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benralizumab (Fasenra)

Indications: - add-on therapy for asthma with eosinophils - prevention of exacerbations in severe eosinophilic asthma - >= 3 asthma exacerbations/year despite high-dose inhaled glucocorticoids & long acting bronchodilators [1] * associated with reduced oral glucocorticoid use in patients with severe eosinophilic asthma [2,6] Contraindications: - not for COPD with or without eosinophilia [5] Dosage: - 30 mg SC q4weeks for 1st 3 doses, q8weeks thereafter Laboratory: - complet blood count - eosinophil count > 300/uL Mechanism of action: - anti-interleukin-5 antibody [1] - monoclonal IgG1, kappa - inhibits IL5-receptor alpha - IL5-receptor is expressed on the surface of eosinophils & basophils - reduces pulmonary eosinophils & basophils vai antibody- dependent cell-mediated cytotoxicity - reduces asthma exacerbations - improves pulmonary function - reduces need for glucocorticoids [3] Notes: - > $30,000 per year [1] (every 4 week dosing)

Interactions

drug adverse effects of pharmaceutical monoclonal antibodies

General

pharmaceutical monoclonal antibody

References

  1. Young K, Fairchild DG Benralizumab Associated with Fewer Exacerbations in Severe Asthma with Eosinophilia Physician's First Watch, Sept 6, 2016 David G. Fairchild, MD, MPH, Editor-in-Chief Massachusetts Medical Society http://www.jwatch.org - 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 beta2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. The Lancet. Published Online: September 4, 2016 PMID: 27609408 http://thelancet.com/journals/lancet/article/PIIS0140-6736(16)31324-1/fulltext - FitzGerald JM, Bleecker ER, Nair P et al Benralizumab, an anti-interleukin-5 receptor alpha monoclonal antibody, as add-on treatment for patients with severe, uncontrolled, eosinophilic asthma (CALIMA): a randomised, double-blind, placebo-controlled phase 3 trial. The Lancet. Published Online: September 4, 2016 PMID: 27609406 http://thelancet.com/journals/lancet/article/PIIS0140-6736(16)31324-1/fulltext - Castro M, Bacharier LB Treatment for severe eosinophilic asthma - consistent effect of anti-interleukin-5 antibodies? The Lancet. Published Online: September 4, 2016 PMID: 27609409 http://thelancet.com/journals/lancet/article/PIIS0140-6736(16)31537-9/fulltext
  2. Nair P, Wenzel S, Rabe KF et al Oral Glucocorticoid-Sparing Effect of Benralizumab in Severe Asthma. N Engl J Med. May 22, 2017 PMID: 28530840 http://www.nejm.org/doi/full/10.1056/NEJMoa1703501
  3. Windle ML. FDA New Drug and Biologic Approvals -- 2017 Year-in-Review Medscape - Jan 11, 2018. https://reference.medscape.com/viewarticle/890871 - U.S. Food and Drug Administration. Novel Drug Approvals for 2017. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm537040.htm
  4. Nair P, Wenzel S, Rabe KF et al Oral Glucocorticoid-Sparing Effect of Benralizumab in Severe Asthma. N Engl J Med. 2017 Jun 22;376(25):2448-2458. Epub 2017 May 22. PMID: 28530840 Free Article
  5. Criner GJ, Celli BR, Brightling CE et al. Benralizumab for the prevention of COPD exacerbations. N Engl J Med 2019 May 20 PMID: 31112385 https://www.nejm.org/doi/10.1056/NEJMoa1905248
  6. Jackson DJ, Heaney LG, Humbert M et al. Reduction of daily maintenance inhaled corticosteroids in patients with severe eosinophilic asthma treated with benralizumab (SHAMAL): A randomised, multicentre, open-label, phase 4 study. Lancet 2023 Dec 7; [e-pub]. PMID: 38071986 Free article. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)02284-5/fulltext