Dupilumab in the Treatment of Severe Uncontrolled CRSwNP: a Multicentre Observational Real-life Study (DUPIREAL)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS600 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

600

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (19)

AUSL Bologna

Bologna, Italy

Azienda Ospedaliero-Universitaria Policlinico S. Marco

Catania, Italy

AUSL Latina

Latina, Italy

ASST Santi Paolo e Carlo - Presidio San Paolo

Milan, Italy

IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, Italy

IRCCS San Raffaele

Milan, Italy

Azienda Ospedaliero-Universitaria di Modena

Modena, Italy

A.O.R.N. Ospedali dei Colli

Napoli, Italy

Azienda Ospedaliera Policlinico Federico II

Napoli, Italy

Ospedale maggiore di Novara

Novara, Italy

...and 9 more locations

Outcomes

Primary Outcomes

Nasal Polyp Score (NPS)

Polyps volume. Range 0-4 for each nostril. Higher score describes a worse condition

Time frame: 12 months

Secondary Outcomes

Nasal Polyp Score (NPS)

Polyps volume. Range 0-4 for each nostril. Higher score describes a worse condition

Time frame: 24 months

Nasal congestion score (NCS)

Nasal congestion. Range 0-3. Higher score describes a worse condition