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Breaking News: AbbVie’s Upadacitinib Shows High Efficacy in Alopecia Areata Trial, Offering Hope for Hair Regrowth – North Chicago, IL – August 5, 2025 – A Phase 3 clinical trial has revealed highly promising results for upadacitinib (Rinvoq), a Janus kinase (JAK) inhibitor, in treating severe alopecia areata (AA). The trial, known as UP-AA, demonstrated significant scalp hair regrowth in patients receiving 30 mg of the medication.
The study, conducted across 68 sites in the United States, europe, and Asia, involved 161 adult patients with severe AA, defined as 80% or greater scalp hair loss.Participants were randomized to receive either 15 mg, 30 mg of upadacitinib, or a placebo.
Results indicated that 90% of patients in the 30 mg upadacitinib group achieved 80% or greater scalp hair coverage, a statistically significant advancement compared to just 1.4% of patients receiving placebo (P < 0.001). Additional secondary endpoints, including the proportion of patients achieving complete hair coverage, were also successfully met, according to AbbVie, the pharmaceutical company developing the drug.
“This is a significant step forward in addressing a condition that has historically had limited treatment options,” stated Dr. Wallace, a lead investigator on the trial, in a company press release. “It is important for AA to be seen as the immune-mediated disease it is.”
Alopecia areata is an autoimmune disorder where the immune system mistakenly attacks hair follicles, leading to hair loss. Ofen misconstrued as merely a cosmetic concern, AA can profoundly impact a person’s quality of life, affecting not onyl scalp hair but also eyebrows and eyelashes. The condition is estimated to affect approximately 147 million peopel worldwide, with onset typically occurring before age 30, tho it can develop at any age.
Recent research underscores the psychological burden of AA. A study published last month in Advances in Therapy found that individuals with severe hair loss due to AA experienced a diminished quality of life and reported greater impairment in work productivity.2 The study, authored by Hanson KA, Austin J, Clayton N, et al., highlighted the need for effective treatments that address both the physical and psychosocial aspects of the disease.
The UP-AA trial also assessed the safety of upadacitinib. the safety profile observed was consistent with previous findings for other approved uses of the therapy. Serious treatment-emergent adverse events were reported in 1.4% of patients in the 15 mg group and 2.8% in the 30 mg group. Discontinuation of treatment due to adverse events occurred in 0.7% and 1.4% of patients in the respective groups.
Common treatment-related side effects included acne, nasopharyngitis (inflammation of the nose and throat), and upper respiratory infections.
Arash Mostaghimi, MD, MPA, MPH, a dermatologist at Brigham and Women’s Hospital and Harvard Medical School, commented on the trial results, stating they are “encouraging” and demonstrate the potential of upadacitinib as “an critically important new treatment option.” He emphasized the “pressing need for more treatments that help enable regrowth of scalp and non-scalp hair.”
References
1. AbbVie announces positive topline results from the Phase 3 UP-AA trial evaluating upadacitinib (Rinvoq) for alopecia areata. News release. AbbVie. Published July 30, 2025. Accessed August 5, 2025. https://news.abbvie.com/2025-07-30-AbbVie-Announces-Positive-Topline-Results
