AbbVie’s Rinvoq Performs Well in Head-to-Head Phase 3b AD Study

Topline results from the phase 3b “Heads Up” study show that a greater proportion of subjects treated with AbbVie’s Rinvoq (upadacitinib 30mg, once daily) achieved at least a 75 percent improvement in the Eczema Area Severity Index (EASI 75) at week 16, compared to dupilumab (300mg, every other week). EASI 75 was the primary endpoint in the study in adults with moderate to severe atopic dermatitis. 

Seventy one percent of upadacitinib-treated subjects achieved EASI 75 at week 16, compared to 61 percent of dupilumab-treated patients. AbbVie says upadacitinib showed superiority to dupilumab for all ranked secondary endpoints, including additional measures of skin clearance and itch reduction. Patients were randomized to receive upadacitinib or dupilumab, both as monotherapy treatments, for 24 weeks.

Rinvoq is not FDA approved for AD. Dupixent is the only approved systemic treatment for AD that has been studied for up to three years in a phase 3 trial of adults.

“As we enter a new era of advanced therapies in atopic dermatitis, head-to-head studies like this will be important to help healthcare providers understand differences in therapies," said Michael Severino, MD, vice chairman and president, AbbVie. "These results add to our growing body of evidence for Rinvoq in atopic dermatitis, 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 had a 31 percent reduction in itch (as measured by Worst Pruritus Numerical Rating Scale [NRS]), compared to nine percent in the dupilumab group. Itch improvements were maintained through week 16. Additionally, 44 percent of upadacitinib-treated patients achieved EASI 75 response at week 2, versus 18 percent of dupilumab-treated patients. 

The safety profile of upadacitinib was consistent with that observed in the phase 3 pivotal studies, Measure Up 1, Measure Up 2, and AD Up. Through week 16, the most common adverse events were acne for the upadacitinib group and conjunctivitis for the dupilumab group. Serious adverse events occurred in 2.9 percent of patients receiving upadacitinib and 1.2 percent of patients receiving dupilumab. Serious infections were reported infrequently in both treatment groups (1.1 percent in patients who received upadacitinib and 0.6 percent in patients who received dupilumab). One treatment-emergent death due to bronchopneumonia associated with influenza A occurred in a patient who received upadacitinib. No malignancies were reported in the upadacitinib group; one non-melanoma skin cancer was reported in the dupilumab group. No major adverse cardiac events or venous thromboembolic events were reported in either treatment group.

Full results from the Heads Up study will be submitted for publication in a peer-reviewed journal.