About 160 million people around the world live with alopecia areata, a chronic autoimmune skin disease causing hair loss on the head, face, and other parts of the body.
There is currently no cure for alopecia areata. The condition is treated with different types of medications, including corticosteroids, immunotherapy, and Janus kinase (JAK) inhibitors.
“Alopecia areata is an autoimmune condition causing hair loss that carries a profound psychosocial burden for patients,” Arash Mostaghimi, MD, MPH, vice chair of clinical trials and innovation in the Department of Dermatology at Brigham and Women’s Hospital in Boston, associate professor at Harvard Medical School, told Medical News Today.
“Despite the introduction of FDA-approved medications over the past few years, many individuals still do not respond sufficiently to existing therapies. Developing new medications is critical to expanding effective options for these patients,” he noted.
Mostaghimi is the first author of a new study published in the journal JAMA Dermatology, which found that a JAK inhibitor medication currently being used to treat rheumatoid arthritis may help people with alopecia areata regrow enough hair to cover at least 80% of their scalp within 24 weeks of use.
For this randomized phase 3 clinical trial, researchers recruited almost 1,400 participants — including both adults and adolescents — with severe alopecia areata.
Study participants received either a 15 milligram (mg) or 30 mg dose of the JAK inhibitor upadacitinib, which is currently used to treat several chronic inflammatory and autoimmune diseases such as rheumatoid arthritis, ulcerative colitis, Crohn’s disease, and atopic dermatitis.
“Upadacitinib is a once-daily oral medication that targets the JAK/STAT pathway, a key cellular signaling route that drives inflammation,” Mostaghimi explained.
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“Given its mechanism of action, along with real-world observations of hair regrowth in patients treated for eczema who also had co-occurring alopecia areata, investigating upadacitinib as a dedicated treatment for alopecia areata was a natural next step,” he told us.
At the study’s conclusion, Mostaghimi and his team found that about half of study participants taking the 15 mg dose of upadacitinib grew back enough hair to cover at least 80% of their scalp within 24 weeks. And 54% of participants taking the 30 mg dose had the same result.
“These findings demonstrate both rapid onset and substantial depth of response with upadacitinib,” Mostaghimi said. “While this was not a direct head-to-head comparative trial, the data suggest that upadacitinib may be among the most effective systemic treatments evaluated for alopecia areata to date.”
Additionally, researchers reported that study participants had improved eyebrows and eyelashes while on upadacitinib, and said they felt better emotionally and socially.
“The ultimate goal of treating alopecia areata is not just hair count, but restoring patients’ confidence and quality of life,” Mostaghimi explained. “Achieving regrowth in critical non-scalp areas like eyebrows and eyelashes, along with measurable improvements in emotional and social well-being, confirms that upadacitinib delivers clinically meaningful outcomes.”
“Based on these clinical data, upadacitinib has already been approved for severe alopecia areata in Europe,” he added. “The findings are currently under review by the FDA, and we are hopeful the therapy will be approved for patients in the United States in the near future.”
MNT had the opportunity to speak with Joseph W. Fakhoury, MD, dermatologist, clinical trialist, and director of the Alopecia Clinic at Henry Ford Hospital in Detroit, MI, and spokesdoctor for the National Alopecia Areata Foundation, who commented the results are encouraging.
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“Upadacitinib works by blocking certain JAK pathways, which are involved in the abnormal immune response underlying alopecia areata,” Fakhoury, who was not involved in this study, explained. “By decreasing the immune system’s attack on the hair follicle, upadacitinib may help the follicle return to its normal hair-growth cycle.”
“Alopecia areata affects patients differently, and not all patients respond to currently available treatments,” he continued. “Having more treatment options will allow us to better personalize care and hopefully help more patients achieve meaningful and durable control of this condition.”
MNT also spoke with Alexis Young, MD, a board-certified dermatologist at Hackensack University Medical Center (HUMC) in New Jersey, who likewise was not involved in this study.
Young said her first reaction to the study’s results was one of tremendous optimism.
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“Seeing that up to 55% of patients on the 30-mg dose of upadacitinib achieved at least 80% scalp hair coverage in just 24 weeks is a massive step forward. It is especially exciting to see such rapid, robust results — with significant improvements observed as early as eight weeks — for both adult and adolescent patients, a demographic that currently has very limited systemic treatment options.”
– Alexis Young, MD
While the 24-week data demonstrates a highly positive benefit-risk profile with safety consistent with its other approved indications, Young said she looks forward to reviewing the longer-term data.
“This study program includes a 28-week blinded extension period, and seeing the 52-week and beyond results will be critical,” she continued. “That long-term data will help us understand the durability of the hair regrowth, identify any optimal dosing adjustments needed over time, and ensure there are no delayed adverse safety events before routinely prescribing it in clinical practice.”
