Mepolizumab add-on therapy in a real world cohort of patients with severe eosinophilic asthma: response rate, effectiveness, and safety

Abstract

Introduction: Severe eosinophilic asthma is an incapacitating disease. Mepolizumab, a humanized anti-interleukin-5 monoclonal antibody, proved to be effective as an add-on therapy in patients with severe eosinophilic asthma. However, only data from randomized controlled trials are available and real world data are lacking. Methods: A retrospective observational longitudinal study was conducted in a real world cohort of patients with severe eosinophilic asthma treated with mepolizumab. The primary objective was to determine response rate, based on a global evaluation of treatment effectiveness by the treating pulmonologist. Secondary objectives were to assess exacerbation frequency, systemic maintenance glucocorticoid usage, Asthma Control Questionnaire (ACQ), lung function, and adverse events. Results: Seventy-eight patients were included. Treatment with mepolizumab was considered beneficial and was therefore continued in 75.6% of patients 12 months from the initiation of mepolizumab. The most common reason for drop-out was insufficient response. Secondary objectives: 12 months from the initiation of mepolizumab there was a decrease of 3.2 (CI 2.5-4.1; p < 0.001) severe asthma exacerbations per year, a decrease of ACQ of 0.80 points (CI 0.49-1.12; p < 0.001), and an increase of 3.7 (CI 0.3-7.2; p ¼ 0.034) percent of predicted FEV1 compared to baseline. At baseline 51.3% of patients were treated with systemic glucocorticoid maintenance therapy, compared to 15.4% (p < 0.001) of patients 12 months from the initiation of mepolizumab. No serious adverse events considered to be related to mepolizumab were reported. Conclusion:This study confirms that mepolizumab add-on therapy is effective and safe in a real world cohort of patients with severe eosinophilic asthma.

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

“…Severe asthma exacerbations per year were significantly reduced after 12 months of treatment accompanied by a reduction of 0.80 points in ACQ, and an increase in FEV 1 compared to baseline. A reduction in OCS usage was also observed (51.3% at baseline vs. 15.4%), 12 months after drug initiation and importantly, no serious adverse events related to mepolizumab treatment were reported [27]. Similar findings come from a retrospective study of 138 patients treated with mepolizumab for at least 12 months in Italy where mepolizumab confirmed its effectiveness in significantly reducing exacerbation rates and OCS usage, thus replicating the efficacy and safety profile shown in RCTs [28].…”

A Comprehensive Evaluation of Mepolizumab Effectiveness in a Real-Life Setting

“…In randomized clinical trials (RCT), mepolizumab has been demonstrated to produce a significant reduction in exacerbations and steroid intake and to improve asthma control in patients with a peripheral eosinophil count >300 cell/mm 3 [9, 10]. These results have also been reported in real-world studies, confirming the cost-effectiveness and good safety profile of the drug [11, 12].…”

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

“…In severe persistent eosinophilic asthma, the percentage of patients that received daily OCS dropped from 76% before starting mepolizumab treatment to 12% after 1 year of treatment [54]. Additionally, in the study of van Toor et al [58], the percentage of patients requiring OCS was reduced to 15.4% after 1 year of treatment with mepolizumab. The predesigned interim analysis of a 2-year study [53] reported that in patients who completed 1 year of therapy with mepolizumab, a 56% reduction in the dose of OCS was achieved, from 10.1 mg/day to 4.5 mg/day.…”

“…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].…”