Real‐world experience with mepolizumab: Does it deliver what it has promised?

Abstract

Background: Randomized control trials performed in selected populations of severe eosinophilic asthmatics have shown that mepolizumab, an anti-IL5 therapy, was able to reduce exacerbations and OCS maintenance dose and in some studies, to improve asthma control and lung function.Objective: The aim of this study was to confirm the results of the RCTs in real-life in a population of 116 severe eosinophilic asthmatics treated with mepolizumab and who were followed up at the asthma clinic every month for at least 18 months. Severe asthmatics underwent FENO, lung function, asthma control and quality of life questionnaires, sputum induction and gave a blood sample at baseline, after 6 months and then every year. Results:We found a significant reduction in exacerbations by 85% after 6 months (P < .0001), which was maintained over time. We also found a significant and maintained reduction by 50% in the dose of oral corticosteroids (P < .001). Patients improved their ACT (+5.31pts, p<0.0001) ACQ (-1.13pts, P < .0001) and their AQLQ score (+1.24, P < .0001) at 6 months and this was maintained during follow-up. Only 37% reached asthma control (ACQ <1.5, ACT> 20). We observed a progressive increase in post-BD FEV1 that reached significance after 18 months (190ml or 11%, P < .01). Patients improving their FEV1had higher baseline sputum eosinophils than those not improving airway caliber. We found a significant reduction in sputum eosinophil counts by 60% after 6 months (P < .01) and a maintained reduction in blood eosinophil counts by 98% (P < .0001). Conclusion:In our real-life study, we confirm the results published in the RCTs showing a sharp reduction in exacerbation and oral corticosteroids dose and an improvement in asthma control and quality of life. Clinical relevance: Mepolizumab is efficient in severe eosinophilic asthma in real life. K E Y W O R D S eosinophils, exacerbations, lung function, mepolizumab, severe asthma, sputum

Oral Corticosteroids Dependence and Biologic Drugs in Severe Asthma: Myths or Facts? A Systematic Review of Real-World Evidence

“…Of the 1757 potentially relevant records identified in the initial search, 59 real-world studies were deemed eligible for a qualitative analysis. Six studies were carried out on benralizumab [34][35][36][37][38][39], 1 on dupilumab [40], 18 on mepolizumab [41][42][43][44][45][46][47][48][49][50][51][52][53][54][55][56][57][58], 27 on omalizumab [18,, and 3 on reslizumab [85][86][87]. Four studies investigated different mAbs in the same report [88][89][90][91].…”

“…In a large and long-term study [46] carried out in severe eosinophilic asthmatic patients, the treatment with mepolizumab for 2.5 years elucidated a significant and maintained reduction by 50% in the dose of oral corticosteroids as compared to baseline. This data was confirmed by another large and long-term study [47] in which, after 1 year and 2 years of treatment with mepolizumab, the use of OCS dropped from 92.8% at baseline to 41.1% and 34.7%, respectively.…”

Recent Insights into the Management of Inflammation in Asthma

“…[231][232][233][234][235][236][237] Real-world studies have similarly shown that these drugs were safe and efficacious, with response rates around 70%, and improvements in clinical asthma outcomes (exacerbations, OCS dependence, asthma control, quality of life, lung function), as early as 4-weeks into therapy. 26,[238][239][240][241][242][243][244][245][246][247][248] Their clinical efficacy was also observed in real-world patients who had failed Omalizumab therapy. 225,226,249,250 Real-world characterisation of patients receiving anti-IL-5/IL-5R drugs has identified a group who are older in age, have adult-onset asthma, predominantly male and have a high prevalence of nasal polyposis.…”

Treatment Challenges in Severe Eosinophilic Asthma: Differential Response to Anti-IL-5 and Anti-IL-5R Therapy

“…In a real-world study including 116 patients from Belgium, the best predictor of a reduction in exacerbations with mepolizumab was a higher baseline total serum IgE level. This implies IgE-mediated mechanisms in propagating IL-5 [29]. In accordance, benralizumab might also interfere with IgE-dependent immune responses, since in a real-world study from Italy all 22 patients recruited who decreased significantly the rate of exacerbations were allergic [35].…”

“…Patients significantly improved their asthma control, as assessed by ACT and ACQ scores as well as quality of life (AQLQ score) at 6 months and this was also maintained throughout the follow-up. Eventually, a progressive improvement in FEV 1 that reached significance after 18 months was observed, and this was more pronounced in patients with a higher baseline sputum eosinophil percentage [29].…”