AbbVie's upadacitinib (15 mg and 30 mg, once daily) (Rinvoq) plus topical corticosteroids (TCS) met the co-primary endpoints and all secondary endpoints in AD Up, the third pivotal Phase 3 study of Rinvoq in atopic dermatitis. AD Up evaluated the efficacy and safety of both doses of upadacitinib therapy versus placebo in adults and adolescents with moderate to severe atopic dermatitis; all treatment groups, including placebo, received concomitant TCS. 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.
Significantly more patients receiving either dose of upadacitinib plus TCS showed improvement in skin clearance compared to placebo plus TCS at week 16. In the study, 65/77 percent of patients receiving upadacitinib 15/30 mg plus TCS achieved EASI 75, respectively, versus 26 percent receiving placebo plus TCS (p<0.001). Of patients treated with upadacitinib 15/30 mg plus TCS, 40/59 percent achieved vIGA-AD 0/1, respectively, versus 11 percent of patients receiving placebo plus TCS (p<0.001).1
"These data build on the positive results from our previous studies in atopic dermatitis, now with additional perspective on the efficacy of Rinvoq used with a mainstay treatment for people living with the disease – topical steroids," says Tom Hudson, MD, senior vice president of R&D and chief scientific officer, AbbVie, in a news release. "With our deep heritage in serious skin diseases, we look forward to advancing research with Rinvoq as part of our ultimate goal to address unmet needs and improve care for people living with the relentless itch and skin symptoms of atopic dermatitis."
Additionally, more patients treated with upadacitinib plus TCS experienced a clinically meaningful reduction in itch, defined as improvement in Worst Pruritus Numerical Rating Scale (NRS)≥4, compared to patients treated with placebo plus TCS. At week 16, 52/64 percent of patients receiving upadacitinib 15/30 mg plus TCS achieved this endpoint compared to 15 percent of patients receiving placebo plus TCS (p<0.001).
In a pre-specified additional analysis, treatment with either dose of upadacitinib also led to a higher mean number of topical corticosteroid-free days (TCS-free days) up to week 16 versus placebo. A TCS-free day is defined by a response of EASI 75 or greater without the use of TCS.1 Patients treated with upadacitinib 15/30 mg had a mean of 34/47 TCS-free days while maintaining EASI 75, respectively, compared with a mean of 8 days for those treated with placebo plus TCS (nominal p<0.001).
"These results are encouraging, including the analysis showing some patients in the upadacitinib treatment groups were able to control their skin symptoms without topical corticosteroids," says Kristian Reich, MD, professor of translational research in inflammatory skin diseases at the University Medical Center Hamburg Eppendorf, and Skinflammation Center, Hamburg, Germany and principal investigator. "Many of the current treatment options rely on patients to self-manage their condition, often with multiple applications of topicals. Patients could benefit from more therapeutic options that can help control symptoms without the constant need for concomitant topicals, as they strive for relief from this life-long, chronic disease.
Safety results were consistent with the two previously reported Phase 3 studies in atopic dermatitis, with no new safety risks observed during the 16-week placebo-controlled period.