Eosinophilic granulomatosis with polyangiitis (EGPA), formerly known as Churg-Strauss Syndrome, is a rare autoimmune disorder characterized by necrotizing vasculitis of small-to medium-sized blood vessels and eosinophilic infiltration into tissues and organs. Symptoms of EGPA can vary in patients and may include shortness of breath, sinus problems including nasal polyps, rashes, neuropathy, and fatigue.1-3 It can be difficult to recognize EGPA because the clinical presentation can be very heterogeneous.
While the exact incidence and prevalence is not known, an estimated 118,000 people throughout the world have EGPA.4 Patients with EGPA can experience substantial disease burden due to multi-organ systems being involved, frequency of relapse, and adverse events due to standard treatments. Oral corticosteroids (OCS) and immunosuppressants have been the mainstay for managing EGPA, but the disease frequently remains poorly controlled or relapses. Additionally, these medications can be associated with undesirable effects.3,5-7 This highlights an unmet need for effective treatment options that can help address disease activity and inflammation, aiming to achieve remission and reduce relapses.
FASENRA® (benralizumab): A Targeted Treatment Option for EGPA
FASENRA® (benralizumab) injection for subcutaneous use is approved for the treatment of adults with EGPA. For the treatment of EGPA, the recommended dosage of FASENRA is 30 mg (one injection) administered once every 4 weeks by subcutaneous injection.8
The US FDA approval of FASENRA stems from the positive results of the MANDARA Phase III trial. The MANDARA clinical trial was a 52-week, randomized, double-blind, active-controlled, head-to-head noninferiority trial comparing the efficacy and safety of FASENRA to mepolizumab in adult patients with relapsing or refractory EGPA. 140 patients were randomized 1:1 to receive, once every 4 weeks, either 30 mg of FASENRA or 300 mg of mepolizumab in addition to continued background therapy. The MANDARA trial was not designed to assess whether FASENRA was superior to mepolizumab.8,9
The primary endpoint in MANDARA was the proportion of patients in remission, defined as Birmingham Vasculitis Activity Score (BVAS) = 0 and OCS dose <=4 mg/day at both Weeks 36 and 48. In patients taking FASENRA, 59% achieved remission (n=41) versus 57% of patients taking mepolizumab (n=40). FASENRA demonstrated noninferiority to mepolizumab for both the primary endpoint of remission and the components of remission.8-9 There were several secondary endpoints that are descriptive only as there was no pre-specified multiple testing procedure.
During Weeks 48 to 52, a 100% reduction in OCS dose was observed in 41% of patients taking FASENRA (n=29) compared to 26% of those taking mepolizumab (n=18). Note that per protocol, the OCS dose was tapered at the discretion of the investigator starting at Week 4.8-9 It is important not to discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with FASENRA. Decrease corticosteroids gradually, if appropriate.
In the MANDARA study, blood eosinophil reduction with FASENRA was seen at the first observed time point, Week 1, and was maintained throughout the 52-week treatment period.8 Results are descriptive only.
FASENRA’s mechanism of action leads to near-complete depletion of eosinophils.8 The mechanism of action in FASENRA in asthma and EGPA has not been definitively established.
The incidence of adverse reactions in the MANDARA study was consistent with those reported in asthma, with the exception of headache, which occurred in 17% of FASENRA-treated patients with EGPA. No new adverse reactions were identified. The most common adverse reactions for FASENRA (incidence greater than or equal to 5%) include headache and pharyngitis.
Addressing Unmet Needs With FASENRA
FASENRA provides a treatment option for adults with EGPA and can help address unmet needs.
FASENRA’s use for the treatment of EGPA represents a step forward for Healthcare Professionals seeking effective ways to manage this challenging condition. With its unique mechanism to deplete eosinophils and reduce inflammation, FASENRA offers a once-monthly (every 4 weeks) treatment option that has the potential to help EGPA patients.
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 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.
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)
Please read full Prescribing Information, including Patient Information at www.fasenrahcp.com.
You may report side effects related to AstraZeneca products (Opens new window).
To learn more about how FASENRA can help support patients with EGPA, visit fasenrahcp.com.
References
- American Partnership for Eosinophilic Disorders. Eosinophilic Granulomatosis with Polyangiitis. https://apfed.org/about-ead/eosinophilic-granulomatosis-with-polyangiitis/ Accessed March 26, 2025.
- 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.
- Chakraborty RK, Aeddula NR. Eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome). In: StatPearls [Internet]. StatPearls Publishing; September 19, 2024.
- Data on File. REF-244520. AstraZeneca Pharmaceuticals LP.
- Chung SA, Langford CA, Maz M, et al. 2021 American College of Rheumatology/Vasculitis Foundation guideline for the management of antineutrophil cytoplasmic antibody associated vasculitis. Arthritis Rheumatol. 2021;73(8):1366- 1383. doi:10.1002/art.41773.
- Hellmich B, Sanchez-Alamo B, Schirmer JH, et al. EULAR recommendations for the management of ANCA-associated vasculitis: 2022 update. Ann Rheum Dis. 2024;83(1):30-47. doi:10.1136/ard-2022-223764.
- 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. doi:10.1038/s41584-023-00958-w.
- FASENRA® (benralizumab) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; September 2024.
- 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.
US-94552 Last Updated 3/25