What is Chronic Rhinosinusitis Market?

Chronic Rhinosinusitis (CRS) is an inflammatory condition of the paranasal sinuses that most often causes chronic sinonasal symptoms. It is a disease of inflammation of the nose and paranasal sinuses and upper airways characterized by 12 weeks of persistent symptoms, including congestion, stuffiness, nasal discharge, pain or facial pressure, impairment or loss of the sense of smell (anosmia), cough, and fatigue. Chronic Rhinosinusitis (CRS) can be classified according to the presence of a nasal polyp (NP): CRS with NP (CRSwNP) and CRS without NP (CRSsNP). CRSwNP has characteristics with high infiltration of tissue eosinophilia with a burst of Th2 inflammatory cytokine. CRSwNP can be further classified into eosinophilic and noneosinophilic. CRS is approximately twice as common in females as compared to males.

CRSwNP is estimated to occur in seven percent of all asthmatics while asthma is reported in 26–48% of patients with CRSwNP. Furthermore, CRSwNP is a disease of middle age with the average age of onset being 42 years and the typical age of diagnosis ranging from 40 years to 60 years.

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In addition, it is estimated that approximately 10% of patients with nasal polyps and nine percent of patients with CRS have Aspirin Exacerbated Respiratory Disease (AERD). Nasal polyps are inflammatory outgrowths of sinonasal tissue that are estimated to occur in one to four percent of the US general population. In addition, among all patients with Chronic Rhinosinusitis (CRS), only ~25–30% have Chronic Rhinosinusitis with Nasal Polyps (CRSwNP).

Chronic rhinosinusitis (CRS) is defined as an inflammatory condition involving the paranasal sinuses and lining of the nasal passages that persist for more than 12 weeks. CRS is one of the most common diseases of the upper airway and is associated with a high risk of poor quality of life. The most common conditions that predispose patients to CRS include allergic and nonallergic rhinitis, nasal polyps, and occasionally anatomic factors, such as a deviated nasal septum.

Thus, the treatment of CRS is aimed at reducing mucosal inflammation, controlling infection, and restoring mucociliary clearance within the sinuses. Eosinophilic inflammation is one of the frequent hallmarks of CRS, and reducing mucosal eosinophilia is one of the therapeutic goals. However, there is no one regimen for the management of CRS, and treatments should be individualized. Management includes the use of topical corticosteroids, nasal steroids, hypertonic and isotonic saline, antibiotic therapy, etc.

Topical corticosteroids constitute first-line therapy in the medical management of CRS. Long-term treatment with topical nasal steroid sprays reduces sinus inflammation and nasal polyp size and improve symptoms associated with CRS. The daily use of topical nasal steroids appears to be associated with minimal risks; however, long-term systemic steroid use is associated with significant side effects. Therefore, a tapered regimen of oral steroids is most commonly given during severe CRS flare-ups or in the postoperative period after sinus surgery. The use of topical nasal steroids has been widely advocated in the treatment of CRS.

Several studies have demonstrated that topical corticosteroids are beneficial in the treatment of small to medium-sized polyps and for rhinitis symptoms. Oral corticosteroids have been effective in treating allergic rhinitis, reducing nasal polyps’ andallergic fungal sinusitis. Intranasal corticosteroids (INS) are helpful in all types of CRS. Their efficacy is supported by a high level of evidence (1a recommendation), and therefore, they are the cornerstone of maintenance treatment. Available data support the use of beclomethasone dipropionate, budesonide, flunisolide, fluticasone propionate, mometasone furoate, and tixocortol pivalate.

Most other currently available medical management approaches, such as leukotriene inhibitors or long courses of antibiotics, are not well studied and probably have varying degrees of efficacy. Though antibiotics may be useful in treating infectious exacerbations of CRS, clinically significant efficacy (i.e., polyp shrinkage) in large, randomized trials is lacking. In a few cases, Functional endoscopic sinus surgery may be considered in patients who fail medical therapy. It results in a reduction of nasal symptoms and improvement of the quality of life.

Over the past decade, significant advances have been made in both the clinical and pathophysiological understanding of CRS, which enhances the research and development for CRS.

Various companies are conducting clinical trials and evaluating the safety and efficacy of several biologics in CRS. Omalizumab, a fully humanized anti-IgE monoclonal antibody, significantly reduced nasal polyp size and improved symptoms when compared to placebo in CRS patients independent of atopic status.

In CRS patients with severe nasal polyposis refractory to corticosteroid therapy, Mepolizumab—a humanized anti-IL-5 antibody—also significantly reduced nasal polyps and improved the sense of smell, postnasal drip, and nasal congestion (but not rhinorrhea) when compared to placebo-treated controls. Finally, Dupilumab, a human monoclonal antibody that binds to the IL-4 receptor alpha subunit and inhibits signaling of IL-4 and IL-13, significantly reduced nasal polyp burden and I proved nasal symptoms when used in conjunction with intranasal steroids in CRS patients with refractory disease.

It should be noted that omalizumab, mepolizumab, and dupilumab are currently not approved for the treatment of nasal polyps. However, given the separate observations that omalizumab, mepolizumab, and dupilumab can also reduce asthma exacerbations, it is possible that these biological agents could have potentially even greater beneficial effects in patients with both asthma and CRS.

A new targeted approach for treating recurrent nasal polyp disease in patients who have had previous ethmoid sinus surgery. It is a corticosteroid-eluting (mometasone furoate) implant indicated for the treatment of nasal polyps, in patients ≥18 years of age who have had ethmoid sinus surgery.

FDA approved Dupixent for use with other medicines to treat patients with chronic rhinosinusitis with nasal polyps. Dupilumab, administered by injection, is a fully-human monoclonal antibody that inhibits the signaling of two proteins that affect type 2 inflammation. According to Regeneron Pharmaceuticals and Sanofi, adverse events in patients who received dupilumab were arthralgia, conjunctivitis, injection site reactions, and gastritis. These occurred in two percent or more of the patients. And in September 2019, The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended Dupixent to be approved as add-on therapy with intranasal corticosteroids for the treatment of adults with severe chronic rhinosinusitis with nasal polyposis (CRS) for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. If approved, Dupixent would be the first biologic medicine available in the European Union (EU) to treat these patients.