MOVE FORWARD WITH FASENRA

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Potential presentation of an ANCA-negative patient

  • History of severe asthma, including multiple severe asthma exacerbations despite taking high-dose ICS/LABA

  • Evidence of other organ involvement, including cardiomyopathy and peripheral neuropathy in feet and hands

  • bEOS: 345 cells/μL

  • 2000 cells/μL prior to OCS use

  • Active vasculitis symptoms

  • Uses OCS (12 mg/day) and cyclophosphamide (1.5 mg/kg, daily)

Hypothetical Patient
ANCA Negative EGPA Patient
ANCA Negative EGPA Patient

Potential presentation of an ANCA-positive patient

  • History of asthma with progressive and persistent respiratory symptoms

  • Recent hospitalization with a severe asthma exacerbation

  • Ongoing symptoms of chronic rhinosinusitis

  • Developed purpuric rash with biopsy showing leukocytoclastic small-vessel vasculitis

  • bEOS: 290 cells/μL

  • 1249 cells/μL prior to OCS use

  • Active vasculitis symptoms

  • Uses a high-dose ICS/LABA and 8
    mg/day of OCS

Hypothetical Patient
ANCA Positive EGPA Patient
ANCA Positive EGPA Patient

Identifying patients with EGPA

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2022 ACR/EULAR Classification Criteria for EGPA1

ACR/EULAR suggest these criteria may be applied only when a diagnosis of small- or medium-vessel vasculitis has been made.

In addition, exclude any diagnoses mimicking vasculitis prior to applying these criteria.1

Clinical Criteria

Score

Obstructive airway disease

+3

Nasal polyps

+3

Mononeuritis multiplex

+1

Lab and Biopsy Criteria

Score

Blood eosinophil count ≥1 x 109/liter

+5

Extravascular eosinophilic-predominant inflammation on biopsy

+2

Positive test for cytoplasmic antineutrophil cytoplasmic antibodies (cANCA) or antiproteinase 3 (anti-PR3) antibodies

-3

Hematuria

-1

ACR/EULAR classification criteria state that a score of ≥6 points suggests a classification of EGPA with a sensitivity of 85% and specificity of 99%1

While EGPA is an AAV, the majority of patients with EGPA are ANCA negative. About 30-47% of EGPA cases are ANCA positive, which is more commonly associated with vasculitic damage. Pathogenesis and roles of ANCA in EGPA are still unknown.2–5

AAV, antineutrophil cytoplasmic antibody-associated vasculitis; ACR, American College of Rheumatology; ANCA, antineutrophil cytoplasmic antibody; bEOS, blood eosinophil; EULAR, European Alliance of Associations for Rheumatology; ICS, inhaled corticosteroid; LABA, long-acting beta-agonist; OCS, oral corticosteroid.

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

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.

Pediatrics: The safety and efficacy of FASENRA in asthma patients less than 6 and in EGPA patients less than 18 years of age has not been established.

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

1. FASENRA® (benralizumab) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2026. 2. Wechsler ME, Nair P, Terrier B, et al; MANDARA Study Group. Benralizumab versus mepolizumab for eosinophilic granulomatosis with polyangiitis. N Engl J Med. 2024;390(10):911-921.

1. Fagni F, Bello F, Emmi G. Eosinophilic granulomatosis with polyangiitis: dissecting the pathophysiology. Front Med (Lausanne). 2021;8:627776. 2. Khoury P, Grayson PC, Klion AD. Eosinophils in vasculitis: characteristics and roles in pathogenesis. Nat Rev Rheumatol. 2014;10(8):474-483. 3. Emmi G, Bettiol A, Gelain E, et al. Evidence-based guideline for the diagnosis and management of eosinophilic granulomatosis with polyangiitis. Nat Rev Rheumatol. 2023;19(6):378-393. 4. Matucci A, Vivarelli E, Perlato M, et al. EGPA phenotyping: not only ANCA, but also eosinophils. Biomedicines. 2023;11(3):776. 5. Furuta S, Iwamoto T, Nakajima H. Update on eosinophilic granulomatosis with polyangiitis. Allergol Int. 2019;68(4):430-436. 6. Chakraborty RK, Rout P. Eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome). In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025. Updated September 19, 2024. Accessed July 8, 2025. https://www.ncbi.nlm.nih.gov/books/NBK537099/ 7. Baldini C, Talarico R, Della Rossa A, Bombardieri S. Clinical manifestations and treatment of Churg-Strauss syndrome. Rheum Dis Clin North Am. 2010;36(3):527-543.

1. FASENRA® (benralizumab) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; September 2024.

1. FASENRA® (benralizumab) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; September 2024. 2. Wechsler ME, Nair P, Terrier B, et al; MANDARA Study
Group. Benralizumab versus mepolizumab for eosinophilic granulomatosis with polyangiitis. N Engl J Med. 2024;390(10):911-921. 3. Merkel PA, Nair PK, Khalidi N, et al; MANDARA Study Group. Two-year efficacy and safety of anti-interleukin-5/receptor therapy for eosinophilic granulomatosis with polyangiitis. Ann Rheum Dis. 2025;84(11):1888-1899. doi:10.1016/j.ard.2025.06.2131 4. Merkel PA, Nair PK, Khalidi N, et al; MANDARA Study Group. Two-year efficacy and safety of anti-interleukin-5/receptor therapy for eosinophilic granulomatosis with polyangiitis. Ann Rheum Dis. 2025;(suppl). doi:10.1016/j.ard.2025.06.2131

1. Grayson PC, Ponte C, Suppiah R, et al. 2022 American College of Rheumatology/European Alliance of Associations for Rheumatology classification criteria for eosinophilic granulomatosis with polyangiitis. Ann Rheum Dis. 2022;81(3):309-314. 2. Jennette JC, Falk RJ, Bacon PA, et al. 2012 revised International Chapel Hill Consensus Conference nomenclature of vasculitides. Arthritis Rheum. 2013;65(1):1-11. 3. Furuta S, Iwamoto T, Nakajima H. Update on eosinophilic granulomatosis with polyangiitis. Allergol Int. 2019;68(4):430-436. 4. Chakraborty RK, Rout P. Eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome). In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025. Updated September 19, 2024. Accessed July 8, 2025. https://www.ncbi.nlm.nih.gov/books/NBK537099/ 5. Trivioli G, Terrier B, Vaglio A. Eosinophilic granulomatosis with polyangiitis: understanding the disease and its management. Rheumatology (Oxford). 2020;59(suppl 3):iii84-iii94.

1. FASENRA® (benralizumab) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; September 2024. 2. Wechsler ME, Nair P, Terrier B, et al; MANDARA Study Group. Benralizumab versus mepolizumab for eosinophilic granulomatosis with polyangiitis. N Engl J Med. 2024;390(10):911-921. 3. Wechsler ME, Nair P, Terrier B, et al; MANDARA Study Group. Benralizumab versus mepolizumab for eosinophilic granulomatosis with polyangiitis. N Engl J Med. 2024;390(10)(suppl):1-46. 4.
Merkel PA, Nair PK, Khalidi N, et al; MANDARA Study Group. Two-year efficacy and safety of anti-interleukin-5/receptor therapy for eosinophilic granulomatosis with polyangiitis. Ann Rheum Dis. 2025;84(11):1888-1899. doi:10.1016/j.ard.2025.06.2131

1. FASENRA® (benralizumab) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; September 2024. 2. Wechsler ME, Nair P, Terrier B, et al; MANDARA Study Group. Benralizumab versus mepolizumab for eosinophilic granulomatosis with polyangiitis. N Engl J Med. 2024;390(10):911-921. 3. Merkel PA, Nair PK, Khalidi N, et al; MANDARA Study Group. Two-year efficacy and safety of anti-interleukin-5/receptor therapy for eosinophilic granulomatosis with polyangiitis. Ann Rheum Dis. 2025;84(11):1888-1899. doi:10.1016/j.ard.2025.06.2131 4. Wechsler ME, Nair P, Terrier B, et al; MANDARA Study Group. Benralizumab versus mepolizumab for eosinophilic granulomatosis with polyangiitis. N Engl J Med. 2024;390(10)(suppl):1-46.

1. FASENRA® (benralizumab) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; September 2024. 2. Wechsler ME, Nair P, Terrier B, et al; MANDARA Study Group. Benralizumab versus mepolizumab for eosinophilic granulomatosis with polyangiitis. N Engl J Med. 2024;390(10):911-921. 3. Wechsler ME, Nair P, Terrier B, et al; MANDARA Study Group. Benralizumab versus mepolizumab for eosinophilic granulomatosis with polyangiitis. N Engl J Med. 2024;390(10)(suppl):1-46.

1. FASENRA® (benralizumab) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; September 2024. 2. Wechsler ME, Nair P, Terrier B, et al; MANDARA Study Group. Benralizumab versus mepolizumab for eosinophilic granulomatosis with polyangiitis. N Engl J Med. 2024;390(10):911-921. 3. Data on File, US-103275, AZPLP. 4. Merkel PA, Nair PK, Khalidi N, et al; MANDARA Study Group. Two-year efficacy and safety of anti-interleukin-5/receptor therapy for eosinophilic granulomatosis with polyangiitis. Ann Rheum Dis. 2025;84(11):1888-1899. doi:10.1016/j.ard.2025.06.2131

1. FASENRA® (benralizumab) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; September 2024. 2. Wechsler ME, Nair P, Terrier B, et al; MANDARA Study Group. Benralizumab versus mepolizumab for eosinophilic granulomatosis with polyangiitis. N Engl J Med. 2024;390(10):911-921. 3. Nucala® (mepolizumab) [package insert]. Philadelphia, PA: GlaxoSmithKline LLC; August 2025.