ABSTRACT
Severe chronic rhinosinusitis with nasal polyps (CRSwNP), a form of diffuse bilateral (usually type 2) CRS, is a debilitating disease with a significant impact on quality of life (QoL). With novel knowledge and treatment options becoming available, there is a growing need to update or revise key definitions to enable communication across different specialties dealing with CRS, and to agree on novel goals of care in CRSwNP. The European Forum for Research and Education in Allergy and Airway diseases (EUFOREA) and EPOS expert members discussed how to measure treatment responses and set new treatment goals for CRSwNP. In this paper a consensus on a list of definitions related to CRSwNP is provided: control, remission, cure, recurrence/exacerbation, treatable traits, remodeling, progression, and disease modification. By providing these definitions, the involved experts hope to improve communication between all stakeholders involved in CRSwNP treatment for use in routine care, basic and clinical research and international guidelines aimed to harmonize and optimize standard of care of patients with CRSwNP in the future.
Subject(s)
Nasal Polyps , Rhinitis , Sinusitis , Humans , Sinusitis/therapy , Rhinitis/therapy , Chronic Disease , Nasal Polyps/therapy , Nasal Polyps/complications , Quality of LifeABSTRACT
In March 2023, the European Forum for Research and Education in Allergy and Airways diseases (EUFOREA) organized its bi-annual Summit in Brussels with expert panel members of EUFOREA, representatives of the EUFOREA patient advisory board, and the EUFOREA board and management teams. Its aim was to define the research, educational and advocacy initiatives to be developed by EUFOREA over the next 2 years until the 10th anniversary in 2025. EUFOREA is an international non-for-profit organization forming an alliance of all stakeholders dedicated to reducing the prevalence and burden of chronic allergic and respiratory diseases via research, education, and advocacy. Based on its medical scientific core competency, EUFOREA offers an evidence-supported platform to introduce innovation and education in healthcare leading to optimal patient care, bridging the gap between latest scientific evidence and daily practice. Aligned with the mission of improving health care, the expert panels of asthma, allergic rhinitis (AR), chronic rhinosinusitis (CRS) & European Position Paper on Rhinosinusitis and Nasal Polyps (EPOS), allergen immunotherapy (AIT) and paediatrics have proposed and elaborated a variety of activities that correspond to major unmet needs in the allergy and respiratory field. The current report provides a concise overview of the achievements, ambitions, and action plan of EUFOREA for the future, allowing all stakeholders in the allergy and respiratory field to be up-dated and inspired to join forces in Europe and beyond.
ABSTRACT
Severe chronic rhinosinusitis with nasal polyps (CRSwNP) is a debilitating disease with a significant impact on the quality of life (QoL). It is typically characterized by a type 2 inflammatory reaction and by comorbidities such as asthma, allergies and NSAID-Exacerbated Respiratory Disease (N-ERD). Here, the European Forum for Research and Education in Allergy and Airway diseases discusses practical guidelines for patients on biologic treatment. Criteria for the selection of patients who would benefit from biologics were updated. Guidelines are proposed concerning the monitoring of the drug effects that provide recognition of responders to the therapy and, subsequently, the decision about continuation, switching or discontinuation of a biologic. Furthermore, gaps in the current knowledge and unmet needs were discussed.
Subject(s)
Biological Products , Nasal Polyps , Rhinitis , Sinusitis , Humans , Nasal Polyps/drug therapy , Quality of Life , Rhinitis/drug therapy , Sinusitis/therapy , Biological Products/therapeutic use , Chronic DiseaseABSTRACT
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.
Subject(s)
Environmental Medicine , Nasal Polyps , Nasal Surgical Procedures , Rhinitis , Sinusitis , Adult , Humans , Rhinitis/drug therapy , Chronic Disease , Sinusitis/drug therapy , Delivery of Health CareABSTRACT
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.
Subject(s)
Nasal Polyps , Rhinitis , Sinusitis , Adult , Humans , Nasal Polyps/drug therapy , Rhinitis/drug therapy , Sinusitis/drug therapy , Chronic Disease , Adrenal Cortex Hormones/therapeutic use , Delivery of Health Care , DocumentationABSTRACT
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.
Subject(s)
Environmental Medicine , Nasal Polyps , Nasal Surgical Procedures , Otolaryngology , Rhinitis , Sinusitis , Adrenal Cortex Hormones/therapeutic use , Adult , Allergists , Antibodies, Monoclonal, Humanized , Chronic Disease , Delivery of Health Care , Humans , Nasal Polyps/therapy , Rhinitis/drug therapy , Sinusitis/drug therapySubject(s)
Environmental Medicine , Nasal Polyps , Nasal Surgical Procedures , Sinusitis , Humans , OmalizumabABSTRACT
Innovative and effective vaccination strategies are the most important lever to address the global SARS-COV2 pandemic. Within months scientists all over the world have developed promising new vaccines, many of which use adenoviral vectors to incorporate immunogenic molecules of SARS-coronavirus in order to elicit effective immune responses. The Gamaleya institute developed the COVID-19 vaccine named Sputnik (Gam-COVID-Vac) using adenoviral vectors ad 26 and ad5 to incorporate a full SARS-Spike Protein for vaccination. Two differing vectors enable so called prime-boost, thus avoiding neutralizing effects against the vector itself, ensuring proper immunogenicity against the vaccine. Current available published evidence has raised controversy among small sample sizes in phase II and early endpoints in phase III studies with Sputnik and scientific community took notice that full study protocols and clinical data haven't been made available yet. Patient subgroups and vaccination efficacy in healthy vaccinated may be at risk in case of partial viral replication of Ad5 vectors or when batch to batch reproducibility is not warranted, as concerns from authorities in Brazil and Slovakia have recently been raised. Final approval by governing health authorities (e.âg. EMA) should therefore be awaited.
Subject(s)
COVID-19 Vaccines , COVID-19 , Antibodies, Neutralizing , Antibodies, Viral , Humans , RNA, Viral , Reproducibility of Results , SARS-CoV-2 , VaccinationABSTRACT
Allergic reactions against mRNA COVID-19 vaccine are yet uncommon, but due to the high number of people who get this vaccination anaphylaxis will be seen. This is especially so in people who are sensitized to components of the vaccine. This article focuses on practical aspects of diagnostic possibilities, prevention, recognition and therapy of anaphylactic reactions. High-risk population, who should not get vaccinated; as well as people who need allergy diagnostics before vaccinations are discussed. In opinion of allergy experts patients with atopic allergies or venom allergies do not have a higher risk regarding anaphylaxic reaction due to COVID vaccination.
Subject(s)
Anaphylaxis , COVID-19 , Vaccines , Anaphylaxis/diagnosis , Anaphylaxis/etiology , Anaphylaxis/prevention & control , BNT162 Vaccine , COVID-19 Vaccines , Humans , RNA, Messenger , SARS-CoV-2 , VaccinationABSTRACT
BACKGROUND: For patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP) which cannot be controlled by continuous therapy with intranasal corticosteroids (INCS) and systemic corticosteroids and/or surgical treatment, there were no approved curative options for a long time. For CRSwNP treatment with T2-addressing biologics is possible. On October 24, 2019, the European Commission granted extended approval for dupilumab as the first biological agent for treatment of insufficiently controlled severe CRSwNP. The Federal Joint Committee (GBA) evaluates the benefits of reimbursable drugs with new active ingredients. This includes assessment of the additional benefit and its therapeutic relevance. METHODS: A meta-analysis was performed using individual patient data based on two phase III studies. Both studies examined the safety and efficacy of dupilumab as an add-on therapy to INCS for treatment of CRSwNP in adults inadequately controlled with systemic corticosteroids and/or surgery compared to INCS alone. RESULTS: Based on the present data, the GBA decided that there is an indication of a considerable additional benefit of dupilumab compared to mometasone furoate. CONCLUSION: For patients with severe CRSwNP inadequately controlled with INCS and systemic corticosteroids and/or surgery, there is an indication of a considerable additional benefit for the administration of dupilumab as an add-on therapy to INCS compared to mometasone furoate alone.
Subject(s)
Nasal Polyps , Rhinitis , Adult , Antibodies, Monoclonal, Humanized , Chronic Disease , Humans , Nasal Polyps/complications , Nasal Polyps/drug therapy , Rhinitis/complications , Rhinitis/diagnosis , Rhinitis/drug therapy , Treatment OutcomeABSTRACT
Vaccinations are the gold-standard in order to prevent dangerous infectious diseases. Within 12 months since the RNA sequence of SARS-COV2 has been published already two RNA vaccines against COVID-19 have been licensed and are broadly used in many relevant parts of the world. Matching the challenge of an unprecedented global pandemic unique collaborative approaches have made available several vaccines based on a variety of technological platforms that are under current development. This article explains the characteristics, biology and pharmacology of subunit-vaccines, inactivated and attenuated vaccines, Virus-like-Particle vaccines, recombinant strategies based on adenoviral vectors and newly developed and first time in human licensed RNA-vaccines that came into scope recently. Allergic reactions against the vaccine and its components have been reported but are yet uncommon, however need good documentation such as other side-effects and immune-phenomena. In rare cases where allergy against vaccine components such as PEGs is considered, such PEGs can be tested using a skin-prick test. Development of innovative vaccine technology and antiviral medication is of strategic relevance in the best sense of "pandemic preparedness" for the future.
Subject(s)
COVID-19 , Hypersensitivity , BNT162 Vaccine , COVID-19 Vaccines , Humans , RNA, Messenger , RNA, Viral , SARS-CoV-2 , VaccinationABSTRACT
With BNT162b2 (approved in the EC on 27th of December 2020) and mRNA-1273 (approved in the EC on 6th of January 2021) for the first time ever two RNA-vaccines received conditional approval within the EC in order to effectively combat the SARS-COV2 pandemic. The emergence of sporadic cases of anaphylaxis following vaccination with these new compounds and the identification of PEGs (polyethylenglycols) as potential, widely used but yet usually unknown culprits have led to uncertainty among treating physicians and patients. The aim of this article series is to summarize current available pathophysiological and clinical information (part 1), to describe the characteristics of the vaccines (part 2) and to provide practical solutions for diagnosis and treatment of potential allergy against mRNACovid19 vaccines.
