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

Marella Reale; Giuseppe Licci; Pietro Orlando; Andrea Matucci; Franco Trabalzini; Giandomenico Maggiore; Oreste Gallo

doi:10.1007/s00405-024-08725-7

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

Eur Arch Otorhinolaryngol. 2024 May 19. doi: 10.1007/s00405-024-08725-7. Online ahead of print.

Authors

Marella Reale^#^{1

2}, Giuseppe Licci^#¹, Pietro Orlando³, Andrea Matucci⁴, Franco Trabalzini^{2

5}, Giandomenico Maggiore¹, Oreste Gallo^{1

5}

Affiliations

¹ Department of Otorhinolaryngology, Careggi University Hospital, Largo Brambilla, 3 - 50134, Florence, Italy.
² Department of Otorhinolaryngology, Meyer Children's Hospital IRCCS, Florence, Italy.
³ Department of Otorhinolaryngology, Careggi University Hospital, Largo Brambilla, 3 - 50134, Florence, Italy. pietro.orlando@unifi.it.
⁴ Department of Immunology, Careggi University Hospital, Largo Brambilla 3, 50134, Florence, Italy.
⁵ Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.

^# Contributed equally.

PMID: 38762844
DOI: 10.1007/s00405-024-08725-7

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.

Keywords: Biologic therapy; CRSwNP; Dupilumab; Paranasal sinuses; Rhinology.

Publication types

Review