Alopecia Areata Market to Witness Dynamic Shift as AbbVie Reports Positive Topline Results from Phase III UP-AA Trial of RINVOQ | DelveInsight

AbbVie is actively pursuing entry into the alopecia areata market. In the second replicate study (Study 1) of its pivotal Phase III UP-AA clinical program (NCT06012240), RINVOQ met the primary endpoint. The results showed that 45.2% of patients receiving 15 mg and 55.0% of those receiving 30 mg of upadacitinib achieved 80% or greater scalp hair coverage by week 24, according to the Severity of Alopecia Tool (SALT) score less than or equal to 20.
RINVOQ: A Promising New Treatment Option for Alopecia Areata

RINVOQ, a JAK inhibitor, is under investigation for multiple immune-mediated inflammatory conditions. In human leukocyte assays, it demonstrated more potent inhibition of cytokine-driven STAT phosphorylation via JAK1 and JAK1/JAK3 compared to JAK2-mediated pathways. However, the clinical significance of targeting specific JAK enzymes for efficacy and safety remains uncertain.

Initially approved in 2019 for rheumatoid arthritis, RINVOQ has since expanded into several other indications, including psoriatic arthritis, atopic dermatitis, Crohn's disease, and ulcerative colitis. RINVOQ is currently in Phase III trials for alopecia areata, hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus, and vitiligo. AbbVie recently reported Q2 sales of $2.03 billion, reflecting 42% growth year over year, with total 2024 revenues reaching $5.97 billion.

What do RINVOQ Positive Top Results Mean for Alopecia Areata?

AbbVie is expanding its presence with RINVOQ, a JAK1-selective oral inhibitor. The company reported positive topline results from the second of two pivotal Phase III UP-AA studies evaluating upadacitinib (RINVOQ; 15 mg and 30 mg, once daily) for adult and adolescent patients with severe alopecia areata, who had an average baseline SALT score of 84.0 (around 16% scalp hair coverage).

In the first study, both upadacitinib doses met the primary endpoint: 45.2% of patients on 15 mg and 55.0% on 30 mg achieved 80% or greater scalp hair coverage (SALT score less than or equal to 20) at week 24, compared to 1.5% in the placebo group (p



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