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Efficacy and safety of dupilumab in the treatment of CRSwNP in the real-life setting: a review of the literature

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Abstract

Introduction

The recent approval of Dupilumab has profoundly revolutionized the management of patients affected by severe and recalcitrant Chronic Rhinosinusitis with Nasal Polyps (CRSwNP). However, a review that summarizes the results of real-life studies and compares them to phase 3 studies SINUS-24 and 52 is still lacking.

Materials and methods

A search of all real-life studies published from 2019 to 2023 was performed. Patients characteristics at baseline and 6 and 12 months after starting Dupilumab were extracted and compared to those from phase 3 trials: age, sex, smoking habits, comorbid asthma and aspirin-exacerbated respiratory disease (AERD), previous endoscopic sinus surgery (ESS), hematic eosinophils and total IgE, NasalAQ2 Polyps Score (NPS), smell, SNOT-22, adverse events (AEs), and response to treatment.

Results

15 papers were included with an overall number of 1658 patients. A higher rate of comorbidities and previous ESS was found in patients from real-life studies. In addition, they had worse smell and SNOT-22 at baseline compared to patients from SINUS-24 and 52. Comorbid and post-ESS patients tended to have a faster NPS and SNOT-22 improvement, although the absolute values were not clinically relevant. A more extensive surgery and a number of ESS ≥ 2 were related to worse olfactory outcomes, probably due to iatrogenic damage. No correlation was found between hematic eosinophils and outcomes. AEs were reported by 12.4% of patients and 2.2% had to discontinue dupilumab. Weight gain was an emergent AE (0.8%), probably related to the restored sense of smell and taste. Non-responders were 3.5% and they were switched to systemic steroid, ESS, or another biologic.

Conclusion

Despite some differences in prescription criteria between countries, dupilumab was demonstrated to be effective even in the real-life scenario. However, emerging AEs and possible unknown long-term AEs of a likely lifelong therapy should be considered.

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Data availability

Data supporting this study are available on request from the corresponding author.

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Author notes

  1. Marella Reale and Giuseppe Licci Both equally contributed to the present work.

Authors and Affiliations

  1. Department of Otorhinolaryngology, Careggi University Hospital, Largo Brambilla, 3 - 50134, Florence, Italy

    Marella Reale, Giuseppe Licci, Pietro Orlando, Giandomenico Maggiore & Oreste Gallo

  2. Department of Otorhinolaryngology, Meyer Children’s Hospital IRCCS, Florence, Italy

    Marella Reale & Franco Trabalzini

  3. Department of Immunology, Careggi University Hospital, Largo Brambilla 3, 50134, Florence, Italy

    Andrea Matucci

  4. Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy

    Franco Trabalzini & Oreste Gallo

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  1. Marella Reale
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Reale, M., Licci, G., Orlando, P. et al. Efficacy and safety of dupilumab in the treatment of CRSwNP in the real-life setting: a review of the literature. Eur Arch Otorhinolaryngol (2024). https://doi.org/10.1007/s00405-024-08725-7

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