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JAMA Dermatology Publishes Data Showing RINVOQ® (upadacitinib) Achieved Superiority Versus DUPIXENT® (dupilumab) for Primary and All Ranked Secondary Endpoints in Phase 3b Head-to-Head Study in Adults with Atopic Dermatitis

Published: 2021-08-04 16:01:00 ET
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- Upadacitinib (30 mg, once daily) monotherapy demonstrated significantly greater rates of skin clearance improvement and itch reduction compared to dupilumab (300 mg, every other week) monotherapy at 16 weeks[1]

- Early, significant results were seen in upadacitinib-treated patients -- including skin clearance improvements (EASI 75) at two weeks and itch reduction at one week -- compared to dupilumab[1]

- The safety profile of upadacitinib was consistent with previous atopic dermatitis studies, with no new safety risks observed[1-3]

NORTH CHICAGO, Ill., Aug. 4, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that JAMA Dermatology has published 24-week results from the Phase 3b Heads Up study evaluating the efficacy and safety of RINVOQ® (upadacitinib, 30 mg, once daily) versus DUPIXENT® (dupilumab, 300 mg, every other week) – both as monotherapy treatments – in adults with moderate to severe atopic dermatitis who were candidates for systemic therapy.

The publication expands upon previously announced topline results and showed upadacitinib (30 mg, once daily) achieved superiority compared to dupilumab for the primary endpoint, the proportion of patients with at least a 75 percent improvement in the Eczema Severity Index (EASI 75) at week 16.1 Of those treated with upadacitinib, 71 percent achieved EASI 75 at week 16 compared to 61 percent of those treated with dupilumab.1 Additionally, upadacitinib demonstrated statistically significant greater efficacy across all ranked secondary endpoints compared to dupilumab through week 16, including early reduction in itch and rates of skin clearance improvement.1

"In this study, upadacitinib 30 mg demonstrated a more rapid onset of action compared to dupilumab, with patients experiencing a reduction in itch at one week and skin clearance improvements at two weeks. In addition, more upadacitinib-treated patients achieved high levels of skin clearance, such as EASI 90 and 100, by 16 weeks of treatment," said Andrew Blauvelt, MD, MBA, lead investigator for the Heads Up study and president of Oregon Medical Research Center in Portland, Oregon. "The results from this important comparative study will help inform how physicians work with their patients to set treatment goals for atopic dermatitis."

Results for select ranked secondary endpoints include:

  • After one week of treatment, the upadacitinib 30 mg 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