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Omalizumab Treatment in Uncontrolled Asthma and CRSwNP Patients, with Previous Endoscopic Sinus Surgery, to Improve Quality of Life and Endoscopic Outcomes: a Two-Year Real-Life Study

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Abstract

Purpose of Review

Despite molecular underlying advances, limited and divergent data on monoclonal antibodies (mAb) therapy in chronic rhinosinusitis with nasal polyps (CRSwNP) make further analysis necessary. The objective of this study is to evaluate the effect of omalizumab as an adjunct to endoscopic sinus surgery (ESS) on the treatment of CRSwNP under real-life conditions.

Recent Findings

Since the introduction of omalizumab, as the first biologic agent for the treatment of diseases such as severe allergic asthma, different studies have demonstrated an effect of omalizumab on CRSwNP, with significant improvements in sinonasal symptoms and endoscopic scores. The high efficacy derived from mAb therapy and the need for ESS prior to mAb recommended by guidelines, has led to compare both therapeutic alternatives, finding discrepancies in their effect on quality of life (QoL) and complementary tests outcomes.

Summary

Patients with moderate-to-severe asthma with clinical criteria for omalizumab indication, and coexistent CRSwNP disease, were selected for a non-randomized interventional retrospective study into four treatment subgroups. Measures were analyzed and compared between groups and over time at the baseline, 16 weeks and 1 and 2 years after treatment. Omalizumab treatment in patients with previous ESS exhibited an earlier and more pronounced improvement in QoL, symptoms scale and endoscopic findings (nasal polyp score and the bilateral modified Lund-Kennedy) as early from week 16, which improvement persisted for 2 years. A greater mean improvement of 33.4 ± 6.5 (95% CI: 20.3–46.4; p < 0.001) points in sinonasal outcome test 22 (SNOT-22) was associated with ESS at week 16, against omalizumab effect (17.8 ± 7.6 [95% CI: 2.6–33.0]; p = 0.023). At year 2, an improvement in SNOT-22 of 62.6 ± 8.9 (95% CI: 48.4–84.1; p < 0.001) points was exclusively associated with omalizumab. Clinical evidence of the effect of omalizumab added to ESS treatment is provided in this study in the short- and long-term.

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Availability of Data and Materials

All the data and materials used in this publication are available in the DIRAYA System of the Andalusian Health System. Those that required paper format are kept in the Otolaryngology Department of the Virgen Macarena University Hospital in Seville, Spain.

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Acknowledgements

We are grateful to all the participants, who voluntarily enrolled in this project and our most sincere gratitude goes to members of the Severe Asthma Committee of the Virgen Macarena University Hospital (A. Gómez-Bastero, V. Merino-Bohórquez, C. Segura-Sánchez, J. Delgado-Romero, A. Navarro-Pulido, I. Márquez-González, C. Benito-Bernáldez, E. Campos-Alonso, M. Ferrer-Galván, R. Aparcero-López, C. García-García, M. Rodríguez-Téllez, JM Vega-Sánchez, R. Vera, D. Botello) for the joint monitoring of patients with inflammatory pathology and their predisposition to the development of research activity. We thank David G. Plant for editing the manuscript and editorial assistance.

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JMS, ACL, DMJ and RML wrote the manuscript. ACL and DMJ performed the statistical study. ACL prepared all figures. All authors reviewed the manuscript.

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Correspondence to Daniel Martin-Jimenez.

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Conflict of Interest

JMS has received honoraria for consultancy, projects, advisory boards and talks from AstraZeneca, GlaxoSmithKline, MSD, Novartis and Sanofi. ACL has no conflicts of interest regarding specific financial interests relevant to this manuscript. DMJ has no conflicts of interest regarding specific financial interests relevant to this manuscript. RML has received fees from GlaxoSmithKline and Sanofi for talks at scientific events and as member of advisory boards. JGG has received lecture fees from GlaxoSmithKline and Sanofi. AC has received honoraria from AstraZeneca, GlaxoSmithKline, MSD, Novartis, Teva and Sanofi for talks at scientific events and as member of advisory boards. SSG has received honoraria for projects, advisory boards and talks from GlaxoSmithKline and Sanofi.

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The study was conducted according to the guidelines of the Declaration of Helsinki and approved by the Institutional Review Board of an independent Ethics Committee (FIS-OMA-2022-01). Statements on consent to participate and consent to publish are not applicable.

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Juan Maza-Solano and Amparo Callejon-Leblic contributed equally as first authors.

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Maza-Solano, J., Callejon-Leblic, A., Martin-Jimenez, D. et al. Omalizumab Treatment in Uncontrolled Asthma and CRSwNP Patients, with Previous Endoscopic Sinus Surgery, to Improve Quality of Life and Endoscopic Outcomes: a Two-Year Real-Life Study. Curr Allergy Asthma Rep 23, 555–566 (2023). https://doi.org/10.1007/s11882-023-01106-w

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