Effectiveness of Dupilumab in the Treatment of Severe Uncontrolled CRSwNP: a Multicentre Observational Real-life Study (DUPIREAL)
Overview
- Phase
- Not Applicable
- Intervention
- Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Enrollment
- 600
- Locations
- 19
- Primary Endpoint
- Nasal Polyp Score (NPS)
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
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
Investigators
DE CORSO EUGENIO
Principal Investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Eligibility Criteria
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
Arms & Interventions
Severe, uncontrolled CRSwNP patients in therapy with Dupilumab
Intervention: Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]
Outcomes
Primary Outcomes
Nasal Polyp Score (NPS)
Time Frame: 12 months
Polyps volume. Range 0-4 for each nostril. Higher score describes a worse condition
Secondary Outcomes
- Nasal Polyp Score (NPS)(24 months)
- Nasal congestion score (NCS)(12 months and 24 months)
- Sinonasal outcome test (SNOT-22)(12 months and 24 months)
- Sniffin' sticks identification test(12 months and 24 months)
- Visual Analog Scale (VAS) for nasal congestion(12 months and 24 months)
- Visual Analog Scale (VAS) for olfaction loss(12 months and 24 months)
- Visual Analog Scale (VAS) for craniofacial pain(12 months and 24 months)
- Visual Analog Scale (VAS) for sleeping disorders(12 months and 24 months)
- Need for surgery(12 months and 24 months)
- Intranasal corticosteroid adherence(12 months and 24 months)
- Need for rescue oral corticosteroids(12 months and 24 months)
- Visual Analog Scale (VAS) for rhinorrhea(12 months and 24 months)
- Visual Analog Scale (VAS) for quality of life(12 months and 24 months)