A phase 3 study evaluating the efficacy and safety of upadacitinib (Rinvoq; AbbVie) for the treatment of adults with moderate to severe atopic dermatitis met its primary and all ranked secondary end points.
The multicenter, randomized, double-blind, double-dummy, active-controlled Heads Up study included 692 patients aged 18 to 75 years with moderate to severe atopic dermatitis who are candidates for systemic therapy. Patients were randomized 1:1 to receive either upadacitinib 30mg orally once daily or dupilumab (Dupixent; Sanofi US and Regeneron) 600mg subcutaneously as an initial dose followed by 300mg every other week for 24 weeks. The primary end point was the proportion of patients achieving Eczema Area Severity Index (EASI 75) at week 16.
Findings showed that 71% of patients treated with upadacitinib achieved EASI 75 at week 16, compared with 61% of patients treated with dupilumab (P =.006). Moreover, the study met all ranked secondary end points with a greater proportion of patients treated with upadacitinib achieving the following results compared with dupilumab, respectively:
- Percent reduction from baseline in Worst Pruritus Numerical Rating Scale (NRS) at week 1: 31% vs 9% (P <.001); and at week 16: 67% vs 49%;
- Worst Pruritus NRS improvement greater than or equal to 4 at week 16: 55% vs 36%.
- EASI 75 at week 2: 44% vs 18% (P <.001);
- EASI 90 at week 16: 61% vs 39%;
- EASI 100 at week 16: 28% vs 8%.
The safety profile of upadacitinib was consistent with that seen in previous phase 3 studies: Measure Up 1, Measure Up 2 and AD Up. The most common adverse events reported were acne in the upadacitinib arm and conjunctivitis in the dupilumab arm. Serious adverse events occurred in 2.9% of the upadacitinib group and 1.2% of the dupilumab group.
“As we enter a new era of advanced therapies in atopic dermatitis, head-to-head studies like this will be important to help health care 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.”
Rinvoq, a selective and reversible Janus Kinase (JAK) inhibitor, is FDA-approved for the treatment of moderately to severely active rheumatoid arthritis in adults who have had an inadequate response or intolerance to methotrexate.
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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. [press release]. North Chicago, IL: AbbVie; December 10, 2020.