Key Takeaways:
- Upadacitinib met its primary endpoint in both UP-AA trials, with 45.2% (15 mg) and 55.0% (30 mg) of patients reaching 80%+ scalp hair regrowth by Week 24, versus just 1.5%-3.4% on placebo.
- Beyond the scalp, roughly 40%-60% of patients saw meaningful eyebrow and eyelash regrowth, addressing losses that are especially hard to camouflage.
- No new safety signals emerged, and the drug showed the most favorable risk-benefit ratio in adolescents, the group most affected psychosocially by alopecia areata.
The European Commission approved upadacitinib for adolescents and adults 12 years and older with severe alopecia areata in July 2026, while a decision on AbbVie's supplemental new drug application remains pending at the FDA.² The application draws on the phase 3 UP-AA1 and UP-AA2 trials, which also captured hair regrowth beyond the scalp and a consistent safety profile through Week 24.¹
At baseline, about two-thirds of patients had meaningful eyebrow loss and half had meaningful eyelash loss, deficits difficult to camouflage and carrying a functional role in protecting the eyes.¹ By Week 24, meaningful eyebrow regrowth occurred in about 40% of patients on the 15-mg dose and 60% on the 30-mg dose, with a similar pattern for eyelash regrowth.¹
Safety findings showed no new signals across the trials, consistent with upadacitinib's established profile in rheumatoid arthritis, inflammatory bowel disease, and atopic dermatitis.¹ For clinicians, this combination of efficacy and a familiar safety profile offers a well-characterized option for patients who have often exhausted other therapies.
Safety data across the age spectrum studied showed the most favorable risk-benefit ratio in adolescents, a population in which alopecia areata carries substantial psychosocial impact.¹ Many patients with severe alopecia areata have discontinued treatment altogether after limited success with other options, underscoring demand for therapies with higher regrowth rates.
Melinda Gooderham, MD, FRCPC, is a dermatologist and medical director at SKiN Centre for Dermatology and an assistant professor at Queen's University. In the following HCPLive Q&A interview, Gooderham discusses eyebrow and eyelash outcomes, the safety profile, and where upadacitinib fits among treatment options for severe alopecia areata.
HCPLive: Beyond scalp regrowth, the study showed improvement in eyebrow, eyelash hair, and quality-of-life measures. Why are these endpoints significant?
Gooderham: Those are important endpoints as well, because at baseline, about two-thirds of patients had meaningful eyebrow loss and half of patients had meaningful eyelash loss, and that's difficult for patients because it's hard to hide. You can hide scalp hair loss by wearing a wig, but eyebrows need to be tattooed on, and eyelashes are also hard to hide.
There's functionality involved too: eyebrows keep sweat from running into your eyes, and eyelashes keep dirt from getting into your eyes, so it's not only a cosmetic problem but a functional one. At Week 24, eyebrow growth was seen in about 40% of patients on the 15 mg dose and about 60% of patients on the 30 mg dose, and we saw the same pattern with the eyelashes. They had meaningful growth in their eyebrows and eyelashes, so the results are both functionally and cosmetically significant.
HCPLive: There were no new safety signals. How does this shape your confidence in upadacitinib for this population, including adolescents?
Gooderham: I have high confidence because we haven't yet seen levels of regrowth like this with any other drugs, and that's been exciting. This is a cross-trial comparison to the other studies, not head-to-head, but we saw about 35% SALT20 scores with some of the other drugs, not 45% to 55%, so these are really great levels of improvement.
We're familiar with upadacitinib from treating patients with atopic dermatitis, and we have loads of safety data from other indications, such as rheumatoid arthritis, inflammatory bowel disease, and atopic dermatitis, so we're comfortable with the safety profile and know how to use this drug. Paired with the high levels of response, I think this is really going to raise the bar for this population of patients.
HCPLive: Looking at the bigger picture, where does this data position upadacitinib among treatment options for severe alopecia areata?
Gooderham: I hope clinicians see this raises the bar, and we're able to do better for our patients by giving them a well-established medication with really good results. Half of our patients get to SALT20, a third to half get to SALT90 depending on the dose used, and even 1 out of 5 patients get complete full regrowth. I hope clinicians will see severe AA can be treated now. There are many patients out there who have given up on treatment, so knowing severe AA is treatable, and knowing it treats not only the scalp but also the eyebrows, the eyelashes, and the beard in men looking to grow one, is meaningful.
It's safe in adolescence, and when you look at the safety data for upadacitinib across the whole age spectrum, we see the best risk-benefit ratio in that adolescent group. When alopecia areata develops in adolescence, it can have the greatest psychosocial impact, so it's really important to see the efficacy, the safety, and the great risk-benefit ratio in the adolescent age group.
Editor's Note: This transcript has been edited for grammar and clarity using artificial intelligence tools. Gooderham has 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
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.
