The REALISM Study: The Experience of Pulmonologists with Benralizumab in Greece

<bold>Introduction:</bold> Benralizumab is a humanized monoclonal antibody targeting the receptor a of interleukin-5 on the surface of eosinophils, resulting in rapid and near complete depletion of eosinophils. It is approved for the treatment of severe eosinophilic asthma. <bold>Aim:</bold> Evaluate the clinical experience, effectiveness, and safety of Benralizumab in Greek patients with severe eosinophilic asthma in a real-world setting. <bold>Methods:</bold> A multicenter prospective observational study which was conducted in 19 different Pulmonary Centers in Greece. The recruitment period lasted 18 months and the follow-up period is 2 years. <bold>Preliminary results:</bold> 122 patients were eligible (70 women), with an average age of 56 years. The majority (102/122) has late-onset asthma, with a mean ACT score of 15.9. All patients had at least one exacerbation in the previous year. 106 patients have already completed the 12-month follow-up, and 68 patients the 2-years. Significant improvements were observed in both ACT score (6 units in the 1st year and 7 units in the 2-years) and FEV1%pred (340ml in the 1st year and 370ml in the 2-years). Additionally, a significant reduction was reported in the annual exacerbation rate with 77% reduction in the 1st and 91% reduction in the 2-years. 65% of patients discontinued completely the use of OCS in the 1st year. The efficacy of Benralizumab was regardless of eosinophil levels, number of previous exacerbations and previous use of biological agents. Adverse events were experienced by 12 patients (9.8%), most commonly headache, while no serious adverse events were observed. <bold>Conclusions:</bold> The preliminary results of the REALISM study confirm the efficacy and safety of Benralizumab in daily clinical practice.

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Published
2024-09-14
DOI
https://doi.org/10.1183/13993003.congress-2024.pa3925
Primary Topic
Microscopic Colitis
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article
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article

The REALISM Study: The Experience of Pulmonologists with Benralizumab in Greece

Νikolaos Tzanakis, Agapi Aggelopoulou, Κonstantinos Κatsoulis, Andrianna Papaioannou et al.
Microscopic Colitis
article

The REALISM Study: The Experience of Pulmonologists with Benralizumab in Greece

Νikolaos Tzanakis, Agapi Aggelopoulou, Κonstantinos Κatsoulis, Andrianna Papaioannou, Dimitrios Latsios, Maria Kipourou, Evangelia Fouka, Athena Gogali, Konstantinos Tatsis, Dimosthenis Papapetrou, Despoina Papakosta, Stylianos Vittorakis, Εleftherios Ζervas, Κonstantinos Porpodis, Νikoletta Ρovina, Nikolaos Zias, Petros Bakakos, Eleni Tzortzaki, Eleftheria Chaini, Ourania S. Kotsiou, Katerina Dimakou, Paschalis Steiropoulos, Stelios Loukides, Katerina M. Antoniou, Κonstantinos Κostikas, Μiltiadis Μarkatos, Pantelis Avarlis, Aikaterini-Ioanna Sakellaropoulou, Sofia Koukidou, Κonstantinos Samitas, Chrysoula Kontogianni, Εleni Gaki, Ιlias Papanikolaou, Maria Hatzimitrova, Georgios Hillas, Aggelos Ladias, Niki Georgatou
article en

Abstract

<bold>Introduction:</bold> Benralizumab is a humanized monoclonal antibody targeting the receptor a of interleukin-5 on the surface of eosinophils, resulting in rapid and near complete depletion of eosinophils. It is approved for the treatment of severe eosinophilic asthma. <bold>Aim:</bold> Evaluate the clinical experience, effectiveness, and safety of Benralizumab in Greek patients with severe eosinophilic asthma in a real-world setting. <bold>Methods:</bold> A multicenter prospective observational study which was conducted in 19 different Pulmonary Centers in Greece. The recruitment period lasted 18 months and the follow-up period is 2 years. <bold>Preliminary results:</bold> 122 patients were eligible (70 women), with an average age of 56 years. The majority (102/122) has late-onset asthma, with a mean ACT score of 15.9. All patients had at least one exacerbation in the previous year. 106 patients have already completed the 12-month follow-up, and 68 patients the 2-years. Significant improvements were observed in both ACT score (6 units in the 1st year and 7 units in the 2-years) and FEV1%pred (340ml in the 1st year and 370ml in the 2-years). Additionally, a significant reduction was reported in the annual exacerbation rate with 77% reduction in the 1st and 91% reduction in the 2-years. 65% of patients discontinued completely the use of OCS in the 1st year. The efficacy of Benralizumab was regardless of eosinophil levels, number of previous exacerbations and previous use of biological agents. Adverse events were experienced by 12 patients (9.8%), most commonly headache, while no serious adverse events were observed. <bold>Conclusions:</bold> The preliminary results of the REALISM study confirm the efficacy and safety of Benralizumab in daily clinical practice.

Mediterranean Agronomic Institute of Chania (GR), University of Ioannina (GR), Technological Educational Institute of Peloponnese (GR), Hellenic Agency for Local Development and Local Government (GR), University Hospital of Larissa (GR), General Hospital of Drama (GR), Corfu General Clinic (GR), Chania General Hospital ”St. George” (GR), University Hospital of Heraklion (GR), Athens City (GR), University Hospital of Alexandroupolis (GR), e-Trikala (Greece) (GR)
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Microscopic Colitis
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