Baricitinib: the ins and outs of a miracle cure for baldness | science and technology

The happy world of an 11-year-old girl began to crumble one summer day in 2015. María Guaita’s hair began to fall out suddenly, like in a crazy nightmare or a horror movie. Without medication to treat his specific condition, his doctors decided to prescribe corticosteroids which caused him to gain 45 pounds. The girl was suddenly bald and overweight, a difficult burden to bear in the often cruel world of teenagers. “It was a really big blow. I was so young and I was like, ‘Why me? Why did this happen to me? turned 18. The young woman from Cuenca (Spain) later became one of the first patients to receive a breakthrough drug to reverse baldness called baricitinib. After seven cruel years, she regained her hair and regained her weight. normal.

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 usually manifests as 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 regrow hair within weeks. US regulators approved the drug on June 13 and the European Medicines Agency (EMA) recommended its authorization in May. The European Commission will likely make a final decision on approval by the end of June, according to EMA spokesman Stefan de Keersmaecker.

Dermatologist Sergio Vañó, director of the trichology unit at the Ramón y Cajal hospital in Madrid, believes that baricitinib is the start of a “new era”. The drug inhibits JAK proteins which launch ferocious attacks on the scalp. Now that baricitinib (made by pharmaceutical giant Eli Lilly and Company) has been approved in the United States, similar drugs like Pfizer’s tofacitinib are also expected to be approved. “These drugs are revolutionizing the treatment of this disease and will significantly improve the quality of life of these patients,” said Vañó, who treated young María Guaita at the Pedro Jaén group clinic in Madrid.

María Guaita before and after taking baricitinib. Images courtesy of Sergio Vañó.

But Vañó warns that the drug has some downsides. “It’s not a cure. You cannot take this for six months and be permanently cured of alopecia areata. It will only have effect as long as it is used,” he said. “If a patient stops taking the drug, the condition usually returns. It’s a big step forward, but it’s not a panacea.

A treatment that can cost $38,000 a year

Another disadvantage of baricitinib is its prohibitive price. The drug has already been approved in Spain to treat rheumatoid arthritis and atopic dermatitis, but it costs around $990 a month. It is also not effective in all patients with alopecia areata. Pharmacist Jesús Sierra does the math based on the partial effectiveness seen in clinical trials – if for every three patients treated, one patient’s hair is restored, it would cost nearly US$38,000 a year to be successful for a single patient. “Good patient selection is important – it should only be prescribed to patients who can benefit the most from the treatment. And negotiate the costs with the pharmaceutical company to review the current prices,” said Sierra, who works at the University Hospital of Jerez de la Frontera in Cadiz (Spain). In 2021, Eli Lilly and Company had revenue of US$5.25 billion.

Sergio Vañó dispelled other misconceptions. “The approval of this drug by the European Commission does not mean that the Spanish national health system will cover the costs. The Ministry of Health must first assess whether it will cover this drug and in which cases. This process can take a year or more. At this time, we are unable to automatically prescribe baricitinib. You would have to ask for it individually [from the national health system] and most likely they will say no.

María Guaita and her mother, Paloma Torrecilla, in Los Moralejos Park.  June 2022. Cuenca (Spain).
María Guaita and her mother, Paloma Torrecilla, in Los Moralejos Park. June 2022. Cuenca (Spain).Jaime Villanueva

Vañó explains that alopecia areata is not just a cosmetic problem. “Imagine losing all the hair on your body overnight. It completely changes your self-image and stigmatizes you. People ask you if you have cancer and if it can affect society and your the workplace. I’ve had young patients here with this problem, and some have attempted suicide,” Vañó said. 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 don’t have eyelashes, they are at greater risk of having corneal erosion. It can be uncomfortable to play sports because sweat gets into the eyes. They also have more nose and ear infections because they don’t have hair in those areas,” Vañó said.

Dermatologist Joan Ferrando, honorary professor at the University of Barcelona, ​​says baricitinib should only be given 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 can also lead to a higher incidence of lymphoma or brain infarction,” Ferrando said. Sergio Vañó notes that the most common side effects are mild respiratory infections, acne, and a higher risk of shingles. “It is a very safe drug. Getting your hair back improves your quality of life and self-esteem, which offsets potential side effects.

Vañó estimates that 0.05% of the population could suffer from severe alopecia, or about 25,000 people in Spain. “I think the high cost will limit the use of the drug to those severe cases,” he said. Vañó predicts that the baricitinib price will drop to around $525 per month. María Guaita’s mother, Paloma Torrecilla, recalls the “ordeal” her daughter went through as a teenager, enduring hundreds of unnecessary drug injections into her scalp. She hopes Spain’s national health system will cover the cost of baricitinib for the most severe cases. “María is now starting to feel good. It’s amazing how much hair can change a person – it’s a transformation,” said Torrecilla.

María Guaita shows extraordinary maturity when she talks about her illness and would like the government to fund drugs to treat alopecia areata. “As the number of cases is low, it seems viable. I would ask them to try, by all means,” urged Guaita. “And I would say to other people like me don’t give up hope, that there is a way out. Sooner or later, they will be able to get out of this pit.

About Sally Dominguez

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