Omalizumab and quality of life in nasal polyps: A post hoc analysis

Han, Joseph K.; Yoo, Bongin; Saenz, R.; Braid, Jessica; Millette, Lauren A.; Lee, Stella E.

doi:10.1002/alr.22963

Cited by 7 publications

(8 citation statements)

References 8 publications

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“…In pooled POLYP 1 and POLYP 2, there were greater improvements (lower score) from baseline in the SNOT-22 sleep scores with omalizumab than placebo through week 24 (Figure 1 and Table S3), which is in line with previously published findings for overall SNOT-22 scores 21,22 and data at week 24 versus baseline for the SNOT-22 sleep domain. 23 At week 24, adjusted mean (95% CI) SNOT-22 sleep scores had reduced from POLYP 1 and POLYP 2 baseline by −8.5 (−9.9 to −7.1) with omalizumab versus −2.7 (−4.1 to −1.3) with placebo. In the OLE treatment period, in which all patients received omalizumab through week 52, there were continued improvements in the SNOT-22 sleep scores in patients who received omalizumab in POLYP 1 or POLYP 2 (Figure 1 and Table S3).…”

Section: Sleep Domain Of Snot-22mentioning

confidence: 95%

Omalizumab improves sleep and health status for patients with chronic rhinosinusitis with nasal polyps: An analysis of randomized clinical trials

Meltzer,

Mullol,

et al. 2024

Int Forum Allergy Rhinol

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BackgroundPatients with chronic rhinosinusitis with nasal polyps (CRSwNP) have high incidence of sleep impairment. We evaluated the impact of omalizumab treatment on sleep characteristics and associated health status in patients with CRSwNP.MethodsPrespecified exploratory analysis assessed outcomes from patients included in the POLYP 1 and POLYP 2 phase 3 clinical trials and the open‐label extension. Sleep was assessed by the sleep domain of the Sino‐Nasal Outcome Test‐22 (SNOT‐22; MCID > 4 in patients with CRS) and the Medical Outcomes Study Sleep Scale (MOS‐Sleep). Health status was assessed by Healthy Days Core Module (HDCM) and sinonasal‐specific Patient Global Impression of Change (PGIC).ResultsOmalizumab improved sleep as assessed by the SNOT‐22 sleep domain. At week 24, adjusted mean (95%CI) SNOT‐22 sleep scores had reduced from baseline by −8.5 (–9.9 to –7.1) with omalizumab versus –2.7 (–4.1 to –1.3) with placebo. At week 52 (all patents on OMA), adjusted mean (95%CI) SNOT‐22 sleep scores had reduced from baseline by −10.1 (–11.4 to –8.7) with omalizumab. Improvements were observed in all eight items of the SNOT‐22 sleep domain: difficulty falling asleep, fatigue, frustration/restlessness/irritability, lack good night's sleep, reduced concentration, reduced productivity, wake up tired, and wake up at night. In addition, omalizumab improved six of eight sleep outcomes on the MOS‐Sleep scale. There were concurrent improvements in HDCM and PGIC.ConclusionOmalizumab improved sleep and self‐reported health status in patients with CRSwNP. This contributes to evidence that omalizumab provides value for patients beyond the reduction of sinonasal symptoms.

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Section: Sleep Domain Of Snot-22mentioning

confidence: 95%

Omalizumab improves sleep and health status for patients with chronic rhinosinusitis with nasal polyps: An analysis of randomized clinical trials

Meltzer,

Mullol,

et al. 2024

Int Forum Allergy Rhinol

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“…The Food and Drug Administration (FDA) originally approved omalizumab, a humanized anti-IgE monoclonal antibody, to treat severe allergic asthma (31). Later, it was also licensed to treat refractory chronic spontaneous urticaria (32) and CRSwNP (33)(34)(35). It was originally developed to prevent free IgE from attaching to high-affinity receptors on effector cells, such as basophils and mast cells, but it may also make it easier for inflammatory complexes to separate from one another.…”

Section: Targeting Ige and Allergic Pathwaysmentioning

confidence: 99%

Omalizumab for the reduction of allergic reactions to foods: a narrative review

Ghouri,

Habib,

Nazir

et al. 2024

Front. Allergy

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The frequency of food allergies varies between 2% and 10%, depending on characteristics including age, region, race, and method of diagnosis self-reported by patients or oral food challenges (OFCs). The most common allergies reported are tree nuts (1.2%), milk (1.9%), peanuts (2.2%), and shellfish (1.3%). Omalizumab injection has now been approved by the FDA for the treatment of immunoglobulin E-mediated food allergies in specific adults and children aged one year or older. This medication reduces the risk of allergic reactions (Type I), which can include anaphylaxis, when an individual accidentally encounters one or more food allergens. Omalizumab functions by binding to IgE and altering IgE-mediated pathways, which lessens IgE's capacity to cause allergic reactions. Promising outcomes from clinical trials and case studies include lowered anaphylactic risk and enhanced tolerance to allergens. Omalizumab, however, may have adverse effects; thus, close observation is required. Overall, this review sheds light on the efficacy, safety, and clinical implications of omalizumab, highlighting its potential as a useful intervention for IgE-mediated food allergies.

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Section: Evidence For the Efficacy Of Omalizumab In Ar And Crswnpmentioning

confidence: 99%

“…Omalizumab, a humanized anti-IgE monoclonal antibody, was first approved by the Food and Drug Administration (FDA) for the treatment of severe allergic asthma, 99 subsequently for refractory chronic spontaneous urticaria, 100 and CRSwNP. [101][102][103] It was developed to block the binding of free IgE to highaffinity receptors on effector cells including mast cells and basophils but may also facilitate the dissociations between inflammatory complexes. Omalizumab is the only FDA-approved anti-IgE biologic that targets and blocks IgE.…”

Section: Evidence For the Efficacy Of Omalizumab In Ar And Crswnpmentioning

confidence: 99%

“…116 Two Phase III RCTs, POLYP1 and POLYP2, indicate that nasal polyp burden, nasal and CRS-specific symptoms are improved after 4 weeks of post omalizumab use and last for 24 weeks of the treatment period. 102 Other biologics for treating AR and CRSwNP are also under studies and evaluations. Dupilumab and mepolizumab, together with omalizumab, have been approved in the United States for CRSwNP treatment.…”

Section: Evidence For the Efficacy Of Omalizumab In Ar And Crswnpmentioning

confidence: 99%

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B Lineage Cells and IgE in Allergic Rhinitis and CRSwNP and the Role of Omalizumab Treatment

Bai

Tan

2023

Am J Rhinol�Allergy

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Background Allergic rhinitis (AR) and chronic rhinosinusitis (CRS) are two prevalent nasal diseases where both type 2 inflammation and immunoglobulin E (IgE) may play important roles. Although they can exist independently or comorbidly, subtle but important differences exist in immunopathogenesis. Objective To summarize current knowledge of pathophysiological roles of B lineage cells and IgE in AR and CRS with nasal polyps (CRSwNP). Methods Searched PubMed database, reviewed AR and CRSwNP-related literature, and discussed disease diagnosis, comorbidity, epidemiology, pathophysiology, and treatment. Similarities and differences in B-cell biology and IgE are compared in the 2 conditions. Results Both AR and CRSwNP have evidence for pathological type 2 inflammation, B-cell activation and differentiation, and IgE production. However, distinctions exist in the clinical and serological profiles at diagnosis, as well as treatments utilized. B-cell activation in AR may more frequently be regulated in the germinal center of lymphoid follicles, whereas CRSwNP may occur via extrafollicular pathways although controversies remain in these initial activating events. Oligoclonal and antigen-specific IgE maybe predominate in AR, but polyclonal and antigen-nonspecific IgE may predominate in CRSwNP. Omalizumab has been shown efficacious in treating both AR and CRSwNP in multiple clinical trials but is the only Food and Drug Administration-approved anti-IgE biologic to treat CRSwNP or allergic asthma. Staphylococcus aureus frequently colonizes the nasal airway and has the ability to activate type two responses including B-cell responses although the extent to which it modulates AR and CRSwNP disease severity is being investigated. Conclusion This review highlights current knowledge of the roles of B cells and IgE in the pathogenesis of AR and CRSwNP and a small comparison between the 2 diseases. More systemic studies should be done to elevate the understanding of these diseases and their treatment.

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Omalizumab and quality of life in nasal polyps: A post hoc analysis

Cited by 7 publications

References 8 publications

Omalizumab improves sleep and health status for patients with chronic rhinosinusitis with nasal polyps: An analysis of randomized clinical trials

Omalizumab improves sleep and health status for patients with chronic rhinosinusitis with nasal polyps: An analysis of randomized clinical trials

Omalizumab for the reduction of allergic reactions to foods: a narrative review

B Lineage Cells and IgE in Allergic Rhinitis and CRSwNP and the Role of Omalizumab Treatment

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