AbbVie announced top-line results from the phase 3b Heads Up study showing that upadacitinib (30 mg, once daily) achieved superiority to dupilumab (300 mg, every other week) for the first endpoint, the proportion of patients with a minimum of a 75 percent improvement within the Eczema Area Severity Index (EASI 75) at week 16, in adults with moderate to severe atopic eczema . 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 eczema who are candidates for systemic therapy. Patients were randomized to receive upadacitinib or dupilumab, both as monotherapy treatments, for twenty-four weeks.
“As we enter a replacement era of advanced therapies in atopic eczema , head-to-head studies like this may be important to assist healthcare providers understand differences in therapies,” said Michael Severino, M.D., president and president, AbbVie. “These results increase our growing body of evidence for Rinvoq in atopic eczema , which is currently under review by health authorities.”
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 within the dupilumab group