Clinical trial NCT06258772: Mepolizumab in the Treatment of Patients With Severe Uncontrolled CRSwNP: a Multicentric Real Life Observational Study
Official title: Effectiveness of Mepolizumab in the Treatment of Patients With Severe Uncontrolled CRSwNP: a Multicentric Real Life Observational Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Rhinosinusitis With Nasal Polyps
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-02-14
Enrollment: 199
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We included all patients that were referred to Mepolizumab therapy, prescribed accordingly to the plan provided by AIFA

Brief summary: Chronic rhinosinusitis with nasal polyposis (CRSwNP) is a complex chronic inflammatory disease of the nasosinusal mucosa that has a significant negative impact on patients' quality of life.

In CRSwNP, chronic inflammation is primarily driven by type 2 pro-inflammatory interleukins (ILs )such as IL-5, IL-4, and IL-13 along- side high levels of eosinophils in the surrounding tissue. Mepolizumab is a targeted, humanized anti-IL-5 antibody that prevents IL-5 from binding to its receptor on eosinophils and selectively inhibits eosinophilic inflammation.

So far, randomized clinical trials have assessed efficacy and safety of Mepolizumab in a large number of patients, whereas evidences in real life clinical practice are limited to few monocentric series.

Herewith, we present a multicenter, observational, prospective/retrospective nationwide real-life study with the aim to confirm the effectiveness and the safety of Mepolizumab over the first year of treatment in a real life setting.

The primary objective of this study is to evaluate the reduction of dimension of nasal polyps and the improvement of quality of life in the patient measured through symptomatologic questionnaires.

The secondary objective is to evaluate improvements in terms of smell dysfunction, comorbidities, biomarkers (nasal cytology and blood eosinophilia), need of surgery or systemic steroids.


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years of age who can sign a written informed consent Confirmed clinical / radiological diagnosis of chronic rhinosinusitis with diffuse naso-sinusal polyposis by nasal endoscopy and/or massive facial CT scan without contrast medium carried out within 6 months prior to the start of therapy;
* Blood eosinophils \>150
* Severe disease stage, defined by Nasal Polyp Score (NPS) ≥ 5 or nasal obstruction symptom visual analogue scale (VAS) score of \>5 and/or Sinonasal outcome tests-22 (SNOT-22) ≥ 50);
* Inadequate symptom control with intranasal local corticosteroid therapy;
* Failure of previous medical treatments (at least 2 cycles in the last year of systemic corticosteroid) and failure of previous surgical treatment through nasal endoscopic surgery (FESS), with no clinical benefit or postoperative complications.

Exclusion Criteria:

* Age \<18 years;
* Patients undergoing immunosuppressive therapies;
* Patients undergoing radio/chemotherapy treatments for cancer in the 12 months before the start of therapy;
* Patients on concomitant long-term corticosteroid therapy for chronic autoimmune disorders.

Primary outcomes:
measure: Nasal Polyp Score
timeFrame: 24 months
measure: Sinonasal Outcome Test - 22
timeFrame: 24 months
Secondary outcomes:
measure: Visual Analogue Scale for nasal obstruction
timeFrame: 24 moths
measure: Nasal Congestion Score (NCS); score (range 0-3);
timeFrame: 24 months
measure: Visual Analogue Scale for smell
timeFrame: 24 months
measure: Sniffing sticks identification test
timeFrame: 24 months
measure: Change in blood eosinophil count
timeFrame: 24 months
measure: Adherence to drug therapy with Mepolizumab
timeFrame: 24 months
measure: Need for rescue oral corticosteroids
timeFrame: 24 months
measure: Need for surgery
timeFrame: 24 months
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Ospedali PO di Venere e San Paolo
city: Bari
country: Italy
facility: Policlinico Universitario di Bari, Ospedale Giovanni XXIII,
city: Bologna
country: Italy
facility: AUSL Bologna
city: Brescia
country: Italy
facility: ASST degli spedali civili di Brescia,
city: Catania
country: Italy
facility: Azienda Ospedaliero Universitaria Policlinico - S. Marco,
city: Firenze
country: Italy
facility: Azienda Ospedaliero Universitaria Careggi
city: Genova
country: Italy
facility: Ospedale Policlinico San Martino,
city: Lecce
country: Italy
facility: Ospedale Vito Fazzi, ASL Lecce
city: Milano
country: Italy
facility: ASST Santi Paolo e Carlo
city: Milano
country: Italy
facility: IRCCS Ca' Granda Ospedale Maggiore Policlinico
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
city: Modena
country: Italy
facility: Azienda Ospedaliero-Universitaria di Modena - Modena
city: Napoli
country: Italy
facility: Azienda ospedaliera policlinico Federico II di Napoli
city: Novara
country: Italy
facility: Ospedale Maggiore della Carità di Novara,
city: Orbassano (TO)
country: Italy
facility: Azienda Ospedaliera Universitaria San Luigi Gonzaga,
city: Padova
country: Italy
facility: Azienda Ospedaliera Università di Padova
city: Pavia
country: Italy
facility: Fondazione I.R.C.C.S. Policlinico San Matteo
city: Pisa
country: Italy
facility: Azienda Ospedaliero-Universitaria Pisana - Pisa
city: Reggio Emilia
country: Italy
facility: Azienda USL - IRCCS di Reggio Emilia
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo-Forlanini
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A.Gemelli IRCCS
city: Roma
country: Italy
facility: Ospedaliero- Universitaria Policlinico Umberto I
city: Roma
country: Italy
facility: Policlinico Tor Vergata: Fondazione PTV
city: Roma
country: Italy
facility: Presidio Ospedaliero San Filippo Neri,
city: Siena
country: Italy
facility: Azienda Ospedaliero- Universitaria Senese
city: Tivoli
country: Italy
facility: i ASL ROMA 5 - Distretto Sanitario di Tivoli
city: Varese
country: Italy
facility: ASST sette laghi Varese,
Study officials:
References: