This disease removes pigment from their skin. Now a new drug could help restore skin color to vitiligo patients.

But when her teenage daughter came home from school sobbing two years ago, saying she didn’t want to end up like her mother – white spots were already starting around the teenager’s eyes – Birleanu was determined to find a easier path for his children. She discovered a study at Tufts Medical Center testing a new cream to treat vitiligo and was the first volunteer to enroll.

Left is an image of Adriana Birleanu’s elbow before she volunteered for a study at Tufts Medical Center testing a new cream to treat vitiligo. Right, what does his elbow look like now.Jean Tlumacki

Based on the results of this study, the Food and Drug Administration on Monday gave the green light to the drug, known as ruxolitinib. It is now the first federally approved home treatment for repigmentation in vitiligo patients.

“It’s one thing to take care of it on your own, but you don’t want it for your children,” said Birleanu, a 48-year-old mother of two from North Andover.

Medical experts estimate that up to 2% of the population suffer from vitiligo, which causes a person’s immune system to mistakenly attack cells that produce a pigment, known as melanin, resulting in patches of skin. white that usually spread over time.

Vitiligo is not contagious or fatal. But it can be life changing.

“I was a shy girl and that kind of pulled me back,” Birleanu said. “It doesn’t hurt on the outside but it hurts a lot on the inside.”

Adriana Birleanu’s skin discoloration is now mostly on her hands and feet.John Tlumacki/Globe Team

The results of this trial have yet to be released, but preliminary data shows that approximately 30% of participants experienced a 75% restoration of pigment to their face after using the cream twice daily for six months. Within a year, that number had grown to about half of the participants.

Also after one year, about half of the patients saw 50% improving the pigmentation of their body.

“Some people react very early and quickly, while others take longer, and some people don’t react at all, and we don’t yet know why,” said Dr. David Rosmarin, vice president of research. and education in dermatology at Tufts Medical Center and principal investigator of the trial.

The study was funded by Incyte Corp., the company that makes the new drug, sold under the brand name Opzelura, and won FDA approval.

A vexing problem with other vitiligo treatments, which include anti-inflammatory and steroid medications and ultraviolet light sessions, is that when stopped, up to 40% of patients relapse during the first year.

What happens when patients stop using ruxolitinib cream is an open question, Rosmarin said.

“We don’t have a good answer to that yet. People may need to use it twice a week for maintenance,” he said.

Rosmarin continues to investigate this concern.

“It really fills a gap that existed for our vitiligo patients. »

Dr. Nicole Gunasekera, Vitiligo Clinic Director at Brigham and Women’s Hospital

Side effects reported in the study include mild acne in about 6% of participants, and a similar percentage reported red or itchy skin.

But federal regulators have required Incyte to include a warning label for its ruxolitinib cream because it belongs to a class of drugs known as Janus kinase (JAK) inhibitors, which have been shown to they cause serious infections and cardiovascular problems in patients receiving the drug by mouth. Other terms.

The FDA first approved Incyte cream last fall to treat eczema, a chronic condition that makes skin red and itchy. Since then, some doctors prescribe the “off label” cream for vitiligo. By also endorsing the vitiligo drug, doctors are more likely to prescribe it and insurance companies to cover the costs, which can be significant for patients without such coverage.

“It really fills a gap that existed for our vitiligo patients,” said Dr. Nicole Gunasekera, director of the vitiligo clinic at Brigham and Women’s Hospital.

She said the handful of vitiligo patients she’s prescribed the cream to since last fall had to go to a compounding pharmacy that made it especially for them at a price of about $400 per tube.

The FDA has approved the cream for use by patients 12 years of age and older, on 10% of their body. Doctors say a tube of the cream would last about a month for patients who use it on 4% of their body, an area the size of about four palms.

While some patients choose not to treat their vitiligo, claiming that their white patches are now part of their identity, others eagerly await the cream’s approval.

Aliya Sawyer, 12, suffers from vitiligo and has tried various treatments. Her skin has darkened as her pigmentation has returned, especially on her face over the past year. She can’t wait to try a new anti-vitiligo cream that has just been approved by the FDA.John Tlumacki/Globe Team

That includes 12-year-old Aliya Sawyer of Dracut, who set an alert on her cell phone this week to remind her mother that FDA approval was likely coming and she needed to make an appointment with a dermatologist to get a prescription.

“I haven’t had treatments in a long time because the last time I felt like a lab rat,” said Sawyer, who was first diagnosed at age 5. year.

She underwent ultraviolet light therapy sessions three times a week for several months when she was 5, but the vitiligo progressed faster than the treatments. By first grade, large white patches covered her once caramel-colored skin, and she gave up on treatments.

In the summer, some of her pigment usually returns when she spends time outside in the sun. And then her skin becomes more mottled deeper into the fall, a relentless cycle that has caused bullying.

“One person said to me, ‘I think you’d be a lot prettier if you didn’t have vitiligo,'” said Sawyer, who has become a beacon for many children with the condition, speaking at the conferences and offering support.

A year ago, Sawyer had lost 90% of her pigment, but with more of her color returning this summer than ever before, she hopes the new cream will be the tipping point for her.

A photo of Aliya Sawyer in the summer of 2021, when she had lost a lot of pigment. Her face was mostly white, and she had large spots on the white skin on her back.John Tlumacki/Globe Team

For Adriana Birleanu, the North Andover mother who signed up for the trial to help find a better treatment for her daughter, the new cream has made a significant difference. The white spots have almost disappeared from her face and elbow and are easily covered with makeup.

But she has yet to see any improvement on her hands and feet.

“It’s not like cancer, I know, it’s not something that hurts, but it’s something that I had to accept, and it’s hard some days even after all these years” , she said. “My hope [with this medication] is for the kids, boys and girls out there, that they don’t have to go through this.

Kay Lazar can be reached at [email protected] Follow her on Twitter @GlobeKayLazar.