NORTH CHICAGO, Ill. - AbbVie (NYSE: NYSE:ABBV) today announced results from the LEVEL UP study, which showed upadacitinib demonstrating superior efficacy over dupilumab in treating moderate-to-severe atopic dermatitis. The study focused on adult and adolescent patients who had an inadequate response to systemic therapy or for whom such therapies were inadvisable.
The primary endpoint of the Phase 3b/4 head-to-head trial was the simultaneous achievement of near complete skin clearance (EASI 90) and no to little itch (WP-NRS 0/1) at Week 16. Upadacitinib, with a starting dose of 15 mg once daily, led to 19.9% of patients achieving this combined endpoint, compared to 8.9% for those on dupilumab.
Secondary endpoints also favored upadacitinib, with a rapid onset of achieving near complete skin clearance and minimal to no itch. Notably, 40.8% of patients treated with upadacitinib reached EASI 90 at Week 16, versus 22.5% for dupilumab. Additionally, 30.2% of upadacitinib patients achieved a WP-NRS of 0/1, compared to 15.5% for the dupilumab group.
The study's safety profile for upadacitinib remained consistent with previous studies, showing no new safety signals. The most common adverse events reported were nasopharyngitis for both treatment groups, and the rate of serious adverse events was 0.9% for both medications. No serious infections were reported in the upadacitinib group, while one was reported in the dupilumab group.
Dr. Roopal Thakkar, senior vice president and chief medical officer at AbbVie, emphasized the study's significance, stating that it shows the potential for patients with moderate-to-severe atopic dermatitis to achieve both clearer skin and relief from itch.
AbbVie plans to present the detailed results of the LEVEL UP study at a future medical congress. The trial is the first head-to-head study in atopic dermatitis to assess upadacitinib against dupilumab at their respective starting doses. The information is based on a press release statement.
InvestingPro Insights
AbbVie (NYSE: ABBV), following the promising results from the LEVEL UP study for upadacitinib, continues to demonstrate a strong presence in the biopharmaceutical market. With a robust market capitalization of $297.63 billion, the company is a heavyweight in the industry, reflecting investor confidence and the scale of its operations. The company's Price/Earnings (P/E) ratio, sitting at 22.46 for the last twelve months as of Q4 2023, suggests that investors are willing to pay a premium for AbbVie's earnings, which could be attributed to its innovative product pipeline and consistent performance.
InvestingPro Tips highlight that AbbVie has raised its dividend for 11 consecutive years, indicating a commitment to returning value to shareholders. Moreover, the company is expected to see net income growth this year, which may further solidify its financial position. These factors, combined with the company's low price volatility and its status as a prominent player in the Biotechnology industry, provide a compelling narrative for both existing and potential investors.
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