Efficacy and safety of omalizumab in nasal polyposis: 2 randomized phase 3 trials

Gevaert, Philippe; Omachi, Theodore A.; Corren, Jonathan; Mullol, Joaquim; Han, Joseph K.; Lee, Stella E.; Kaufman, Derrick; Ligueros‐Saylan, Monica; Howard, Monet; Zhu, Rui; Owen, Ryan; Wong, Kit; Islam, Lutaf; Bachert, Claus

doi:10.1016/j.jaci.2020.05.032

Cited by 456 publications

(535 citation statements)

References 41 publications

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“…5,[58][59][60][61][62] Among these, phase 3 trials conducted in patients with CRSwNP uncontrolled with intranasal corticosteroids have demonstrated the efficacy of monoclonal antibody therapies targeting IL-4/IL-13 (dupilumab), IgE (omalizumab), and IL-5 (mepolizumab). 58,63,64 The primary endpoints of these trials (reduction in nasal polyp score [NPS] and nasal congestion/obstruction score) were met with significant improvements in the treated patients versus placebo. Significant improvements in other measures including smell and disease-specific quality of life (SNOT-22) were also seen with all three drugs.…”

Section: Journal Of Asthma and Allergy 2021:14mentioning

confidence: 99%

Burden of Disease in Chronic Rhinosinusitis with Nasal Polyps

Bachert¹,

Bhattacharyya²,

Desrosiers³

et al. 2021

JAA

Self Cite

132

122

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Chronic rhinosinusitis with nasal polyps (CRSwNP) is a predominantly type 2 inflammation-mediated disease of the nasal mucosa and paranasal sinuses with an underrecognized clinical, humanistic, and economic burden. Patients with CRSwNP experience a high symptom burden, including nasal congestion, loss of smell, and rhinorrhea, which has a negative impact on physical and mental health-related quality of life, including sleep quality. Existing medical and surgical interventions, including local and systemic corticosteroids and endoscopic sinus surgery, may be associated with recurrence of nasal polyps and associated symptoms and with an increased risk of short-and long-term adverse effects, especially with repeated or long-term use. Because type 2 inflammation is implicated in the pathogenesis of several coexisting diseases, patients with CRSwNP often have comorbid asthma and/or nonsteroidal anti-inflammatory drug-exacerbated respiratory disease. These patients, as well as those with high corticosteroid use and/or sinonasal surgical history, have more severe disease and associated symptom burden and represent a difficult-to-treat population under the existing management paradigm. This article reviews the clinical, humanistic, and economic burden of CRSwNP; it highlights the unmet need for effective and safe CRSwNP therapies that effectively control symptoms and minimize recurrence by targeting the underlying type 2 inflammatory disease pathophysiology.

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Section: Journal Of Asthma and Allergy 2021:14mentioning

confidence: 99%

Burden of Disease in Chronic Rhinosinusitis with Nasal Polyps

Bachert¹,

Bhattacharyya²,

Desrosiers³

et al. 2021

JAA

Self Cite

132

122

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“…Type 2 targeting biologics are emerging treatment options for severely uncontrolled patients with eosinophilic CRS 130,131 . Dupilumab, 130,132 mepolizumab, 9,133 benralizumab 134 and omalizumab 135 are effective treatments for eosinophilic CRS. Dupilumab reduced NP, sinus opacification and symptom severity in a phase III clinical study.…”

Section: Clinical Characteristics and Pathophysiology Of Adult‐onsetmentioning

confidence: 99%

Adult‐onset eosinophilic airway diseases

Asano

Ueki

Tamari

et al. 2020

Allergy

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Allergic diseases in the upper and the lower airways such as allergic rhinitis and atopic asthma are usually accompanied by local eosinophilia and sometimes by peripheral blood eosinophilia. Chronic rhinosinusitis with nasal polyps (CRSwNP) and nonatopic asthma are also characterized by local and systemic eosinophilia; however, there are substantial differences in the age of onset and the presence of atopy. Atopic asthma and allergic rhinitis develop during childhood in most cases and mediated by type 1 hypersensitivity reactions to allergen(s), as are other childhood-onset allergic diseases such as food allergies and eczema. Patients often develop these diseases consecutively as an allergic march (Figure 1), suggesting the presence of common genetic backgrounds and pathophysiology. In contrast to childhood-onset disease, adult-onset asthma frequently presents as a nonatopic and eosinophilic condition, 1-6

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“…Omalizumab (Xolair) has completed 2 phase 3 trials, POLYP I (n ¼ 138) and POLYP II (n ¼ 127), with promising results. 15 Subjects were randomized to subcutaneous omalizumab versus placebo for 24 weeks. Omalizumab dosing was based on weight and serum IgE levels.…”

mentioning

confidence: 99%

The Role of Biologics in Chronic Rhinosinusitis With Nasal Polyps

Patel

Peters

2020

Ear Nose Throat J

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Biologic therapy is a new treatment option for patients with chronic rhinosinusitis with nasal polyps (CRSwNP). Currently, the only biologic with Food and Drug Administration–approval status for CRSwNP is dupilumab. Several other biologics are likely to be approved for CRSwNP, including mepolizumab and omalizumab, based on their promising phase 3 trial results. The role of biologics in the treatment paradigm requires consideration of multiple factors that have yet to be clearly established. This includes identifying patients most appropriate for biologic therapy while considering long-term safety and cost-effectiveness in the context of patient preferences and goals.

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Efficacy and safety of omalizumab in nasal polyposis: 2 randomized phase 3 trials

Cited by 456 publications

References 41 publications

Burden of Disease in Chronic Rhinosinusitis with Nasal Polyps

Burden of Disease in Chronic Rhinosinusitis with Nasal Polyps

Adult‐onset eosinophilic airway diseases

The Role of Biologics in Chronic Rhinosinusitis With Nasal Polyps

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