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Journal of Asthma and Allergy logoLink to Journal of Asthma and Allergy
. 2026 Sep 26;19:646978. doi: 10.2147/JAA.S646978

Real-World Comparative Effectiveness of Mepolizumab versus Benralizumab in an Older Population with Asthma: A US Medicare Fee-for-Service Analysis

Guillaume Germain 1, Emmeline Burrows 2, Jacob Klimek 3, Patrick Gravelle 4, Kioumars Tavakoli Tafti 1, François Laliberté 1, Arijita Deb 5,✉
PMCID: PMC13625837  PMID: 42819412

Abstract

Background

Biologic therapies, including mepolizumab and benralizumab, are used to treat uncontrolled asthma. However, real-world evidence comparing these treatments is limited. This study compared asthma-related hospitalizations and asthma exacerbations between mepolizumab and benralizumab among Medicare fee-for-service (FFS) beneficiaries with asthma.

Methods

Data were obtained from Komodo Research Database (01/01/2018-05/31/2025). Eligible patients included Medicare FFS beneficiaries with asthma and a first claim for mepolizumab or benralizumab on or after January 1, 2019 (index date). An adherent subgroup included those who remained adherent to their index biologic for ≥6 months. Overlap weighting based on a propensity score model was used to balance cohorts. Asthma-related hospitalizations and asthma exacerbations were evaluated while on treatment. Rates were reported as the number of events per-patient-year (PPY) and compared between weighted cohorts using rate ratios (RRs) with 95% confidence intervals (CIs). Non-inferiority using a fixed-margin approach was used to compare rates of asthma-related hospitalizations between cohorts.

Results

In total, 125 and 177 patients were included in the mepolizumab and benralizumab cohorts, respectively (mean age: 70.7 years, 69.1 years). After weighting, baseline characteristics were well-balanced. At 1-year post-index, mepolizumab demonstrated superiority over benralizumab for asthma-related hospitalizations, showing a 77% rate reduction (0.036 PPY vs 0.155 PPY; RR: 0.23, 95% CI: 0.07, 0.74; p=0.013) and was associated with comparable rates of asthma exacerbations (1.056 PPY vs 1.302 PPY; RR: 0.81, 95% CI: 0.52, 1.26; p=0.348). In the adherent subgroup, mepolizumab remained superior to benralizumab for asthma-related hospitalizations (0.040 PPY vs 0.167 PPY; RR: 0.24, 95% CI: 0.07, 0.79; p=0.019) and remained associated with comparable rates of asthma exacerbations (0.927 PPY vs 1.249 PPY; RR: 0.74, 95% CI: 0.44, 1.25; p=0.265). Consistent results were observed at 2-years post-index.

Conclusion

Mepolizumab was superior to benralizumab for asthma-related hospitalizations, while asthma exacerbation rates were comparable between the two therapies.

Keywords: asthma, benralizumab, biologic therapy, medicare, mepolizumab, real-world evidence

Introduction

Asthma imposes a considerable clinical burden in the United States (US), affecting an estimated 7.7% of the population and contributing to substantial healthcare resource utilization (HRU), including emergency department (ED) visits and hospitalizations.1 Asthma is a chronic inflammatory disease characterized by variable airway obstruction and recurrent respiratory symptoms, including cough, wheeze, chest tightness, and shortness of breath.2,3 Patients with severe asthma experience poor symptom control and frequent exacerbations despite receiving guideline-recommended treatment, contributing to disproportionately high HRU and costs.4,5

Severe asthma with an eosinophilic phenotype is a key type 2 (T2) inflammation-associated form of the disease, characterized by elevated blood eosinophil (EOS) levels, frequent exacerbations, and irreversible airway obstruction.2,4 Interleukin (IL)-5 plays a central role in EOS migration, maturation, and survival, and biologic therapies targeting IL-5 or its receptor have become important treatment options for patients with severe asthma with eosinophilic phenotype who remain uncontrolled despite inhaled therapies.6 Emerging evidence suggests that IL-5 may also act on a broader range of cell types beyond eosinophils.7

The IL-5-directed monoclonal antibodies mepolizumab and benralizumab are approved as add-on maintenance treatments for patients with severe asthma with eosinophilic phenotype.8–11 Mepolizumab is a cytokine-targeted therapy that binds circulating IL-5, primarily blocking IL-5 binding to the IL-5 receptor-alpha (IL-5Rα) on EOS to reduce EOS levels, while potentially influencing other IL-5Rα-expressing cells.7,12 Benralizumab, in contrast, is a receptor-targeted therapy that binds directly to IL-5Rα and promotes near-complete EOS depletion via antibody-dependent cellular cytotoxicity.7,12 Despite differing upstream mechanisms, both clinical trials and real-world studies have demonstrated that mepolizumab and benralizumab reduce asthma exacerbations and oral corticosteroid (OCS) use, as well as improve lung function.13

Eligibility for mepolizumab and benralizumab is primarily guided by exacerbation history and blood EOS levels; notably, neither the Food and Drug Administration (FDA) prescribing information for either agent9,11 nor the current Global Initiative for Asthma (GINA) report4 specifies an EOS threshold for prescribing mepolizumab or benralizumab, and the pivotal trials for each agent used different EOS eligibility criteria (mepolizumab: ≥150 cells/µL; benralizumab: ≥300 cells/µL).14–16 Many patients may be candidates for both agents, and treatment selection may depend on predictors of response, patient comorbidities, treatment goals, and practical considerations.4,12 Combined with the difference in trial-eligible populations, these factors raise the possibility that baseline EOS levels differ systematically between patients selected for mepolizumab versus benralizumab.17

While several biologic classes with distinct therapeutic targets (including IgE, IL-4/IL-13, and thymic stromal lymphopoietin) are available for severe asthma, there is a critical need for real-world comparative evidence within the same biologic pathway to guide treatment decisions, especially from studies able to adjust for baseline EOS levels using laboratory data.18,19 Within the IL-5–eosinophil pathway, mepolizumab and benralizumab represent clinically proximate comparators and both agents are indicated for severe asthma with eosinophilic phenotype. However, mepolizumab and benralizumab differ in their precise targeting mechanisms and dosing schedules, and their comparative effectiveness remains uncertain, particularly among Medicare fee-for-service (FFS) beneficiaries, who represent an older and clinically complex population.20 Notably, asthma is associated with higher morbidity and mortality among older adults, including elevated rates of hospitalizations and readmissions, and management is complicated by polypharmacy, age-related physiologic changes, and a history of underrepresentation in pivotal clinical trials.21–23 Additionally, real-world comparative effectiveness may be influenced by patterns of treatment adherence, with recent evidence demonstrating that adherence to biologic therapy is associated with significantly fewer exacerbations compared with less or non-adherence.24 Medicare beneficiaries, specifically, have lower biologic adherence than patients with other insurance types.24,25 The objective of this real-world study was to compare rates of asthma-related hospitalizations and asthma exacerbations between Medicare FFS beneficiaries with asthma initiating mepolizumab versus benralizumab, including within a subgroup adherent to biologic therapy.

Materials and Methods

Data Source

This study was conducted using the Komodo Research Database (KRD+), with data spanning from January 1, 2018, to May 31, 2025. KRD+ contains more than 65 billion de-identified clinical, pharmacy, and laboratory encounters. The open claims subset, used for this study and sourced directly from healthcare providers and claims clearinghouses, includes data for Medicare FFS beneficiaries. This data does not provide information on patients’ insurance eligibility, unlike the closed claims subset provided directly from payers across Medicaid, commercial, and Medicare Advantage insurers. Variables within KRD+ include, but are not limited to, inpatient and outpatient diagnoses and procedures, mortality data, and demographic information such as race and ethnicity data.

This study was considered exempt research under 45 CFR § 46.104(d)(4) as it involved only the secondary use of data that were de-identified in compliance with the Health Insurance Portability and Accountability Act (HIPAA), specifically, 45 CFR § 164.514.

Study Design

A retrospective, longitudinal cohort design was used to compare asthma-related hospitalizations and asthma exacerbations, and to describe time to treatment discontinuation, between patients treated with mepolizumab (ie, mepolizumab cohort) versus benralizumab (ie, benralizumab cohort) (Figure 1). For patients in the mepolizumab and benralizumab cohorts, the index date was defined as the first observed claim for mepolizumab or benralizumab, respectively, on or after January 1, 2019. The baseline period included the 12 months preceding the index date, while the follow-up period comprised the index date to the earliest of the end of continuous clinical activity, end of data availability, final day of supply for the index biologic, switch to another asthma biologic, or death.

Figure 1.

The study design scheme outlining the timing of continuous clinical activity and index date identification, as well as baseline and observation periods.

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Study design.

Abbreviation: FFS, fee-for-service.

Study Population

Adult patients were eligible for inclusion in the mepolizumab or benralizumab cohort if they had ≥2 consecutive claims for the respective biologic within 6 months, with the first claim occurring on or after January 1, 2019. Additionally, all patients were required to have ≥12 months of Medicare FFS continuous clinical activity pre-index, defined as consecutive quarters with ≥1 medical and ≥1 pharmacy claim, and each of the following during the baseline period or on the index date: ≥2 diagnoses of asthma on separate visits (International Classification of Diseases, 10th Revision, Clinical Modification [ICD-10-CM]: J45.3x, J45.4x, J45.5x, J45.9xx), ≥1 asthma exacerbation, and ≥1 laboratory assessment measuring EOS levels.

Patients were ineligible if they had ≥1 claim for mepolizumab, omalizumab, reslizumab, benralizumab, dupilumab, or tezepelumab pre-index, or ≥1 diagnosis of cystic fibrosis, lung cancer, interstitial lung disease, α-1 antitrypsin deficiency, eosinophilic granulomatosis with polyangiitis (EGPA), hypereosinophilic syndrome (HES), chronic rhinosinusitis with nasal polyps (CRSwNP), or pulmonary eosinophilia during the baseline period or on the index date.

An adherent subgroup was identified within the overall study population and was composed of patients who were adherent to their index biologic for ≥6 months following initiation. Adherence was defined as no treatment gap exceeding the equivalent of 2 consecutive doses and the receipt of >50% of the expected doses based on labeled dosing frequency.24

Study Outcomes

Demographic (ie, age, sex, geographic region, race/ethnicity, index year) and clinical (ie, prescribing physician specialty, respiratory medication use, asthma exacerbations, severe asthma diagnosis, HRU, Quan-Charlson Comorbidity Index [Quan-CCI],26 asthma-related comorbidities, Elixhauser comorbidities27) characteristics were evaluated during the baseline period.

Rates of asthma-related hospitalizations and asthma exacerbations (overall, outpatient [OP]-defined, inpatient [IP]/ED-defined) were evaluated while on treatment, defined as the period spanning from the index date to the final day of supply for the index biologic. Analyses were conducted up to 1 year and 2 years post-index, separately, among the overall study population and the adherent subgroup (ie, patients with ≥6 months of continuous index biologic therapy). Asthma-related hospitalizations were defined as IP stays with a primary diagnosis of asthma. OP-defined exacerbations included OP visits with a primary diagnosis of asthma and a medical or pharmacy claim for a systemic corticosteroid (SCS; parenteral or OCS) with 2 to 28 days of supply within 5 days before or after the OP visit. IP/ED-defined exacerbations included IP stays and ED visits with a primary diagnosis of asthma, or all-cause IP stays that occurred within 1 day after an ED visit with a primary diagnosis of asthma.

Time to treatment discontinuation was evaluated up to 3 years post-index among the overall study population, with treatment discontinuation defined as the final day of supply of the index biologic prior to a switch or occurring ≥60 days before the end of continuous clinical activity, end of data availability, or death.

Statistical Analyses

To reduce potential confounding between the mepolizumab and benralizumab cohorts, overlap weighting was applied using propensity scores (PSs) estimated from a logistic regression model.28 The binary dependent variable was mepolizumab treatment, and patient characteristics (ie, demographic characteristics, HRU, asthma-related comorbidities, asthma-related medication use) with a prevalence >5% were considered for inclusion in the PS model. Additionally, the presence of a severe asthma diagnosis pre-index, proxies for asthma severity (eg, baseline exacerbation rates), and baseline EOS levels were included in the model to account for potential differences in disease severity between cohorts. Standardized differences were used to assess differences between cohorts, with values >10% considered meaningfully different.29

Continuous variables were summarized using means, standard deviations (SDs), and medians; categorical variables were summarized using frequencies and proportions.

Asthma-related hospitalization rates and asthma exacerbation rates were calculated as the number of events per person-year (PPY) of observation and compared between weighted cohorts using rate ratios (RRs), 95% confidence intervals (CIs), and p-values obtained from Poisson regression models with robust standard errors (SEs). Additionally, non-inferiority of mepolizumab versus benralizumab was evaluated for asthma-related hospitalizations using a non-inferiority margin of 1.22, derived according to the FDA-recommended fixed-margin approach.30–32 Rates of asthma-related hospitalizations and asthma exacerbations were assessed for superiority, defined as a statistically significant rate reduction for mepolizumab (with a type 1 error of 5%).

Time to treatment discontinuation was estimated among the weighted cohorts using Kaplan-Meier analyses and reported at 3-month intervals.

All statistical analyses were conducted using SAS Enterprise Guide Software version 7.15 (SAS Institute, Cary, NC).

Results

Baseline Characteristics

A total of 302 patients met the study eligibility criteria, of whom 125 (41.4%) were included in the mepolizumab cohort and 177 (58.6%) were included in the benralizumab cohort (Figure 2).

Figure 2.

Flowchart of patient selection for mepolizumab and benralizumab, with exclusion criteria. The flowchart details the selection process for patients starting biologic therapy with mepolizumab or benralizumab under Medicare FFS from Jan 1, 2019, to May 31, 2025. Starting with 28,018 patients, requiring two consecutive administrations of the same biologic agent reduce the number to 22,553. Continuous clinical activity for 12 months prior to the index date narrows it to 7,569 patients. Those aged 18+ at the index date total 7,554. Two asthma diagnoses during the baseline or index date reduce the count to 6,010. At least one asthma exacerbation during the baseline or index date results in 3,737 patients. One EOS measurement during the baseline or index date leaves 461 patients. Exclusions include 159 patients with specific diagnoses or prior biologic agent use, resulting in 302 patients. The final cohort includes 125 in the mepolizumab group and 177 in the benralizumab group, with adherence rates of 67.2% and 67.8%, respectively.

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Patient disposition.

Notes: Patients who initiated multiple biologics on their index date were excluded. Diagnoses of cystic fibrosis, lung cancer, interstitial lung disease, or α-1 antitrypsin deficiency were identified in either primary or secondary position. Patients adherent to biologic therapy included those who were adherent to their index biologic for ≥6 months following initiation.

Abbreviations: COPD, chronic obstructive pulmonary disease; CRSwNP, chronic rhinosinusitis with nasal polyps; EGPA, eosinophilic granulomatosis with polyangiitis; EOE, eosinophilic esophagitis; FFS, fee-for-service; HES, hypereosinophilic syndrome; ICD-10-CM, International Classification of Diseases, Tenth Revision, Clinical Modification.

Prior to overlap weighting, the mean (SD) age was 70.7 (9.6) years in the mepolizumab cohort and 69.1 (10.2) years in the benralizumab cohort, and 73.6% and 77.4% of patients were female, respectively (Figure 3 and Table S1-S2).

Figure 3.

Table comparing unweighted and weighted baseline characteristics and standardized differences for mepolizumab versus benralizumab cohorts. The table compares baseline demographics and clinical characteristics of two cohorts, Mepolizumab and Benralizumab, with both unweighted and weighted data. Standardized differences show weighted markers closer to zero. Key characteristics prior to weighting include: Age (mean plus or minus standard deviation): Mepolizumab 70.7 plus or minus 9.6, Benralizumab 69.1 plus or minus 10.2; Female (percent): Mepolizumab 73.6, Benralizumab 77.4; Office administration (percent): Mepolizumab 77.6, Benralizumab 80.2; Severe asthma diagnosis (percent): Mepolizumab 74.4, Benralizumab 83.6; Asthma exacerbations (mean plus or minus SD): Mepolizumab 2.09 plus or minus 1.53, Benralizumab 2.29 plus or minus 1.62; EOS count (mean plus or minus SD): Mepolizumab 0.38 plus or minus 0.35, Benralizumab 0.43 plus or minus 0.36; Maintenance medications (percent): Mepolizumab 94.4, Benralizumab 92.7; Quan-CCI (mean plus or minus SD): Mepolizumab 2.5 plus or minus 1.7, Benralizumab 2.4 plus or minus 1.7. Comorbidities include GERD, COPD, allergic rhinitis, hypertension, cardiac arrhythmias, obesity, hypothyroidism and diabetes, with varying prevalence between cohorts.

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Select baseline demographic and clinical characteristics for the overall population.

Notes: Overlap weighting was used to balance baseline characteristics between the two cohorts. Variables that were considered for inclusion in the propensity score included but were not limited to the following: age, sex, region, index year, physician specialty, Quan-CCI score, asthma exacerbations (OP and IP/ED), HRU, and SCS and OCS use. Respiratory and other medications, and Elixhauser and asthma-related comorbidities with ≥5% prevalence in at least one cohort were also considered for inclusion. Type of biologic administration was evaluated using medical or pharmacy claims on the index date. Patients were identified as having office administration if the index date was defined with a medical claim with a procedure code for a biologic or if the index date was defined with a pharmacy claim for a biologic and the patient had a medical claim with a procedure code for subcutaneous or intramuscular drug administration (CPT: 96372) within 28 days on or after the index pharmacy claim. Patients were identified as having at-home administration if the index date was defined by a pharmacy claim for a biologic and the patient did not have a medical claim with a procedure code for subcutaneous or intramuscular drug administration within 28 days on or after the index pharmacy claim. Severe asthma diagnoses were identified from medical claims with ICD-10-CM code J45.5x during the baseline period. When multiple EOS measurements were recorded, the measurement closest to the index date was used.

Most patients in the mepolizumab (77.6%) and benralizumab (80.2%) cohorts were administered their index biologic in an office setting. Additionally, most patients had a diagnosis of severe asthma (mepolizumab: 74.4%, benralizumab: 83.6%). The mean (SD) number of asthma exacerbations during the baseline period was 2.09 (1.53) in the mepolizumab cohort and 2.29 (1.62) in the benralizumab cohort. Per the study eligibility criteria, all patients had ≥1 laboratory assessment measuring EOS levels; the mean (SD) EOS count was 380 (350) cells/µL and 430 (360) cells/µL in the mepolizumab and benralizumab cohorts, respectively. A total of 12 (9.6%) patients in the mepolizumab cohort and 27 (15.3%) patients in the benralizumab cohort had EOS counts ≥1000 cells/µL.

Maintenance controller medications were used by nearly all patients (mepolizumab: 94.4%, benralizumab: 92.7%), as were rescue medications (100.0%, 98.9%).

The mean (SD) Quan-CCI was similar in the mepolizumab (2.5 [1.7]) and benralizumab (2.4 [1.7]) cohorts. The most common asthma-related comorbidities included gastroesophageal reflux disease (mepolizumab: 65.6%, benralizumab: 54.2%), chronic obstructive pulmonary disease (COPD) (51.2%, 49.2%), and allergic rhinitis (47.2%, 59.9%), and the most common Elixhauser comorbidities included hypertension (77.6%, 76.8%), cardiac arrhythmias (40.8%, 28.8%), obesity (40.0%, 45.8%), hypothyroidism (32.8%, 29.9%), and diabetes (39.2%, 32.2%) (Table S2).

The adherent subgroup included 204 patients, with 84 of 125 (67.2%) included from the mepolizumab cohort and 120 of 177 (67.8%) included from the benralizumab cohort (mean [SD] age: 70.6 [9.2] years, 69.2 [9.8] years) (Table S3-S4).

In both the overall study population and the adherent subgroup, all eligible baseline demographic and clinical characteristics were balanced between cohorts after overlap weighting was applied (ie, standardized difference <10%), including mean EOS counts and the proportion of patients with EOS counts ≥1000 cells/µL. Standardized differences before and after weighting are presented for the overall study population in Tables S1-S2 and for the adherent subgroup in Tables S3-S4.

Asthma-Related Hospitalizations

During the 1-year post-index period, the median observation period for the overall study population was 365 days for both the mepolizumab and benralizumab cohorts (mepolizumab: 99 person-years, benralizumab: 136 person-years) (Figure 4 and Table S5). The weighted rate of asthma-related hospitalizations was 0.036 PPY for patients in the mepolizumab cohort and 0.155 PPY for patients in the benralizumab cohort, with 4 and 21 hospitalizations, respectively. Mepolizumab demonstrated superiority to benralizumab, corresponding to a significant 77% rate reduction (RR: 0.23, 95% CI: 0.07, 0.74; p=0.013; non-inferiority margin: 1.22). During the 2-year post-index period, the median observation period was 622 days (165 person-years) and 474 days (217 person-years) for the mepolizumab and benralizumab cohorts, respectively. The weighted rate of asthma-related hospitalizations was 0.043 PPY for patients in the mepolizumab cohort and 0.143 PPY for patients in the benralizumab cohort, with 7 and 31 hospitalizations, respectively. Mepolizumab remained superior to benralizumab, corresponding to a significant 70% rate reduction (RR: 0.30, 95% CI: 0.12, 0.78; p=0.013; non-inferiority margin: 1.22).

Figure 4.

Two forest plots presenting rate ratios at 1 year and 2 years post index, comparing asthma-related hospitalizations between cohorts, both marked superior for Mepolizumab. Image A and B depict forest plots comparing Mepolizumab and Benralizumab with similar layouts. Both plots feature an x-axis labeled ′Rate ratio, Mepolizumab vs Benralizumab′ ranging from 0 to 1.25, with ticks at intervals of 0.25. A vertical line at 1.0 indicates ′No difference,′ while a dashed line at 1.22 marks the ′Non inferiority margin.′ In Image A, for 1 Year Post Index, the rate ratio (RR) is 0.23 with a 95 percent confidence interval (CI) from 0.07 to 0.74. For 2 Years Post Index, RR is 0.30 with a CI from 0.12 to 0.78. In Image B, for 1 Year Post Index, RR is 0.24 with a CI from 0.07 to 0.79. For 2 Years Post Index, RR is 0.34 with a CI from 0.12 to 1.00. Both images have ′Superior′ aligned with each row and directional labels below the axis: ′Favors Mepolizumab′ on the left and ′Favors Benralizumab′ on the right. The legend explains line styles for ′Superior,′ ′Non inferior only,′ ′No difference 1.0,′ and ′Non inferiority margin.′.

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Asthma-related hospitalizations during follow-up for the (A) overall population and (B) adherent subgroup.

In the adherent subgroup, the median observation period during the 1-year post-index period was 365 days in both the mepolizumab and benralizumab cohorts (mepolizumab: 79 person-years, benralizumab: 113 person-years). The weighted rate of asthma-related hospitalizations was 0.040 PPY and 0.167 PPY for patients in the mepolizumab and benralizumab cohorts, respectively, with 3 and 19 hospitalizations. Mepolizumab demonstrated superiority to benralizumab, corresponding to a significant 76% rate reduction (RR: 0.24, 95% CI: 0.07, 0.79; p=0.019; non-inferiority margin: 1.22). During the 2-year post-index period, the median observation period was 730 days in both the mepolizumab and benralizumab cohorts (mepolizumab: 134 person-years, benralizumab: 191 person-years). The weighted rate of asthma-related hospitalizations was 0.050 PPY for patients in the mepolizumab cohort and 0.147 PPY for patients in the benralizumab cohort, with 7 and 28 hospitalizations, respectively. Mepolizumab remained superior to benralizumab, corresponding to a significant 66% rate reduction (RR: 0.34, 95% CI: 0.12, 1.00; p=0.0497; non-inferiority margin: 1.22).

Asthma Exacerbations

In the overall study population, patients initiating mepolizumab versus benralizumab experienced 105 and 178 exacerbations, respectively, during the 1-year post-index period; weighted rates of overall asthma exacerbations were comparable between cohorts (1.056 PPY vs 1.302 PPY; RR: 0.81, 95% CI: 0.52, 1.26; p=0.348) (Table S6). During the 2-year post-index period, patients initiating mepolizumab versus benralizumab experienced 154 and 243 exacerbations, respectively, and likewise had comparable weighted rates of overall asthma exacerbations (0.928 PPY vs 1.120 PPY; RR: 0.83, 95% CI: 0.55, 1.25; p=0.366).

In the adherent subgroup, patients initiating mepolizumab versus benralizumab experienced 73 and 142 exacerbations, respectively, during the 1-year post-index period; weighted rates of overall asthma exacerbations were comparable between cohorts (0.927 PPY vs 1.249 PPY; RR: 0.74, 95% CI: 0.44, 1.25; p=0.265). During the 2-year post-index period, patients initiating mepolizumab versus benralizumab experienced 113 and 206 exacerbations, respectively, and weighted rates of overall asthma exacerbations remained comparable between cohorts (0.842 PPY vs 1.078 PPY; RR: 0.78, 95% CI: 0.49, 1.25; p=0.304).

Time to Treatment Discontinuation

In the overall study population, the risk of treatment discontinuation was higher among patients initiating benralizumab compared with mepolizumab at 1, 2, and 3 years post-index. After 1 year, 80.1% of patients initiating mepolizumab and 69.8% of patients initiating benralizumab were estimated to have remained on-treatment (Figure S1). After 2 years, on-treatment estimates were 63.1% and 56.5% for patients in the mepolizumab and benralizumab cohorts, respectively, and 56.8% and 49.1%, respectively, after 3 years.

Discussion

This real-world study identified Medicare FFS beneficiaries with asthma who initiated mepolizumab or benralizumab and found that mepolizumab was associated with significantly lower rates of asthma-related hospitalizations compared with benralizumab. Specifically, mepolizumab was superior to benralizumab for asthma-related hospitalizations within the overall population and the adherent subgroup, both during the 1- and 2-year follow-up periods. Patients treated with mepolizumab versus benralizumab had comparable rates of asthma exacerbations. Findings within the adherent subgroup were consistent with those of the overall population, with mepolizumab remaining superior to benralizumab for asthma-related hospitalizations and having comparable rates of asthma exacerbations between cohorts. Patients initiating mepolizumab also remained on-treatment longer than those initiating benralizumab throughout the 3-year follow-up period. Collectively, results of the current analysis highlight that mepolizumab may provide clinically meaningful real-world benefit for patients with severe asthma with eosinophilic phenotype and high baseline disease burden.

The focus on asthma-related hospitalizations in the present study reflects the clinical importance of these events as markers of severe disease burden and major drivers of HRU and costs, making them both a clinically and economically relevant outcomes.33 In the US, asthma-related hospitalizations represent a substantial component of the overall economic burden of asthma.34 However, asthma-related hospitalizations have rarely been compared directly between patients initiating mepolizumab versus benralizumab. In one administrative claims-based analysis conducted in the US, matched cohorts of patients treated with mepolizumab versus benralizumab had similar asthma-related hospitalization rates, with no statistically significant difference observed between groups (IRR: 0.87, 95% CI: 0.64, 1.18; p=0.36).18 In contrast, mepolizumab was superior to benralizumab for asthma-related hospitalizations over both the 1- and 2-year follow-up periods in the present study. This divergence may reflect, in part, differences in the ability to account for EOS levels, important for assessing exacerbation risk, between studies. While the prior administrative claims-based analysis lacked access to laboratory data and could not adjust for EOS levels,18 the present study incorporated baseline EOS levels directly into the propensity score model. In the unweighted population, mean baseline EOS levels were numerically higher among patients initiating benralizumab versus mepolizumab but were balanced between cohorts following overlap weighting. Additionally, the prior study did not report excluding patients with EGPA, HES, or other eosinophilic conditions for which the dosing regimens of mepolizumab and benralizumab are different from those in asthma.18 As such patients may also have an asthma diagnosis, their inclusion could have biased comparative effectiveness estimates in that analysis. The present study explicitly excluded these conditions during the baseline period, reducing this potential source of misclassification. More broadly, nearly all baseline demographic and clinical characteristics were balanced between cohorts after overlap weighting was applied, limiting the potential for residual confounding by measured baseline characteristics. The populations evaluated in the two studies also differed considerably, with the prior analysis reflecting a predominately privately insured, employer-based population with a mean age of ~57 years,18 whereas the present study evaluated Medicare FFS beneficiaries with a mean age of ~70 years. These methodological differences may help to explain the variation in findings and support the robustness of the superiority observed for mepolizumab among older and clinically complex adults with asthma in the present study.

Additionally, real-world studies comparing asthma exacerbations between patients treated with mepolizumab versus benralizumab remain limited,35,36 and existing evidence across US-based analyses has varied. Some administrative claims-based studies, which lacked access to laboratory data and could not adjust for baseline EOS levels, have reported modestly higher asthma exacerbation rates among patients treated with mepolizumab versus benralizumab.18,19 In contrast, an electronic health record- and claims-based target trial emulation, which incorporated EOS >300 cells/µL as a matching covariate for approximately half the study population, found no difference in the rate of asthma exacerbations with mepolizumab versus benralizumab treatment (RR: 1.0; 95% CI: 0.84, 1.17; p=0.99).37 Similarly, in the present study, asthma exacerbation rates were comparable among patients treated with mepolizumab versus benralizumab over 1- and 2-years of follow-up, including among patients adherent to biologic therapy. As described above, baseline EOS levels were numerically higher among patients initiating benralizumab in the unweighted population but were fully balanced following overlap weighting, reducing the likelihood that EOS-related confounding accounts for this finding. The observed differences across real-world studies may also be attributable to variations between study populations and in methodological approaches. The average age in the present analysis (~70 years) was higher than that reported in prior comparative studies of mepolizumab and benralizumab (49 to 58 years), and populations may have further differed with regard to clinical characteristics and comorbidity burden.18,19,37 Overall, the present study adds to existing evidence, suggesting that exacerbation outcomes are comparable, and may even be even lower, among patients treated with mepolizumab versus benralizumab, including among Medicare FFS beneficiaries with asthma.

Mepolizumab and benralizumab have each been evaluated in randomized placebo-controlled trials.14–16,38 Across pivotal trials, both IL-5-directed therapies reduced exacerbation risk among patients with severe asthma with eosinophilic phenotype.14–16,38 Indirect treatment comparisons have generally found comparable efficacy between the two biologics, with some analyses reporting mepolizumab to be more effective than benralizumab.39–41 The present findings among Medicare FFS beneficiaries are therefore also consistent with broader trial results demonstrating the effectiveness of both agents for reducing exacerbation burden. By evaluating outcomes in routine care, the current analysis complements this existing evidence and provides additional comparative data within a population not typically well represented in clinical trials.42

The adherent subgroup analysis was conducted to evaluate outcomes among patients with sustained exposure to mepolizumab (n=84 [41.2%]) or benralizumab (n=120 [58.8%]). The analysis was particularly relevant given differences in maintenance dosing schedules between the two agents, with mepolizumab and benralizumab administered once every 4 weeks and 8 weeks, respectively, which may influence treatment patterns and exposure duration.9,11 By focusing on patients who continued treatment, the subgroup analysis provided an opportunity to assess whether findings from the overall population were maintained among patients with longer biologic use. Results were consistent with the overall population, as mepolizumab remained superior to benralizumab for asthma-related hospitalizations, and exacerbation rates were similar between treatment groups. These findings thus support the stability of the overall results among patients adherent to biologic therapy, while recognizing that adherence-based analyses may reflect a select population of patients who tolerated or responded to initial therapy.

The time to treatment discontinuation analysis showed that a greater proportion of patients initiating mepolizumab remained on-treatment than those initiating benralizumab at 1-, 2-, and 3-years following biologic initiation. Notably, this pattern was observed despite benralizumab’s less frequent maintenance dosing schedule.9,11 One possible contributing factor is the immunogenicity of benralizumab, as approximately 12% of patients develop neutralizing anti-drug antibodies (ADA) within the first year of treatment and high ADA titers have been linked to increased drug clearance.11 Given that some prior research has identified lower treatment adherence among Medicare beneficiaries relative to those with commercial insurance, the specific reasons underlying treatment discontinuation, including perceived effectiveness, tolerability, or access-related factors, warrant additional investigation.24,25

Further research is needed to better understand why IL-5- and IL-5Rα-directed therapies may produce different clinical outcomes, despite targeting the same signaling pathway. Divergent outcomes between these two agents have also been observed outside of asthma. For example, mepolizumab significantly reduced exacerbations in patients with eosinophilic COPD in one of two Phase 3 trials (METREX), whereas benralizumab did not meet its primary endpoint in three separate Phase 3 COPD trials (GALATHEA, TERRANOVA, and RESOLUTE).43–45 These divergent findings across diseases underscore that mechanistic differences between IL-5 and IL-5Rα blockade may translate into clinically meaningful differences in efficacy that are not yet fully understood.

Limitations

This study is subject to several limitations. First, claims-based data may be affected by missing information, coding errors, and misclassification; for example, the presence of a diagnosis code does not necessarily confirm the presence of disease. Additionally, as a result of using claims-based data, only approximately 12% of eligible patients had an EOS lab value available, resulting in the exclusion of many potentially eligible patients. To reduce potential misclassification, multiple asthma diagnoses and index agent claims were required for study inclusion. Further, because the analysis relied on open claims, which may not capture all medical and pharmacy encounters for a given patient, adherence to biologic therapy may be misclassified if administrations, dispensings, treatment gaps, switches, or discontinuations occurred outside the observable claims network. However, this limitation is unlikely to differentially affect the mepolizumab and benralizumab cohorts, and therefore is not expected to meaningfully bias the comparative adherence-based results in favor of either treatment. A pharmacy claim indicates that a medication was dispensed but does not confirm that it was consumed or taken as prescribed, and medications not captured in claims, such as over-the-counter products or drug samples, were not observed. Second, although overlap weighting was used to balance measured baseline characteristics between cohorts, residual confounding may remain for characteristics not available in claims data. Therefore, even with overlap weighting, residual between-cohort differences in asthma severity cannot be completely ruled out. Third, although patients with a diagnosis of EGPA were excluded, a subset of patients in each cohort had baseline EOS levels ≥1000 cells/µL. Claims-based diagnosis codes may not fully capture undocumented eosinophilic conditions, and residual clinical heterogeneity cannot be excluded. However, given that the proportion of patients with EOS ≥1000 cells/µL was higher in the benralizumab versus mepolizumab cohort, it is unlikely that this variation accounted for the observed superiority of mepolizumab. Fourth, the while-on-treatment analytic strategy may have introduced informative censoring if treatment discontinuation, switching, or loss of continuous clinical activity was related to patient prognosis or treatment response. Fifth, the study period overlapped with the COVID-19 pandemic, during which access to healthcare and HRU may have differed from other time periods. Some baseline characteristics may also have been affected by pandemic-related changes in care; however, there is no reason to expect that the mepolizumab and benralizumab cohorts were differentially affected. Sixth, the study population was relatively small, driven in part by the requirement for a laboratory assessment measuring EOS levels. This limited sample size reduced the statistical power to detect between-group differences, and wide 95% CIs associated with some findings indicate uncertainty in the precision and magnitude of the estimated treatment effects. Finally, because analyses were limited to Medicare FFS beneficiaries, results may not be generalizable to patients with other types of insurance, uninsured patients, or asthma populations outside of the US.

Conclusions

In this retrospective study of Medicare FFS beneficiaries with asthma, mepolizumab was superior to benralizumab for asthma-related hospitalizations, while asthma exacerbation rates were comparable between the two therapies. Results were consistent among a subgroup of patients adherent to biologic therapy. These findings support the effectiveness of mepolizumab in routine clinical practice among patients with severe asthma with eosinophilic phenotype and suggest that real-world outcomes observed with mepolizumab are favorable to those of benralizumab within the current biologic landscape. In a setting where multiple biologics may be considered, the present results may help inform treatment decision-making for patients who are eligible for both mepolizumab and benralizumab.

Acknowledgments

Medical writing assistance was provided by a professional medical writer, Molly Gingrich, MSc, MWC, an employee of Analysis Group, Inc., a consulting company that has provided paid consulting services to GSK, which funded the development and conduct of this study and manuscript.

Funding Statement

This study was funded by GSK (study #308856). The study sponsor was involved in several aspects of the research, including the study design, the interpretation of data, and the writing of the manuscript. All authors contributed to the development of the manuscript and maintained control over the final content.

Abbreviations

COPD, chronic obstructive pulmonary disease; CRSwNP, chronic rhinosinusitis with nasal polyps; ED, emergency department; EGPA, eosinophilic granulomatosis with polyangiitis; EOS, eosinophil; FFS, fee-for-service; HES, hypereosinophilic syndrome; HRU, healthcare resource utilization; FDA, Food and Drug Administration; GINA, Global Initiative for Asthma; HIPAA, Health Insurance Portability and Accountability Act; ICD-10-CM, International Classification of Diseases, 10th Revision, Clinical Modification; IL-5, interleukin 5; IL-5Rα, interleukin 5 receptor alpha; IP, inpatient; KRD+, Komodo Research Database; OCS, oral corticosteroid; OP, outpatient; PPY, per person-year; PS, propensity score; Quan-CCI, Quan-Charlson Comorbidity Index; RR, rate ratio; SCS, systemic corticosteroid; SD, standard deviation; SE, standard error; T2, type 2; US, United States.

Data Sharing Statement

The data that support the findings of this study are available from Komodo Health. Restrictions apply to the availability of these data, which were used under license for this study.

Ethics Statement

The study was considered exempt research under 45 CFR § 46.104(d)(4) as it involved only the secondary use of data that were de-identified in compliance with the Health Insurance Portability and Accountability Act (HIPAA), specifically, 45 CFR § 164.514.

Author Contributions

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Disclosure

Emmeline Burrows and Arijita Deb are employees of GSK and own stock/stock options.

Guillaume Germain, Jacob Klimek, Patrick Gravelle, Kioumars Tavakoli Tafti, and François Laliberté are employees of Analysis Group, Inc., a consulting company that has provided paid consulting services to GSK, which funded the development and conduct of this study and manuscript.

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Associated Data

This section collects any data citations, data availability statements, or supplementary materials included in this article.

Data Availability Statement

The data that support the findings of this study are available from Komodo Health. Restrictions apply to the availability of these data, which were used under license for this study.

Articles from Journal of Asthma and Allergy are provided here courtesy of Dove Press

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