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

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Active, not recruiting

Conditions: Chronic Rhinosinusitis With Nasal Polyps

Treatments: Drug: Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]

Study type: Observational

Funder types: Other

Identifiers

NCT05529784

0034704/21

Details and patient eligibility

About

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

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

600 participants in 1 patient group

Severe, uncontrolled CRSwNP patients in therapy with Dupilumab

Treatment:

Drug: Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]