<p>Real-World Effectiveness of Mepolizumab in Patients with Severe Asthma: An Examination of Exacerbations and Costs</p>

Abstract

Rationale: Results from clinical trials in patients with severe eosinophilic asthma have demonstrated that mepolizumab is well tolerated and is associated with improved asthma control as evidenced by reductions in both exacerbations and maintenance oral corticosteroid use, and improvements in lung function, asthma control, and quality of life. However, real-world data are lacking on the impact of mepolizumab treatment. Objective: To assess the effect of mepolizumab treatment on the rate of asthma exacerbations and asthma exacerbation-related costs in a real-world setting.Methods: This retrospective cohort study (GSK ID: 209017; HO-18-19168) analyzed data from patients with severe asthma ≥12 years of age at mepolizumab treatment initiation (index date) with ≥12 months pre-(baseline) and post-index (follow-up) data from a commercial claims database (patients were identified from November 1, 2015 to March 31, 2017). Asthma exacerbations (primary objective) and asthma exacerbationrelated costs (secondary objective) in the baseline and follow-up periods were compared. Other analyses included the number of mepolizumab administrations and the use of concomitant asthma medications. Results: Data were analyzed from 346 patients. Mepolizumab significantly reduced the proportion of patients with any exacerbation and exacerbations requiring hospitalization, compared with baseline. Significant reductions in the rate of all exacerbations of 38.4% (from 2.68 to 1.65 events/patient/year; P<0.001) and of exacerbations requiring hospitalization of 72.7% (from 0.11 to 0.03 events/patient/year; P=0.004) were observed, compared with baseline. Mean total asthma exacerbation-related costs (excluding mepolizumab acquisition and administrative costs) per person were significantly lower during follow-up compared with baseline (P<0.05) and the use of asthma medications, including oral and inhaled corticosteroids, was also lower. Conclusion: This study confirms the clinical benefit observed in previous mepolizumab clinical trials and demonstrates that mepolizumab is effective in a real-world setting. Plain-Language SummaryWhy was the study done? Mepolizumab is a biologic therapy given as an add-on treatment to patients with severe asthma whose symptoms are not controlled with controller therapy. Mepolizumab has been shown to reduce the rate of asthma exacerbations and use of oral corticosteroids in clinical trials, but there is currently a lack of data on the impact of mepolizumab treatment initiation in a real-world setting.

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

“…As expected, our results confirmed the effectiveness of the drug in terms of reduction of exacerbation rate, and consequently need for systemic steroids, and also in terms of improvement of asthma control and functional parameters. There have been many reports in the literature on the efficacy of mepolizumab from RCTs and real-life studies [22, 23]. Our study contributes to the topic, confirming that mepolizumab is very effective in reducing respiratory symptoms, the number and severity of exacerbations, and OCS intake, enabling significant health gains in patients with severe eosinophilic asthma.…”

<p>Real-World Reductions in Oral Corticosteroid Use in the USA Following Mepolizumab Therapy for Severe Asthma</p>

“…11 The fact that we observed broadly similar results in a real-world setting highlights the robust OCS-sparing effect associated with mepolizumab and is also consistent with results from several other smaller, real-world studies. [15][16][17][18] We also found that mepolizumab treatment was associated with a 45.5% reduction in the annualized rate of asthma exacerbations and 60% reduction in the annualized rate of exacerbations resulting in hospitalization. The reductions we observed are broadly in line with those reported in smaller real-world studies, [15][16][17][18] and with results from the SIRIUS study where, despite receiving a reduced OCS dose, patients in the mepolizumab group had a relative reduction of 32% in the annualized rate of exacerbations compared with those in the placebo group.…”

“…[15][16][17][18] We also found that mepolizumab treatment was associated with a 45.5% reduction in the annualized rate of asthma exacerbations and 60% reduction in the annualized rate of exacerbations resulting in hospitalization. The reductions we observed are broadly in line with those reported in smaller real-world studies, [15][16][17][18] and with results from the SIRIUS study where, despite receiving a reduced OCS dose, patients in the mepolizumab group had a relative reduction of 32% in the annualized rate of exacerbations compared with those in the placebo group. 11 Our data also support the efficacy of mepolizumab observed in other clinical trials (using the licensed dose, 100 mg subcutaneously), where reductions of 53-58% in the rate of all exacerbations versus placebo and 69% in the rate of exacerbations requiring hospitalization versus placebo were reported.…”

“…[11][12][13][14] Initial evidence from several real-world studies have also demonstrated that mepolizumab therapy in these individuals reduces OCS use and exacerbation rates compared with placebo; however, interpretation is limited by small sample sizes and limited assessment of OCS use. [15][16][17][18] The aim of this study was to build on the findings from previous real-world studies and comprehensively examine the impact of mepolizumab treatment initiation on OCS use, rate of asthma exacerbations and asthma exacerbation-related HCRU and costs in patients with severe asthma using data from a large commercial US healthcare claims database.…”

Assessing the cost-effectiveness of mepolizumab as add-on therapy to standard of care for severe eosinophilic asthma in Singapore

“…However, several studies have reported similar outcomes in the realworld setting, suggesting that the results are consistent and likely to be generalizable. (50)(51)(52)Lastly, some of the model inputs such as the local mortality rate from asthma exacerbations at the ED (24) and utility decrements due to asthma exacerbations (25) were informed by data older than 5 years. Nonetheless, these inputs are likely to still be valid as they were verified by local clinical experts, and similar utility decrements were used in the CEAs conducted by Whittington et al (2017) and NICE TA431 (2017).…”