FASENRA is indicated for the add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma, and with an eosinophilic phenotype. FASENRA is not for the relief of acute bronchospasm or status asthmaticus.

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STUDY DESIGNS

A total of 1204 (SIROCCO) and 1306 (CALIMA) patients aged 12-75 years old with severe asthma uncontrolled on high-dose ICS (SIROCCO) and medium- to high-dose ICS (CALIMA) plus LABA with or without additional controllers were included. Patients had a history of ≥2 exacerbations requiring systemic corticosteroids or temporary increase in usual dosing in the previous year. Patients were stratified by geography, age, and blood eosinophil counts (≥300 cells/μL and <300 cells/μL). The primary endpoint was annual exacerbation rate ratio vs placebo in patients with blood eosinophil counts of ≥300 cells/μL on high-dose ICS/LABA. Exacerbations were defined as a worsening of asthma that led to use of systemic corticosteroids for ≥3 days, temporary increase in a stable OCS background dose for ≥3 days, emergency/
urgent care visit because of asthma that needed systemic corticosteroids, or inpatient hospital stay of ≥24 hours because of asthma. Key secondary endpoints were prebronchodilator FEV1 and total asthma symptom score at Week 48 (SIROCCO) and Week 56 (CALIMA) in the same population.

SIROCCO

Flow Chart Representing SIROCCO Study Design

Flow Chart Representing SIROCCO Study Design

CALIMA

Flow Chart Representing CALIMA Study Design

Flow Chart Representing CALIMA Study Design

*Patients in the Q8W FASENRA arm received a placebo injection at the 4-week interval between FASENRA injections.2,3

†Patients randomized were stratified for blood eosinophil counts of ≥300 cells/μL and <300 cells/μL.2,3

EOT, end of treatment; FEV1, forced expiratory volume in 1 second; ICS, inhaled corticosteroid; LABA, long-acting beta-agonist; OCS, oral corticosteroid; Q4W, every 4 weeks; Q8W, every 8 weeks; SC, subcutaneous.

A total of 220 adult (18-75 years old) patients with severe asthma on high-dose ICS plus LABA and daily OCS (7.5 to 40 mg/day), blood eosinophil counts of ≥150 cells/μL, and a history of ≥1 exacerbation in the previous year were included. The primary endpoint was the median percent reduction from baseline in the final daily OCS dose while maintaining asthma control.

Flow Chart Representing ZONDA Study Design

Flow Chart Representing ZONDA Study Design

EOT, end of treatment; ICS, inhaled corticosteroid; LABA, long-acting beta-agonist; OCS, oral corticosteroid; Q4W, every 4 weeks; Q8W, every 8 weeks; SC, subcutaneous.

Patients originally randomized to FASENRA continued FASENRA 30 mg SC Q8W or benralizumab SC Q4W. Patients previously receiving placebo were re-randomized 1:1 to FASENRA 30 mg SC Q4W for the first 3 doses, then Q8W thereafter; or benralizumab 30 mg SC Q4W except for adolescent patients in the EU who were randomized to FASENRA 30 mg SC Q8W. Patients were to be maintained on their same dose of ICS/LABA. End of treatment was at Week 56 for adults and Week 108 for adolescents. The primary objective was assessment of safety and tolerability. Secondary objectives included assessments of asthma exacerbations, prebronchodilator FEV1, and impact of treatment on blood eosinophil counts.

Flow Chart Representing BORA Study Design

Flow Chart Representing BORA Study Design

Inclusion Criteria

  • All patients who completed treatment in the SIROCCO, CALIMA, or ZONDA trials were eligible for enrollment
  • Patients 12 to 75 years of age who were diagnosed with asthma and treated with medium-dosage or high-dosage inhaled ICS/LABA for ≥12 months prior to enrollment

*Patients in this study also received FASENRA Q4W, either continuing from the previous double-blind trial (n=518) or were randomized after originally receiving placebo (n=265).

†Patients randomized were stratified for blood eosinophil count of ≥300 cells/µL and <300 cells/µL.

EOT, end of treatment; FEV1, forced expiratory volume in 1 second; ICS, inhaled corticosteroid; LABA, long-acting beta-agonist; Q4W, every 4 weeks; Q8W, every 8 weeks; SC, subcutaneous.

In predecessor studies, patients received placebo or FASENRA 30 mg SC, either Q4W or Q8W (first 3 doses Q4W); in BORA, patients receiving placebo were randomized to FASENRA Q4W or Q8W and continued on the same treatment in MELTEMI until FASENRA was commercially available in their local market. In MELTEMI, patients received either FASENRA 30 mg SC Q4W or FASENRA 30 mg SC Q8W. Patients enrolled in MELTEMI were aged 18 years or older, had a diagnosis of severe asthma, and were being treated with ICS/LABA therapy ± OCS and/or other asthma controllers. Mean treatment duration for FASENRA Q8W was 3.7 years. Efficacy analysis includes patients with bEOS ≥300 cells/μL receiving high-dose ICS at baseline. Of the patients receiving FASENRA Q8W, 59% had zero exacerbations across the extension study period (n=110; over 304 total follow-up years). The primary endpoint was safety and tolerability measured by rates of AEs and SAEs.

Study Limitations

Patients who did not experience benefits with their asthma treatment may have been more likely to discontinue the study vs those who did experience benefits and, similarly, patients who experienced certain SAEs in predecessor studies were not eligible to enter MELTEMI, both of which could contribute to selection bias.

Inclusion Criteria

  • Enrolled in the double-blind BORA extension study
  • At baseline, treated with ICS/LABA therapy ± OCS and/or other asthma controllers
  • Adults (aged 18-75 years) with severe, uncontrolled asthma
  • At baseline, treated with ICS/LABA therapy ± OCS and/or other asthma controllers
  • Adults (aged 18-75 years) with severe, uncontrolled asthma
  • Completed one of the three Phase 3, randomized, double-blind, placebo-controlled predecessor studies
Flow Chart Representing MELTEMI Study Design Flow Chart Representing MELTEMI Study Design

*FASENRA 30 mg Q4W or 30 mg Q8W and placebo.6

†FASENRA 30 mg Q4W or 30 mg Q8W.6

‡Eligible patients transitioned into BORA at the EOT visit of the predecessor study.6

§Includes patients who discontinued treatment in MELTEMI but attended all study visits.6

||447 patients enrolled in MELTEMI; 1 patient did not receive treatment with study drug and was not included in the full analysis set.6

AE, adverse event; bEOS, blood eosinophil; EOT, end of treatment; ICS, inhaled corticosteroid; LABA, long-acting beta-agonist; OCS, oral corticosteroid; Q4W, every 4 weeks; Q8W, every 8 weeks; SAE, serious adverse event; SC, subcutaneous.

Patients received FASENRA 30 mg SC Q4W for the first 3 doses, then Q8W thereafter. The benralizumab treatment period consisted of a 4-week induction phase with no OCS adjustments, followed by a variable, personalized OCS reduction phase, and a 24 -32 week maintenance phase. A total of 598 adult (≥18 years old) patients on high-dose ICS plus LABA for ≥6 months and daily OCS (≥5 mg) for ≥3 months were included. Patients had a blood eosinophil count of ≥150 cells/μL at baseline or ≥300 cells/μL in the previous 12 months for inclusion in the study. The primary endpoints were percentage of patients who achieved a 100% reduction in daily OCS dosage and percentage of patients who achieved a 100% dosage reduction or achieved a daily OCS dosage ≤5 mg if further reduction was not possible because of adrenal insufficiency. After the OCS reduction phase, patients spent approximately 6 months in the maintenance phase. During this time, they continued treatment with 30 mg benralizumab Q8W and either continued without OCS treatment or continued with the final dosage they had achieved in the reduction phase. Investigators could prescribe corticosteroids for exacerbations or increase daily dose in cases of decreased asthma control.

Exacerbations were defined as worsening of asthma symptoms leading to the temporary need for systemic corticosteroids, emergency department or urgent care visit because of asthma that required a systemic corticosteroid bolus, or inpatient hospitalization related to asthma.

In PONENTE, FASENRA was administered in addition to daily OCS (≥5 mg) plus SOC, which is defined as high-dose ICS plus LABA.

Flow Chart Representing PONENTE Study Design

Flow Chart Representing PONENTE Study Design

Study Limitations

  • Open-label study design with lack of comparator arm
  • Lack of an OCS dosage-optimization phase
  • Analyses were descriptive only

EOS, eosinophil; EOT, end of treatment; ICS, inhaled corticosteroid; LABA, long-acting beta-agonist; OCS, oral corticosteroid; Q4W, every 4 weeks; Q8W, every 8 weeks; SC, subcutaneous; SOC, standard of care.

This integrated analysis included adults (≥18 years) with SEA who received FASENRA as defined in each national study and who had available follow-up data of ≥3 months from the index date. Patients were excluded if they were receiving FASENRA or any other biologic for the treatment of asthma in a clinical trial at the time of enrollment; previous treatment with all other biologic therapies for asthma was allowed. Patients received FASENRA according to approved local labels and routine clinical practice. This XALOC-1 integrated analysis includes data from 5 individual studies from Canada (VOLTS), Italy (ANANKE), Portugal (BETREAT), Spain (ORBE II), and the UK (BPAP).

This index date was the date FASENRA was started, the baseline period was the 12 months prior to the index date, and the follow-up period was from the index date up to 48 ± 4 weeks.

Flow Chart Representing XALOC-1 Study Design

Flow Chart Representing XALOC-1 Study Design

Primary Outcomes

AERs were evaluated over 48 weeks before and after treatment initiation and analyzed based on overall population and baseline subgroup characteristics.

Baseline Characteristics

  • Total number of patients: 1002
  • Mean age at asthma diagnosis: 38.2 years
  • Positive atopic status*†: 43.8%
  • Concomitant CRSwNP*†: 31.5%
  • FeNO, mean‡: 55.2 PPB
  • Maintenance OCS use during 12-month baseline period: 53.1%*
  • Peak bEOS during baseline period, median: 510 cells/μL
  • AER during 12-month baseline period, mean: 3.05

Study Limitations

  • This is a retrospective, observational, real-world study program; clinical implications cannot be determined from these data. Results are descriptive only
  • Lack of a control arm
  • Analyses were restricted to data available in routine clinical practice

*Percentage of total number of patients, which includes missing n=346 (34.5%) for age at asthma diagnosis, n=9 (0.9%) for maintenance OCS use (missing or unknown) in the 12-month baseline period, n=369 (36.8%) for atopic status, and n=6 (0.6%) for CRSwNP.

†Based on medical records available at the index date.

‡The most recent measurement in the 12-month baseline period.

AER, annual exacerbation rate; bEOS, blood eosinophil; CRSwNP, chronic rhinosinusitis with nasal polyps; FeNO, fractional exhaled nitric oxide; OCS, oral corticosteroid; PPB, parts per billion; SEA, severe eosinophilic 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.

This study consisted of 3 non-mutually exclusive cohorts. Patients in the first cohort (n=429) had ≥2 records of FASENRA during the follow-up period and were stratified based on ≥1 blood eosinophil count value during the pre-index period. Patients in the second cohort (n=349) had ≥2 records of FASENRA during the follow-up period and were stratified into 2 mutually exclusive subgroups based on ≥1 record of mepolizumab or omalizumab use during the pre-index period with no other biologic use during the post-index period. The third cohort was an extended follow-up of 1042 patients stratified into 2 subgroups. Subgroup 1 comprised patients with ≥18 months of follow-up post index with at least 1 claim between 18-24 months and ≥9 records of FASENRA during the follow-up period. Subgroup 2 comprised patients with ≥24 months of follow-up post index with at least 1 claim between 24-30 months and ≥11 records of FASENRA during the follow-up period.

Study Limitations

  • The study evaluated the treatment effect of FASENRA 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
  • This is an observational study; clinical implications cannot be determined from this payer database study
Flow Chart Representing ZEPHYR 2 Study Design
Flow Chart Representing ZEPHYR 2 Study Design

Real-World Study Objective

To assess real-world effectiveness of FASENRA on asthma exacerbations and OCS use in subsets of patients that included those with different blood eosinophil counts (ranging from <150 to ≥300 cells/µL) and those who had switched from other respiratory biologics.

Eligibility Requirements

  • Diagnosed with asthma
  • Aged ≥12 years at index
  • Had 24 months of continuous insurance enrollment
  • Experienced ≥2 asthma exacerbations in the pre-index period

Many Patients in ZEPHYR 2 Had Comorbidities

Some common comorbidities in the cohorts were allergic rhinitis, hypertension, gastroesophageal reflux disease, hyperlipidemia, COPD, obesity, and nasal polyps.

COPD, chronic obstructive pulmonary disease; OCS, oral corticosteroid.

ACQ scores from Weeks 1 to 56 in a real-world study (ACQ scores were assessed at Weeks 1, 2, 4, 8, 24, and 56)

Flow Chart Representing XALOC-2 Study Design

Flow Chart Representing XALOC-2 Study Design

Outcome Measures

ACQ-5 or ACQ-6 scores were evaluated at baseline (Week 0) and after FASENRA initiation and were collected during routine clinical visits or electronically at Weeks 1, 2, 4, 8, 24, and 56.*†

Select Baseline Patient Characteristics

  • Total number of patients: 535‡
  • Median age at FASENRA initiation: 58 years
  • Maintenance OCS use (n=315): 59%§
  • AER, median (IQR): 2.0 (1.0-4.0)§
  • ACQ score, mean (SD): 3.0 (1.2)*

Study Limitations

  • Clinical implications cannot be determined from these data. Results are descriptive only
  • Lack of control arm
  • Analyses were restricted to data available in routine clinical practice outside of the United States

*The ACQ score includes both ACQ-6 scores, based on an average of 6 items in Canada (POWER), Belgium (BE-REAL), and Germany (imPROve) and ACQ-5 scores, based on an average of 5 items in Switzerland (BEEPS).

†In the Swiss cohort, patients were assessed at Week 16, instead of at Week 24.

‡The N number represents the total number of patients recruited from each country (POWER, Canada; n=142; BE-REAL, Belgium; n=76; imPROve, Germany, n=244; BEEPS, Switzerland, n=73).

§During the 12 months prior to baseline (Week 0).

ACQ, Asthma Control Questionnaire; AER, annual exacerbation rate; IQR, interquartile range; OCS, oral corticosteroid; Q4W, every 4 weeks; Q8W, every 8 weeks; SC, subcutaneous; SD, standard deviation.

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Important Information for the Healthcare Professional

This study discusses some information about FASENRA® (benralizumab) that is not contained in FDA-approved Prescribing Information. AstraZeneca manufactures and markets FASENRA and is the sponsor of and provided funding for this study. Some authors may have a financial interest in either FASENRA or AstraZeneca and/or may have received compensation from AstraZeneca in connection with this study or other engagements. AstraZeneca recommends use of FASENRA only in accordance with its approved Prescribing Information. Prescription drugs used outside of an approved indication may not be eligible for reimbursement by third-party payers, including Medicare or Medicaid.

In connection with the discussions contained in the reprint, please note:

  • The study evaluated FASENRA's treatment effect using an open-label, single-arm study design and did not include a control group to adjust for potential changes not due to treatment
  • Patients did not undergo an oral corticosteroid dosage-optimization phase and prednisolone levels were only assessed at baseline in patients who switched from another oral corticosteroid and were not assessed during the study duration
  • This study was conducted in an adult population, and the results cannot be extrapolated to children and adolescents

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    YOU ARE ABOUT TO LEAVE FASENRAHCP.COM

    Important Information for the Healthcare Professional

    This study discusses some information about FASENRA® (benralizumab) that is not contained in FDA-approved Prescribing Information. AstraZeneca manufactures and markets FASENRA and is the sponsor of and provided funding for this study. Some authors may have a financial interest in either FASENRA or AstraZeneca and/or may have received compensation from AstraZeneca in connection with this study or other engagements. AstraZeneca recommends use of FASENRA only in accordance with its approved Prescribing Information. Prescription drugs used outside of an approved indication may not be eligible for reimbursement by third-party payers, including Medicare or Medicaid.

    In connection with the discussions contained in the reprint, please note:

  • The study evaluated FASENRA's treatment effect using an open-label, single-arm study design and did not include a control group to adjust for potential changes not due to treatment
  • Patients did not undergo an oral corticosteroid dosage-optimization phase and prednisolone levels were only assessed at baseline in patients who switched from another oral corticosteroid and were not assessed during the study duration
  • This study was conducted in an adult population, and the results cannot be extrapolated to children and adolescents

    • Would you like to continue to an external link?

    Continue
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    YOU ARE ABOUT TO LEAVE FASENRAHCP.COM

    Important Information for the Healthcare Professional

    This study discusses some information about FASENRA® (benralizumab) that is not contained in FDA-approved Prescribing Information. AstraZeneca manufactures and markets FASENRA and is the sponsor of and provided funding for this study. Some authors may have a financial interest in either FASENRA or AstraZeneca and/or may have received compensation from AstraZeneca in connection with this study or other engagements. AstraZeneca recommends use of FASENRA only in accordance with its approved Prescribing Information. Prescription drugs used outside of an approved indication may not be eligible for reimbursement by third-party payers, including Medicare or Medicaid.

    In connection with the discussions contained in the reprint, please note:

  • The study evaluated FASENRA's treatment effect using an open-label, single-arm study design and did not include a control group to adjust for potential changes not due to treatment
  • Patients did not undergo an oral corticosteroid dosage-optimization phase and prednisolone levels were only assessed at baseline in patients who switched from another oral corticosteroid and were not assessed during the study duration
  • This study was conducted in an adult population, and the results cannot be extrapolated to children and adolescents

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    Continue
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    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.

    Acute Asthma Symptoms or Deteriorating Disease

    FASENRA should not be used to treat acute asthma symptoms, acute exacerbations, or acute bronchospasm.

    Reduction of Corticosteroid Dosage

    Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with FASENRA. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.

    Parasitic (Helminth) Infection

    It is unknown if FASENRA will influence a patient’s response against helminth infections. Treat patients with pre-existing helminth infections before initiating therapy with FASENRA. If patients become infected while receiving FASENRA and do not respond to anti-helminth treatment, discontinue FASENRA until infection resolves.

    ADVERSE REACTIONS

    The most common adverse reactions (incidence ≥ 5%):

    • Asthma: headache, pharyngitis
    • EGPA: headache
    • HES: headache, hypersensitivity reactions, influenza-like illness

    Injection site reactions (eg, pain, erythema, pruritus, papule) occurred at a rate of 2.2% in patients treated with FASENRA compared with 1.9% in patients treated with placebo in asthma exacerbation studies.

    USE IN SPECIFIC POPULATIONS

    A pregnancy exposure registry monitors pregnancy outcomes in women exposed to FASENRA during pregnancy. To enroll call 1-877-311-8972 or visit www.mothertobaby.org/fasenra.

    The data on pregnancy exposure from the clinical trials are insufficient to inform on drug-associated risk. Monoclonal antibodies such as benralizumab are transported across the placenta during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy.

    INDICATIONS

    FASENRA is indicated for:

    • the add-on maintenance treatment of patients with severe asthma aged 6 years and older and with an eosinophilic phenotype. FASENRA is not indicated for the relief of acute bronchospasm or status asthmaticus
    • the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA)
    • the treatment of adult and adolescent patients aged 12 years and older with hypereosinophilic syndrome (HES) without an identifiable non-hematologic secondary cause

    Please read full Prescribing Information, including Patient Information.

    Please read full Prescribing Information, including Patient Information.

    You may report side effects related to AstraZeneca products .

    IMPORTANT SAFETY INFORMATION

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    References

    Reference

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    1. Skolnik NS, Carnahan SP. Primary care of asthma: new options for severe eosinophilic asthma. Curr Med Res Opin. 2019;35(7):1309-1318. 2. Global Initiative for Asthma. 2025 GINA Report, Global Strategy for Asthma Management and Prevention. Accessed May 27, 2025. https://ginasthma.org/reports 3. Bleecker ER, FitzGerald JM, Chanez P, et al; SIROCCO study investigators. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting β2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016;388(10056):2115-2127. 4. Tran TN, Zeiger RS, Peters SP, et al. Overlap of atopic, eosinophilic, and TH2-high asthma phenotypes in a general population with current asthma. Ann Allergy Asthma Immunol. 2016;116(1):37-42.

    1. Data on File, US-94507, AZPLP.

    1. FASENRA® (benralizumab) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; April2024 .

    1. Data on File, REF-211303, AZPLP. 2. Jackson DJ, Pelaia G, Emmanuel B, et al. Benralizumab in severe eosinophilic asthma by previous biologic use and key clinical subgroups: real-world XALOC-1 programme. Eur Respir J. 2024;64(1):2301521. 3. Carstens D, Maselli DJ, Mu F, et al. Real-world effectiveness study of benralizumab for severe eosinophilic asthma: ZEPHYR 2. J Allergy Clin Immunol Pract. 2023;11(7):2150-2161.e4. 4. FASENRA® (benralizumab) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; September 2024. 5. Bleecker ER, FitzGerald JM, Chanez P, et al; SIROCCO study investigators. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting ß2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016;388(10056):2115-2127. 6. Penz E, Rothe T, Dupont L, et al. Early and sustained asthma control and remission in real-world patients with severe eosinophilic asthma treated with benralizumab: XALOC-2. Clin Exp Allergy. Published online October 29, 2025. doi:10.1111/cea.70162 7. Penz E, Rothe T, Dupont L, et al. Early and sustained asthma control and remission in real-world patients with severe eosinophilic asthma treated with benralizumab: XALOC-2. Supplemental materials. Clin Exp Allergy. Published online October 29, 2025. doi:10.1111/cea.70162

    1. FASENRA® (benralizumab) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; September 2024. 2. Bleecker ER, FitzGerald JM, Chanez P, et al; SIROCCO study investigators. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting ß2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016;388(10056):2115-2127. 3. FitzGerald JM, Bleecker ER, Nair P, et al; CALIMA study investigators. Benralizumab, an anti-interleukin-5 receptor α monoclonal antibody, as add-on treatment for patients with severe, uncontrolled, eosinophilic asthma (CALIMA): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2016;388(10056):2128-2141. 4. Nair P, Wenzel S, Rabe KF, et al. Oral glucocorticoid–sparing effect of benralizumab in severe asthma. N Engl J Med. 2017;376(25):2448-2458. 5. Busse WW, Bleecker ER, FitzGerald JM, et al; BORA study investigators. Long-term safety and efficacy of benralizumab in patients with severe, uncontrolled asthma: 1-year results from the BORA phase 3 extension trial. Lancet Respir Med. 2019;7(1):46 -59. 6. Korn S, Bourdin A, Chupp G, et al. Integrated safety and efficacy among patients receiving benralizumab for up to 5 years. J Allergy Clin Immunol Pract. 2021;9(12):4381-4392.e4. 7. Menzies-Gow A, Gurnell M, Heaney LG, et al. Oral corticosteroid elimination via a personalised reduction algorithm in adults with severe, eosinophilic asthma treated with benralizumab (PONENTE): a multicentre, open-label, single-arm study. Lancet Respir Med. 2022;10(1):47-58. 8. Menzies-Gow A, Corren J, Bel EH, et al. Corticosteroid tapering with benralizumab treatment for eosinophilic asthma: PONENTE trial. ERJ Open Res. 2019;5(3):00009-2019. 9. Menzies-Gow A, Gurnell M, Heaney LG, et al. Adrenal function recovery after durable oral corticosteroid sparing with benralizumab in the PONENTE study. Eur Respir J. 2022;60(6):2103226. 10. Data on File, REF -211303, AZPLP. 11. Jackson DJ, Pelaia G, Emmanuel B, et al. Benralizumab in severe eosinophilic asthma by previous biologic use and key clinical subgroups: real-world XALOC-1 programme. Eur Respir J. 2024;64(1):2301521. 12. Carstens D, Maselli DJ, Mu F, et al. Real-world effectiveness study of benralizumab for severe eosinophilic asthma: ZEPHYR 2. J Allergy Clin Immunol Pract. 2023;11(7):2150-2161.e4. 13. Penz E, Rothe T, Dupont L, et al. Early and sustained asthma control and remission in real-world patients with severe eosinophilic asthma treated with benralizumab: XALOC-2. Clin Exp Allergy. Published online October 29, 2025. doi:10.1111/cea.70162 14. Penz E, Rothe T, Dupont L, et al. Early and sustained asthma control and remission in real-world patients with severe eosinophilic asthma treated with benralizumab: XALOC-2. Supplemental materials. Clin Exp Allergy. Published online October 29, 2025. doi:10.1111/cea.70162

    1. FASENRA® (benralizumab) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; September 2024. 2. Korn S, Bourdin A, Chupp G, et al. Integrated safety and efficacy among patients receiving benralizumab for up to 5 years. J Allergy Clin Immunol Pract. 2021;9(12):4381-4392.e4. 3. Data on File, US-103275, AZPLP. 4. ClinicalTrials.gov [Internet]. National Library of Medicine (US). Identifier NCT00783289 ClinicalTrials.gov website. Accessed July 10, 2025. https://clinicaltrials.gov/ct2/show/NCT00783289

    1. FASENRA® (benralizumab) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; September 2024. 2. Ferguson GT, Cole J, Aurivillius M, Roussel P, Barker P, Martin UJ; GRECO study investigators. Single-use autoinjector functionality and reliability for at-home administration of benralizumab for patients with severe asthma: GRECO trial results. J Asthma Allergy. 2019;12:363-373.

    1. FASENRA® (benralizumab) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; April 2024. 2. Bleecker ER, FitzGerald JM, Chanez P, et al; SIROCCO study investigators. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting ß2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016;388(10056):2115-2127. 3. FitzGerald JM, Bleecker ER, Nair P, et al; CALIMA study investigators. Benralizumab, an anti-interleukin-5 receptor α monoclonal antibody, as add-on treatment for patients with severe, uncontrolled, eosinophilic asthma (CALIMA): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2016;388(10056):2128-2141.

    1. Formulary data are provided by Fingertip Formulary® and are current as of October 6, 2025.