Exacerbations & Lung Function

Consistent asthma exacerbation rate data at blood eosinophil counts ≥150 and ≥300 cells/μL1-4

Annual asthma exacerbation rates were less than 1

SIROCCO (48 weeks)

≥150 cells/μL*1

≥300 cells/μL2-4

Reduction in asthma exacerbation rate with FASENRA chart
Reduction in asthma exacerbation rate with FASENRA chart

AER with FASENRA was 0.65 vs 0.98 with
placebo + SOC in CALIMA (56 weeks)*1
FASENRA (n=309); Placebo (n=324)
*The analyses of these endpoints were not multiplicity protected. Results are descriptive only.

Reduction in asthma exacerbation rate with FASENRA chart

AER with FASENRA was 0.73 vs 1.01 with
placebo + SOC in CALIMA (56 weeks, P=0.019)2,4
FASENRA (n=239); Placebo (n=248)

In SIROCCO and CALIMA, FASENRA and placebo were administered plus standard of care (SOC), which is defined as high-dose ICS/LABA (inhaled corticosteroids/long-acting ß2-agonist) with or without other controllers, including systemic steroids. The primary endpoint for SIROCCO and CALIMA was the rate of asthma exacerbations in patients with baseline blood eosinophil counts ≥300 cells/μL who were taking high-dose ICS and LABA.2

Annual exacerbation rate (AER) was defined as the total number of exacerbations multiplied by 365.25, divided by the total duration of follow-up (days) within the treatment group.

Asthma exacerbation prevention data over 2 years5,6

In patients who continued on FASENRA Q8W from SIROCCO and CALIMA into BORA

Asthma exacerbation rate data from baseline in Years 1 and 2‡5

Exacerbation prevention with FASENRA chart Exacerbation prevention with FASENRA chart

The analyses of these endpoints were not multiplicity protected. Results are descriptive only.

Annual exacerbation rate (AER) was defined as the total number of exacerbations multiplied by 365.25, divided by the total duration of follow-up (days) within the treatment group.

Patients who had baseline blood eosinophil counts ≥300 cells/μL, receiving high-dose ICS/LABA, and who received FASENRA 30 mg Q8W during SIROCCO, CALIMA, and BORA.5

§Exacerbation rate over the year before pivotal study entry.5

People Icon

74% of patients who continued on Q8W dosing from SIROCCO or CALIMA into BORA (56 weeks) had 0 exacerbations∥6

The analysis of this endpoint was not multiplicity protected. Results are descriptive only.

In BORA, patients from SIROCCO and CALIMA were to be maintained on their same dose of ICS/LABA.6

In patients with baseline blood eosinophil counts ≥300 cells/μL in SIROCCO and CALIMA who continued on FASENRA every 8 weeks (n=339).6

Better breathing after the first dose¶2-4,7

Improvement in lung function was seen as early as Week 4 and was sustained through Year 1¶2-4,7

Improvement in lung function at week 4 chart Improvement in lung function at week 4 chart

FASENRA is not indicated for the relief of acute bronchospasm or status asthmaticus.

In CALIMA, significant improvement in FEV1 for FASENRA + SOC (330 mL; n=238) was 116 mL greater than placebo + SOC (215 mL; n=244), with FASENRA + SOC showing a 19% improvement from mean baseline FEV1 of 1.76 L (P=0.010).2,4

FASENRA and placebo were administered plus standard of care (SOC), which is defined as high-dose ICS/LABA (inhaled corticosteroids/long-acting β2-agonist) with or without other controllers, including systemic steroids.2

Better breathing maintained over 2 years2-5,8

Impact on lung function over 2 years with FASENRA compared to baseline FEV1#5,8

Lung function preservation chart Lung function preservation chart

The analyses of these endpoints were not multiplicity protected. Results are descriptive only.

#Pooled analysis of adult (treated with high-dose ICS/LABA) and adolescent (treated with medium- to high-dose ICS/LABA) patients with severe asthma and baseline blood eosinophil counts ≥300 cells/μL in SIROCCO and CALIMA randomized to treatment with FASENRA 30 mg SC Q8W. BORA Week 56 results are adults only.5

**Statistical significance for FEV1 improvement was established at end of treatment. Week 4 results were descriptive only. FASENRA demonstrated greater improvements in change from baseline in pre-bronchodilator FEV1 compared with placebo at Week 4 (first measured time point after administration of treatment dose) that were maintained through end of treatment.3,4,7

††End of treatment (EOT) pooled results from Week 48 for SIROCCO and Week 56 for CALIMA.5

Reduction in rescue medication use observed as early as Day 39

Inhaler with Percentage Icon Inhaler with Percentage Icon

Reduction in rescue medication use observed as early as Day 39

78% greater reduction in mean rescue medication use at Day 3 in patients who received FASENRA + SOC9

(-0.89 puffs/day; n=486) compared to placebo + SOC (-0.50 puffs/day; n=498)‡‡9

32% greater reduction in mean rescue medication use at end of treatment for FASENRA

(-2.93 puffs/day; n=500) compared to placebo + SOC (-2.23 puffs/day; n=514)‡‡9

The analyses of these endpoints were not multiplicity protected. Results are descriptive only.

‡‡Results from a post hoc, pooled analysis of patients from SIROCCO and CALIMA with baseline blood eosinophil counts ≥300 cell/µL who received FASENRA 30 mg SC every 8 weeks or placebo. Mean baseline rescue medication use was 4.4 puff/day for FASENRA and 5.1 puffs/day for placebo. Reductions are least-squares mean changes from baseline.9

Please see full study descriptions for SIROCCO, CALIMA, and BORA.

Comorbid Conditions

AER* data vs placebo for patients with comorbid nasal polyps by baseline blood eosinophil counts10

Percentage of annual exacerbation rate reduction with FASENRA compared with placebo in a pooled
subgroup analysis of patients in SIROCCO and CALIMA

SIROCCO and CALIMA: pooled post hoc analysis10

Annual exacerbation rates in patients with nasal polyps chart Annual exacerbation rates in patients with nasal polyps chart

The analyses of these endpoints were not multiplicity protected. Results are descriptive only.

Full analysis set:

In a separate modeling scenario, exacerbation rate reduction in the full analysis set was 27% for patients on FASENRA with blood eosinophil counts <300 cells/μL and 42% for patients on FASENRA with blood eosinophil counts ≥300 cells/μL.10

In SIROCCO and CALIMA, FASENRA and placebo were administered plus standard of care (SOC), which is defined as high-dose ICS/LABA (inhaled corticosteroids/long-acting ß2-agonist) with or without other controllers, including systemic steroids.2

*Annual exacerbation rate (AER) was defined as the total number of exacerbations multiplied by 365.25, divided by the total duration of follow-up (days) within the treatment group.

AER* data in patients with serum IgE >30 - ≤700 kU/L and blood eosinophil counts ≥300 cells/µL at baseline11-13

Post hoc subanalysis: SIROCCO (48 weeks)11,13

Annual exacerbation rates across IgE levels chart Annual exacerbation rates across IgE levels chart

The analyses of these endpoints were not multiplicity protected. Results are descriptive only.

CALIMA (56 weeks): In a post hoc subanalysis of patients with serum IgE >30 to ≤700 kU/L, FASENRA + SOC (0.63; n=167) reduced AER* by 39% compared to placebo + SOC (1.04; n=183).12,13

In SIROCCO and CALIMA, FASENRA and placebo were administered plus standard of care (SOC), which is defined as high-dose ICS/LABA (inhaled corticosteroids/long-acting β2-agonist) with or without other controllers, including systemic steroids.2

Please see full study descriptions for SIROCCO and CALIMA.

*Annual exacerbation rate (AER) was defined as the total number of exacerbations multiplied by 365.25, divided by the total duration of follow-up (days) within the treatment group.

OCS Dependent

OCS reduction in patients with OCS dependence and blood eosinophil counts ≥150 cells/μL2,14

In ZONDA (Trial 3), the primary endpoint was median percent reduction from baseline in final OCS dose while maintaining asthma control. OCS-dependent patients were defined as those requiring daily OCS.2

75 Percent Reduction Icon

in median OCS dose compared to 25% reduction with placebo + SOC in ZONDA (28 weeks)2

FASENRA (n=73) Placebo (n=75) (P<0.001)14

52 Percent Icon 52 Percent Icon

Patients who were optimized to OCS doses ≤12.5 mg compared to placebo + SOC (19%) in ZONDA (28 weeks)*2,14

FASENRA (n=42) Placebo (n=42)

*The analysis of this endpoint was not multiplicity protected. Results are descriptive only.

Exacerbation data for OCS-dependent patients with blood eosinophil counts ≥150 cells/µL2,14,15

70 Percent Icon

in AER (0.54) compared to placebo + SOC (1.83) in ZONDA (28 weeks)14

FASENRA (n=73) Placebo (n=75)

Hospital Icon Hospital Icon

(0.02) compared to placebo + SOC (0.32) in ZONDA (28 weeks)2,14,15

FASENRA (n=73) Placebo (n=75)

The analyses of these endpoints were not multiplicity protected. Results are descriptive only.

Exacerbations (defined as an increase in OCS dose ≥3 days or an ER visit/hospitalization) were evaluated in the context of a population on daily OCS.

In ZONDA, FASENRA and placebo were administered in addition to daily OCS (7.5 to 40 mg) plus SOC, which is defined as high-dose ICS/LABA with or without other controllers.2

Please see full study description for ZONDA.

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%) include headache and pharyngitis.

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.

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.

INDICATION

FASENRA is indicated for the 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
  • FASENRA is not indicated for the relief of acute bronchospasm or status asthmaticus

Please read full Prescribing Information, including Patient Information.

You may report side effects related to AstraZeneca products by clicking here.

References: 1. FASENRA [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; October 2019. 2. Bleecker ER, FitzGerald JM, Chanez P, et al. 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;388:2115-2127. 3. FitzGerald JM, Bleecker ER, Nair P, et al. 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;388:2128-2141. 4. FitzGerald JM, Bleecker ER, Bourdin A, et al. Two-year integrated efficacy and safety analysis of benralizumab SIROCCO, CALIMA, ZONDA, and BORA trials in severe asthma. Presented at: the American Thoracic Society (ATS) International Conference; May 17-22, 2019; Dallas, TX. 5. Busse WW, Bleecker ER, FitzGerald JM, et al. 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;7:46-59. 6. Data on File, REF-51332, AZPLP. 7. Pham TH, Damera G, Newbold P, Ranade K. Reductions in eosinophil biomarkers by benralizumab in patients with asthma. Respir Med. 2016;111:21-29. 8. Data on File, REF-28001, AZPLP.

References: 1. FASENRA [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; October 2019. 2. Pham TH, Damera G, Newbold P, Ranade K. Reductions in eosinophil biomarkers by benralizumab in patients with asthma. Respir Med. 2016;111:21-29. 3. Data on File, REF-28001, AZPLP. 4. Busse WW, Bleecker ER, FitzGerald JM, et al. 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;7:46-59. 5. Busse WW, Bleecker ER, FitzGerald JM, et al. Supplementary Appendix to: 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;7:46-59. 6. Nair P, Wenzel S, Rabe KF, et al. Supplementary Appendix to: Oral glucocorticoid–sparing effect of benralizumab in severe asthma. N Engl J Med. 2017;376:2448-2458.

References: 1. Data on File, REF-51332, AZPLP. 2. de Groot JC, Storm H, Amelink M, et al. Clinical profile of patients with adult-onset eosinophilic asthma. ERJ Open Res. 2016;2(2):00100-2015. 3. de Groot JC, ten Brinke A, Bel EH. Management of the patient with eosinophilic asthma: a new era begins. ERJ Open Res. 2015;1:00024-2015. 4. Price DB, Rigazio A, Campbell JD, et al. Blood eosinophil count and prospective annual asthma disease burden: a UK cohort study. Lancet Respir Med. 2015;3:849-858. 5. Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention, 2019. https://ginasthma.org/wp-content/uploads/2019-main-report-June-2019-wms.pdf. 6. Skolnik NS, Carnahan SP. Primary care of asthma: new options for severe eosinophilic asthma. Curr Med Res Opin. 2019;35:1309-1318. 7. 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. 8. Carr TF, Berdnikovs S, Simon H-U, et al. Eosinophilic bioactivities in severe asthma. World Allergy Organ J. 2016;9:21. 9. Ortega H, Llanos J-P, Lafeuille M-H, et al. Effects of systemic corticosteroids on blood eosinophil counts in asthma: real-world data. J Asthma. 2019;56(8):808-815. 10. FASENRA [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; October 2019.

References: 1. Data on File, REF-60828, AZPLP. 2. FASENRA [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; October 2019. 3. Bleecker ER, FitzGerald JM, Chanez P, et al. 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;388:2115-2127. 4. FitzGerald JM, Bleecker ER, Nair P, et al. 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;388:2128-2141. 5. FitzGerald JM, Bleecker ER, Bourdin A, et al. Two-year integrated efficacy and safety analysis of benralizumab SIROCCO, CALIMA, ZONDA, and BORA trials in severe asthma. Presented at: the American Thoracic Society (ATS) International Conference; May 17-22, 2019; Dallas, TX. 6. Busse WW, Bleecker ER, FitzGerald JM, et al. 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;7:46-59. 7. Data on File, REF-19697, AZPLP. 8. Data on File, REF-59636, AZPLP. 9. O’Quinn S, Xu X, Hirsch I. Rescue medication use reduction with benralizumab for patients with severe, uncontrolled eosinophilic asthma. Ann Allergy Asthma Immunol. 2018;121:S18-S21. 10. Bleecker ER, Wechsler M, FitzGerald JM, et al. Baseline patient factors impact on the clinical efficacy of benralizumab for severe asthma. Eur Respir J. 2018;52:1800936. 11. Bleecker ER, FitzGerald JM, Chanez P, et al. Appendix to: 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;388:2115-2127. 12. FitzGerald JM, Bleecker ER, Nair P, et al. Appendix to: 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;388:2128-2141. 13. Data on File, REF-19698, AZPLP. 14. Nair P, Wenzel S, Rabe KF, et al. Oral glucocorticoid–sparing effect of benralizumab in severe asthma. N Engl J Med. 2017;376:2448-2458. 15. Nair P, Wenzel S, Rabe KF, et al. Supplementary Appendix to: Oral glucocorticoid–sparing effect of benralizumab in severe asthma. N Engl J Med. 2017;376:2448-2458.

References: 1. Data on File, REF-60828, AZPLP. 2. FASENRA [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; October 2019. 3. Bleecker ER, FitzGerald JM, Chanez P, et al. 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;388:2115-2127. 4. FitzGerald JM, Bleecker ER, Nair P, et al. 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;388:2128-2141. 5. FitzGerald JM, Bleecker ER, Bourdin A, et al. Two-year integrated efficacy and safety analysis of benralizumab SIROCCO, CALIMA, ZONDA, and BORA trials in severe asthma. Presented at: the American Thoracic Society (ATS) International Conference; May 17-22, 2019; Dallas, TX. 6. Busse WW, Bleecker ER, FitzGerald JM, et al. 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;7:46-59. 7. Data on File, REF-19697, AZPLP. 8. Data on File, REF-59636, AZPLP. 9. O’Quinn S, Xu X, Hirsch I. Rescue medication use reduction with benralizumab for patients with severe, uncontrolled eosinophilic asthma. Ann Allergy Asthma Immunol. 2018;121:S18-S21. 10. Bleecker ER, Wechsler M, FitzGerald JM, et al. Baseline patient factors impact on the clinical efficacy of benralizumab for severe asthma. Eur Respir J. 2018;52:1800936. 11. Bleecker ER, FitzGerald JM, Chanez P, et al. Appendix to: 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;388:2115-2127. 12. FitzGerald JM, Bleecker ER, Nair P, et al. Appendix to: 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;388:2128-2141. 13. Data on File, REF-19698, AZPLP. 14. Nair P, Wenzel S, Rabe KF, et al. Oral glucocorticoid–sparing effect of benralizumab in severe asthma. N Engl J Med. 2017;376:2448-2458. 15. Nair P, Wenzel S, Rabe KF, et al. Supplementary Appendix to: Oral glucocorticoid–sparing effect of benralizumab in severe asthma. N Engl J Med. 2017;376:2448-2458.

References: 1. Data on File, REF-60828, AZPLP. 2. FASENRA [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; October 2019. 3. Bleecker ER, FitzGerald JM, Chanez P, et al. 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;388:2115-2127. 4. FitzGerald JM, Bleecker ER, Nair P, et al. 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;388:2128-2141. 5. FitzGerald JM, Bleecker ER, Bourdin A, et al. Two-year integrated efficacy and safety analysis of benralizumab SIROCCO, CALIMA, ZONDA, and BORA trials in severe asthma. Presented at: the American Thoracic Society (ATS) International Conference; May 17-22, 2019; Dallas, TX. 6. Busse WW, Bleecker ER, FitzGerald JM, et al. 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;7:46-59. 7. Data on File, REF-19697, AZPLP. 8. Data on File, REF-59636, AZPLP. 9. O’Quinn S, Xu X, Hirsch I. Rescue medication use reduction with benralizumab for patients with severe, uncontrolled eosinophilic asthma. Ann Allergy Asthma Immunol. 2018;121:S18-S21. 10. Bleecker ER, Wechsler M, FitzGerald JM, et al. Baseline patient factors impact on the clinical efficacy of benralizumab for severe asthma. Eur Respir J. 2018;52:1800936. 11. Bleecker ER, FitzGerald JM, Chanez P, et al. Appendix to: 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;388:2115-2127. 12. FitzGerald JM, Bleecker ER, Nair P, et al. Appendix to: 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;388:2128-2141. 13. Data on File, REF-19698, AZPLP. 14. Nair P, Wenzel S, Rabe KF, et al. Oral glucocorticoid–sparing effect of benralizumab in severe asthma. N Engl J Med. 2017;376:2448-2458. 15. Nair P, Wenzel S, Rabe KF, et al. Supplementary Appendix to: Oral glucocorticoid–sparing effect of benralizumab in severe asthma. N Engl J Med. 2017;376:2448-2458.

References: 1. FASENRA [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; November 2017. 2. Bleecker ER, FitzGerald JM, Chanez P, et al. 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;388:2115-2127. 3. FitzGerald JM, Bleecker ER, Nair P, et al. 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;388:2128-2141. 4. FitzGerald JM, Bleecker ER, Menzies-Gow A, et al. Predictors of enhanced response with benralizumab for patients with severe asthma: pooled analysis of the SIROCCO and CALIMA studies. Lancet Respir Med. 2018;6(1):56-64. 5. Bleecker ER, Wechsler M, FitzGerald JM, et al. Baseline patient factors impact on the clinical efficacy of benralizumab for severe asthma. Eur Respir J. 2018;52:1800936. 6. Bleecker ER, FitzGerald JM, Chanez P, et al. Appendix to: 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;388:2115-2127. 7. FitzGerald JM, Bleecker ER, Nair P, et al. Appendix to: 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;388:2128-2141. 8. Nair P, Wenzel S, Rabe KF, et al. Oral glucocorticoid–sparing effect of benralizumab in severe asthma. N Engl J Med. 2017;376:2448-2458. 9. Nair P, Wenzel S, Rabe KF, et al. Supplementary Appendix to: Oral glucocorticoid–sparing effect of benralizumab in severe asthma. N Engl J Med. 2017;376:2448-2458. 10. FitzGerald JM, Bleecker ER, Bourdin A, et al. Two-year integrated efficacy and safety analysis of benralizumab SIROCCO, CALIMA, ZONDA, and BORA trials in severe asthma. Presented at: the American Thoracic Society (ATS) International Conference; May 17-22, 2019; Dallas, TX. 11. Busse WW, Bleecker ER, FitzGerald JM, et al. 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;7:46-59. 12. Data on File, REF-19697, AZPLP. 13. O’Quinn S, Xu X, Hirsch I. Rescue medication use reduction with benralizumab for patients with severe, uncontrolled eosinophilic asthma. Ann Allergy Asthma Immunol. 2018;121:S18-S21. 14. Data on File, REF-52421, AZPLP.

References: 1. FASENRA [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; October 2019. 2. Nucala [package insert]. Research Triangle Park, NC: GlaxoSmithKline LLC; September 2019. 3. Xolair [package insert]. South San Francisco, CA: Genentech Inc; May 2019. 4. Dupixent [package insert]. Tarrytown, NY: Regeneron Pharmaceuticals, Inc. and sanofi-aventis U.S. LLC; June 2019. 5. Barker P, Ferguson GT, Cole J, et al. Single-use autoinjector functionality and reliability for at-home benralizumab administration: GRECO trial results. Presented at: the American Academy of Allergy, Asthma and Immunology (AAAAI) Congress; February 22-25, 2019; San Francisco, CA. Poster P289.

References: 1. FASENRA [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; October 2019. 2. Busse WW, Bleecker ER, FitzGerald JM, et al. 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;7:46-59.