AbbVie’s phase 3 UP-AA trrial evaluating Upadacitinib for Alopecia Areata receives positive topline results

AbbVie recently announced that their new positive topline results from the first of two pivotal studies of the Phase 3 UP-AA clinical program evaluating the safety and efficacy of upadacitinib in adult and adolescent patients with severe alopecia areata with a mean baseline SALT score of 83.8.

“Often misunderstood as a cosmetic issue, AA is a systemic immune-mediated disease that can cause total hair loss, involving the scalp, eyebrows and eyelashes. People living with AA may face difficulties in managing their disease, which can significantly affect their quality of life,” said Kori Wallace, M.D., Ph.D., vice president, global head of immunology clinical development, AbbVie. “UP-AA is the first pivotal program to have ranked and met the rigorous standard of SALT=0, indicating complete scalp hair regrowth. These data underscore AbbVie’s commitment to advancing novel treatments that have the potential to improve the lives of individuals with immune-mediated diseases.”

“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. “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.”

Note that the safety profile of both doses of upadacitinib in the 24-week, placebo-controlled period was generally consistent with that observed in approved indications. Treatment-emergent serious adverse events occurred in 1.4% and 2.8% of patients in the upadacitinib 15 mg and 30 mg groups, respectively, and none in the placebo group. Discontinuations due to treatment-emergent adverse events occurred in 0.7% and 1.4% of subjects in the upadacitinib 15 mg and 30 mg groups, respectively, and none in the placebo group.

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Related Topics and Keywords

AbbVie, alopecia areata, Phase 3, rinvoq, Trial Evaluating Upadacitinib (RINVOQ®)