Sinus Study

[Su Mcdowall]

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Background: Patients with chronic rhinosinusitis with nasal polyps (CRSwNP) generally have a high symptom burden and poor health-related quality of life, often requiring recurring systemic corticosteroid use and repeated sinus surgery. Dupilumab is a fully human monoclonal antibody that inhibits signalling of interleukin (IL)-4 and IL-13, key drivers of type 2 inflammation, and has been approved for use in atopic dermatitis and asthma. In these two studies, we aimed to assess efficacy and safety of dupilumab in patients with CRSwNP despite previous treatment with systemic corticosteroids, surgery, or both.

Methods: LIBERTY NP SINUS-24 and LIBERTY NP SINUS-52 were two multinational, multicentre, randomised, double-blind, placebo-controlled, parallel-group studies assessing dupilumab added to standard of care in adults with severe CRSwNP. SINUS-24 was done in 67 centres in 13 countries, and SINUS-52 was done in 117 centres in 14 countries. Eligible patients were 18 years or older with bilateral CRSwNP and symptoms despite intranasal corticosteroid use, receiving systemic corticosteroids in the preceding 2 years, or having had sinonasal surgery. Patients in SINUS-24 were randomly assigned (1:1) to subcutaneous dupilumab 300 mg or placebo every 2 weeks for 24 weeks. Patients in SINUS-52 were randomly assigned (1:1:1) to dupilumab 300 mg every 2 weeks for 52 weeks, dupilumab every 2 weeks for 24 weeks and then every 4 weeks for the remaining 28 weeks, or placebo every 2 weeks for 52 weeks. All patients were randomly assigned centrally with a permuted block randomisation schedule. Randomisation was stratified by asthma or non-steroidal anti-inflammatory drug-exacerbated respiratory disease status at screening, previous surgery at screening, and country. Patients with or without comorbid asthma were included. Coprimary endpoints were changes from baseline to week 24 in nasal polyp score (NPS), nasal congestion or obstruction, and sinus Lund-Mackay CT scores (a coprimary endpoint in Japan), done in an intention-to-treat population. Safety was assessed in a pooled population of both dupilumab groups in SINUS-52 up to week 24 and the dupilumab group in SINUS-24 and the placebo groups in both studies until week 24. The trials are complete and registered at ClinicalTrials.gov, NCT02912468 and NCT02898454.

Interpretation: In adult patients with severe CRSwNP, dupilumab reduced polyp size, sinus opacification, and severity of symptoms and was well tolerated. These results support the benefits of adding dupilumab to daily standard of care for patients with severe CRSwNP who otherwise have few therapeutic options.

One of the most common reasons for clinical visits in the United States is sinusitis, also known as rhinosinusitis. It is also one of the top reasons that antibiotics are prescribed. Over a one-year period, there were up to 73 million restricted-activity days related to sinusitis and total direct medical costs of almost 2.4 billion, not including surgery or radiographic imaging. In addition, up to 14.7 percent of individuals surveyed in the National Health Interview Survey reported having had sinusitis the preceding year. This activity reviews the cause, presentation, and pathophysiology of sinusitis and highlights the role of the interprofessional team in its management.

Objectives:Describe exam findings consistent with rhinosinusitis.Describe the management of rhinosinusitis.List complications of rhinosinusitis.Explain how an interprofessional approach is imperative to the effective management of patients with rhinosinusitis.Access free multiple choice questions on this topic.

Sinusitis is one of the most common health complaints leading to a physician visit in the United States, as well as one of the leading causes of antibiotic prescriptions. In 1 year, there were up to 73 million restricted activity days in patients with sinusitis and total direct medical costs of almost $2.4 billion (not including surgery or radiographic imaging). In addition, up to 14.7% of people in one National Health Interview Survey had sinusitis the preceding year. The newer term is rhinosinusitis because purulent sinus disease without similar rhinitis is rare.

Causes are a combination of environmental and host factors. Acute sinusitis is most commonly due to viruses and is usually self-limiting. Approximately 90% of patients with colds have an element of viral sinusitis. Those with atopy commonly get sinusitis. It can be caused by allergens, irritants, viruses, fungi, and bacteria. Popular irritants are animal dander, polluted air, smoke, and dust.

Most commonly, a viral upper respiratory infection causes rhinosinusitis secondary to edema and inflammation of the nasal lining and the production of thick mucus that obstructs the paranasal sinuses and allows a secondary bacterial overgrowth. There are frontal, maxillary, sphenoid, and ethmoid sinuses. Allergic rhinitis can lead to sinusitis also due to ostial obstruction. Ciliary immobility can lead to increased mucus viscosity, further blocking drainage. Bacteria are introduced into the sinuses by coughing and nose blowing. Bacterial sinusitis usually occurs after a viral upper respiratory infection and worsening symptoms after 5 days or persistent symptoms after 10 days.

A physical exam is best performed after a topical decongestant. On exam, look for facial swelling, erythema, edema (most commonly periorbital), cervical adenopathy, postnasal drainage, or pharyngitis. Anterior rhinoscopy may reveal mucosal edema, mucous crusting, frank purulence, obstructive polyps, or other anatomical defects. Percuss the forehead and cheeks for deep tenderness. Transillumination of the sinuses may be helpful. There are five independent predictors of sinusitis: maxillary dental pain, abnormal sinus transillumination, poor response to nasal decongestants or antihistamines, colored nasal discharge, and mucopurulent, seen on examination. The presence of four or more is highly predictive of sinusitis. The overall impression of the examining physician may be more accurate than any single finding[4].

No laboratory tests are indicated in the emergency department for acute uncomplicated sinusitis because the diagnosis is usually clinical. A plain sinus X-ray may detect the maxillary, frontal, or sphenoid disease but is not useful for evaluating the anterior ethmoid cells or the ostiomeatal complex from which most sinus disease originates. Positive findings on plain films are air-fluid levels, sinus opacity, or mucosal thickening of 6 mm or more. Coronal CT at a thickness of 3 mm to 4 mm is the modality of choice. The CT findings suggestive of sinusitis are sinus opacification, air-fluid levels, sinus wall displacement, and 4 mm or greater mucosal thickening[5]. Culture and biopsy are indicated for chronic bacterial and fungal sinusitis[6].

Humidification, nasal wash, decongestants (topical or systemic) such as pseudoephedrine. Remember that oxymetazoline cannot be used for more than 3 days due to rebound congestion and that oral decongestants should be used with caution in hypertensive patients. Antihistamines have not been shown to be useful and can lead to impaired drainage. They are only of benefit in early allergic sinusitis. Topical steroids are used to diminish nasal mucosal edema but are more efficacious in chronic and allergic sinusitis. Only start antibiotics if you strongly suspect bacterial disease[7].

Antibiotics: Use empirically and based on community patterns of resistance. Ten to 14 days of amoxicillin or amoxicillin-clavulanate is first-line treatment. In some communities, amoxicillin effectiveness is less than 70%. Trimethoprim-sulfamethoxazole well for some, but there is a higher rate of resistance. Failure of symptoms to resolve after 7 days of therapy should prompt one to switch to a broader spectrum agent, such as ten to fourteen days of amoxicillin-clavulanate, cefuroxime axetil, other second or third-generation cephalosporins, clindamycin alone or along with ciprofloxacin, sulfamethoxazole, a macrolide, or one of the fluoroquinolones.[8] Metronidazole may be added to any one of these agents to increase anaerobic coverage. For chronic sinusitis, antibiotics should cover S. aureus and be effective against the higher incidence of beta-lactamase-producing organisms that are common in chronic disease. If the patient is not improving after 5 to 7 days, add metronidazole or clindamycin. Adults who respond to treatment should be treated for 5 to 7 days. Children should be treated for 10 to 14 days.

The most common malady mistaken for sinusitis is rhinitis or an upper respiratory infection. A maxillary toothache can also mimic the pain caused by maxillary sinusitis. Tension headaches, vascular headaches, foreign bodies, brain abscesses, epidural abscesses, meningitis, and subdural empyema can also be mistaken for sinusitis[9].

Most cases of uncomplicated acute bacterial sinusitis can be treated as an outpatient with a good prognosis. Frontal or sphenoid sinusitis with air-fluid levels may require hospitalization with intravenous (IV) antibiotics. Patients who are immunocompromised or are toxic appearing require admission. Fungal sinusitis is associated with high morbidity and mortality[10].

Sinusitis may extend to the bones and soft tissues of the face and orbits. Facial cellulitis, periorbital cellulitis, orbital abscess, and blindness can develop. Sinusitis can lead to intracranial complications such as cavernous sinus thrombosis, epidural or subdural empyema, and meningitis.[11][12]

Sinusitis is a common disease that is best managed by an interprofessional team that includes nurses and pharmacists. The key to treatment is to reduce the triggers. Patients should be urged to quit smoking. In addition, the early empirical use of antibiotics should be avoided. The outcomes depend on the cause, but irrespective of treatment, recurrences are common and lead to poor quality of life.

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