AbbVie announced positive topline results from the second of two pivotal studies of the Phase 3 UP-AA clinical program evaluating the safety and efficacy of upadacitinib (RINVOQ®; 15 mg and 30 mg, once daily) in adult and adolescent patients with severe alopecia areata (AA) with a mean baseline SALT score of 84.0 (approximately 16% scalp hair coverage).

In Study 1, both doses of upadacitinib achieved the primary endpoint, with 45.2% and 55.0% of patients treated with upadacitinib 15 mg and 30 mg, respectively, reaching 80% or more scalp hair coverage (SALT score ≤ 20) at week 24, compared to 1.5% of patients receiving placebo (p<0.001).1 These results are consistent with the topline results previously announced from the first parallel replicate study (Study 2) of the Phase 3 UP-AA clinical program.

"These positive results strengthen the growing body of evidence supporting the potential of upadacitinib to improve the lives of people with AA," said Kori Wallace, vice president, global head of immunology clinical development, AbbVie.

"We are very encouraged by the improvements in both scalp and non-scalp hair regrowth observed with both doses of upadacitinib and look forward to submitting these data to regulatory bodies, bringing us one step closer to delivering upadacitinib to those living with this complex immune-mediated disease."

"People living with AA often face considerable uncertainty related to both the severity and duration of hair loss, despite current treatment options," 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. "These encouraging results are consistent with and reinforce the outcomes observed in the first pivotal trial. Together, these findings underscore the potential of upadacitinib to provide meaningful hair regrowth, offering hope for those enduring the psychosocial burden associated with this disease."

Use of upadacitinib in AA is not approved and its safety and efficacy have not been evaluated by regulatory authorities.