Upadacitinib Improves Scalp Hair Coverage for Patients With Severe Alopecia Areata

Approximately 45.2% and 55% of patients with severe alopecia areata (AA) achieved 80% or more scalp hair coverage at week 24 with 15 mg and 30 mg of upadacitinib (Rinvoq), respectively. The results from the new data from the phase 3 UP-AA clinical program remain consistent with data from previous studies of the drug.¹

"These positive results strengthen the growing body of evidence supporting the potential of upadacitinib to improve the lives of people with AA," Kori Wallace, MD, PhD, vice president and global head of immunology clinical development at AbbVie, said in a news release.¹ "We are very encouraged by the improvements in both scalp and nonscalp hair regrowth observed with both doses of upadacitinib and look forward to submitting these data to regulatory bodies, bringing us one step closer to delivering upadacitinib to those living with this complex immune-mediated disease."

In the study (NCT06012240), investigators assessed the safety, efficacy, and tolerability of upadacitinib for adolescents and adults who have severe AA. Patients included in the study were split into 3 treatment groups who received oral tablets of upadacitinib 15 mg, upadacitinib 30 mg, or the placebo for up to 160 weeks. Patients could receive another treatment at weeks 24 and 52. There were 3 separate study groups: Study 1, Study 2, and Study 4, which were used as parallel studies. The primary outcome included the percentage of individuals achieving a Severity of Alopecia Tool (SALT) score of 20 or more at week 24 and the number of adverse events (AEs) up to 164 weeks.

Secondary outcomes included achievement of a SALT score of 20 or more for either upadacitinib dose compared with the placebo, the percentage of patients achieving a clinician-reported outcome for eyebrow hair loss or eyelash loss, and the percentage change from baseline in SALT score.²

In study 1, approximately 35.2% and 45.8% of patients treated with upadacitinib 15 mg and 30 mg, respectively, had 90% or more scalp hair coverage compared with 0.7% of patients treated with the placebo at week 24. Other secondary end points, including improvements in eyebrows and eyelashes, were met.

The safety profile was generally consistent with those observed for the approved indications, with treatment-emergent AEs occurring in 1.9% and 1.8% for patients treated with upadacitinib 15 mg and 30 mg, respectively, compared with 0.7% for the placebo. The most common AEs included upper respiratory tract infection, acne, increased blood creatine phosphokinase, and nasopharyngitis.¹

In previously announced data of study 2, upadacitinib 15 mg and 30 mg achieved the primary end point with 44.6% and 54.3%, respectively, achieving 80% or more scalp hair coverage compared with 3.4% in the placebo group. Similarly for 90% or more scalp hair coverage, 36% and 47.1% of patients receiving upadacitinib, respectively, achieved the end point compared with 1.4% in the placebo group. The secondary end points of improvements in eyebrows and eyelashes and the percentage of patients with complete hair coverage were met.³

"People living with AA often face considerable uncertainty related to both the severity and duration of hair loss, despite current treatment options," Arash Mostaghimi, MD, MPA, MPH, associate professor of dermatology and vice chair of clinical trials and innovation at Brigham & Women's Hospital and Harvard Medical School, said in the news release.¹ "These encouraging results are consistent with and reinforce the outcomes observed in the first pivotal trial. Together, these findings underscore the potential of upadacitinib to provide meaningful hair regrowth, offering hope for those enduring the psychosocial burden associated with this disease."

READ MORE: Dermatology Resource Center

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REFERENCES

1. AbbVie announces positive topline results from second phase 3 UP-AA Trial evaluating upadacitinib (Rinvoq) for alopecia areata. News release. AbbVie. August 21, 2025. Accessed August 21, 2025. https://news.abbvie.com/2025-08-21-AbbVie-Announces-Positive-Topline-Results-from-Second-Phase-3-UP-AA-Trial-Evaluating-Upadacitinib-RINVOQ-R-for-Alopecia-Areata

2. A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata (Up-AA). ClinicalTrials.gov identification: NCT06012240. Updated July 16, 2025. Accessed August 21, 2025. https://clinicaltrials.gov/study/NCT06012240?id=NCT06012240&rank=1

3. AbbVie announces positive topline results from phase 3 UP-AA trial evaluating upadacitinib (Rinvoq) for alopecia areata. News release. AbbVie. July 30, 2025. Accessed August 21, 2025. https://news.abbvie.com/2025-07-30-AbbVie-Announces-Positive-Topline-Results-from-Phase-3-UP-AA-Trial-Evaluating-Upadacitinib-RINVOQ-R-for-Alopecia-Areata