Effects of Omalizumab Treatment in Patients With Recalcitrant Nasal Polyposis and Mild Asthma: A Multicenter Retrospective Study

Abstract

Background Chronic rhinosinusitis with nasal polyps (CRSwNP) is a clinical entity with specific features that impacts significantly on patient quality of life (QoL). CRSwNP is often associated with asthma and is difficult to control and manage despite pharmacological and/or surgical treatment. Omalizumab, a monoclonal anti-IgE antibody, has emerged as a putative therapeutic option. Objective To evaluate the effects of omalizumab on nasal polyp (NP) size and QoL assessed by Sino-Nasal Outcome Test-22 (SNOT-22) in patients with recalcitrant CRSwNP and mild asthma. Methods A multicenter retrospective analysis of patient data from the Community of Valencia (Spain) was performed. Adult patients with recalcitrant CRSwNP and comorbid mild asthma receiving compassionate use of omalizumab were included. NP size measured by total nasal endoscopic polyp score (TPS) and QoL evaluated through the SNOT-22 questionnaire were assessed at baseline and monthly over 12 months. An ordinal regression model was built to analyze the results. Results A total of 23 CRSwNP patients with a mean age (± SD) of 54.78 ± 9.46 years were included. Nineteen suffered from aspirin-exacerbated respiratory disease (AERD). In all patients, a significant and sustained reduction in TPS was observed over time, accompanied by improvements in QoL reflected in lower SNOT-22 scores. In the ordinal regression model, time but not total IgE, age or tissue eosinophilia impacted on NP size and SNOT-22 outcomes. Additionally, improvements in QoL were not explained by reductions in the size of polyps. Conclusion Omalizumab was effective for the treatment of patients with recalcitrant CRSwNP and mild asthma, even when AERD was present, by reducing NP size and improving QoL; treatment time was a key factor. SNOT-22 improvements were not explained by decreases in TPS, indicating that omalizumab may be effective in all patients, regardless of polyp size.

Omalizumab is effective in nasal polyposis with or without asthma, a real-life study

“…In a multicenter retrospective study, 23 patients with recalcitrant nasal polyposis and mild asthma were detected and in all patients, a significant and sustained reduction in total nasal endoscopic polyp score and lower SNOT-22 scores were observed over time. 19 In our study, we evaluated our patients monthly but here we did not determine statistics for each month.…”

Chronic Rhinosinusitis With Nasal Polyps: Quality of Life in the Biologics Era

“…Mean SNOT-22 scores decreased from 58.96 at baseline to 19.71 at 12 months. 87 Similarly to dupilumab, discontinuation of omalizumab treatment in an extension study of patients from POLYP-1 and -2 resulted in worsening SNOT-22 scores and decreased nasal polyp score (NPS) and nasal congestion scores, although they remained improved above pretreatment levels. 85 Mepolizumab (GSK, Brentford, UK), a humanized mAb targeting IL-5, was submitted to the US Food and Drug Administration for approval in late 2020.…”

Improving predictability of IgE-high type 2 chronic sinusitis with nasal polyps in the biologic era

“…It is intuitive to believe that patients with elevated serum IgE are more likely to have a significant change in objective treatment outcomes due to the mechanism of action of omalizumab. Currently, there is one omalizumab study that demonstrated no significant impact of baseline serum IgE levels on the nasal polyp size and SNOT-22 score [ 51 ]. However, this study was limited by its small population (n = 23) which caused their regression analysis to not follow the one in ten rule [ 51 ].…”

“…Currently, there is one omalizumab study that demonstrated no significant impact of baseline serum IgE levels on the nasal polyp size and SNOT-22 score [ 51 ]. However, this study was limited by its small population (n = 23) which caused their regression analysis to not follow the one in ten rule [ 51 ]. Additional research is needed to confirm the impact of baseline IgE serology on omalizumab efficacy.…”