Phase IIIb trial of Rinvoq shows superiority to dupilumab in atopic dermatitis.- AbbVie

AbbVie announced top-line results from the Phase IIIb Heads Up study showing that Rinvoq (upadacitinib) (30 mg, once daily) achieved superiority to dupilumab (300 mg, every other week) for the primary endpoint, the proportion of patients with at least a 75 percent improvement in the Eczema Area Severity Index (EASI 75) at week 16, in adults with moderate to severe atopic dermatitis. Of patients treated with upadacitinib, 71 percent achieved EASI 75 at week 16 compared to 61 percent of dupilumab-treated patients (p=0.006). Upadacitinib also showed superiority compared to dupilumab for all ranked secondary endpoints, including additional measures of skin clearance and itch reduction. The Heads Up study evaluated the efficacy and safety of upadacitinib versus dupilumab in adults with moderate to severe atopic dermatitis who are candidates for systemic therapy. Patients were randomized to receive upadacitinib or dupilumab, both as monotherapy treatments, for 24 weeks. Results of ranked secondary endpoints showed higher efficacy in early improvements of itch and skin clearance in patients treated with upadacitinib compared to patients treated with dupilumab. After one week of treatment, the upadacitinib treatment group had a 31 percent reduction in itch (as measured by Worst Pruritus Numerical Rating Scale [NRS]) compared to 9 percent in the dupilumab group (p<0.001). itch improvements were maintained through week 16. additionally, after two weeks of treatment, 44 percent of upadacitinib-treated patients achieved easi 75 response versus 18 percent of dupilumab-treated patients (p><0.001). the safety profile of upadacitinib was consistent with what was observed in the phase iii pivotal studies, measure up 1, measure up 2 and ad up.>