AbbVie’s upadacitinib holds potential to cement dominant place in alopecia areata with latest results: GlobalData

AbbVie recently announced topline results from one of two parallel studies of the pivotal Phase III UP-AA trial evaluating upadacitinib in severe alopecia areata (AA). Upadacitinib’s latest results could provide AbbVie with a dominant place in AA while potentially addressing the need for treatment options with higher efficacy, according to GlobalData.

Vinie Varkey, Healthcare Analyst at GlobalData, comments, “Upadacitinib’s 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. It has the potential to set a new precedent for JAK inhibitors in this disease space.”

On the primary endpoint of patients achieving 80 per cent or more scalp hair coverage as defined by Severity of Alopecia Tool (SALT) score ≤20, response rates observed in the upadacitinib arms are impressive, with 44.6 per cent and 54.3 per cent of patients treated with once-daily upadacitinib 15mg and 30mg, respectively, achieving this score at week 24 compared to 3.4 per cent in the placebo arm. These response rates 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. Additionally, 36.0 per cent and 47.1 per cent of patients in the 15mg and 30mg upadacitinib arms, respectively, reached 90 per cent or more scalp hair coverage (SALT score ≤10).

Upadacitinib’s latest results address a key unmet need highlighted by key opinion leaders (KOLs) interviewed by GlobalData: the need for therapies with higher efficacy to improve clinical outcomes in patients with AA.

Varkey adds, “Upadacitinib’s latest set of results can help close this gap. Additionally, the asset is being evaluated in both adults and adolescents with severe AA, similar to Pfizer’s 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, a class that is anticipated to reach $2 billion in sales in the US in 2033 in this disease space.

Varkey concludes, “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.”