The German National Cohort (NAKO) is a multidisciplinary, population-based prospective cohort study that aims to investigate the causes of widespread diseases, identify risk factors and improve early detection and prevention of disease. Specifically, NAKO is designed to identify novel and better characterize established risk and protection factors for the development of cardiovascular diseases, cancer, diabetes, neurodegenerative and psychiatric diseases, musculoskeletal diseases, respiratory and infectious diseases in a random sample of the general population. Between 2014 and 2019, a total of 205,415 men and women aged 19–74 years were recruited and examined in 18 study centres in Germany. The baseline assessment included a face-to-face interview, self-administered questionnaires and a wide range of biomedical examinations. Biomaterials were collected from all participants including serum, EDTA plasma, buffy coats, RNA and erythrocytes, urine, saliva, nasal swabs and stool. In 56,971 participants, an intensified examination programme was implemented. Whole-body 3T magnetic resonance imaging was performed in 30,861 participants on dedicated scanners. NAKO collects follow-up information on incident diseases through a combination of active follow-up using self-report via written questionnaires at 2–3 year intervals and passive follow-up via record linkages. All study participants are invited for re-examinations at the study centres in 4–5 year intervals. Thereby, longitudinal information on changes in risk factor profiles and in vascular, cardiac, metabolic, neurocognitive, pulmonary and sensory function is collected. NAKO is a major resource for population-based epidemiology to identify new and tailored strategies for early detection, prediction, prevention and treatment of major diseases for the next 30 years.
Summary Background Chronic rhinosinusitis with nasal polyps (CRSwNP), an inflammatory disease of the paranasal mucosa, is primarily characterized by type 2 inflammation. Three antibodies (dupilumab, omalizumab, and mepolizumab) are now approved for the treatment of severe CRSwNP. Documentation of disease severity during the course of treatment is essential. Methods A literature search of Medline, PubMed, and the national and international trial and guideline register, and the Cochrane Library was performed to analyze the immunology of CRSwNP and determine the evidence for the effect of dupilumab, omalizumab, and mepolizumab in this disease. This has resulted in 3 position papers prepared by our group of authors, which form the basis of this summarizing review. Results Based on the information from the international literature, recommendations for the use of dupilumab, omalizumab, and mepolizumab in CRSwNP in the German health care system are given by an expert panel. Conclusion Dupilumab, omalizumab, and mepolizumab are approved for patients 18 years of age and older with CRSwNP as add-on therapy to intranasal corticosteroids when, for dupilumab and mepolizumab, therapy with systemic corticosteroids and/or surgery does not achieve sufficient disease control. Therapy with omalizumab is indicated when therapy with intranasal corticosteroids does not result in sufficient disease control. Dedicated recommendations for the documentation of the use in the German health care system are given, which are based on the position papers of our author group already published on this topic.
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