AbbVie’s JAK inhibitor RINVOQ "Measures Up" in AD

In the Measure Up 1, Measure Up 2, and AD Up Phase 3 studies, a significantly higher proportion of patients treated with upadacitinib achieved the co-primary endpoints of improvement in skin clearance.

New Phase 3 research supports the long-term efficacy and safety of RINVOQ (upadacitinib) in moderate to severe atopic dermatitis (AD), according to data analyses from the Measure Up 1, Measure Up 2, and AD Up studies presented at the European Academy of Dermatology and Venereology (EADV) Congress in Berlin.

In the Measure Up 1, Measure Up 2, and AD Up Phase 3 studies, a significantly higher proportion of patients treated with upadacitinib (15 mg or 30 mg) achieved the co-primary endpoints of improvement in skin clearance, measured by an Eczema Area and Severity Index (EASI) score of 75 (EASI 75) and the validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD 0/1) at week 16, compared to those who received placebo.

Additionally, more upadacitinib-treated patients achieved the secondary endpoint of improvement in skin clearance, measured by an EASI score of 90 (EASI 90), and an additional endpoint of itch reduction (WP-NRS 0/1) at week 16, compared to placebo-treated patients. The efficacy of both upadacitinib doses was consistently maintained for these important measures across all three studies through week 140.

Upadacitinib (15 mg and 30 mg) was generally well tolerated, and the safety data in the long-term extension of the three studies were consistent with the known safety profile of upadacitinib, with no new safety signals observed. The most common adverse events across all three studies were COVID-19, upper respiratory tract infection, acne, and nasopharyngitis.

"We are encouraged by these results as they solidify upadacitinib's potential to improve care for people living with atopic dermatitis," says Jonathan Silverberg, MD, PhD, MPH, professor of dermatology and director of clinical research at the George Washington University School of Medicine and Health Sciences in Washington, DC in a news release. "While upadacitinib has been shown to be an effective treatment option for patients with atopic dermatitis in the short term, these data demonstrate a consistent safety profile and efficacy with long-term treatment."

About Measure Up

Measure Up 1 and Measure Up 2 are Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled studies designed to evaluate the safety and efficacy of RINVOQ in adult and adolescent (12 years or older) patients with moderate to severe atopic dermatitis who are candidates for systemic treatment. Patients were randomized to RINVOQ 15 mg, RINVOQ 30 mg, or placebo. The co-primary endpoints were the percentage of patients achieving EASI 75 and a validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0/1 after 16 weeks of treatment. Patients receiving placebo were switched to either RINVOQ 15 mg or RINVOQ 30 mg at week 16.

About AD Up

AD Up is a Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled study designed to evaluate the safety and efficacy of RINVOQ in adult and adolescent (12 years or older) patients with moderate to severe atopic dermatitis who are candidates for systemic treatment. Patients were randomized to RINVOQ 15 mg, RINVOQ 30 mg, or placebo, all in combination with topical corticosteroids (TCS). The co-primary endpoints were the percentage of patients achieving EASI 75 and a vIGA-AD of 0/1 after 16 weeks of treatment. Patients receiving placebo plus TCS were switched to either RINVOQ 15 mg or RINVOQ 30 mg plus TCS at week 16.