Melinda Gooderham, MD, is a dermatologist and the medical director at the SKiN Centre for Dermatology.

Melinda Gooderham, MD

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 

 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 

 Q&A interview, Gooderham discusses eyebrow and eyelash outcomes, the safety profile, and where upadacitinib fits among treatment options for severe alopecia areata.

: Beyond scalp regrowth, the study showed improvement in eyebrow, eyelash hair, and quality-of-life measures. Why are these endpoints significant?

 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.

: There were no new safety signals. How does this shape your confidence in upadacitinib for this population, including adolescents?

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.

: Looking at the bigger picture, where does this data position upadacitinib among treatment options for severe alopecia areata?

 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.

Mostaghimi A, et al. Upadacitinib for severe alopecia areata in adults and adolescents: two phase 3 UP-AA randomized clinical trials. 

. Published online August 12, 2026. doi:10.1001/jamadermatol.2026.2853.

Bosslett M. EU approves upadacitinib for severe alopecia as US review remains pending. 

. Published August 6, 2026. Accessed August 20, 2026. 

https://www.dermatologytimes.com/view/eu-approves-upadacitinib-for-severe-alopecia-as-us-review-remains-pending

Articles

Upadacitinib has been approved in the EU for severe alopecia areata in patients aged ≥12 years, with US FDA review still pending, supported by phase 3 UP-AA1/UP-AA2 data through Week 24. Beyond scalp endpoints, eyebrow and eyelash regrowth addressed common, hard-to-camouflage deficits with functional implications. Meaningful eyebrow regrowth occurred in ~40% (15 mg) and ~60% (30 mg), with similar eyelash outcomes. Safety was consistent with the established profile across other immune-mediated diseases, with particularly favorable adolescent risk–benefit.

This Q&A interview continues Gooderham's discussion of new upadacitinib treatment data on patients living with severe alopecia areata.

Q&A: Upadacitinib Drives Eyebrow, Eyelash Regrowth with Consistent Safety

 to the US Food and Drug Administration (FDA) in April 2026 seeking approval of upadacitinib for 

 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 (

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 

 from UP-AA as well as the trial design and what the primary endpoint results mean for patients with severe alopecia areata:

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

 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.

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

 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.

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

 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.

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

AbbVie filed an FDA sNDA (April 2026) for upadacitinib in severe alopecia areata for adults and adolescents ≥12 years, supported by replicate phase 3 UP-AA1/UP-AA2 trials (n=1,399; 118 adolescents). Patients with ≥50% scalp hair loss (mean baseline SALT ~84; ~16% coverage) were randomized 2:2:1 to 15 mg, 30 mg, or placebo for 24 weeks. Week-24 SALT≤20 responses were ~45% (15 mg) and ~54–55% (30 mg) versus 1.5–3.4% placebo (P<.001), with substantial SALT≤10 rates.

This Q&A interview highlights key new data from the UP-AA1 and UP-AA2 trials on upadacitinib for severe alopecia areata.

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

At Week 24, meaningful eyebrow and eyelash regrowth was achieved by roughly 40% of patients on the 15-mg dose and 60% on the 30-mg dose.

No new safety signals were identified, and Gooderham noted extensive existing safety data from upadacitinib's other approved indications supports its use in this population.

Gooderham said the data reflect a favorable risk-benefit profile in adolescents, a group in which alopecia areata can carry significant psychosocial impact.

Melinda Gooderham, MD, MSc, medical director of the SKiN Centre for Dermatology in Peterborough, Ontario, continued her discussion of 

 for severe alopecia areata, recently published in 

, focusing on secondary end points involving eyebrow and eyelash regrowth, along with safety findings from the UP-AA1 and UP-AA2 trials.

Both replicate global trials randomized adolescent and adult patients with severe alopecia areata, defined as a Severity of Alopecia Tool (SALT) score of 50 or greater, to 15 mg upadacitinib, 30 mg upadacitinib, or placebo, with a primary end point of SALT score 20 or less at the 24-week mark.

Upadacitinib Shows Strong Safety Profile in Severe Alopecia Areata

What Did the Trials Show for Eyebrow and Eyelash Regrowth?

Gooderham said eyebrow and eyelash outcomes were clinically meaningful secondary end points, noting that roughly two-thirds of patients had significant eyebrow loss and half had significant eyelash loss at baseline. She explained that this type of hair loss is particularly difficult for patients to conceal compared with scalp hair loss, and also carries functional consequences, since eyebrows and eyelashes help protect the eyes from sweat and debris. At Week 24, approximately 40% of patients on the 15-mg dose and 60% of patients on the 30-mg dose achieved meaningful eyebrow and eyelash regrowth.

How Do the Safety Findings Affect Confidence in Upadacitinib for This Population?

Gooderham said no new safety signals were identified in the trials, reinforcing her confidence in upadacitinib given the extensive existing safety data from other approved indications, including atopic dermatitis, rheumatoid arthritis, and inflammatory bowel disease. She noted that in a cross-trial comparison, other therapies for severe alopecia areata have shown SALT score 20 or less response rates around 35%, compared with 45% and 55% for the 15-mg and 30-mg upadacitinib doses, respectively, though she cautioned this was not a head-to-head comparison.

Gooderham said the data may raise the standard of care for patients with severe alopecia areata, many of whom have previously abandoned treatment. She emphasized that upadacitinib's benefits extend beyond the scalp to eyebrows, eyelashes, and beard growth in men, and pointed to a favorable risk-benefit profile in adolescents specifically, a population in which alopecia areata can carry significant psychosocial impact.

Editor’s note: Gooderham’s has 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.

Mostaghimi A, Gooderham MJ, Lynde C, 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. 

Smith T. UP-AA: Upadacitinib Attains Primary Endpoint in New Alopecia Areata Data. HCPLive. August 13, 2026. Accessed August 20, 2026. 

https://www.hcplive.com/view/up-aa-upadacitinib-attains-primary-endpoint-alopecia-areata-data

Videos

In this interview, Melinda Gooderham, MD, MSc, touches on eyebrow and eyelash regrowth data and safety findings for upadacitinib in severe alopecia areata.

Melinda Gooderham, MD, MSc, medical director of the SKiN Centre for Dermatology in Peterborough, Ontario, discussed 

Alopecia areata remains a chronic, immune-mediated condition with limited systemic treatment options, and ritlecitinib is currently the only therapy approved for adolescent patients, leaving a clear need for additional effective treatments across age groups. Gooderham said this unmet need helped shape the rationale behind evaluating upadacitinib in a broad population that included both adults and adolescents with severe disease.

How Much Hair Regrowth Did Upadacitinib Achieve in Severe Alopecia Areata?

What Was the Design of the UP-AA1 and UP-AA2 Trials?

UP-AA1 and UP-AA2 were 2 replicate, global, randomized, double-blinded, placebo-controlled phase 3 trials designed to confirm efficacy findings across independent patient populations. The trials enrolled adolescents and adults ages 12 to younger than 64 years with severe alopecia areata, defined as a Severity of Alopecia Tool (SALT) score of 50 or greater, reflecting at least 50% scalp hair loss. Patients were randomized in a 2:2:1 ratio to receive 15 mg upadacitinib, 30 mg upadacitinib, or placebo once daily.

The primary 24-week double-blinded treatment period, referred to as period A, was followed by a 28-week blinded extension period. The primary end point was achievement of a SALT score of 20 or less, corresponding to at least 80% scalp hair coverage, at Week 24. Secondary end points included eyebrow and eyelash outcome measures, earlier SALT score improvements at weeks 4, 8, and 12, achievement of a SALT score of 10 or less, complete hair regrowth (SALT score of 0), and patient-reported quality of life and global impression of change measures.

What Did the Trial Results Show About Hair Regrowth?

Gooderham explained that patients had a mean baseline SALT score of 84, corresponding to roughly 16% scalp hair coverage. At week 24, the primary end point of SALT score 20 or less was achieved by 45% of patients receiving the 15-mg dose and 55% of patients receiving the 30-mg dose, compared with just 1% to 3% of patients receiving placebo.

She noted that a SALT score of 10 or less, corresponding to 90% scalp coverage, was achieved by approximately one-third of patients on the 15-mg dose and half of patients on the 30-mg dose. Gooderham said this level of regrowth carries meaningful clinical significance, since patients reaching 80% to 90% scalp coverage can typically style their hair, reduce reliance on wigs or head coverings, and no longer have hair loss as the most visible feature to others.

Smith T. UP-AA: Upadacitinib Attains Primary Endpoint in New Alopecia Areata Data. HCPLive. August 13, 2026. Accessed August 19, 2026. 

Melinda Gooderham, MD, MSc, discusses new JAMA data on upadacitinib's efficacy for severe alopecia areata in adults and adolescents.