Two clinical trials have shown that the autoimmune drug upadacitinib may help restore hair growth in people with severe alopecia areata.
The two trials included 1,399 adolescents and adults who had lost at least half of their scalp hair due to the disease. Participants received either 15 mg or 30 mg of upadacitinib daily, or a placebo, while researchers monitored hair growth over 24 weeks.
The researchers focused on the percentage of patients who were able to regain hair covering at least 80% of the scalp.
After 24 weeks, approximately half of the patients who received the 15 mg dose achieved this coverage rate, while the rate exceeded 54% among those who received the 30 mg dose. In contrast, the rate did not exceed 2% among those who received a placebo.
The results were most pronounced in patients who regained 90% or more of their scalp hair, with more than 35% of those taking the low dose and about 46% of those taking the high dose achieving this, compared to only about 1% in the placebo group.
Approximately 13% of patients who took 15 mg and about 23% of those who took 30 mg experienced complete regrowth of scalp hair. More than half of the participants who received the higher dose also experienced significant improvement in eyebrow and eyelash growth.
Upadacitinib belongs to a class of drugs known as Janus kinase (JAK) inhibitors, which work by disabling proteins involved in regulating immune system activity and inflammation.
In alopecia areata, the immune system mistakenly attacks hair follicles, leading to hair loss and the appearance of bald patches that, in severe cases, may extend to most of the scalp.
Researchers believe that inhibiting JAK pathways can reduce the immune response targeting hair follicles, thus allowing hair regrowth to resume. Previous studies on other JAK inhibitors have shown promising results in some individuals with alopecia.
Researchers tested upadacitinib in two Phase III trials, UP-AA1 and UP-AA2. The first included up to 112 medical centers in 25 countries, while the second extended to 125 centers in 28 countries in Asia, Europe, North America, and Central and South America.
Both studies included teenagers aged 12 to 17, and adults up to the age of 64, with participants having lost at least 50% of their scalp hair.
The researchers randomly divided the participants into three groups: the first received 15 mg of upadacitinib daily, the second 30 mg, and the third a placebo. Assessments were conducted at weeks 4, 8, 12, and 24, with follow-up to monitor treatment safety.
After the first phase, participants entered a 28-week extension period, with the aim of assessing the continued effectiveness and safety of the treatment in the longer term.
Increased hair growth began to appear in some patients within eight weeks of starting treatment, indicating an early response in those with severe cases.
The improvement wasn't limited to hair growth; participants who received upadacitinib also reported improvements in their psychological and social well-being. This is particularly important because alopecia areata can significantly impact a person's self-confidence and quality of life, especially when hair loss is extensive.
The most common side effects recorded during the study were acne, colds, throat irritation, and upper respiratory tract infections, while serious side effects remained limited.
The results of the two trials indicate that upadacitinib may represent a promising treatment option for adolescents and adults with severe alopecia areata, with the continued need to monitor its long-term effectiveness and safety.
