Upadacitinib Approved For Adults and Children Aged 12 Years and Older With Refractory, Moderate to Severe Atopic Dermatitis Advances

Data from the largest registrational Phase 3 programs (Measure Up 1, Measure Up 2, and AD Up) showed that upadacitinib demonstrated significant efficacy and safety in adults and children aged 12 years and older with moderate to severe atopic dermatitis (AD).¹

The 3 pivotal studies consisted of more than 2500 patients with AD who received upadacitinib at 15 mg and 30 mg once a day via monotherapy (Measure Up 1 and 2) and topical corticosteroids (AD Up), which were compared with placebo. Of these patients, about 52% underwent systemic AD treatment prior to the studies. Across all 3 studies, upadacitinib met all primary and secondary end points by week 16, with some patients achieving skin clearance at Eczema Area and Severity Index (EASI) 90 and 100. ^2-3

Both Measure Up 1 and Measure Up 2 were replicate multicenter, double-blind, placebo-controlled, Phase 3 trials that randomized adolescent and adult participants with AD in a 1:1:1 ratio to receive a daily oral dose of upadacitinib 30 mg, upadacitinib 15 mg, or matching placebo. Results of the Measure Up 1 study showed that the percentage of patients who achieved EASI-75 at week 16 was significantly higher in the upadacitinib 15 mg (70%) and upadacitinib 30 mg (80%) groups compared with the placebo group (16%). The Measure Up 2 results had found that about 60% of patients in the 15 mg group and 73% in the 30 mg group achieved EASI-75 at week 16 compared with placebo (13%).²

The AD Up study was a double-blind, placebo-controlled, Phase 3 trial that consisted of adults and adolescents aged 12 years and older with chronic moderate to severe AD who were randomized (1:1:1) to receive upadacitinib 15 mg, upadacitinib 30 mg, or placebo once daily in combination with topical corticosteroids for 16 weeks. In this trial, about 65% of the 15 mg group achieved EASI-75 at week 16 in addition to 77% of the 30 mg group compared with only 26% in the placebo group.³ In all 3 studies, there was a significant improvement in itch (Worst Pruritus Numerical Rating Scale ≥4) as early as week 1 compared with placebo.

Upadacitinib is a selective JAK inhibitor that demonstrated greater inhibitory potency for JAK-1 vs JAK-2, JAK-3, and TYK-2.² It is also approved in the United States for adults with moderate to severe active rheumatoid arthritis at 15 mg in addition to adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers. Currently, there are Phase 3 trials being conducted on upadacitinib for rheumatoid arthritis, AD, psoriatic arthritis, axial spondyloarthritis, Crohn disease, ulcerative colitis, giant cell arteritis, and Takayasu arteritis.¹

References

1. U.S. FDA approves Rinvoq (upadacitinib) to treat adults and children 12 years and older with refractory, moderate to severe atopic dermatitis. AbbVie. Accessed August 1, 2022. https://news.abbvie.com/news/press-releases/us-fda-approves-rinvoq-upadacitinib-to-treat-adults-and-children-12-years-and-older-with-refractory-moderate-to-severe-atopic-dermatitis.htm
2. Guttman-Yassky E, Teixeira H, Simpson E, et al. Once-daily upadacitinib versus placebo in adolescents and adults with moderate-to-severe atopic dermatitis (Measure Up 1 and Measure Up 2): results from two replicate double-blind, randomised controlled phase 3 trials. Lancet. Published online May 20, 2021. doi:10.1016/S0140-6736(21)00588-2.
3. Reich K, Teixeira HD, de Bruin-Weller M, et al. Safety and efficacy of upadacitinib in combination with topical corticosteroids in adolescents and adults with moderate-to-severe atopic dermatitis (AD Up): results from a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. Published online August 28, 2021. doi:10.1016/S0140-6736(21)00589-4