RELIght: A two‐year REal‐LIfe study of mepolizumab in patients with severe eosinophilic asTHma in Greece: Evaluating the multiple components of response

Kallieri, Maria; Ζervas, Εleftherios; Fouka, Evangelia; Porpodis, Κonstantinos; Mitrova, Marija Hadji; Tzortzaki, Eleni G.; Makris, Michaël; Ntakoula, Maria; Papaioannou, Andriana Ι.; Lyberopoulos, Panagiotis; Dimakou, Katerina; Koukidou, Sofia; Ampelioti, Sevasti; Papaporfyriou, Anastasia; Κatsoulis, Κonstantinos; Kipourou, Maria; Ρovina, Νikoletta; Αντωνίου, Κατερίνα; Vittorakis, Stylianos; Bakakos, Petros; Steiropoulos, Paschalis; Μarkopoulou, Κaterina; Avarlis, Panteleimon; Papanikolaou, Ilias; Markatos, Miltiadis; Gaki, Eleni; Samitas, Κonstantinos; Glynos, Konstantinos; Papiris, Spyros; Papakosta, Despoina; Tzanakis, Νikolaos; Gaga, Mina; Κostikas, Κonstantinos; Loukides, Stelios

doi:10.1111/all.15382

Cited by 13 publications

(6 citation statements)

References 5 publications

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“…As such, remission outcomes generated from registration trial data have limited applicability to outcomes in standard clinical care. Other studies have focused on assessing a patient’s level of treatment response to identify responders and super-responders, such as the RELIght study, a real-world study in which patients with severe eosinophilic asthma were treated with mepolizumab ( 10 ). A recent Delphi consensus defined the criteria for identifying super-responders as patients who had achieved dramatic improvements in at least three or more domains after 1 year of treatment ( 11 ).…”

Section: Discussionmentioning

confidence: 99%

Remission outcomes in severe eosinophilic asthma with mepolizumab therapy: Analysis of the REDES study

Pavord

Gardiner²,

Heaney

et al. 2023

Front. Immunol.

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IntroductionClinical remission as a multicomponent treatment goal in severe asthma is being explored in clinical practice. This post hoc analysis used data from the REDES study to assess the proportion of patients with severe eosinophilic asthma achieving our multicomponent definitions of clinical remission after 1 year of mepolizumab treatment.MethodsThe real-world, retrospective observational REDES study enrolled patients with severe eosinophilic asthma who were newly prescribed mepolizumab and with ≥12 months of medical records pre-enrolment. Multicomponent clinical remission was defined as: oral corticosteroid (OCS)-free; exacerbation-free; asthma control test (ACT) score ≥20; and with or without post-bronchodilator forced expiratory volume in 1 second ≥80%. Baseline characteristics were also assessed in those who did/did not achieve clinical remission.Results37% and 30% of patients with severe eosinophilic asthma met our proposed three- and four-component on-treatment clinical remission definitions; an increase from 2% and 3% at baseline. Most frequently achieved individual components of clinical remission were: OCS-free; ACT score ≥20. For patients fulfilling the multicomponent clinical remission definitions, at baseline we observed higher blood eosinophil counts, better ACT scores and lung function, lower maintenance OCS use, and a slightly lower rate of prior exacerbations versus those who did not.DiscussionClinical remission is a realistic target in clinical practice for a subset of patients with severe eosinophilic asthma receiving mepolizumab. Further studies are required to elucidate whether features linked to the underlying endotype can help predict treatment outcomes, increase rates of clinical remission, and potentially modify disease progression.

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Section: Discussionmentioning

confidence: 99%

Remission outcomes in severe eosinophilic asthma with mepolizumab therapy: Analysis of the REDES study

Pavord

Gardiner²,

Heaney

et al. 2023

Front. Immunol.

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“…Patients were classified as responders and super-responders according to changes in ACT score, lung function, and asthma exacerbations with reference to previous studies [ 16 , 17 , 18 , 19 , 20 , 21 , 22 ]. A responder with benralizumab treatment was defined as meeting two of the following three criteria after 1 year of treatment with benralizumab without a significant deterioration in any other criterion: (1) Improvement in ACT score of at least 3 points (including patients who achieved an ACT score of 25 points) and an increase in ACT score of at least 3 points, which was previously suggested as the minimal clinically important difference [ 23 , 24 ].…”

Section: Methodsmentioning

confidence: 99%

Pretreatment Frequency of Circulating Th17 Cells and FeNO Levels Predicted the Real-World Response after 1 Year of Benralizumab Treatment in Patients with Severe Asthma

et al. 2023

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Benralizumab treatment reduces exacerbations and improves symptom control and quality of life in patients with severe eosinophilic asthma. However, the determination of biomarkers that predict therapeutic effectiveness is required for precision medicine. Herein, we elucidated the dynamics of various parameters before and after treatment as well as patient characteristics predictive of clinical effectiveness after 1 year of benralizumab treatment in severe asthma in a real-world setting. Thirty-six patients with severe asthma were treated with benralizumab for 1 year. Lymphocyte subsets in peripheral blood samples were analyzed using flow cytometry. Treatment effectiveness was determined based on the ACT score, forced expiratory volume in 1 s (FEV1), and the number of exacerbations. Benralizumab provided symptomatic improvement in severe asthma. Benralizumab significantly decreased peripheral blood eosinophil and basophil counts and the frequencies of regulatory T cells (Tregs), and increased the frequencies of Th2 cells. To our knowledge, this is the first study to show benralizumab treatment increasing circulating Th2 cells and decreasing circulating Tregs. Finally, the ROC curve to discriminate patients who achieved clinical effectiveness of benralizumab treatment revealed that the frequency of circulating Th17 cells and FeNO levels might be used as parameters for predicting the real-world response of benralizumab treatment in patients with severe asthma.

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“…1 However, both clinical trials and real-world experience revealed that most patients do not achieve a complete clinical response. [2][3][4] We aimed to analyze the rate of patients with complete clinical response to mAbs in a real-world setting and to investigate what factors are associated with suboptimal response. Response was defined in two ways:…”

Section: Factors Associated With Suboptimal Response To Monoclonal An...mentioning

confidence: 99%

“…The majority of patients treated with mAbs do not attain complete response, defined here as the achievement of the main clinical goals (Response 1), or as the achievement of what has been termed "clinical remission" (Response 2), 5 in most cases due to suboptimal symptom control. [2][3][4] It remains to be demonstrated whether achieving "clinical remission" has a disease-modifying effect, especially in terms of loss of lung function over time. We also found that women are less likely to achieve control, in concordance with previous studies reporting gender differences attributable to a combination of physiology and cultural expectations and behaviors.…”

Section: Factors Associated With Suboptimal Response To Monoclonal An...mentioning

confidence: 99%

Factors associated with suboptimal response to monoclonal antibodies in severe asthma

Llano

Malanda

Urrutia

et al. 2023

Allergy

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RELIght: A two‐year REal‐LIfe study of mepolizumab in patients with severe eosinophilic asTHma in Greece: Evaluating the multiple components of response

Cited by 13 publications

References 5 publications

Remission outcomes in severe eosinophilic asthma with mepolizumab therapy: Analysis of the REDES study

Remission outcomes in severe eosinophilic asthma with mepolizumab therapy: Analysis of the REDES study

Pretreatment Frequency of Circulating Th17 Cells and FeNO Levels Predicted the Real-World Response after 1 Year of Benralizumab Treatment in Patients with Severe Asthma

Factors associated with suboptimal response to monoclonal antibodies in severe asthma

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