Becker's Hospital Review

ZEPHYR 2 REAL-WORLD EVIDENCE STUDY 3,4 FASENRA is indicated as an add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype. FASENRA is not indicated for treatment of other eosinophilic conditions or for the relief of acute bronchospasm or status asthmaticus. OBSERVED ASTHMA EXACERBATION REDUCTIONS IN ZEPHYR 2 ONE OF THE LARGEST RWE STUDIES IN RESPIRATORY BIOLOGICS Observed reduction in AER similar to rates in pivotal trials IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Known hypersensitivity to benralizumab or excipients. WARNINGS AND PRECAUTIONS Hypersensitivity Reactions Hypersensitivity reactions (eg, anaphylaxis, angioedema, urticaria, rash) have occurred after administration of FASENRA. These reactions generally occur within hours of administration, but in some instances have a delayed onset (ie, days). Discontinue in the event of a hypersensitivity reaction. Please see additional Important Safety Information throughout and Brief Summary of full Prescribing Information on adjacent pages. This Article Was Sponsored by AstraZeneca FASENRA® (benralizumab) Subcutaneous Injection 30 mg a The record for benralizumab occurring the day before the index day is included in the count of benralizumab records. b All patients included in the final sample had at least 1 encounter record every 12 months in the pre- and post-index periods. c Biologics included omalizumab, mepolizumab, reslizumab, and dupilumab. ZEPHYR 2 Real-World Evidence Study: Select Cohorts Selection 3 Cohort stratified by bEOS level Switch Cohort At least 1 asthma diagnosis pre-index At least 12 years old on index date Patients with at least 2 records of benralizumab a,b At least 1 benralizumab record (N=8473) (n=7276) (n=7254) (n=6571) Omalizumab record during the pre-index period and benralizumab only c use during the post-index period (n=633) Switched from omalizumab Patients with at least 2 asthma exacerbation episodes during the 12-month pre-index period (n=205) Switched from mepolizumab Patients with at least 2 asthma exacerbation episodes during the 12-month pre-index period (n=144) Mepolizumab record during the pre-index period and benralizumab only c use during the post-index period (n=483) At least 1 blood eosinophil lab measure in the data At least 12 years old on index date At least 1 blood eosinophil lab measure during the pre-index period Patients with at least 2 records of benralizumab a,b Patients with at least 2 asthma exacerbation episodes during the 12-month pre-index period At least 1 benralizumab record (N=8473) (n=3011) (n=3008) (n=2203) (n=1991) (n=429) Eosinophils <150 cells/µL (n=114) Eosinophils <300 cells/µL (n=194) Eosinophils ≥150 cells/µL (n=315) Eosinophils ≥300 cells/µL (n=235) Real-World Evidence Study Objective To assess real-world effectiveness of benralizumab on asthma exacerbations, OCS use, exacerbation-related healthcare resource utilization, and medical costs in patients with severe eosinophilic asthma, including those with available bEOS measures and who switched from omalizumab or mepolizumab Study Design ZEPHYR 2 was a retrospective cohort study utilizing claims data between 2016-2020 from a large US payer dataset, examining effectiveness of FASENRA in patients with asthma. A pre–post design was implemented to descriptively analyze and compare asthma exacerbations, OCS use, and other outcomes between the 12-month pre-index and 12-month post-index periods. Asthma exacerbations were defined based on a combination of asthma exacerbation diagnosis codes in the inpatient, emergency, and outpatient settings along with records for systemic corticosteroid use. Eligible patients initiating FASENRA (N=8473) were diagnosed with asthma, aged ≥12 years at index, had 24 months of continuous insurance enrollment, and had ≥2 asthma exacerbations in the pre-index period. The primary cohort (n=1292) was biologically naïve and focused on patients with ≥2 records of FASENRA. Subgroups included a persistent cohort (≥6 records of FASENRA, n=708) and a OCS-dependent cohort (patients with a cumulative dose of ≥450 mg prednisone equivalent OCS over 90 consecutive days or ≥180-day supply of OCS during the 12-month pre-index period, n=1065). Additional cohorts included patients who switched to FASENRA from omalizumab (n=205) or mepolizumab (n=144), and a cohort stratified by blood eosinophil level (n=429). Study Limitations The study evaluated FASENRA's treatment effect using a pre–post study design and did not include a control arm to adjust for potential temporal changes not due to treatment It is possible that some patients received their first FASENRA dose as a free dose that was not visible in the payer data The exact reasons behind a patient's switch from one medication to another cannot be ascertained from the data This is an observational study; clinical implications cannot be determined from this payer database study In SIROCCO (48 weeks), a 51% reduction in the annual asthma exacerbation rate (AER) was observed in patients treated with FASENRA + SOC (n=267) vs placebo + SOC (n=267) (0.74 vs 1.52, P<0.0001). 1,2 AER = annual exacerbation rate; bEOS = blood eosinophils; ICS = inhaled corticosteroid; n = cohort size; OCS = oral corticosteroid; RWE = real-world evidence; SOC = standard of care.

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