On 30 July 2025, AbbVie announced topline results from one of two parallel studies of the pivotal Phase III UP-AA trial (NCT06012240) evaluating upadacitinib in alopecia areata (AA). The results are impressive, given the positive response rates in a higher number of patients compared to other Janus kinase (JAK) inhibitors that are currently approved for AA, and could potentially help AbbVie cement a dominant place in the treatment landscape for AA while reinforcing the potential of this drug class for AA. Upadacitinib’s latest results have the potential to set a new precedent for JAK inhibitors in this disease space while potentially addressing the need for treatment options with higher efficacy.
Aforementioned topline results from the pivotal Phase III UP-AA clinical trial demonstrated 44.6% and 54.3% of patients with severe alopecia areata treated with once-daily upadacitinib 15mg and 30mg, respectively, reached 80% or more scalp hair coverage (Severity of Alopecia Tool [SALT] score ≤20) at Week 24 compared to 3.4% in the placebo arm. These response rates in the active treatment arms are much higher than the threshold set by pivotal trials that evaluated currently approved JAK inhibitors, with average values among the latter hovering around the one-third mark (Eli Lilly’s Olumiant [baricitinib] 4mg/day [once daily]: 32–35% at Week 36; Pfizer’s Litfulo [ritlecitinib] 50mg/day [once daily]: 23% at Week 24; Sun Pharmaceuticals’ Leqselvi [deuruxolitinib] 8mg [twice daily]: 29–32% at Week 24). Additionally, 36.0% and 47.1% of patients in the 15mg and 30mg upadacitinib arms, respectively, reached 90% or more scalp hair coverage (SALT score ≤10). Upadacitinib’s latest results take it up a notch compared to currently available JAK inhibitors, with potential for AbbVie to cement a leadership position in this disease space. Results from the other parallel study of the pivotal trial will be closely watched for data replicability, with AbbVie expecting these results in Q3 2025.
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Key opinion leaders (KOLs) interviewed by GlobalData have expressed the need for therapies with higher efficacy to improve clinical outcomes in patients with AA. Upadacitinib’s results can help close this gap; additionally, the asset is being evaluated in both adults and adolescents with severe AA, similar to Litfulo’s patient profile, implying an advantage of a larger patient population for both these agents. Furthermore, clinicians are familiar with upadacitinib’s clinical profile as it is a marketed therapy for other dermatology indications such as atopic dermatitis, a plus when it comes to market access and physician familiarity. According to GlobalData estimates, upadacitinib is anticipated to launch in the US in 2029 for AA, and this asset’s recent results are expected to further bolster its position within the JAK inhibitors drug class, a treatment modality that is anticipated to reach $2bn in sales in the US in 2033 in this disease space.
