Charles Lynde, MD, is an associate professor in the Department of Medicine at the University of Toronto. He is the also Chief Medical Director of Lynde Institute for Dermatology and Lynderm Research.

Charles Lynde, MD

Upadacitinib's safety profile in patients with 

 mirrors what clinicians already see across its other approved indications, including psoriatic arthritis (PsA), Crohn's disease, and atopic dermatitis. AbbVie submitted a supplemental new drug application to the 

 on April 28, 2026, seeking approval for adults and adolescents aged 12 years and older with severe disease.

Charles Lynde, MD, FRCPC, medical director of the Lynde Institute for Dermatology & Lynderm Research in Markham, Ontario, Canada, co-authored the phase 3 findings supporting the application. The UP-AA1 and UP-AA2 trials, assessing once-daily upadacitinib 15 mg and 30 mg against placebo in 1399 adults and adolescents with severe alopecia areata over 24 weeks,

 suggest safety findings were consistent with upadacitinib's established profile in other autoimmune conditions, with no new safety signals identified.¹ Reported events included upper respiratory tract infections, acne, herpes simplex reactivation, and herpes zoster.

Approval down to age 12 would distinguish upadacitinib from JAK inhibitors currently limited to older adolescents or adults. Clinicians can mitigate herpes zoster risk with recombinant zoster vaccination before or during treatment. If cleared, upadacitinib would become the fourth systemic option approved for severe alopecia areata in the US, following baricitinib, ritlecitinib, and deuruxolitinib.²

In the following Q&A interview segment, Lynde discusses the safety profile observed in the UP-AA trials and how the data may reshape his treatment algorithm for severe alopecia areata:

: What are your thoughts on the safety data for upadacitinib in this population?

 This is a drug that's widely used. These JAK inhibitors are used for people with Crohn's disease, psoriatic arthritis, and atopic dermatitis, and we're now finding this is a pathway that many autoimmune diseases can be made better by. The side effect profile is pretty well known: some people get acne, some get a little more upper respiratory tract infections, and if you get cold sores, they can reactivate a little more frequently. We know people can get herpes zoster, shingles, and even at a younger age.

Normally in the population you get shingles when you're 65 or 70 years old, but in this case, people who are 30 years old might develop it. That can be mitigated by getting them vaccinated with Shingrix, which can usually prevent it, or if it doesn't completely prevent it, they're at least covered so it isn't as bad if they get it. The side effect profile is the one seen in other conditions with autoimmune diseases, there were no new signals here, and these side effects occur in a smaller number of patients. People want their hair back, and they're willing to put up with the potential side effects.

: How does this new data change where upadacitinib sits in your treatment algorithm for severe disease?

 This is another JAK inhibitor, and luckily we have several that can be useful. What's beneficial with upadacitinib is it goes down to age 12, while some of the other JAKs with approval only go down to age 18, though they're doing further trials and will likely get subsequent approval for a younger age. Think about it: you're in high school, you're 14 years old, and you lose all your hair. It's hard to go to school, and you can become very anxious, depressed, and everything else, so having a drug that's on-license, that you can get drug coverage for, is extremely important. The other thing is this drug may be working a little earlier than some of the other JAK inhibitors, and may also give a greater number of people who respond to it.

Editor's Note: This transcript has been edited for grammar and clarity using artificial intelligence tools.

AbbVie. AbbVie submits application to FDA for upadacitinib (Rinvoq) for adults and adolescents with severe alopecia areata. News release. Published April 28, 2026. Accessed August 24, 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

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 2026. doi:10.1001/jamadermatol.2026.2853.

Articles

AbbVie filed an sNDA (April 28, 2026) for upadacitinib in severe alopecia areata for adults and adolescents ≥12 years. Phase 3 UP-AA1/UP-AA2 (n=1399; 24 weeks; 15 mg or 30 mg QD vs placebo) showed an adverse-event spectrum consistent with established experience across autoimmune indications, without new safety signals. Common events included URTIs, acne, HSV reactivation, and herpes zoster. Earlier access for younger patients could meaningfully affect psychosocial burden, and zoster risk may be reduced with recombinant vaccination.

In this segment of his Q&A interview, Charles Lynde, MD, reviews upadacitinib's safety profile in the UP-AA trials and how it could reshape alopecia areata care.

Q&A: Upadacitinib's Safety Profile and Role in Severe Alopecia Areata Care

, defined by a Severity of Alopecia Tool (SALT) score of 50 or greater, has left clinicians with few systemic options for adults and adolescents with extensive or total scalp hair loss. Charles Lynde, MD, FRCPC, medical director of the Lynde Institute for Dermatology & Lynderm Research in Markham, Ontario, Canada, co-authored new phase 3 data addressing this gap.

UP-AA1 and UP-AA2, 2 replicate phase 3 randomized trials published in 

 Dermatology, assigned 1399 adults and adolescents with severe disease to once-daily upadacitinib 15 mg, 30 mg, or placebo for 24 weeks.¹ Participants averaged more than a decade of disease duration, and roughly half entered with SALT scores of 95 or higher, indicating near-total scalp hair loss.¹ The trials included 118 adolescents aged 12 - 17 years, broadening the evidence base beyond currently available adolescent options.²

At Week 24, 45.2% and 55.0% of UP-AA1 patients on the 15-mg and 30-mg doses, respectively, reached the primary endpoint of SALT score ≤20 versus 1.5% on placebo (

<.001).¹ UP-AA2 showed comparable results, with 44.6% and 54.3% reaching the endpoint versus 3.4% on placebo, and separation from placebo emerged by Week 8 in both trials.¹ Complete regrowth, defined as SALT 0, occurred in up to 22.5% of treated patients.¹

Achieving SALT score ≤20 corresponds to roughly 80% scalp coverage, a threshold clinicians associate with reduced reliance on wigs and greater tolerance of residual patches. Gains extended beyond the scalp as well, with improvements in eyebrow and eyelash regrowth alongside quality-of-life measures.¹ Below, Lynde discusses the trial population, the clinical significance of the primary endpoint, and why regrowth beyond the scalp matters for patients.

: What made this severe alopecia areata population difficult to treat, and how did the UP-AA trial design address that?

Alopecia areata can present as small localized areas of hair loss, but in this trial we were looking at people with very severe disease. To get into the trial, you had to have a SALT score, a measure of the amount of hair loss, greater than 50, which translates to 50% loss of all your hair. If you and I look at each other, we're both lucky to have all our hair, but people with 50% loss can't hide it, and many patients in the trial had a SALT score of 100, meaning they had completely lost all their hair.

These are severe, or very severe, patients with alopecia areata. Luckily, there have been a number of newer drugs, mostly JAK inhibitors, found to be useful for this condition, taking people who had lost all their hair for seven or eight years and getting it back again. It's quite amazing.

: Clinically, what does hitting 80% scalp coverage by Week 24 mean for a patient in your chair?

 For people getting a complete response, that's a different bar. Complete response means going from SALT 100 to SALT 0 or SALT 10. Some people got down to SALT 20, meaning they still had 20% loss in their scalp, but at that level, you can usually comb over and find ways to make sure other people don't notice it, so you don't have to wear a wig. When you have SALT 100, everybody notices, and you usually have to wear a wig if you want to hide it.

: Why does it matter that eyebrow and eyelash regrowth and quality-of-life scores improved alongside scalp coverage?

 People want to feel normal again once treatment is over. If you got all your hair back on your scalp but you're missing your eyebrows, you look a little funny. Missing your eyebrows and eyelashes might seem like nothing, but they protect your eyes. Without them, dirt, pollen, and bacteria in the air get into your eyes, so you're getting conjunctivitis all the time. People also miss nose hair in this condition, which acts as a filter to protect your lungs from upper respiratory tract infections, so you want regrowth on the scalp and the face at the same time.

Interestingly, some patients I've had with this and other drugs like it get their eyelashes and eyebrows back, and if they're a guy who doesn't get all their scalp hair back, they're extremely happy because they can shave their head and still look normal because of the eyebrows and eyelashes.

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. 

Two replicate phase 3 trials (UP-AA1/UP-AA2) evaluated once-daily upadacitinib 15 or 30 mg in 1399 adults/adolescents (12–17) with severe alopecia areata (SALT ≥50), long-standing disease, and frequent near-total loss. At Week 24, ~45% (15 mg) and ~54–55% (30 mg) achieved SALT ≤20 versus 1.5–3.4% with placebo, with separation by Week 8; up to 22.5% reached SALT 0. SALT ≤20 (~80% coverage) often eliminates need for wigs and permits cosmetic camouflage of residual patches; facial hair restoration also improves ocular and airway protection.

In this Q&A, Charles Lynde, MD, highlighted upadacitinib's impact on severe alopecia areata in new phase 3 data addressing the hair loss condition.