The manufacturer of upadacitinib has submitted an application with the FDA for approval of the oral JAK inhibitor for treating severe alopecia areata in adults and adolescents, the manufacturer AbbVie announced in a press release.

Upadacitinib, marketed as Rinvoq, is approved for the treatment of children aged 12 years or older and adults with moderate-to-severe atopic dermatitis. The drug is currently being studied for use in patients with alopecia areata, hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus, and vitiligo, according to AbbVie.

The new application is supported by results of the phase 3 UP-AA clinical trials program, including a double-blind placebo-controlled trials (studies 1 and 2), followed by a blinded extension study through 52 weeks. Both studies evaluated once-daily 15-mg and 30-mg doses of upadacitinib in tablet form. At baseline, the mean Severity of Alopecia Tool (SALT) score was 84; about half had a SALT score of 95 or greater (near-total or total scalp hair loss).

In study 1, significantly more patients treated with 15 mg or 30 mg of upadacitinib met the primary endpoint, a SALT score ≤ 20 (indicating mild hair loss) after 24 weeks of once-daily use (45.2% and 55%, respectively, compared with 1.5% of patients on placebo). Similar results were seen in study 2, with 44.6% and 54.3% of patients in the 15-mg and 30-mg groups, respectively, meeting the primary endpoint at 24 weeks compared with 3.4% of those on placebo.

In the 52-week extension period, more than half of the patients in the treatment groups in both studies met the primary endpoint: 59.3% and 55.0% of those on 15 mg upadacitinib, respectively, and 63.8% and 63.3% of those on 30 mg upadacitinib in studies 1 and 2, respectively.

In addition, at week 52, more than 25% had achieved a SALT score of 0, indicating complete scalp coverage (28.5% and 35.8%, respectively, of patients treated with 15 mg and 30 mg in study 1, and 26.6% and 37.0%, respectively, for the two treatment groups in study 2).

As previously reported by the manufacturer, the safety profile for upadacitinib at both doses was similar to that seen in approved indications. The most common treatment-emergent adverse events were upper respiratory tract infections, acne, increased blood creatine phosphokinase, and nasopharyngitis.

Upadacitinib also is approved for multiple conditions in adults including giant cell arteritis, moderate-to-severe ulcerative colitis, moderate-to-severe Crohn’s disease, moderate-to-severe rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondyloarthritis, and active nonradiographic axial spondyloarthritis.

A liquid version (Rinvoq LQ) is approved for two additional indications: to treat children aged 2 years or older with active polyarticular juvenile idiopathic arthritis and to treat children aged 2 years to < 18 years with active psoriatic arthritis.

The research supporting upadacitinib’s application was funded by AbbVie.