benralizumab (Fasenra)
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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)
More general terms
References
- ↑ 1.0 1.1 1.2 1.3 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 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/27609408 <Internet> 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 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/27609406 <Internet> 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 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/27609409 <Internet> http://thelancet.com/journals/lancet/article/PIIS0140-6736(16)31537-9/fulltext - ↑ 2.0 2.1 Nair P, Wenzel S, Rabe KF et al Oral Glucocorticoid-Sparing Effect of Benralizumab in Severe Asthma. N Engl J Med. May 22, 2017 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/28530840 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMoa1703501
- ↑ 3.0 3.1 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 - ↑ 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: https://www.ncbi.nlm.nih.gov/pubmed/28530840 Free Article
- ↑ 5.0 5.1 Criner GJ, Celli BR, Brightling CE et al. Benralizumab for the prevention of COPD exacerbations. N Engl J Med 2019 May 20 PMID: https://www.ncbi.nlm.nih.gov/pubmed/31112385 https://www.nejm.org/doi/10.1056/NEJMoa1905248
- ↑ 6.0 6.1 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: https://www.ncbi.nlm.nih.gov/pubmed/38071986 Free article. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)02284-5/fulltext