#United States #North Chicago #Alopecia Areata #RINVOQ #Upadacitinib

Positive Results from the Second Phase 3 UP-AA Trial

AbbVie has recently disclosed optimistic topline results from the second pivotal study of the Phase 3 UP-AA clinical program evaluating the efficacy of upadacitinib (RINVOQ®) for treating severe alopecia areata (AA). The study, known as Study 1, demonstrated that both doses (15 mg and 30 mg) of upadacitinib met the primary endpoint, indicating substantial improvement in scalp hair coverage among treated patients.

In the study, 45.2% of participants on a 15 mg dosage and 55.0% on a 30 mg dosage achieved at least 80% scalp hair coverage as measured by the Severity of Alopecia Tool (SALT) score of 20 or below after 24 weeks. Conversely, only 1.5% of those on placebo reached this threshold. Furthermore, the percentage of subjects reaching a SALT score of 10 or below—indicating 90% or more scalp coverage—was also significant, with 35.2% for the 15 mg group and 45.8% for the 30 mg group compared to just 0.7% among placebo users. These results were akin to those revealed in the first parallel study (Study 2) of the same clinical program.

Dr. Kori Wallace, AbbVie’s Vice President and Global Head of Immunology Clinical Development, expressed that such encouraging findings bolster the evidence supporting upadacitinib as a potential treatment option for individuals suffering from alopecia areata. He emphasized the company’s eagerness to present these results to regulatory authorities, aiming to provide this significant therapy to those enduring this difficult immune-mediated condition.

Dr. Arash Mostaghimi, an associate professor of dermatology at Brigham and Women's Hospital from Harvard Medical School, also highlighted the struggles faced by individuals with alopecia areata, which can lead to considerable psychological distress. He noted that these positive results help not only in enhancing scalp hair regrowth but also in alleviating the psychosocial burdens linked to the condition.

As for safety, the profile of both dosages in study participants was consistent with previously established safety measures in other approved indications. Serious side effects emerged in 1.9% and 1.8% of patients in the 15 mg and 30 mg groups respectively, with only 0.7% in the placebo cohort. Rare occurrences of serious infections were reported, alongside other mild to moderate adverse effects such as upper respiratory tract infections and acne.

The UP-AA clinical trial involved a structured protocol with randomized participants across two replicate studies. In total, 1,399 individuals aged between 12 and 64 were enrolled at 248 different sites worldwide. Participants had a mean baseline SALT score of 84.0, which translates to approximately 16% scalp hair coverage, illustrating the degree of severity facing those with this condition and the essential nature of this research.

Upadacitinib (RINVOQ) continues to be under examination for various immune-mediated inflammatory diseases, including hidradenitis suppurativa and systemic lupus erythematosus, alongside alopecia areata. Further study and data collection from ongoing phases of the program are expected to contribute significantly to understanding the long-term impacts of this treatment.

As of now, the use of upadacitinib for alopecia areata has not yet gained regulatory approval, and its safety and efficacy in this regard are still under evaluation. However, the hope these results convey cannot be understated, marking a potentially transformative point for those afflicted by severe alopecia areata.