Real-life effectiveness of mepolizumab in severe asthma: a systematic literature review

Israel, Elliot; Canonica, Giorgio Walter; Brusselle, Guy; Yang, Shibing; Howarth, Peter H.; Martin, Amber; Koufopoulou, Maria; Smith, Steven G.; Alfonso-Cristancho, Rafael

doi:10.1080/02770903.2021.2008431

Cited by 25 publications

(21 citation statements)

References 51 publications

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“…The results of our study resemble these data, with a 74% reduction in exacerbations requiring emergency or hospitalization and a significant improvement in mean FEV1 of 10.3%. Real-life studies also reported improvements in lung function, asthma control, reduced the usage of OCS bursts, and maintenance OCS, and decreased eosinophil counts and exacerbations [29,31,[42][43][44][45][46][47]. Among these studies, we found a systematic review by Israel E. et al (2021) reflecting similar results in both prospective and retrospective studies [42].…”

Section: Discussionsupporting

confidence: 73%

“…Real-life studies also reported improvements in lung function, asthma control, reduced the usage of OCS bursts, and maintenance OCS, and decreased eosinophil counts and exacerbations [29,31,[42][43][44][45][46][47]. Among these studies, we found a systematic review by Israel E. et al (2021) reflecting similar results in both prospective and retrospective studies [42]. Consistent with our results, the retrospective studies included in the review showed significant reductions of 54% to 94% (p < 0.001 and p = 0.0012, respectively) in OCS bursts; reductions of 55% (p < 0.001) in exacerbations requiring emergency or hospitalization.…”

Section: Discussionmentioning

confidence: 93%

“…Consistent with our results, the retrospective studies included in the review showed significant reductions of 54% to 94% (p < 0.001 and p = 0.0012, respectively) in OCS bursts; reductions of 55% (p < 0.001) in exacerbations requiring emergency or hospitalization. The 73% (p = 0.004) and 83% (p values not reported) showed reductions in the rate of exacerbations requiring hospitalization; 27% to 84% had discontinued maintenance OCS and from 32% to 100% had reduced the initial maintenance dose (p < 0.001); lung function improved by 3% to 8% (p < 0.05); reductions in blood eosinophilic counts from 69% to 92% (p < 0.05); and changes in ACT from 5 to 8 points [42]. However, there are studies in which an improvement in lung function was not achieved, which may be due to the difference in population, history of smoking, or smaller sample size [45][46][47].…”

Section: Discussionmentioning

confidence: 97%

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Impact of Anti-IL5 Therapies on Patients with Severe Uncontrolled Asthma and Possible Predictive Biomarkers of Response: A Real-Life Study

Rojo-Tolosa

González-Gutiérrez

Jiménez-Gálvez

et al. 2023

IJMS

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Severe Uncontrolled Asthma (SUA) counts for more than 25% of cases of severe asthma. The main factors that impair the quality of life of these patients are high doses of oral corticosteroids, the presence of exacerbations, and reduced lung function. The objective of this study was to evaluate, in real life, the clinical improvement of patients with SUA treated with anti-interleukin 5 (IL5) therapies: mepolizumab and benralizumab, together with the search for biomarkers associated with the response. We conducted a retrospective observational cohort study that included patients with severe uncontrolled eosinophilic asthma in a tertiary hospital receiving biological therapies. Three types of response were evaluated: improvement in lung function, reduction in exacerbations, and decrease in the use of oral corticosteroids. After 12 months of treatment, significant reductions were found in the number of exacerbations, the use of oral corticosteroids, and blood eosinophil levels for both biological therapies (p < 0.001). Lung function improved, achieving a significant improvement in %FEV1 (p < 0.001), as well as asthma control, with a significant increase in asthma control test (ACT) scores in both therapies. The markers associated with the corticosteroid-saving effect were the low doses of oral corticosteroids and absence of exacerbations for mepolizumab, and higher blood eosinophilia, absence of chronic obstructive pulmonary disease (COPD), and reduction in oral corticosteroid cycles for benralizumab. The greatest improvement in lung function in both therapies was linked to lower previous FEV1 levels and absence of other respiratory diseases. The reduction in exacerbations was associated with absence of exacerbations the previous year for mepolizumab and never smokers for benralizumab. The results of this real-life study confirm the clinical benefit obtained after the introduction of an anti-IL5 biological therapy and the possible predictive biomarkers of response to treatment.

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Section: Discussionsupporting

confidence: 73%

Section: Discussionmentioning

confidence: 93%

Section: Discussionmentioning

confidence: 97%

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Impact of Anti-IL5 Therapies on Patients with Severe Uncontrolled Asthma and Possible Predictive Biomarkers of Response: A Real-Life Study

Rojo-Tolosa

González-Gutiérrez

Jiménez-Gálvez

et al. 2023

IJMS

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“…The DREAM study identified a B-EOS count of 300/μL or greater as a high predictive biomarker of response to mepolizumab ( 41 ), but the subsequent clinical trials enrolled severe asthmatic patients with a peripheral eosinophil count of at least 150 cells/μL at screening or at least 300 cells /μL at some time during the previous year ( 42 , 43 ). In studies in real life, concerning the efficacy of anti-IL-5 drugs, regardless of the number of eosinophils, provided that above 300 cells/μl, B-EOS correlated with risk of asthma exacerbations, the decline in respiratory function, mortality, and systemic corticosteroid dependence ( 44 ). Moreover, a relationship between the reduction of eosinophil, with anti-IL-5 drugs, and the consequent decrease in the frequency of exacerbations was reported ( 45 ).…”

Section: Systemic Biomarkersmentioning

confidence: 99%

Critical evaluation of asthma biomarkers in clinical practice

Guida

Bagnasco²,

Carriero³

et al. 2022

Front. Med.

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The advent of personalized medicine has revolutionized the whole approach to the management of asthma, representing the essential basis for future developments. The cornerstones of personalized medicine are the highest precision in diagnosis, individualized prediction of disease evolution, and patient-tailored treatment. To this aim, enormous efforts have been established to discover biomarkers able to predict patients' phenotypes according to clinical, functional, and bio-humoral traits. Biomarkers are objectively measured characteristics used as indicators of biological or pathogenic processes or clinical responses to specific therapeutic interventions. The diagnosis of type-2 asthma, prediction of response to type-2 targeted treatments, and evaluation of the risk of exacerbation and lung function impairment have been associated with biomarkers detectable either in peripheral blood or in airway samples. The surrogate nature of serum biomarkers, set up to be less invasive than sputum analysis or bronchial biopsies, has shown several limits concerning their clinical applicability. Routinely used biomarkers, like peripheral eosinophilia, total IgE, or exhaled nitric oxide, result, even when combined, to be not completely satisfactory in segregating different type-2 asthma phenotypes, particularly in the context of severe asthma where the choice among different biologics is compelling. Moreover, the type-2 low fraction of patients is not only an orphan of biological treatments but is at risk of being misdiagnosed due to the low negative predictive value of type-2 high biomarkers. Sputum inflammatory cell analysis, considered the highest specific biomarker in discriminating eosinophilic inflammation in asthma, and therefore elected as the gold standard in clinical trials and research models, demonstrated many limits in clinical applicability. Many factors may influence the measure of these biomarkers, such as corticosteroid intake, comorbidities, and environmental exposures or habits. Not least, biomarkers variability over time is a confounding factor leading to wrong clinical choices. In this narrative review, we try to explore many aspects concerning the role of routinely used biomarkers in asthma, applying a critical view over the “state of the art” and contemporarily offering an overview of the most recent evidence in this field.

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“…Main T2 targets are IgE with omalizumab (OMA), IL-5 with mepolizumab (MEP) and reslizumab, IL-4 with dupilumab (DUP), and IL-5 receptor Alpha with benralizumab (BEN) [17]. All the above-mentioned biologics demonstrated an efficacy in the reduction of exacerbations, OCS-sparing effect and improved quality-of-life in treated patients, both in clinical trials [18][19][20][21][22][23][24][25]26,27] and in real-life settings [28][29][30][31][32][33][34][35].…”

Section: Asthmamentioning

confidence: 99%

The new indications for biologicals in type 2 diseases: perspectives

Bagnasco

Canevari

Passalacqua

et al. 2022

Current Opinion in Allergy &Amp; Clinical Immunology

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Purpose of reviewTo provide a literature review of what is on the market and under study for some diseases treated with drugs targeting type 2 (T2) inflammation.Recent findingsLiterature data have shown that drugs targeting type 2 inflammation are effective in asthma and nasal polyposis, conditions for which they are on the market, and have promising expectations in the case of eosinophilic esophagitis, especially using anti-IL-5/IL-5 receptor and IL-4 receptor antibodies, while concerning eosinophilic granulomatosis with polyangitis (EGPA), mepolizumab (MEP) was approved by FDA and EMA as a drug for the treatment of this condition because of the promising results obtained in trials and in real life.SummaryThe use of these drugs is certainly an important achievement in the treatment of complex diseases such as those mentioned above, which are too often orphaned from innovative treatments and limited to the use of immunosuppressants and systemic corticosteroid for their control.

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Real-life effectiveness of mepolizumab in severe asthma: a systematic literature review

Cited by 25 publications

References 51 publications

Impact of Anti-IL5 Therapies on Patients with Severe Uncontrolled Asthma and Possible Predictive Biomarkers of Response: A Real-Life Study

Impact of Anti-IL5 Therapies on Patients with Severe Uncontrolled Asthma and Possible Predictive Biomarkers of Response: A Real-Life Study

Critical evaluation of asthma biomarkers in clinical practice

The new indications for biologicals in type 2 diseases: perspectives

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