Upadacitinib in severe alopecia areata: about half reached near-full scalp coverage at 24 weeks

Design

Two replicate phase 3, double-blind, placebo-controlled randomised trials

Population

1399 people aged 12 to 63 with severe alopecia areata (SALT ≥50)

Primary outcome

SALT score 20 or less at week 24

Effect

15 mg 45.2%/44.6%, 30 mg 55.0%/54.3%, placebo 1.5%/3.4%

UP-AA1 and UP-AA2 were replicate, double-blind phase 3 trials randomising 1399 people aged 12 to 63 with severe alopecia areata (SALT 50 or more; mean 83.9) to upadacitinib 15 mg, 30 mg or placebo, 2:2:1.

At week 24, SALT 20 or less — 80% or more scalp coverage — was reached by 45.2% and 44.6% on 15 mg, 55.0% and 54.3% on 30 mg, and 1.5% and 3.4% on placebo. Adolescents and adults had similar safety. Upper respiratory infection, acne, raised creatine kinase and nasopharyngitis were the commonest adverse events; serious adverse events occurred in 1.6%, 2.3% and 0.4%.

The results were consistent across two trials, which strengthens them. Upadacitinib is already licensed for other inflammatory diseases; whether it is licensed for alopecia areata where you practise should be checked. As with other JAK inhibitors in this condition, relapse after stopping is common, so treatment is likely to be long-term.

• Consider upadacitinib for severe alopecia areata (SALT 50 or more) where it is licensed for this use, in adults and adolescents.
• Record a baseline SALT score so response at 24 weeks can be judged objectively.
• Discuss acne and raised creatine kinase as common, usually manageable side effects.
• Set expectations: response builds over months, and hair loss is likely to return if treatment stops.
• Complete infection screening, including tuberculosis, before the first dose.

Why it matters

Two replicate trials give a second oral JAK option for adolescents as well as adults with severe disease.

Don't overread it

These are 24-week results; durability, relapse after stopping and long-term safety in this population need longer follow-up.

The statistics, in plain English

SALT measures the percentage of scalp hair lost; SALT 20 or less means at least 80% coverage. Going from about 2–3% on placebo to 45–55% on drug is a large absolute difference — roughly one extra responder for every two people treated.

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