Marco Caminati1,2, Luca Cegolon3, Andrea Vianello4, Fulvia Chieco Bianchi4, Giuliana Festi5, Maria R Marchi4, Claudio Micheletto5, Francesco Mazza6, Silvia Tognella7, Gianenrico Senna1. 1. Asthma Center and Allergy Unit, Verona University Hospital, Verona, Italy. 2. Department of Medicine, University of Verona, Verona, Italy. 3. Local Health Unit N. 2 "Marca Trevigiana", Public Health Department, Treviso, Veneto Region, Italy. 4. Respiratory Pathophysiology Division, University-City Hospital of Padua, Padua, Italy. 5. Pulmonary Unit, Verona University Hospital, Verona, Italy. 6. Pulmonary Unit, Presidio Ospedaliero di Pordenone, Pordenone, Italy. 7. Respiratory Unit, Orlandi General Hospital, Verona, Italy.
Abstract
Background: Few studies have provided real-world evidence of mepolizumab efficacy and safety. We aimed to evaluate mepolizumab for severe eosinophilic asthma in daily clinical practice.Research design and methods: Patients included in the RINOVA (Interdisciplinary Network for the management of severe asthma in Veneto region, Italy) database were investigated. Blood eosinophil count, forced expiratory volume in 1 second, % of predicted (FEV1%), fractional exhaled nitric oxide (FeNO), asthma control test (ACT), oral steroid (OCS) intake, and exacerbation rate were evaluated during mepolizumab treatment. Results: 69 patients were enrolled (mean age: 55.1 years; 60.9% females). A significant improvement was detected at one month with respect to blood eosinophils (median level at baseline: 710/μl; -620/μl, p < 0,001), FEV1% (median value at baseline 87; range: 79-101; +4, p = 0.001) and ACT (median value at baseline 18; range: 14-20.5;+4, <0.001). A significant reduction of FeNO was observed six months after the treatment start, when the exacerbation rate and the mean OCS dose significantly decreased (respectively: Δ reduction -3; p < 0.001 and -5 mg; p < 0.001).Conclusions: Our study provides real-world evidence of mepolizumab safety and confirms its dramatic steroid sparing effect. The greatest clinical change (ACT and FEV1) was observed within the first month.
Background: Few studies have provided real-world evidence of mepolizumab efficacy and safety. We aimed to evaluate mepolizumab for severe eosinophilic asthma in daily clinical practice.Research design and methods: Patients included in the RINOVA (Interdisciplinary Network for the management of severe asthma in Veneto region, Italy) database were investigated. Blood eosinophil count, forced expiratory volume in 1 second, % of predicted (FEV1%), fractional exhaled nitric oxide (FeNO), asthma control test (ACT), oral steroid (OCS) intake, and exacerbation rate were evaluated during mepolizumab treatment. Results: 69 patients were enrolled (mean age: 55.1 years; 60.9% females). A significant improvement was detected at one month with respect to blood eosinophils (median level at baseline: 710/μl; -620/μl, p < 0,001), FEV1% (median value at baseline 87; range: 79-101; +4, p = 0.001) and ACT (median value at baseline 18; range: 14-20.5;+4, <0.001). A significant reduction of FeNO was observed six months after the treatment start, when the exacerbation rate and the mean OCS dose significantly decreased (respectively: Δ reduction -3; p < 0.001 and -5 mg; p < 0.001).Conclusions: Our study provides real-world evidence of mepolizumab safety and confirms its dramatic steroid sparing effect. The greatest clinical change (ACT and FEV1) was observed within the first month.
Entities:
Keywords:
Severe asthma; asthma network; eosinophils; mepolizumab; real-world evidence
Authors: Sumita B Khatri; Jonathan M Iaccarino; Amisha Barochia; Israa Soghier; Praveen Akuthota; Anna Brady; Ronina A Covar; Jason S Debley; Zuzana Diamant; Anne M Fitzpatrick; David A Kaminsky; Nicholas J Kenyon; Sandhya Khurana; Brian J Lipworth; Kevin McCarthy; Michael Peters; Loretta G Que; Kristie R Ross; Elena K Schneider-Futschik; Christine A Sorkness; Teal S Hallstrand Journal: Am J Respir Crit Care Med Date: 2021-11-15 Impact factor: 21.405