Upadacitinib Approved for Patients with Moderate to Severe AD

The Food and Drug Administration announced approval of upadacitinib, a selective oral Janus kinase 1 inhibitor, for the treatment of moderate to severe atopic dermatitis (AD) in patients aged 12 years and older.

Upadacitinib is indicated for AD that was unresponsive to previous treatment in adults and children aged 12 years and older who weigh at least 40 kg. It will be dosed as a once-daily 15 mg oral medication, though the dose may be increased to 30 mg once daily in patients aged less than 65 years who do not achieve an adequate response.

Approval followed reassuring efficacy and safety data from phase 3 trials with more than 2500 patients with AD. Three studies examined the coprimary endpoints of the number of patients who achieved an Eczema Area and Severity Index (EASI) score of 75 and the number of patients who achieved a validated Investigator Global Assessment for AD (vIGA-AD) score of clear or almost clear at week 16. Upon analysis, both upadacitinib monotherapy at 15 mg or 30 mg as well as upadacitinib plus topical corticosteroids met these primary endpoints, with some patients even achieving EASI 90 or EASI 100 after 16 weeks of treatment. Treatment with upadacitinib was also associated with a significant improvement in itch as early as week 1 of the study.

Safety has been a concern for dermatologists looking at the data for upadacitinib. The phase 3 trials evaluating the 15 mg and 30 mg doses found that the safety profile was similar to that observed in patients with rheumatoid arthritis. Upadacitinib will include a black box warning regarding serious infections, including tuberculosis; all-cause mortality; malignancy; major cardiovascular event or death in people aged 50 years and older with at least 1 cardiovascular risk factor; and thrombosis.

Reference
U.S. FDA approves RINVOQ^® (upadacitinib) to treat adults and children 12 years and older with refractory, moderate to severe atopic dermatitis. Press release. AbbvVie; January 14, 2022. Accessed January 14, 2022. https://prnmedia.prnewswire.com/news-releases/us-fda-approves-rinvoq-upadacitinib-to-treat-adults-and-children-12-years-and-older-with-refractory-moderate-to-severe-atopic-dermatitis-301461377.html