Prospective Italian real‐world study of mepolizumab in severe eosinophilic asthma validates retrospective outcome reports

• Published in: Clinical and translational allergy Vol. 11; no. 8; pp. e12067 - n/a
• Main Authors: Pini, Laura, Caruso, Cristiano, Colantuono, Stefania, Bagnasco, Diego, Maxwell, Aoife, Price, Robert G., Howarth, Peter, Canonica, Giorgio Walter
• Format: Journal Article
• Language: English
• Published: Hoboken John Wiley & Sons, Inc 01-10-2021; John Wiley and Sons Inc; Wiley
• Subjects: Asthma; Hospitalization; Letter to the Editor; Patients; Steroids; Italy
• ISSN: 2045-7022; 2045-7022
• DOI: 10.1002/clt2.12067

The therapeutic outcomes observed in such real-world everyday clinical settings will reflect the integrated interaction of a medicine's proven efficacy with factors related to patients' actual medication use, and the healthcare system in which the treatment is used. TABLE 1 Demographics and characteristics of patients Parameter REALITI-A 5 REALITI-A SANI study 6 Total population Italian cohort Italian population Number of subjects 368 87 106 Age (years), mean (SD) 53 (13.7) 56 (10.8) 57 (10.6) Female, n (%) 226 (62) 54 (62) 60 (57) Never smokers, n (%) 221 (61) 55 (63) 89 (84) Exacerbations in the previous year, mean (SD) 4.7 (4.1) 3.5 (2.5) 4.1 (2.7) Receiving maintenance OCS at enrolment, n (%) 174 (48) 39 (45) 84 (79) Prednisone equivalent OCS dose, (mg/day), mean (SD) 14.4 (19.5) 9.9 (7.6) 9.5 (8.5) Comorbid nasal polyps, n (%) 140 (38) 54 (62) 65 (61) Blood eosinophils (cells/μl), geometric mean 370 572 674 Previous treatment with Omalizumab, n (%) 71 (19) 15 (17) Data not available Withdrew from treatment during 12-month follow-up period, n (%) 70 (19) 2 (2) 0 Withdrew from treatment due to lack of efficacy, during 12-month follow-up period, n (%) 13 (4) 0 0 Abbreviations: OCS, oral corticosteroid; SANI, Severe Asthma Network in Italy; SD, standard deviation. CONFLICTS OF INTEREST Laura Pini reports having received research grants and lecture fees from A. Menarini, AstraZeneca, Chiesi Farmaceutici, GSK, and Novartis; Cristiano Caruso reports having received research grants and lecture fees from GSK and AstraZeneca; Stefania Colantuono reports no conflicts of interests; Diego Bagnasco reports having received lecture fees from, AstraZeneca, GSK, Novartis, and Sanofi-Genzyme; Peter Howarth, Aoife Maxwell, and Robert G. Price are employees of GSK and own stocks/shares in GSK; Giorgio Walter Canonica reports research grants and fees from: A. Menarini, Alk-Abello’, Allergy Therapeutics, AstraZeneca, Boehringer Ingelheim, Chiesi Farmaceutici, Genentech, Guidotti-Malesci, GSK, Hal Allergy, Mylan, Merck, Merck Sharp & Dome, Mundipharma, Novartis, Regeneron, Roche, Sanofi-Aventis, Sanofi-Genzyme, Stallergenes-Greer, UCB Pharma, Uriach Pharma, Valeas, and Vibor-Pharma.