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Upadacitinib Demonstrates Significant Hair Regrowth in Severe Alopecia Areata Trials

9/6/2026, 1:43:51 AM

Trial Outcomes

Two parallel phase-3 randomized clinical trials evaluated the anti-inflammatory arthritis medication upadacitinib in adults and adolescents with severe alopecia areata. Participants receiving 15 mg daily achieved the primary efficacy threshold—a SALT score of 20 or less, indicating at least 80 % scalp hair coverage—in 45.2 % and 44.6 % of cases across the two studies. The 30 mg dose produced slightly higher response rates of 55 % and 54.3 %. By contrast, only 1.5 % and 3 % of placebo recipients reached this benchmark. Full scalp hair regrowth was observed in 13 % to 22.5 % of upadacitinib-treated participants, depending on dose and trial, while virtually none of the placebo group experienced complete regrowth.

Study Population and Methodology

The trials enrolled 1,399 individuals aged 12 to 64, including 118 adolescents, all of whom had lost at least half of their scalp hair (SALT >= 50). Over a 24-week period, participants took a daily pill of either 15 mg upadacitinib, 30 mg upadacitinib, or placebo. The primary endpoint was the proportion achieving a SALT score of 20 or less by week 24, with secondary assessments of patient-reported outcomes and safety.

Safety Profile and Patient-Reported Benefits

Serious adverse events were rare across both dosage groups, and the short-term safety profile was described as positive. Participants also reported meaningful improvements in health-related quality-of-life measures and in their own impression of change, suggesting that hair regrowth translated into psychosocial benefit for a condition known for its emotional burden.

Limitations and Industry Involvement

The trials were funded and co-designed by AbbVie, the manufacturer of upadacitinib, and several investigators were AbbVie employees. Researchers acknowledged that the 24-week duration does not reveal long-term efficacy or safety, and they called for additional studies comparing upadacitinib with existing therapies and extended follow-up periods. Despite these caveats, the investigators concluded that the rapid and deep responses observed could position upadacitinib as a valuable treatment option for patients with severe alopecia areata.