AbbVie’s RINVOQ Delivers Strong Results in Phase 3 Alopecia Areata Trial

AbbVie has announced encouraging topline results from the first pivotal Phase 3 study in its UP-AA clinical program, evaluating the safety and efficacy of RINVOQ® (upadacitinib) in patients with severe alopecia areata (AA). The trial involved adult and adolescent participants with a mean baseline SALT score of 83.8, indicating substantial hair loss.

"The sudden and often unpredictable hair loss people living with AA experience can profoundly impact their self-esteem and mental well-being. 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," 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 Study 2, both the 15 mg and 30 mg doses of RINVOQ met the primary endpoint. At 24 weeks, 44.6% and 54.3% of patients receiving the respective doses achieved at least 80% scalp hair coverage, compared to just 3.4% in the placebo group. Moreover, nearly half of the 30 mg group achieved 90% or more scalp hair coverage. Improvements were also seen in eyebrows, eyelashes, and complete scalp hair regrowth.

"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. 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," said Kori Wallace, M.D., Ph.D., vice president, global head of immunology clinical development, AbbVie. 

The treatment demonstrated a consistent safety profile relative to approved indications. Serious adverse events were low, and discontinuation due to side effects was rare. No deaths, malignancies, or major cardiovascular events were reported. However, one case of venous thromboembolism occurred in the 15 mg group in a patient with multiple risk factors. RINVOQ is not yet approved, as it has not yet been examined by the regulatory authorities for use in alopecia areata.