AbbVie has shared promising top-line results from a late-stage study of its JAK inhibitor Rinvoq (upadacitinib) in severe alopecia areata (AA).
Study two of the phase 3 UP-AA clinical programme has been evaluating once-daily 15mg and 30mg doses of the drug in adult and adolescent patients with approximately 16% scalp hair coverage.
Both doses met the primary endpoint, with 44.6% and 54.3% of patients in the Rinvoq 15mg and 30mg groups, respectively, reaching 80% or more scalp hair coverage at week 24, compared to 3.4% of patients randomised to receive placebo.
Among Rinvoq-treated patients, 36% of those in the 15mg cohort and 47.1% in the 30mg group reached 90% or more scalp hair coverage, a key secondary endpoint, compared to 1.4% of patients receiving placebo at week 24.
Other key secondary endpoints, including improvements in eyebrows and eyelashes, as well as the percentage of patients with complete scalp hair coverage at week 24, were met with both doses of Rinvoq.
Approximately 700,000 people in the US currently have some form of AA, which occurs when a patient’s own immune system attacks hair follicles, resulting in varying degrees of hair loss.
Kori Wallace, vice president, global head of immunology clinical development, AbbVie, said: “Often misunderstood as a cosmetic issue, AA is a systemic immune-mediated disease that can cause total hair loss, involving the scalp, eyebrows and eyelashes.
“People living with AA may face difficulties in managing their disease, which can significantly affect their quality of life.”
AbbVie’s Rinvoq is designed to block the action of Janus kinases enzymes, which are involved in processes that lead to inflammation. The drug already holds approvals for a range of indications, including atopic dermatitis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, giant cell arteritis, ulcerative colitis and Crohn’s disease.
Arash Mostaghimi, associate professor of dermatology and vice chair of clinical trials and innovation, Brigham & Women’s Hospital, Harvard Medical School, said: “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 [Rinvoq] to be an important new treatment option.”
Results from study one of the phase 3 UP-AA clinical programme are also expected in the third quarter of 2025.