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The North-Western Italian experience with anti IL-5 therapy amd comparison with regulatory trials

Authors
  • Bagnasco, Diego1
  • Milanese, Manlio2
  • Rolla, Giovanni3
  • Lombardi, Carlo4
  • Bucca, Caterina5
  • Heffler, Enrico6
  • Canonica, Giorgio Walter1, 6
  • Passalacqua, Giovanni1
  • 1 University of Genoa, Allergy and Respiratory Diseases, IRCCS Policlinico San Martino, Genoa, Italy , Genoa (Italy)
  • 2 Division of Pneumology, S.Corona Hospital, Pietra Ligure, Italy , Pietra Ligure (Italy)
  • 3 University of Turin, Allergy and Immunology, AO Mauriziano Hospital, Turin, Italy , Turin (Italy)
  • 4 Departmental Unit of Allergology & Respiratory Diseases, Fondazione Poliambulanza, Brescia, Italy , Brescia (Italy)
  • 5 Azienda Ospedale-Università Città della Salute e della Scienza, S.C. Pneumologia, Turin, Italy , Turin (Italy)
  • 6 Humanitas University, Personalized Medicine Clinic Asthma and Allergy, Humanitas Clinical and Research Center, Department of Biomedical Sciences, Rozzano, Milan, Italy , Milan (Italy)
Type
Published Article
Journal
World Allergy Organization Journal
Publisher
BioMed Central
Publication Date
Dec 06, 2018
Volume
11
Issue
1
Identifiers
DOI: 10.1186/s40413-018-0210-7
Source
Springer Nature
Keywords
License
Green

Abstract

BackgroundThe severe forms of asthma represent a major burden, because of severity of symptoms, costs and impact on everyday life. Recently, Mepolizumab (MEP) was approved and marketed for the treatment of hypereosinophilic severe asthma. This anti-IL-5 monoclonal antibody reduced exacerbation rates and oral corticosteroid (OCS) use in well selected patients. The aim of this study was to evaluate the characteristics of patients receiving MEP in a real-life setting. Thus, we describe a retrospective analysis of patients treated with MEP in six centres in North Western Italy, including those who participated in the main regulatory trials.MethodsThe baseline data, before prescription, from six North Western Italy severe asthma clinics, between June 1st 2017 and December 31st 2017, were evaluated. The collected real-life data were then compared with those of SIRUS, MENSA, DREAM and MUSCA trials.ResultsSixty-five patients were included (45% female; mean age 56 years; age range 19–84). Main observed differences with regulatory trials could be observed in eosinophils blood count at baseline, where the mean of our real-life patients (653 cells/μL) was overall higher than the one of all trials (240 cells/μL, 296 cells/μL, 253 cells/μL; p < 0.0001). The incidence of polyposis was also significantly higher in our sample (72% vs. 24%, 49%, 10%, 19%; p < 0.0001). The daily average dose of OCS was lower in our real-life patients (9 mg), if compared with SIRIUS (13.7 mg), MENSA (13.2) and MUSCA (13), and similar to the data published in DREAM (10.8).ConclusionsThe comparison of real-life patients' characteristics with regulatory trials, displayed several apparent discrepancies. The demographic and clinical aspects were similar in all groups, whereas other features (eosinophil count, pulmonary function FEV1%) differed. These data, for the first time, could represent a basis for a more accurate prescription of the drug.

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