Radiological Versus Clinical 1-Year Outcomes of Dupilumab in Refractory CRSwNP: A Real-Life Study

Francesco Giombi; Gian Marco Pace; Emanuele Nappi; Gianmarco Giunta; Giovanna Muci; Francesca Pirola; Fabio Ferreli; Enrico Heffler; Giovanni Paoletti; Caterina Giannitto; Giuseppe Mercante; Marco Francone; Giuseppe Spriano; Giorgio Walter Canonica; Luca Malvezzi

doi:10.1002/lary.31238

Radiological Versus Clinical 1-Year Outcomes of Dupilumab in Refractory CRSwNP: A Real-Life Study

Laryngoscope. 2023 Dec 21. doi: 10.1002/lary.31238. Online ahead of print.

Authors

Francesco Giombi^{1

2}, Gian Marco Pace^{1

2}, Emanuele Nappi^{1

2}, Gianmarco Giunta¹, Giovanna Muci¹, Francesca Pirola^{3

4}, Fabio Ferreli^{1

3}, Enrico Heffler^{1

2}, Giovanni Paoletti^{1

2}, Caterina Giannitto^{1

5}, Giuseppe Mercante^{1

3}, Marco Francone^{1

5}, Giuseppe Spriano^{1

3}, Giorgio Walter Canonica^{1

2}, Luca Malvezzi^{1

3

4}

Affiliations

¹ Department of Biomedical Sciences, Humanitas University, Milan, Italy.
² Personalized Medicine, Asthma and Allergy, IRCCS Humanitas Research Hospital, Milan, Italy.
³ Otorhinolaryngology Unit, IRCCS Humanitas Research Hospital, Milan, Italy.
⁴ Otorhinolaryngology Head & Neck Surgery Unit, Casa di Cura Humanitas San Pio X, Milan, Italy.
⁵ Department of Diagnostic and Interventional Radiology, IRCCS Humanitas Research Hospital, Milan, Italy.

PMID: 38126613
DOI: 10.1002/lary.31238

Abstract

Objective: To provide real-life evidence on long-term radiological changes in patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP) treated with dupilumab, and to assess possible differences between radiological and clinical results in terms of endoscopic findings and Patient-Reported-Outcomes (PROs).

Methods: Consecutive patients treated with dupilumab for recalcitrant CRSwNP were required to undergo CT scan at baseline (T0) and after 12 (T1) since first administration. A group of patients also performed CT scan at 52 weeks (T2) to assess long-term outcomes. At each timepoint, patients underwent nasal endoscopy, assessment of Nasal-Polyp-Score (NPS), Lund-Kennedy-Score (LKS), and had to fill in the 22-item Sinonasal-Outcome-Test (SNOT-22) and Visual-Analogue-Scales (VAS) for sinonasal symptoms.

Results: In fifty-three included patients, from T0 to T1 we detected a significant reduction in mean Lund-Mackay score (LM), PROs (SNOT-22, VAS) and endoscopic (NPS, LKS) scores (p < 0.05). In the subset of patients that reached T2 (n = 30), compared to T1, we observed a further significant decrease in mean LM, SNOT-22, VAS, and NPS scores, but not in LKS (p = 0.420). At T1, the highest improvement was observed in PROs (SNOT-22: 56.26%), and polyp size (NPS: 49.83%). Conversely, between T1 and T2, sinus opacification was shown to be the most improved outcome (LM: 36.86%).

Conclusions: Our experience showed that poorly controlled CRSwNP patients treated with dupilumab experienced significant improvement in radiologic, endoscopic and clinical disease severity. While in the initial 3 months, PROs garnered attention for showing earlier effectiveness, radiological outcomes revealed sustained and gradual efficacy in a longer term.

Level of evidence: Level 4. According to the Oxford Center for Evidence-Based Medicine 2011 level of evidence guidelines, this non-randomized retrospective cohort study is classified as level 4 evidence Laryngoscope, 2023.

Keywords: CT scan; Lund Mackay; chronic rhinosinusitis; dupilumab; patients reported outcomes.