Chronic rhinosinusitis (CRS) is a complex, and persistent disease that represents a significant health problem, affecting around 5 to 12% of the Western population1. Despite existing treatments, CRS still imposes a significant burden both on patients and the health system due to recurrent and/or uncontrolled symptoms. In this article, Alcimed analyzes 3 key unmet needs of CRS patients’ management.
CRS is an inflammatory condition of the paranasal sinuses and linings of the nasal passages that lasts 12 weeks or longer, whose causes are not fully understood. The main symptoms of the disease, such as nasal obstruction, nasal discharge, and facial pain/pressure, impose a significant burden on patients with important adverse effects on their quality of life (e.g. sleep disturbance, psychological impairment, physical discomfort/pain, comorbidities, etc.). The impact of CRS on social functioning was found to be greater than angina or chronic heart failure. The long-term ramifications of this condition, regarding both medical and surgical treatments, are estimated to cost $30 billion per year in the USA alone, from which $20 billion account for indirect costs1. The healthcare spending is significantly greater in CRS than in other diseases such as peptic ulcer disease, acute asthma, and hay fever. The predisposing factors for CRS are still debated, and under research, however, the evidence connecting CRS to pollution and smoking habits indicates that the disease will continue to be a burden for years to come. Thus, addressing the following unmet needs is paramount for patients and society.
Most recent guidelines on CRS (EPOS2020 and ICAR-RS 2021) define that a positive diagnosis of the disease comprises well-defined subjective and objective criteria. The subjective criteria are related to the clinical history of the patient (e.g., more than 12 weeks of symptoms, nasal obstruction, etc.) that are assessed clinically by the physician. Differently, the objective assessment is done by using a specific set of instruments, such as a nasal endoscope or computed tomography (CT-scan), to find concrete evidence of inflammation and/or purulence on the paranasal sinuses. Most patients who experience CRS symptoms are initially diagnosed in primary care. However, the majority of primary care physicians/general practitioners (GPs) do not have the training or equipment to perform nasal endoscopy and thus rely on symptoms alone for diagnosis. A 2022 study showed that only 26% of the CRS patients of the outpatient clinic of the University Hospital of Leuven (Belgium) were diagnosed with CRS within the first year of their symptoms2. The combination of lack of awareness, knowledge of CRS, and appropriate equipment results in a misdiagnosis of patients, leading to a delayed or mistreatment of the disease.
According to the most recent guidelines on the management of CRS, intranasal corticosteroids (INCS) are considered the first line of treatment, recommended for all patients suffering from CRS, with short-term oral corticosteroid being an alternative for uncontrolled patients.
In real-life practice, the overprescription of antibiotics, particularly due to a lack of knowledge of CRS and its treatments in primary care, contrasts with the guidelines which suggest using macrolide antibiotics as a treatment option only if INCS are ineffective. CRS is said to account for 7.1% of primary care visits in the US where an antibiotic is prescribed, making it the most common diagnosis associated with antibiotic usage in primary care3. Also, in a previous UK study, 91% of antibiotic prescription for the disease was observed4. The mistreatment of patients is one of the main reasons for negative treatment outcomes, and recurrence of the disease, yielding, for example, an average of 4 visits to see a GP by year in the UK before getting a referral to a specialist4, and consequently, the correct treatment.
When oriented to the right care pathway, CRS patients start experiencing a different problem: the lack of a cure for the disease. Today, despite multiple guidelines of care, it is estimated that up to 40%2 of patients with CRS continue to experience bothersome symptoms despite guideline-driven treatment options, including functional endoscopic sinus surgery. This gives the patient almost the certainty that he/she will reexperience the disease in the future.
INCS, the first line of treatment, has a very low systemic effect, and remains recommended even after surgical procedures (second line of treatment for CRS patients with persistent symptoms despite adequate medical treatment). The treatment targets inflammatory pathways in the nasal cavity with the goal of reducing inflammation. The low systemic effect and the difficulty to deliver the drug into the sinus cavities come with the drawback that the drug must be used chronically, multiple times a day, for long periods of time, with a therapeutic effect that takes a couple of weeks to start emerging. These factors contribute to a low treatment compliance rate, with approximately 29%2 of patients showing non-compliance, and a striking 80% of patients failing to use even a single unit of INCS4. The result is frustration from the patients and inappropriate treatment outcomes.
New treatments and innovative approaches such as biologics, endotype assessment, new drug delivery devices (e.g., drug eluting stents, exhalation delivery systems, ultrasonic nebulizers, etc.) are emerging to address these issues. Among the key innovations, the new delivery methods have the ultimate goal of enhancing patient outcomes by ensuring the effective delivery of the INCS to the affected regions. However, implementing these new delivery methods is not without challenges, especially for patients who have not undergone sinus surgery. Another promising rising solution is the biologics (e.g., Dupilumab, Mepolizumab, and Omalizumab), which intend to modulate the immune response and reduce inflammation in CRS patients systemically. Biologics have been experiencing great advancements in the last few years, but are still limited today. First, biologics do not cure CSR. The therapy is also a symptomatic treatment that requires chronic applications (weekly or monthly injections), which can be bothersome to the patient. Second, the available biologics are very specific to a CRS subtype (type 2 inflammation), which accounts for ~30%1 of the patients in Western populations. Lastly, often elevated cost of the treatment may come with additional access and economic challenges for both patients and health systems.
Despite recent advancements in CRS care management, there are still significant unmet needs to address. First, improve CRS patient management by enhancing care pathways, physician education, and patient education to boost accurate treatment prescription, adoption, and compliance. Also, the development of more effective and long-lasting treatments that address the underlying causes of CRS, leveraging more personalized medicine approaches using specific biomarkers to target precise CRS endotypes and improve patients’ treatment outcomes. Alcimed is at your side to address the uncharted territories in CRS. Don’t hesitate to contact our team!
About the author,
Pedro, Consultant in Alcimed’s healthcare team in France
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