AT A GLANCE

AbbVie’s Phase 3 UP-AA trial found that upadacitinib (RINVOQ^®) led to significant scalp and non-scalp hair regrowth in patients with severe alopecia areata (AA). Both 15 mg and 30 mg doses met all primary and key secondary endpoints with a safety profile consistent with prior indications.

AbbVie has reported positive topline data from the pivotal Phase 3 UP-AA program evaluating upadacitinib in adult and adolescent patients with severe AA. Participants entered the study with a mean baseline SALT score of 83.8, reflecting approximately 16% scalp hair coverage.

In Study 2, upadacitinib met its primary endpoint:

• 44.6% (15 mg) and 54.3% (30 mg) of patients achieved ≥80% scalp hair coverage (SALT ≤ 20) at week 24, versus 3.4% on placebo (p<0.001).

• Clinically meaningful secondary endpoints were also achieved, with 36.0% (15 mg) and 47.1% (30 mg) of patients reaching ≥90% scalp coverage (SALT ≤ 10), compared with 1.4% in the placebo group (p<0.001).

• Both doses demonstrated significant improvement in non-scalp hair, including eyebrows and eyelashes. Notably, a proportion of patients achieved complete scalp regrowth (SALT = 0)—a rigorous benchmark not previously reached in AA trials.

Alopecia areata is increasingly recognized as a systemic, immune-mediated disease with profound psychosocial impact. By achieving high thresholds of hair regrowth—including complete regrowth in some patients—these findings provide strong evidence for targeting JAK signaling in AA and further validate SALT = 0 as a clinically meaningful endpoint in future research.

"The sudden and often unpredictable hair loss people living with AA experience can profoundly impact their self-esteem and mental well-being," said Arash Mostaghimi, M.D., M.P.A., M.P.H., associate professor of dermatology and vice chair of clinical trials and innovation, Brigham & Women's Hospital, Harvard Medical School in the company's press release. "There is a pressing need for more treatments that help enable regrowth of scalp and non-scalp hair. I am encouraged by these results that demonstrate the potential of upadacitinib to be an important new treatment option."

The safety profile was consistent with previous indications for upadacitinib. Serious adverse events occurred in 1.4% (15 mg) and 2.8% (30 mg) of patients, with no reports in the placebo group. Discontinuations due to adverse events were rare, and no major cardiovascular events, malignancies, or deaths were reported. The most frequent adverse events included acne, nasopharyngitis, and upper respiratory tract infections.

These results underscore the therapeutic potential of upadacitinib as a targeted, once-daily oral option for severe AA. By setting a new benchmark for clinical response, the UP-AA program highlights an important step forward in the development of disease-modifying treatments for immune-mediated hair loss. Regulatory review will be the next critical milestone in translating these findings into clinical practice.

DRUG AT A GLANCE

Upadacitinib (RINVOQ®) is a Janus kinase (JAK) inhibitor that is U.S. Food and Drug Administration approved for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, atopic dermatitis, ulcerative colitis, and Crohn’s disease.