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

NCT05529784 | Unknown FDA Drug

• 1 other identifier: 0034704/21
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 19

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

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Outcome Measures

Primary Outcomes (1)

• Nasal Polyp Score (NPS)

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

  12 months

Secondary Outcomes (13)

• 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

Study Arms (1)

Severe, uncontrolled CRSwNP patients in therapy with Dupilumab

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

Interventions

Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT] DRUG

Dupilumab 300mg in pre-filled injector Q2W

Severe, uncontrolled CRSwNP patients in therapy with Dupilumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We included all the patients that were referred to Dupilumab therapy, prescribed accordingly to the plan provided by Italian Agency of Drugs.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (19)

AUSL Bologna

Bologna, Italy

Location

Azienda Ospedaliero-Universitaria Policlinico S. Marco

Catania, Italy

Location

AUSL Latina

Latina, Italy

Location

ASST Santi Paolo e Carlo - Presidio San Paolo

Milan, Italy

Location

IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, Italy

Location

IRCCS San Raffaele

Milan, Italy

Location

Azienda Ospedaliero-Universitaria di Modena

Modena, Italy

Location

A.O.R.N. Ospedali dei Colli

Napoli, Italy

Location

Azienda Ospedaliera Policlinico Federico II

Napoli, Italy

Location

Ospedale maggiore di Novara

Novara, Italy

Location

Ospedale S.Luigi Gonzaga, Università di Torino

Orbassano, Italy

Location

Azienda Ospedaliero-Universitaria di Padova

Padua, Italy

Location

Policlinico San Matteo-Università di Pavia

Pavia, Italy

Location

Azienda Ospedaliero-Universitaria Pisana

Pisa, Italy

Location

Azienda USL - IRCCS di Reggio Emilia

Reggio Emilia, Italy

Location

ASL Roma 5

Roma, Italy

Location

Fondazione Policlinico Universitario A.Gemelli IRCCS

Roma, Italy

Location

Università La Sapienza

Roma, Italy

Location

Azienda Ospedaliero-Universitaria di Sassari

Sassari, Italy

Location

MeSH Terms

Interventions

dupilumab

Study Officials

• Eugenio De Corso, MD, PhD

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 2, 2022
• First Posted: September 7, 2022
• Study Start: October 6, 2021
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2023
• Last Updated: February 21, 2023

Record last verified: 2023-02

Locations

IT (19)