Empfehlungen zur Überprüfung der Wirksamkeit und Verlaufsdokumentation von Mepolizumab bei chronischer Rhinosinusitis mit Nasenpolypen (CRSwNP) im deutschen Gesundheitssystem ­ Empfehlungen des Ärzteverbandes Deutscher Allergologen (AeDA) und der AGs Klinische Immunologie, Allergologie und Umweltmedizin und Rhinologie und Rhinochirurgie der Deutschen Gesellschaft für HNO-Heilkunde, Kopf- und Halschirurgie (DGHNOKHC).

BACKGROUND: Chronic rhinosinusitis with nasal polyps (CRSwNP) is a multifactorial inflammatory disease of the mucous membranes of the nose and sinuses. Eosinophilic inflammation is described as a common endotype. The anti-IL5 antibody mepolizumab was approved in November 2021 as an add-on therapy to intranasal glucocorticosteroids for the treatment of adults with severe chronic rhinosinusitis with nasal polyps when systemic glucocorticosteroids or surgery do not provide adequate disease control. While national and international recommendations exist for the use of mepolizumab in CRSwNP, it has not yet been adequately specified how this therapy is to be monitored, what follow-up documentation is necessary, and when it should be terminated if necessary. METHODS: A literature search was performed to analyze previous data on the treatment of CRSwNP with mepolizumab and to determine the available evidence by searching Medline, Pubmed, the national and international trial and guideline registries and the Cochrane Library. Human studies published in the period up to and including 10/2022 were considered. RESULTS: Based on the international literature and previous experience by an expert panel, recommendations for follow-up, adherence to therapy intervals and possible therapy breaks, as well as termination of therapy when using mepolizumab for the indication CRSwNP in the German health care system are given on the basis of a documentation sheet. CONCLUSIONS: Understanding the immunological basis of CRSwNP opens up new non-surgical therapeutic approaches with biologics for patients with severe, uncontrolled courses. Here, we provide recommendations for follow-up, adherence to therapy intervals, possible therapy pauses, or discontinuation of therapy when mepolizumab is used as add-on therapy with intranasal glucocorticosteroids to treat adult patients with severe CRSwNP that cannot be adequately controlled with systemic glucocorticosteroids and/or surgical intervention.

[Prognostic factors for overall survival in oropharyngeal carcinoma depending on HPV status]. / Prognosefaktoren für das Gesamtüberleben bei Oropharynxkarzinomen in Abhängigkeit vom HPV-Status.

BACKGROUND: Due to their differing carcinogenesis, prognosis and clinical manifestation, human papillomavirus (HPV)-associated and HPV-negative oropharyngeal squamous cell carcinoma (OSCC) have been classified separately as two entities since the 8th edition of the AJCC/UICC TNM staging system (UICC 8). MATERIALS AND METHODS: A total of 524 patients with OSCC treated between 2000 and 2016 at the Department of Otorhinolaryngology, Head and Neck Surgery of the University Hospital Muenster, Germany, were examined for the detection of HPV type 16-specific DNA (HPV16-DNA), nicotine and alcohol consumption and the influence of therapy on overall survival (OS). RESULTS: There was a significant increase in the annual prevalence of HPV16-DNA-positive OSCC from 40% (n = 12/30) in 2000 to 46% (n = 18/39) in 2016 (p = 0.025, ß = 0.539). Of the HPV16-DNA-positive OSCC, 89% (n = 212) were downgraded on the basis of UICC 8 compared to UICC 7. In the overall collective, frequent alcohol and nicotine (≥ 10 pack years) consumption showed a significant negative influence on OS (p = 0.004 and p = 0.009, respectively). Frequent alcohol consumption was also prognostically relevant in the HPV16-DNA-negative group (p = 0.049). In the HPV16-DNA-positive group, the prognosis for OS according to UICC 8 showed no statistically significant difference between stages I and II (p = 0,481), or between III and IV (p = 0.439). CONCLUSIONS: The current UICC 8 improves the prognostic stratification of OSCC due to the separation of HPV-positive and HPV-negative tumors in comparison to UICC 7. However, the prognostic significance of UICC 8 for HPV-associated OSCC is still insufficient. In the future, alcohol and nicotine consumption could influence the UICC classification in order to further improve prognostic significance.

Positionspapier: Empfehlungen zur Anwendung von Mepolizumab bei chronischer Rhinosinusitis mit Polyposis nasi (CRSwNP) im deutschen Gesundheitssystem ­ Empfehlungen des Ärzteverbandes Deutscher Allergologen (AeDA) und der AGs Klinische Immunologie, Allergologie und Umweltmedizin und Rhinologie und Rhinochirurgie der Deutschen Gesellschaft für HNO-Heilkunde, Kopf- und Hals-Chirurgie (DGHNO-KHC).

BACKGROUND: Chronic rhinosinusitis with nasal polyps (CRSwNP) is a multifactorial inflammatory disease of the paranasal sinus mucosa with eosinophilic inflammation as the most common endotype. The anti-IL5 antibody mepolizumab was approved for the treatment of severe CRSwNP in the EU in November 2021. METHODS: A literature search was performed to analyze the immunology of CRSwNP and determine the available evidence by searching Medline, Pubmed, and the German national and international trial and guideline registries and the Cochrane Library. Human studies published in the period up to and including 12/2021 that investigated the effect of mepolizumab in CRSwNP were considered. RESULTS: Based on the international literature and previous experience, recommendations for the use of mepolizumab in CRSwNP in the German health care system are given by an expert panel on the basis of a documentation form. CONCLUSIONS: Understanding about the immunological basis of CRSwNP opens new non-surgical therapeutic approaches with biologics for patients with severe courses. Mepolizumab is approved since November 2021 for add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe CRSwNP who cannot be adequately controlled with systemic corticosteroids and/or surgical intervention.

Empfehlungen zur Überprüfung der Wirksamkeit und Verlaufsdokumentation von Dupilumab bei chronischer Rhinosinusitis mit Nasenpolypen (CRSwNP) im deutschen Gesundheitssystem.

BACKGROUND: Chronic rhinosinusitis with nasal polyps (CRSwNP) is a multifactorial inflammatory disease of the nasal and paranasal mucosa. A Type-2 inflammation is described as the most common endotype. Since October 2019 the anti-IL-4/-IL-13 antibody dupilumab has been approved in Germany as an add-on therapy to intranasal corticosteroids for the treatment of adults with severe chronic rhinosinusitis with nasal polyps, when systemic corticosteroids alone or surgery do not provide adequate disease control. While recommendations for the use of dupilumab in CRSwNP exist at both national and international levels, until now it has not been adequately established, how therapy should be monitored and when it should be discontinued in the German Health Care System. METHODS: A literature search was performed analyzing previous data on the treatment of CRSwNP with dupilumab and to determine the available evidence by searching Medline, Pubmed, the national and international trial and guideline registries and the Cochrane Library. Human studies published in the period up to 05/2022 were included. RESULTS: Based on international literature and previous experience, recommendations are given by an expert panel for follow-up and possible therapy breaks, therapy intervals or termination of therapy when using dupilumab for the indication CRSwNP in the German health care system based on a documentation form. CONCLUSIONS: Understanding the immunological basis of CRSwNP opens new non-surgical therapy approaches with biologics for patients with severe courses. The authors give recommendations for follow-up, possible therapy breaks, therapy intervals and a termination for dupilumab treatment as add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe CRSwNP that cannot be adequately controlled with systemic corticosteroids and/or surgical intervention.

[The first year of the SARS-CoV-2 pandemic-impact on otorhinolaryngology]. / Das erste Jahr der Pandemie mit SARS-CoV-2 ­ Auswirkungen auf die Hals-Nasen-Ohren-Heilkunde.

BACKGROUND: The first year of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has already affected our public health care system to an enormous extent and will continue to do so in the future. Otorhinolaryngologists (ORLs) are suspected to be at high risk of infection, due to the high viral load in the mucosa of the upper airways. The current review evaluates the impact of the pandemic on ORLs' activities and assesses the risk infection. METHODS: A selective literature research was conducted using relevant English and German terms for ORL, SARS-CoV­2, risk, and infection at PubMed, medRxiv, and bioRxiv, as well as in the Deutsches Ärzteblatt and on the websites of the Robert Koch Institute and the Johns Hopkins University. RESULTS: Protection recommendations for ORL include general hygiene measures and wearing KN95 masks for routine professional activities. When in contact with coronavirus disease 2019 (COVID-19) patients, it is recommended to extend the personal protective equipment by eye protection, gloves, cap, and gown. International otorhinolaryngology societies have released guidelines for procedures (e.g., tracheostomy, sinus surgery), propagating personal protection for the surgical team and reduction of aerosols. Testing for SARS-CoV­2 in patients and medical staff can contribute to reducing the risk of infection. Vaccination would provide some additional protection for ORLs and other health care professionals with increased exposure to aerosols. There is increasing evidence that ORLs are at a high risk of contracting SARS-CoV­2. CONCLUSION: Consequent personal protection, frequent testing of patients and health care professionals, and the promised SARS-CoV­2 vaccinations may provide adequate protection for highly exposed persons.

Prevalence and risk factors of smell dysfunction - a comparison between five German population-based studies.

BACKGROUND: The prevalence of olfactory impairment increases with age and is known to be an early sign of different neurodegenerative diseases. Only few population-based studies examined the prevalence of olfactory impairment and comparisons across studies are scarce. Aim of this analysis was to compare the prevalence and determinants of normosmia across five population based studies in Germany. METHODOLOGY: Data from five population-based, cross-sectional studies were included. They were independently conducted and used the same test system (Sniffin' Sticks Screening 12) to measure olfactory function. This system consists of 12 odor-dispensing felt-tip pens; the task is a forced-choice selection among four alternative odors per pen. Sociodemographic information and comorbidities were assessed in face-to-face interviews. Univariate, descriptive statistics and multivariable logistic regression models stratified by study, were performed to determine risks, i.e. prevalence odds ratios, associated with olfactory function. RESULTS: The prevalence of normosmic participants varied considerably across studies. Olfactory function was lower in men, decreased with age, and increased with higher education. Several individual comorbidities and a comorbidity index were associated with olfactory dysfunction. Recognition performance for three of the 12 pens was especially low in all studies. CONCLUSION: Four factors, well known to describe population composition, contribute to explain differences in the prevalence of olfactory function between studies when the same test system is used. Our results indicate that comorbidities and educational level should always be considered when test systems based on smell recognition are used in population-based studies.

[Complications and side effects of conservative treatment of rhinological diseases]. / Komplikationen und Nebenwirkungen bei konservativer Therapie rhinologischer Erkrankungen.

BACKGROUND: The spectrum of rhinological diseases is wide, as is that of their drug-based treatment. Only 1272 compounds coded R01 (nasal preparations) are listed in the ATC group (Anatomical Therapeutic Chemical Classification). Conservative therapy of rhinological diseases additionally includes systemic (often oral) application of corticosteroids, antibiotics and immunomodulators. OBJECTIVE: The aim of this paper is to outline possible complications of medication (subdivided into classes of ingredients) commonly used to treat rhinological diseases in hospitals. Useful therapeutic and preventive measures will be presented. MATERIALS AND METHODS: Based on the expert information in the current pharmacological drug index (ATC) for the R01 group as well as literature research in the PubMed, Cochrane Library and MEDLINE databases, medication used for the treatment of rhinological diseases was analysed in terms of side effects and their frequency. RESULTS: Common side effects of intranasally applied medication are local irritations, burning, dryness and epistaxis. Orally or intravenously applied rhinological medication can affect the organs and lead to side effects such as cardiac dysrhythmia or alterations of the blood count. It is recommended that the therapeutic be selected on an individual basis and that the patient be thoroughly informed about possible side effects. CONCLUSION: Particularly when treating children or pregnant or breastfeeding women, the indications of all nasal preparations should be checked carefully. The huge variety of rhinologicals enables an optimal individual selection on the basis of consideration of known side effects.

[The association between allergic rhinitis control and sleep quality]. / Assoziation zwischen Kontrolle der allergischen Rhinitis und Schlafqualität.

BACKGROUND: Allergic rhinitis (AR) is the most common form of atopic disease, comprising 50% of atopic diseases. Recently, this disease has increasingly been the focus of intensive research. Previous work has shown that AR has a significant impact on sleep quality. To date there are no published studies demonstrating a quantitative association between the extent of control of AR and the severity of compromised sleep quality. METHODS: Patients with AR were prospectively recruited into our cross-sectional study. Sleep quality was assessed using five of the sleep subdomain questions from the 22-item Sinonasal Outcome Test (SNOT-22). Control of AR was assessed using the Rhinitis Control Assessment Test (RCAT). Association was sought between the degree of allergic rhinitis control (RCAT) as independent variable and sleep quality as dependent variable using linear regression. RESULTS: A total of 104 patients (54.8% female and 45.2% male) with an average age of 41.4 years (SD: 15.9 years) were included in the study. There were statistically significant associations between the RCAT score and the score of each of the five SNOT-22 questions used to assess decreased sleep quality (p < 0.001). These associations remained significant (p < 0.001) even after controlling participants' clinical and demographic characteristics. CONCLUSION: This is the first study showing that level of control of AR correlates with the severity of subjectively perceived sleep quality detriment. These results indicate that an improvement in AR control could lead to improved subjective sleep quality but a prospective interventional study is needed to confirm these results.

[Epidemiology of chronic rhinosinusitis, selected risk factors, comorbidities and economic burden]. / Epidemiologie der chronischen Rhinosinusitis, ausgewählter Risikofaktoren und Komorbiditäten, und ihre ökonomischen Folgen.

Chronic rhinosinusitis (CRS) is a relevant and prevalent medical condition in Germany, Europe and the world. If analysed in detail, the prevalence of CRS shows regional and temporary variety. In this review, currently available data regarding the prevalence of CRS is therefore sorted by country and/or region, time point of data collection and the CRS-definition employed. Risk factors like smoking and gastro-oesophageal reflux are discussed regarding their influence on CRS prevalence. Moreover, co-morbidities of CRS, like asthma, conditions of the cardiovascular system and depression are listed and their influence on CRS is discussed. Furthermore, data on CRS prevalence in special cohorts, like immunocompromised patients, are presented. To estimate the economic burden of CRS, current data e.g. from Germany and the USA are included in this review.

[Non-allergic Rhinitis: Epidemiology, Diagnostic and Therapy]. / Nicht-allergische Rhinitis: Epidemiologie, Diagnostik und Therapie.

Non-allergic rhinitis is a heterogenous group of medical diseases without an IgE-mediated pathophysiology. In this review, typical subgroups are presented with data regarding their frequency, clinical symptoms and recommendations for an effective and efficient diagnostic and therapeutic approach are indicated. The most common subtype is the non-allergic rhinopathy, also known as idiopathic or vasomotoric rhinitis. Because medication induced rhinitis is still a frequent clinical problem, a step wise approach to wean the patient is presented.

[Position paper "Chemosensory testing for expert opinion in smell disorders"]. / Positionspapier "Die chemosensorische Testung bei der gutachterlichen Abklärung von Riechstörungen"

Providing expert opinion in the context of smell disorders is often challenging, not only with regard to general aspects of providing an expert opinion but particularly with regard to chemosensory testing. Currently there is no consensus which chemosensory test should be selected and how they should be executed. This positions paper from Committee on Olfaction and Gustation of the German Society of Otorhinolaryngology, Head and Neck Surgery aims to give concrete recommendations for chemosensory testing for providing expert opinion for smell disorders with regard to the selection and execution of these test.