Alopecia areata data: Upadacitinib demonstrates improvements in scalp hair coverage | Image Credit: © AliciaFdez - © AliciaFdez - stock.adobe.com.

On July 30, 2025, AbbVie announced positive and topline data from the phase 3 UP-AA clinical program (NCT06012240), in which upadacitinib (Rinvoq) (15 mg and 30 mg) demonstrated that 44.6% and 54.3% of patients with severe alopecia areata (AA), respectively, reached 80% or more scalp hair coverage at week 24, according to a press release from the company. Hair coverage was defined by the severity of alopecia tool (SALT) score of ≤ 20.¹

At baseline, AA patients had a mean SALT score of 83.8, which correlated to approximately 16% of scalp hair coverage. The primary-endpoint data listed above was compared to 3.4% of placebo-receiving patients who achieved 80% or more scalp hair coverage.

Upadacitinib is an oral Janus kinase (JAK) inhibitor that blocks cytokine signaling pathways by inhibiting JAK1 more selectively than JAK2 or JAK3 in human leukocyte assays. The therapy is approved for several immune-mediated inflammatory conditions and continues to be investigated in diseases such as alopecia areata, hidradenitis suppurativa, systemic lupus erythematosus, and vitiligo.

Secondary endpoints for upadacitinib

Key secondary were also met, including scalp hair coverage of 90% or more (SALT ≤10), achieved by 36.0% and 47.1% of patients in the 15 mg and 30 mg groups, respectively, compared to 1.4% on placebo (P < .001). Both treatment groups demonstrated improvements in eyebrow and eyelash hair, as well as complete scalp hair coverage (SALT = 0) at week 24.

"The sudden and often unpredictable hair loss people living with AA experience can profoundly impact their self-esteem and mental well-being," Arash Mostaghimi, MD, MPA, MPH, associate professor of dermatology and vice chair of clinical trials and innovation, Brigham & Women's Hospital, Harvard Medical School, said in a statement. "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."

The safety profile observed in the 24-week, placebo-controlled period was consistent with prior indications for upadacitinib. Treatment-emergent serious adverse events occurred in 1.4% and 2.8% of the 15 mg and 30 mg groups, respectively, with none reported in the placebo group. Discontinuations because of adverse events were low (0.7% for 15 mg; 1.4% for 30 mg). Common adverse events included acne, nasopharyngitis, and upper respiratory tract infection. Serious infections were infrequent, with no reported MACE, malignancies, or deaths.

"UP-AA is the first pivotal program to have ranked and met the rigorous standard of SALT = 0, indicating complete scalp hair regrowth," added Kori Wallace, MD, PhD, vice president, global head of immunology clinical development, AbbVie. "These data underscore AbbVie's commitment to advancing novel treatments that have the potential to improve the lives of individuals with immune-mediated diseases."

Background of the phase 3 UP-AA clinical program for upadacitinib

Data announced was from the first of 2 pivotal studies (Study 2) from the UP-AA program. UP-AA M23-716 was conducted as a single protocol that includes 2 replicate phase 3 randomized, placebo-controlled, double-blind pivotal studies (Study 1 and Study 2) with randomization, investigative sites, data collection, analysis and reporting independent for each study.

In Study 1 and Study 2 Period A, participants are randomized to one of three groups to receive upadacitinib 15 mg, upadacitinib 30 mg or placebo for 24 weeks. In Study 1 and Study 2 Period B, participants originally randomized to upadacitinib dose groups in Period A will continue their same treatment in Period B for 28 weeks. Participants originally randomized to placebo in Period A will either remain on placebo in Period B, or be randomized in 1 of 2 groups, based on their SALT score at week 24.

In total, Study 1 and Study 2 Periods A and B span 52 weeks. Participants who complete Study 1 or Study 2 can join Study 3 and may be re-randomized to receive 1 of 2 doses of upadacitinib for up to 108 weeks. The 2 trials randomized 1,399 participants with severe AA ages 12 to 64 across 248 sites worldwide.

According to AbbVie, results from the Study 1, the parallel replicate study, are expected in the third quarter of 2025.

FDA approved indications for upadacitinib

Currently, upadacitinib is approved in children aged 2 years and older with active polyarticular Juvenile Idiopathic Arthritis (pJIA) and in children aged 2 to less than 18 years with active psoriatic arthritis (PsA) when TNF blockers did not work well or could not be tolerated.²

Click here to read more on upadacitinib to treat JIA, PsA in patients 2 years and up.³

References:

1. AbbVie announces positive topline results from phase 3 UP-AA trial evaluating upadacitinib (Rinvoq) for alopecia areata. AbbVie. Press release. July 30, 2025. Accessed July 30, 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
2. Rinvoq (upadacitinib. Rinvoq.com. Accessed July 30, 2025. https://www.rinvoq.com/?cid=srch_CV73a2739f68ec4e45994f079f38417c45&gad_source=1&gad_campaignid=15623161804&gbraid=0AAAAAoKwhvjOvrg-F9tffXuCgbJyf4U6f&gclid=Cj0KCQjwhafEBhCcARIsAEGZEKLw6Bqt8Mo1zvPhV3trb1nXYEK2Yzf-boCfGvYGGKMaq_zsvd2Vc8MaAjQoEALw_wcB&gclsrc=aw.ds
3. Fitch J. Now available: upadacitinib to treat JIA, psoriatic arthritis in patients 2 years and up. Contemporary Pediatrics. June 4, 2024. Accessed July 30, 2025. https://www.contemporarypediatrics.com/view/now-available-upadacitinib-to-treat-jia-psoriatic-arthritis-in-patients-2-years-and-up