Chronic Rhinosinusitis With Nasal Polyps
Conditions
Brief summary
Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) is a sino-nasal chronic inflammatory disease that strongly affects patients' quality of life, especially in difficult-to-treat cases. In severe uncontrolled CRSwNP, the inflammation is mostly driven by a type 2 inflammatory pathway and its management has been rapidly changing during the last 2 years due to Dupilumab approval. It is a fully human monoclonal antibody that binds the alpha subunit of IL-4 receptors (IL-4Rα type 1 and type 2) to inhibit IL-4 and IL-13 signaling. So far, randomized clinical trials have assessed efficacy and safety of Dupilumab in a large number of patients, whereas evidences in real life clinical practice are limited to few monocentric series. Herewith, the investigators present a multicenter, observational nationwide retrospective real-life study with the aim to confirm the effectiveness and the safety of Dupilumab over the first year of treatment in a real life setting. The primary objective is to evaluate the volumetric reduction of polyps by measuring the variation of total Nasal Polyp Endoscopic Score (NPS). The secondary objectives are: * the evaluation of changes in nasal symptoms, olfactory function and nasal obstruction * the assessment of the patients' quality of life * the recording of major and minor complications * the evaluation of the response to the therapy, according to EPOS2020 criteria and EUFOREA2021 * the assessment of efficacy based on concomitant disease (Asthma and ASA triad) * the evaluation of potential predictors of clinical response to the therapy
Interventions
Dupilumab 300mg in pre-filled injector Q2W
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* confirmed diagnosis of diffuse CRSwNP by endoscopy and CT scan performed at least 6 months prior of the therapy; * severe disease stage defined by NPS ≥5 or SNOT-22 ≥50; * inadequate symptom control with INCS therapy; * failure or intolerance of previous medical treatments (at least 2 cycles of systemic corticosteroid in the last year), and/or failure of previous surgical treatment through nasal endoscopic surgery (ESS), with postoperative complications or no clinical benefit
Exclusion criteria
* pregnant women; * immunosuppressive therapy; * patients undergoing radio-chemotherapy treatments for cancer in the 12 months before the starting of therapy; * concomitant long-term corticosteroid therapy for chronic autoimmune disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nasal Polyp Score (NPS) | 12 months | Polyps volume. Range 0-4 for each nostril. Higher score describes a worse condition |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Need for rescue oral corticosteroids | 12 months and 24 months | Number of short cycles of oral corticosteroids during therapy |
| Need for surgery | 12 months and 24 months | Number of surgeries performed during therapy |
| Nasal Polyp Score (NPS) | 24 months | Polyps volume. Range 0-4 for each nostril. Higher score describes a worse condition |
| Nasal congestion score (NCS) | 12 months and 24 months | Nasal congestion. Range 0-3. Higher score describes a worse condition |
| Sinonasal outcome test (SNOT-22) | 12 months and 24 months | Symptoms. Range 0-110. Higher score describes a worse condition |
| Sniffin' sticks identification test | 12 months and 24 months | Olfaction. Range 0-16. Higher score describes a better condition |
| Intranasal corticosteroid adherence | 12 months and 24 months | Number of days of suspension of intranasal corticosteroids |
| Visual Analog Scale (VAS) for olfaction loss | 12 months and 24 months | Olfaction loss. Range 0-10. Higher score describes a more severe symptom |
| Visual Analog Scale (VAS) for craniofacial pain | 12 months and 24 months | Craniofacial pain. Range 0-10. Higher score describes a more severe symptom |
| Visual Analog Scale (VAS) for sleeping disorders | 12 months and 24 months | Sleeping disorders. Range 0-10. Higher score describes a more severe symptom |
| Visual Analog Scale (VAS) for rhinorrhea | 12 months and 24 months | Rhinorrhea. Range 0-10. Higher score describes a more severe symptom |
| Visual Analog Scale (VAS) for quality of life | 12 months and 24 months | Quality of life. Range 0-10. Higher score describes a worse quality of life |
| Visual Analog Scale (VAS) for nasal congestion | 12 months and 24 months | Nasal congestion. Range 0-10. Higher score describes a more severe symptom |
Countries
Italy
Outcome results
None listed