#USA #AbbVie #North Chicago #Alopecia Areata #Upadacitinib

Promising Results from AbbVie's Phase III UP-AA Trial

AbbVie has announced positive topline results from its Phase III UP-AA clinical trial program focusing on alopecia areata, particularly in its pivotal Study 2. The study evaluated the efficacy and safety of Upadacitinib (brand name: Rinvoq) in patients suffering from severe alopecia areata, defined by an affected scalp area of more than 50%.

In the data presented, the results were quite significant. At the 24-week mark, 44.6% of patients in the 15 mg Upadacitinib group and 54.3% in the 30 mg group achieved an overall scalp hair area of over 80%, as indicated by a Severity of Alopecia Tool (SALT) score of 20 or below. This achievement compares dramatically to just 3.4% in the placebo group, highlighting the drug's efficacy (p<0.001).

Secondary Endpoint Achievements

Furthermore, notable improvements were observed in eyebrow and eyelash growth, and patients achieving 90% scalp hair area (SALT score of 10 or less) were also significantly higher in the Upadacitinib groups, at 36.0% and 47.1%, respectively, compared to only 1.4% in the placebo group (p<0.001). Importantly, the trial did not identify any new safety concerns, and the safety profile for Upadacitinib was consistent with what has been observed in its approved indications.

Dr. Kori Wallace, Vice President and Global Head of Immunology Clinical Development at AbbVie, commented on the findings, explaining that alopecia areata (AA) is not merely a beauty issue, but a systemic immune-mediated disorder that can result in complete hair loss on the scalp, eyebrows, and eyelashes. Managing this condition can be challenging for affected individuals, significantly impacting their quality of life. The UP-AA program sets strict criteria for what constitutes complete hair regrowth, defined as a SALT score of 0.

Long-Term Outlook

The UP-AA clinical trial program also includes an ongoing parallel study (Study 1) with results expected in the third quarter of 2025. This comprehensive program aims to explore Upadacitinib’s safety and efficacy further and includes a total of 1,399 participants aged 12 to 64 across 248 sites worldwide.

Dr. Arash Mostaghimi from Harvard Medical School emphasized the psychological toll that sudden, unpredictable hair loss can have on individuals living with AA, underscoring the urgent need for effective treatments that facilitate hair regrowth.

Safety Profile of Upadacitinib

The safety profile for Upadacitinib observed during the placebo-controlled period reported serious adverse events in just 1.4% of patients in the 15 mg group and 2.8% in the 30 mg group, with none in the placebo group. The common adverse events included acne, nasopharyngitis, and upper respiratory infections, but severe infections were rare. There were no reported incidences of major cardiovascular events, malignancies, or deaths during the trial.

Conclusion

While the use of Upadacitinib for alopecia areata is not yet approved, these findings represent a significant step forward for patients managing this disorder. The results indicate that Upadacitinib could potentially become a valuable treatment option to improve the quality of life for those affected by severe alopecia areata.

For more detailed information about the trial, please visit ClinicalTrials.gov.