Phase III AD Up trial of Rinvoq meets endpoints in atopic dermatitis.- AbbVie

AbbVie announced Rinvoq (upadacitinib 15 mg and 30 mg, once daily) plus topical corticosteroids (TCS) met the co-primary endpoints and all secondary endpoints in AD Up, the third pivotal Phase III 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). 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)of at least 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. 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).