Upadacitinib Shows Strong Efficacy in Phase 3 Alopecia Areata Trial

The Janus kinase inhibitor (JAK) upadacitinib (Rinvoq; Abbvie) appears to spark significant regrowth of scalp hair in patients with alopecia areata (AA), according to new data.1 The data, which come from the company’s phase 3 UP-AA clinical program, were reported in a press release last week.

Upadacitinib has already been approved to treat a number of immune-mediated inflammatory diseases, including rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis. It is not currently approved for AA, the company noted.

The new data are from one of 2 pivotal phase 3 trials designed to study the safety and efficacy of upadacitinib in adults and adolescents with severe AA. The 2 trials together included a randomized patient population of 1399 patients with severe AA ranging in age from 12 to 64 years old. The new data are from the second phase 3 study, dubbed Study 2. Participants were randomized to receive once-daily doses of 15 mg or 30 mg of upadacitinib or placebo. At baseline, patients in Study 2 had a mean baseline Severity of Alopecia Tool (SALT) score of 83.8, indicating that they had approximately 16% hair coverage on their scalps, on average.

The new data are from one of 2 pivotal phase 3 trials designed to study the safety and efficacy of upadacitinib in adults and adolescents with severe AA. | Image Credit: Yurii Kibalnik - stock.adobe.com

At both doses, approximately half of participants achieved the primary end point of a SALT score of 20 or below (indicating scalp hair coverage of 80% or more). Among patients taking the 15 mg dose, the end point was reached in 44.6% of cases at week 24; among patients taking the 30 mg dose, the rate was 54.3%. Among patients receiving placebo, the rate was just 3.4% (P < .001).

Kori Wallace, MD, PhD, the company’s vice president and global head of immunology clinical development, said the data are notable in part because they used rigorous SALT endpoints.

“These data underscore AbbVie’s commitment to advancing novel treatments that have the potential to improve the lives of individuals with immune-mediated diseases,” she said in the press release.1

At week 24, 36.0% of patients in the 15 mg group and 47.1% of patients in the 30 mg group achieved 90% scalp hair coverage, compared with 1.4% of patients receiving placebo (P < 0.001). The company said additional secondary endpoints, including percentage of patients with complete hair coverage, were also met.

Wallace said it is important for AA to be seen as the immune-mediated disease it is.

“Often misunderstood as a cosmetic issue, AA is a systemic immune-mediated disease that can cause total hair loss, involving the scalp, eyebrows, and eyelashes,” Wallace noted. “People living with AA may face difficulties in managing their disease, which can significantly affect their quality of life.”

A study published last month in Advances in Therapy found that patients with severe hair loss due to AA had decreased quality of life and were more likely to report impairment of work productivity.2

In terms of safety and efficacy, the investigators said the safety profile in the study was generally in line with what has been observed in other conditions for which the therapy is already approved.1 Just 1.4% and 2.8% of patients in the 15 mg and 30 mg groups, respectively, reported serious treatment-emergent adverse events, and just 0.7% and 1.4% of patients in the 2 groups, respectively, discontinued therapy due to treatment-emergent adverse events.

The most common treatment-emergent adverse events were acne, nasopharyngitis, and upper respiratory infection, the company said.

Arash Mostaghimi, MD, MPA, MPH, of Brigham and Women’s Hospital and Harvard Medical School, said in the press release that the results of the trial were encouraging and demonstrate the potential of upadacitinib to be “an important new treatment option.”

“There is a pressing need for more treatments that help enable regrowth of scalp and non-scalp hair,” he said.

References

1. AbbVie announces positive topline results from the Phase 3 UP-AA trial evaluating upadacitinib (Rinvoq) for alopecia areata. News release. AbbVie. Published July 30, 2025. Accessed August 5, 2025. https://news.abbvie.com/2025-07-30-AbbVie-Announces-Positive-Topline-Results-from-Phase-3-UP-AA-Trial-Evaluating-Upadacitinib-RINVOQ-R-for-Alopecia-Areata

2. Hanson KA, Austin J, Clayton N, et al. Patient-reported psychosocial burdens and quality of life and work productivity impacts among patients with clinically distinct alopecia areata severity profiles. Adv Ther. Published online July 21, 2025. doi:10.1007/s12325-025-03302-8