PMID- 37948824
OWN - NLM
STAT- MEDLINE
DCOM- 20231216
LR  - 20231216
IS  - 1532-818X (Electronic)
IS  - 0196-0709 (Linking)
VI  - 45
IP  - 1
DP  - 2024 Jan-Feb
TI  - Dupilumab in chronic rhinosinusitis with nasal polyps: Real life data in a 
      multicentric Sicilian experience.
PG  - 104106
LID - S0196-0709(23)00320-4 [pii]
LID - 10.1016/j.amjoto.2023.104106 [doi]
AB  - OBJECTIVE: This study aimed to evaluate the effectiveness and safety of dupilumab 
      during the first year of treatment in a real-life setting, focusing on 
      improvement in nasal polyp score (NPS) as well as specific symptoms, quality of 
      life and olfactory function. METHODOLOGY/PRINCIPAL: A multicentric observational 
      cohort study was carried out. A total of 170 patients were enrolled in the 
      Otorhinolaryngology Unit of the three University Hospitals and considered for 
      dupilumab therapy. All recorder characteristics were age (at the first dupilumab 
      application visit), sex, smoke habits, previous local and systemic corticosteroid 
      therapy, history of endoscopic sinus surgery, number of previous endoscopic sinus 
      surgery, concomitant asthma, history of an allergic condition, immunoglobulin E 
      (IgE), allergy to nonsteroidal anti-inflammatory drugs (NSAIDs), Aspirin 
      Exacerbated Respiratory Disease (AERD), other comorbidities associated, blood 
      eosinophils, nasal polyp score, sinonasal outcome test 22 (SNOT 22), sniffin' 
      stick test, the start date of dupilumab therapy and number of doses of dupilumab 
      and eventually, Dupilumab's adverse events related to administration. The 
      Wilcoxon test for dependent samples was performed to compare variables. 
      Statistical significance was assumed for p values < 0.05. RESULTS: A 
      statistically significant reduction in SNOT-22 and NPS was shown at the 6th and 
      12th month compared to baseline values (p < 0.001 for both comparisons). A 
      statistically significant increase value at the Sniffin' sticks test was shown in 
      the 6th and 12th month compared to baseline values (p < 0.001 for both 
      comparisons). At the 12-month follow-up, according to EUFOREA indications, all 
      patients were considered to remain in treatment with dupilumab and continued the 
      treatment because of a reduced NPS, improved quality of life and a reduced need 
      for system corticosteroids. Dupilumab seemed to be well tolerated by all 
      patients. Any adverse effect of the drug led to the quit of biological treatment. 
      CONCLUSIONS: This multi-centric real-life study supported the effectiveness of 
      dupilumab as an add-on therapy to intranasal corticosteroids in patients with 
      severe uncontrolled CRSwNP in improvement of quality of life, severity of 
      symptoms, polyp size reduction and smell function. Furthermore, our data support 
      the safety profile of monoclonal therapy with dupilumab.
CI  - Copyright (c) 2023 The Authors. Published by Elsevier Inc. All rights reserved.
FAU - Galletti, Cosimo
AU  - Galletti C
AD  - Department of Adult and Development Age Human Pathology "Gaetano Barresi", Unit 
      of Otorhinolaryngology, University of Messina, Via Consolare Valeria 1, 98125 
      Messina, ME, Italy. Electronic address: cosimogalletti92@gmail.com.
FAU - Ragusa, Martina
AU  - Ragusa M
AD  - Department of Medical-Surgical Sciences and Advanced Technologies, E.N.T. Unit, 
      P.O. "G. Rodolico", University of Catania, Catania, Italy.
FAU - Sireci, Federico
AU  - Sireci F
AD  - Otorhinolaryngology Section, Biomedicine, Neuroscience and Advanced Diagnostic 
      Department, University of Palermo, Via del Vespro 129, 133, 90127 Palermo, Italy.
FAU - Ciodaro, Francesco
AU  - Ciodaro F
AD  - Department of Adult and Development Age Human Pathology "Gaetano Barresi", Unit 
      of Otorhinolaryngology, University of Messina, Via Consolare Valeria 1, 98125 
      Messina, ME, Italy.
FAU - Barbieri, Maria Antonietta
AU  - Barbieri MA
AD  - Department of Clinical and Experimental Medicine, University of Messina, Messina, 
      Italy.
FAU - Giunta, Giorgia
AU  - Giunta G
AD  - Department of Medical-Surgical Sciences and Advanced Technologies, E.N.T. Unit, 
      P.O. "G. Rodolico", University of Catania, Catania, Italy.
FAU - Grigaliute, Egle
AU  - Grigaliute E
AD  - Department of Medical-Surgical Sciences and Advanced Technologies, E.N.T. Unit, 
      P.O. "G. Rodolico", University of Catania, Catania, Italy.
FAU - Immordino, Angelo
AU  - Immordino A
AD  - Otorhinolaryngology Section, Biomedicine, Neuroscience and Advanced Diagnostic 
      Department, University of Palermo, Via del Vespro 129, 133, 90127 Palermo, Italy.
FAU - Lorusso, Francesco
AU  - Lorusso F
AD  - Otorhinolaryngology Section, Biomedicine, Neuroscience and Advanced Diagnostic 
      Department, University of Palermo, Via del Vespro 129, 133, 90127 Palermo, Italy.
FAU - Dispenza, Francesco
AU  - Dispenza F
AD  - Otorhinolaryngology Section, Biomedicine, Neuroscience and Advanced Diagnostic 
      Department, University of Palermo, Via del Vespro 129, 133, 90127 Palermo, Italy.
FAU - Freni, Francesco
AU  - Freni F
AD  - Department of Adult and Development Age Human Pathology "Gaetano Barresi", Unit 
      of Otorhinolaryngology, University of Messina, Via Consolare Valeria 1, 98125 
      Messina, ME, Italy.
FAU - Galletti, Francesco
AU  - Galletti F
AD  - Department of Adult and Development Age Human Pathology "Gaetano Barresi", Unit 
      of Otorhinolaryngology, University of Messina, Via Consolare Valeria 1, 98125 
      Messina, ME, Italy.
FAU - Gallina, Salvatore
AU  - Gallina S
AD  - Otorhinolaryngology Section, Biomedicine, Neuroscience and Advanced Diagnostic 
      Department, University of Palermo, Via del Vespro 129, 133, 90127 Palermo, Italy.
FAU - La Mantia, Igo
AU  - La Mantia I
AD  - Department of Medical-Surgical Sciences and Advanced Technologies, E.N.T. Unit, 
      P.O. "G. Rodolico", University of Catania, Catania, Italy.
FAU - Galletti, Bruno
AU  - Galletti B
AD  - Department of Adult and Development Age Human Pathology "Gaetano Barresi", Unit 
      of Otorhinolaryngology, University of Messina, Via Consolare Valeria 1, 98125 
      Messina, ME, Italy.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
DEP - 20231105
PL  - United States
TA  - Am J Otolaryngol
JT  - American journal of otolaryngology
JID - 8000029
RN  - 420K487FSG (dupilumab)
RN  - 0 (Adrenal Cortex Hormones)
SB  - IM
MH  - Humans
MH  - *Nasal Polyps/complications/drug therapy
MH  - Quality of Life
MH  - *Rhinosinusitis
MH  - *Sinusitis/complications/drug therapy
MH  - Adrenal Cortex Hormones
MH  - Chronic Disease
MH  - *Rhinitis/complications/drug therapy
OTO - NOTNLM
OT  - CRSwNP
OT  - Dupilumab
OT  - ENT
OT  - Rhinology
OT  - Smell
COIS- Conflict of interest No conflict of interest exists.
EDAT- 2023/11/11 11:42
MHDA- 2023/12/17 09:42
CRDT- 2023/11/10 18:02
PHST- 2023/07/04 00:00 [received]
PHST- 2023/10/18 00:00 [revised]
PHST- 2023/10/29 00:00 [accepted]
PHST- 2023/12/17 09:42 [medline]
PHST- 2023/11/11 11:42 [pubmed]
PHST- 2023/11/10 18:02 [entrez]
AID - S0196-0709(23)00320-4 [pii]
AID - 10.1016/j.amjoto.2023.104106 [doi]
PST - ppublish
SO  - Am J Otolaryngol. 2024 Jan-Feb;45(1):104106. doi: 10.1016/j.amjoto.2023.104106. 
      Epub 2023 Nov 5.