AbbVie Reports Positive UP-AA Trial Results, Potentially Expanding RINVOQ's Market Presence in Alopecia Areata Treatment.

AbbVie Inc announced positive results from its Phase 3 UP-AA trial for alopecia areata, with both doses of upadacitinib meeting primary and secondary endpoints. The trial showed significant hair regrowth and improvements in eyebrows and eyelashes, with a consistent safety profile. The results align with the first parallel study and position AbbVie as a strong contender in the alopecia areata treatment market. However, the treatment is not yet approved and investors should be cautious of potential risks.

AbbVie Inc. (NYSE: ABBV) announced positive topline results from its Phase 3 UP-AA trial evaluating the safety and efficacy of upadacitinib (RINVOQ®) in adult and adolescent patients with severe alopecia areata (AA). The trial, which included two replicate studies (Study 1 and Study 2), demonstrated significant hair regrowth and improvements in eyebrows and eyelashes with both 15 mg and 30 mg doses of upadacitinib, meeting primary and secondary endpoints [1].

In Study 1, 45.2% and 55.0% of patients treated with upadacitinib 15 mg and 30 mg, respectively, achieved 80% or more scalp hair coverage (SALT score ≤ 20) at week 24, compared to 1.5% of patients receiving placebo (p0.001). Similarly, 35.2% and 45.8% of patients treated with upadacitinib 15 mg and 30 mg, respectively, reached 90% or more scalp hair coverage (SALT ≤ 10), compared to 0.7% of patients receiving placebo at week 24 (p0.001) [1].

The safety profile of both doses of upadacitinib in the 24-week, placebo-controlled period (Period A) was generally consistent with that observed in approved indications. Treatment-emergent serious adverse events occurred in 1.9% and 1.8% of patients in the upadacitinib 15 mg and 30 mg groups, respectively, and 0.7% in the placebo group. Discontinuations due to treatment-emergent adverse events (TEAEs) occurred in 1.1% and 1.5% of patients in the upadacitinib 15 mg and 30 mg groups, respectively, and none in the placebo group. The most common TEAEs observed were upper respiratory tract infection, acne, blood creatine phosphokinase increased, and nasopharyngitis. Serious infections were reported infrequently, with one in the placebo group and one in the upadacitinib 30 mg group, and none in the upadacitinib 15 mg group [1].

The results from the UP-AA trial align with the first parallel replicate study (Study 2) and position AbbVie as a strong contender in the alopecia areata treatment market. However, it is important to note that upadacitinib is not yet approved for the treatment of AA, and investors should be cautious of potential risks associated with the drug's safety profile and regulatory approval process. The trial's positive outcomes may provide a basis for future regulatory submissions and potential market entry for upadacitinib in the treatment of alopecia areata [1].

References:
[1] 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