. I would ask them to try, by all means,” urged Guaita. “And I would tell other people like me not to lose hope, that there is a way out. Sooner or later, they’ll be able to climb out of that pit.”