Q&A: Upadacitinib Meets Primary Endpoint in Severe Alopecia Areata Trials

AbbVie submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) in April 2026 seeking approval of upadacitinib for severe alopecia areata in adults and adolescents ages 12 and older.² The application was supported by 2 replicate phase 3 trials, UP-AA1 and UP-AA2, enrolling 1,399 patients across 248 global sites, including 118 adolescents ages 12 - 17.¹

Patients were randomized 2:2:1 to upadacitinib 15 mg, 30 mg, or placebo for a double-blind, 24-week Period A, and enrollment required at least 50% scalp hair loss.¹ Mean baseline Severity of Alopecia Tool (SALT) score was 83.8 - 84, corresponding to about 16% scalp hair coverage at study entry.¹

At Week 24, the primary endpoint, a SALT score of 20 or less denoting 80% or greater scalp hair regrowth, was met by 45.2% on 15 mg and 55.0% on 30 mg in UP-AA1.¹ Response rates were consistent in UP-AA2, at 44.6% and 54.3%, respectively, versus 1.5% to 3.4% with placebo (P < .001).¹

A SALT score of 10 or less, reflecting 90% or greater regrowth, was reached by about one-third of patients on the 15-mg dose and half of patients on the 30-mg dose.¹ This level of regrowth allows patients to style their hair and forgo wigs or head coverings, marking a clinically meaningful shift from the 16% average coverage seen at baseline.

Melinda Gooderham, MD, FRCPC, is a dermatologist and medical director at SKiN Centre for Dermatology and an assistant professor at Queen's University, where she also serves as an investigator with Probity Medical Research. In the following Q&A interview, Gooderham discusses the latest findings published in JAMA from UP-AA as well as the trial design and what the primary endpoint results mean for patients with severe alopecia areata:

HCPLive: Can you describe the design of the two phase 3 UP-AA trials and why this patient population was important to study?

Gooderham: The UP-AA1 and UP-AA2 trials are replicate, global, randomized, double-blind, controlled trials, so we can confirm the results in two studies. They looked at two doses of upadacitinib compared with placebo, with a 2:2:1 randomization: 15 mg of upadacitinib, 30 mg of upadacitinib, or placebo. The Period A results we're presenting here covered 24 weeks. The subjects enrolled were adolescents or adults with at least 50% hair loss due to alopecia areata.

HCPLive: The trials met their primary endpoint of 80% scalp hair coverage by Week 24. Can you elaborate on this finding?

Gooderham: The primary endpoint was a SALT score of 20 or less, meaning 80% or greater hair regrowth, assessed at week 24. It was met by 45%, almost half, of patients on the 15 mg dose, and over half, 55%, of patients on the 30 mg dose, compared with 1% to 3% in the placebo group.

HCPLive: How meaningful is this 80% threshold clinically for clinicians, and what does it mean for patients in practice?

Gooderham: It's important to look at the mean baseline characteristics of the patients. The mean SALT score at baseline was 84, meaning patients had about 16% scalp hair coverage on average, so very little hair. In 24 weeks, at least half the patients went to having at least 80% coverage, which is a significant shift in the amount of hair grown. Beyond that 80% coverage, if you look at the proportion of patients who had 90% hair coverage, which is clinically significant, about a third of patients had 90% hair growth on the 15 mg dose and half of patients on the 30 mg dose.

That 80% to 90% range is important because it's when you can start to style your hair, cover up some areas, and no longer depend on a wig or a hat. It's not the first thing people see when they see you anymore. They're not looking at your hair loss; you have hair there to live your life.

Editor's Note: This transcript has been edited for grammar and clarity using artificial intelligence tools. Gooderham’s previously reported non-financial support from Takeda in addition to personal fees from AbbVie, Amgen, Arcutis, Bristol Myers Squibb, Boehringer Ingelheim, Eli Lilly, Galderma, Incyte, Janssen, Leo Pharma, Meiji, Dermavant, Moonlake, Nektar, Nimbus, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma, Tarsus, Takeda, UCB, Union, Ventyx, and Apogee.

References

1. Mostaghimi A, et al. Upadacitinib for severe alopecia areata in adults and adolescents: two phase 3 UP-AA randomized clinical trials. JAMA Dermatol. Published online August 12, 2026. doi:10.1001/jamadermatol.2026.2853.

2. AbbVie. AbbVie submits application to FDA for upadacitinib (RINVOQ) for adults and adolescents with severe alopecia areata. Published April 28, 2026. Accessed August 20, 2026. https://news.abbvie.com/2026-04-28-AbbVie-Submits-Application-to-FDA-for-Upadacitinib-RINVOQ-R-for-Adults-and-Adolescents-with-Severe-Alopecia-Areata.