Effectiveness of Dupilumab in the Treatment of Patients with Severe Uncontrolled CRSwNP: A "Real-Life" Observational Study in the First Year of Treatment

被引:66
作者
De Corso, Eugenio [1 ]
Settimi, Stefano [1 ,2 ]
Montuori, Claudio [2 ]
Corbo, Marco [2 ]
Passali, Giulio Cesare [1 ,2 ]
Porru, Davide Paolo [2 ]
Lo Verde, Simone [2 ]
Spanu, Camilla [2 ]
Penazzi, Daniele [2 ]
Di Bella, Giuseppe Alberto [2 ]
Nucera, Eleonora [3 ,4 ]
Bonini, Matteo [4 ,5 ]
Paludetti, Gaetano [1 ,2 ]
Galli, Jacopo [1 ,2 ]
机构
[1] A Gemelli Hosp Fdn IRCCS, Unit Otorhinolaryngol Head & Neck Surg, I-00168 Rome, Italy
[2] Catholic Univ Sacred Hearth, Dept Head & Neck & Sensory Organs, I-00168 Rome, Italy
[3] A Gemelli Hosp Fdn IRCCS, Unit Allergol, I-00168 Rome, Italy
[4] Catholic Univ Sacred Hearth, Dept Internal Med & Geriatr, I-00168 Rome, Italy
[5] A Gemelli Hosp Fdn IRCCS, Unit Pulmonol, I-00168 Rome, Italy
关键词
chronic rhinosinusitis with nasal polyps; type-2; inflammation; asthma; biologics; dupilumab; real life; eosinophilic otitis media; eosinophils; treatment outcomes; CHRONIC RHINOSINUSITIS; PROGNOSTIC VALUE;
D O I
10.3390/jcm11102684
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
The aim of this study was to evaluate the efficacy of dupilumab in the treatment of severe uncontrolled Chronic Rhinosinusitis with Nasal Polyps (CRSwNP), with or without asthma as add-on therapy with intra-nasal corticosteroids in a real-life setting over the first year of treatment. Our data demonstrated that subcutaneous 300 mg dupilumab administered at home via a pre-filled auto-injector every two weeks, based on indications set by the Italian Medicines Agency, was rapidly effective in reducing the size of polyps, decreasing symptoms of disease, improving quality of life, and recovering olfaction. Significant improvement was observed after only 15 days of treatment, and it progressively increased at 6 and 12 months. Dupilumab was also effective in reducing the local nasal eosinophilic infiltrate, in decreasing the need for surgery and/or oral corticosteroids, and in improving control of associated comorbidities such as chronic eosinophilic otitis media and bronchial asthma. After 12 months of treatment, 96.5% of patients had a moderate/excellent response. From our data, it was evident that there was a group of patients that showed a very early response within one month of therapy, another group with early response within six months from baseline, and a last group that improved later within 12 months. The results of this study support the use of dupilumab as an effective option in the current standard of care for patients affected by severe uncontrolled CRSwNP.
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页数:14
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