AbbVie's upadacitinib (Rinvoq) (15 mg and 30 mg, once daily) monotherapy met both primary and all secondary endpoints in Measure Up 2, the second Phase 3 study in individuals with moderate to severe atopic dermatitis. The co-primary endpoints were at least a 75 percent improvement in the Eczema Area Severity Index (EASI 75) from baseline and a validated Investigator’s Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0/1 (clear or almost clear) at week 16.1 The Measure Up 2 study evaluates the efficacy and safety of both doses of upadacitinib monotherapy versus placebo in adolescents and adults with moderate to severe atopic dermatitis who are candidates for systemic therapy.
Significantly more patients receiving either dose of upadacitinib monotherapy showed improvement in skin clearance and reduction in itch compared to placebo at week 16. In the study, 60/73 percent of patients receiving upadacitinib 15/30 mg achieved EASI 75, respectively, versus 13 percent in the placebo group (p<0.001). Of patients treated with upadacitinib 15/30 mg, 39/52 percent achieved vIGA-AD 0/1, respectively, versus five percent of patients receiving placebo (p<0.001).
“We are encouraged by these results that reaffirm the data from Measure Up 1 and underscore the potential impact RINVOQ could have for individuals struggling to control their atopic dermatitis,” says Michael Severino, MD, vice chairman and president, AbbVie, in a news release. “We are committed to delivering on the needs of people living with atopic dermatitis, many of whom continue to endure relentless itch and skin symptoms that can interfere with daily activities.”
At week 16, 42/60 percent of patients on upadacitinib 15/30 mg experienced clinically meaningful reductions in itch, respectively, defined as improvement in Worst Pruritus Numerical Rating Scale (NRS) ≥4, versus 9 percent of patients receiving placebo (p<0.001).1 For both doses, patients experienced an early reduction in itch, which was maintained through week 16. After just one day following the first dose (day 2), reductions in itch compared to placebo were observed for patients receiving upadacitinib 30 mg (8 percent versus 1 percent, p<0.001). For patients receiving upadacitinib 15 mg, 12 percent experienced a reduction in itch after just two days following the first dose (day 3) compared to 3 percent of patients receiving placebo (p<0.001).
“Atopic dermatitis is more than a rash or itchy skin. Many people living with moderate to severe forms continue to suffer from significant physical and emotional burden of the disease,” says Alan Irvine, MD, DSc, professor of dermatology, Trinity College Dublin, Ireland and lead study investigator of Measure Up 2. “These data support our continued efforts to provide additional options for those living with moderate to severe atopic dermatitis.”
No new safety risks were observed compared to the safety profile observed in patients with rheumatoid arthritis and psoriatic arthritis receiving Rinvoq.