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

Original research. Open Access
Diego BagnascoManlio MilaneseGiovanni RollaCarlo LombardiCaterina BuccaEnrico HefflerGiorgio Walter Canonica and Giovanni Passalacqua Email author

Abstract

Background

The 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.

Methods

The 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.

Results

Sixty-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).

Conclusions

The 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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