Benralizumab

Indications

Asthma (see Asthma, Asthma)

Clinical Efficacy

  • SIROCCO Trial of Benralizumab in Adolescents/Adults with Severe Asthma and At Least 2 Exacerbations in the Prior Year Despite High-Dose Inhaled Corticosteroids and LABA Therapy (Lancet, 2016) [MEDLINE]: multi-center, placebo-controlled trial
    • Benralizumab Decreased the Asthma Exacerbation Rate by Approximately 50% in Patients with Peripheral Eosinophilia (Eosinophil Count ≥300/μL)
  • CALIMA Trial of Benralizumab in Patients 12-74 y/o with Moderate-Severe Asthma and At Least 2 Exacerbations in the Prior Year Despite High-Dose Inhaled Corticosteroids and LABA Therapy (Lancet, 2016) [MEDLINE]: placebo-controlled trial over 14 mo, n = 1300
    • Benralizumab Decreased the Asthma Exacerbation Rate (By 28-36%) in Patients with with Peripheral Eosinophilia (Eosinophils ≥300 cells/μL)
  • ZONDA Trial Examining the Effect of Benralizumab in Decreasing Oral Glucocorticoid Dose in Asthma (NEJM, 2017) [MEDLINE]: placebo controlled
    • Benralizumab Significantly Decreased Oral Glucocorticoid Dose: oral glucorticoid dose decreased by 75% from baseline
    • Benralizumab Decreased the Asthma Exacerbation Rate: exacerbation rate was decreased by 55-70% from baseline
    • Benralizumab Did Not Impact the FEV1

Pharmacology

  • Humanized Monoclonal Antibody Against the Interleukin-5 Receptor
    • Results in Depletion of Eosinophils

Metabolism

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Administration

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Dose Adjustment

  • Hepatic:
  • Renal:

Use in Pregnancy (see Pregnancy, Pregnancy)

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Use in Lactation

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Adverse Effects

Other Adverse Effects

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References

  • Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-actingβ2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016;388(10056):2115 [MEDLINE]
  • Benralizumab, an anti-interleukin-5 receptorαmonoclonal 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 [MEDLINE]
  • Oral Glucocorticoid-Sparing Effect of Benralizumab in Severe Asthma. N Engl J Med. 2017 May 22. doi: 10.1056/NEJMoa1703501 [MEDLINE]