This 52-week phase 3 atopic dermatitis (AD) study indicates that upadacitinib with topical corticosteroids has the potential to be a successful and well-tolerated long-term treatment option for people with moderate-to-severe atopic dermatitis.
Atopic dermatitis (AD) causes skin-related disability and burden over the long run. Over the course of 20 to 30 years, most AD patients report symptoms and continue taking medication. There is a need for more (AD) medications that are appropriate for long-term use and produce a sustained clinical response outcome without a high rate of treatment cessation due to adverse effects.
Upadacitinib, an oral Janus kinase (JAK) inhibitor, is approved for treating rheumatoid arthritis and is being developed to treat immune-mediated inflammatory disorders such as AD.
This study, published in the Journal of Allergy and Clinical Immunology, aimed to assess the safety and efficacy of upadacitinib + topical corticosteroid (TCS) for 52 weeks.
Patients with chronic moderate-to-severe atopic dermatitis (>10% of body surface area affected, Eczema Area and Severity Index [EASI] >16, Validated Investigator’s Global Assessment for atopic dermatitis [vIGA-AD] >3, and Worst Pruritus Numeric Rating Scale [WP-NRS] score >4) were randomized 1:1:1 to once-daily upadacitinib (rerandomized at week 16 to upadacitinib + TCS). Three hundred patients were assigned upadacitinib 15 mg and TCS, 297 were assigned upadacitinib 30 mg and TCS, and 304 were assigned placebo and TCS. Efficacy of upadacitinib 15 mg and TCS and upadacitinib 30 mg and TCS at week 16 was maintained through week 52 for all endpoints.
At week 52, 50.8% of patients treated with upadacitinib 15 mg and TCS and 69.0% of patients treated with upadacitinib 30 mg and TCS had greater than 75% improvement in EASI scores; 33.5% and 45.2%, respectively, had more than 2 grades of improvement in vIGA-AD (vIGA-AD 0/1); and 45.3% and 57.5%, respectively and had WP-NRS improvement ≥4.
Furthermore, through 52 weeks, upadacitinib and TCS were well-tolerated; no additional significant safety hazards beyond those listed on the present label were observed.
The phase 3 study results indicated that upadacitinib + TCS has the potential to be a safe and efficient long-term therapy option with a favorable benefit–risk profile for adults and adolescents with moderate-to-severe AD.
Silverberg, J. I., de Bruin-Weller, M., Bieber, T., Soong, W., Kabashima, K., Costanzo, A., . . . Reich, K. (2022). Upadacitinib plus topical corticosteroids in atopic dermatitis: Week 52 AD Up study results. Journal of Allergy and Clinical Immunology, 149(3), 977-987.e914. doi:10.1016/j.jaci.2021.07.036