The non-interventional ANEMO Study: Long-term Effectiveness, Safety and Patient Characteristics in COPD Patients Treated with Dupilumab under Real-World Conditions

Introduction/Background: Chronic Obstructive Pulmonary Disease (COPD) is a heterogenous and progressive disease with a high impact on patients’ quality of life, and one of the leading causes of death worldwide. Dupilumab, a monoclonal antibody that inhibits IL-4 and IL-13 signaling pathways, has shown efficacy in COPD patients with evidence of Type-2 inflammation in the phase 3 NOTUS and BOREAS studies. However, real-world data from clinical practice is lacking. Methods: ANEMO (NCT07052396) is an ongoing prospective, non-interventional, multicenter observational study that will be conducted at approximately 70 centers in Germany, Austria, and Switzerland, with a total duration of 4 years, consisting of a two-year recruitment phase and a two-year observation phase. The study will include 350 adult patients who, despite triple therapy or dual therapy (if ICS is contraindicated), have uncontrolled COPD with elevated eosinophil levels and are newly treated with dupilumab. Each patient will be observed over 24 months with 8 planned visits: at study start (V0), month 1 (V1,±1 week), and at months 3, 6, 9, 12, 18, and 24 (V2-V7,±4 weeks). The primary outcome will be the change in COPD Assessment Test (CAT) score from study start to month 12. Secondary outcomes include the characterization of patient profiles, the annual rate of moderate and severe COPD exacerbations after 12 and 24 months compared to the year before study start, the cumulative number, change over time and time to first moderate and severe exacerbation(s), change in lung function, mMRC score and number of hospitalisations after 6, 12, and 24 months, and change in CAT score after 6 and 24 months. Additional outcomes include the number of missed workdays due to COPD, change in other lung function parameters over time, and all-cause mortality. Safety outcomes will also be assessed. Results: The long-term assessment of effectiveness, safety, and the assessment of patient profiles in clinical routine will further evaluate the role of dupilumab in COPD therapy. Conclusion: The ANEMO study will provide valuable real-world data from clinical practice, thus improving clinical decision making and optimizing personalized treatment for COPD patients with type-2-inflammation. Publication History Article published online: 04 March 2026 © 2026. Thieme. All rights reserved. Georg Thieme Verlag KG Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany