Respir Med. Eur Respir J. Appendix to: Benralizumab, an anti-interleukin-5 receptor α monoclonal antibody, as add-on treatment for patients with severe, uncontrolled, eosinophilic asthma (CALIMA): a randomised, double-blind, placebo-controlled phase 3 trial. Overlap of atopic, eosinophilic, and TH2-high asthma phenotypes in a general population with current asthma. 14. ‡Annual exacerbation rate (AER) was defined as the total number of exacerbations multiplied by 365.25, divided by the total duration of follow-up (days) within the treatment group. 5. Patients received 1 of 3 doses of benralizumab [25 mg (n=6), 100 mg (n=6) or 200 mg (n=6) SC] or placebo (n=6) every 4 weeks for a total of 3 doses. Benralizumab, an anti-interleukin-5 receptor α monoclonal antibody, as add-on treatment for patients with severe, uncontrolled, eosinophilic asthma (CALIMA): a randomised, double-blind, placebo-controlled phase 3 trial. References: South San Francisco, CA: Genentech Inc; May 2019. Secondary objectives included assessments of asthma exacerbations, pre-bronchodilator forced expiratory volume in 1 second (FEV1), and impact of treatment on blood eosinophil levels. 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. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. Medicines such as FASENRA … Bleecker ER, Wechsler M, FitzGerald JM, et al. Check out our FAQ if you have additional questions. Key secondary endpoints were pre-bronchodilator FEV1 and total asthma symptom score at Week 48 (SIROCCO) and Week 56 (CALIMA) in the same population.1,2, A 28-week, randomized, double-blind, parallel-group, placebo-controlled, multicenter OCS reduction study comparing the efficacy and safety of FASENRA (30 mg SC) Q4W for the first 3 doses, then Q8W thereafter; benralizumab (30 mg SC) Q4W, and placebo (SC) Q4W. It is unknown if FASENRA will influence a patient’s response against helminth infections. A pregnancy exposure registry monitors pregnancy outcomes in women exposed to FASENRA during pregnancy. 2019;7:46-59. FASENRA [package insert]. 9. Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with FASENRA. 2016;388:2115-2127. FASENRA is indicated for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype. N Engl J Med. 12. 12. 2017;376:2448-2458. Bleecker ER, Wechsler M, FitzGerald JM, et al. To enroll call 1-877-311-8972 or visit www.mothertobaby.org/fasenra. 6. Long-term safety and efficacy of benralizumab in patients with severe, uncontrolled asthma: 1-year results from the BORA phase 3 extension trial. Poster P289. 2. Data on File, REF-51332, AZPLP. 2016;111:21-29. 2018;121:S18-S21. Ann Allergy Asthma Immunol. Lancet. 3. 2016;388:2115-2127. 6. Login Create Profile Create Profile Lancet. 9. One objective was to assess the effect of benralizumab on blood eosinophil counts and protein biomarkers. 3. de Groot JC, ten Brinke A, Bel EH. The Access 360 Portal allows healthcare providers to manage FASENRA for patients online. 6. Supplementary Appendix to: Long-term safety and efficacy of benralizumab in patients with severe, uncontrolled asthma: 1-year results from the BORA phase 3 extension trial. Data on File, REF-60828, AZPLP. Oral glucocorticoid–sparing effect of benralizumab in severe asthma. FitzGerald JM, Bleecker ER, Nair P, et al. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy. Lancet Respir Med. 4. Nair P, Wenzel S, Rabe KF, et al. 5. Here you can find information about how Connect 360… 4. 2019;7:46-59. Forgot password? FitzGerald JM, Bleecker ER, Bourdin A, et al. Lancet. 2017;376:2448-2458. Two-year integrated efficacy and safety analysis of benralizumab SIROCCO, CALIMA, ZONDA, and BORA trials in severe asthma. Learn how Access 360 can help. Supplementary Appendix to: Oral glucocorticoid–sparing effect of benralizumab in severe asthma. FASENRA helps prevent severe asthma attacks (exacerbations) and may improve your breathing. Tell us who you are. Appendix to: Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting ß2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. It comes as a syringe and an autoinjector pen. These reactions generally occur within hours of administration, but in some instances have a delayed onset (ie, days). 5. 3. FitzGerald JM, Bleecker ER, Nair P, et al. Global Strategy for Asthma Management and Prevention, 2019. https://ginasthma.org/wp-content/uploads/2019-main-report-June-2019-wms.pdf. FitzGerald JM, Bleecker ER, Nair P, et al. You will pay … FASENRA is proven to reduce annual exacerbation rate in patients with severe eosinophilic asthma.1-3, *Data from the US CHRONICLE Study, an observational study of subspecialist-treated adults with severe asthma that evaluated 1168 eligible and 659 enrolled patients between February 27, 2018 and December 1, 2018. Lancet Respir Med. Twenty-four hours post dosing, all benralizumab dosage groups demonstrated complete or near complete depletion of median blood eosinophil levels, which was maintained throughout the dosing period.1,7,8. Appendix to: Benralizumab, an anti-interleukin-5 receptor α monoclonal antibody, as add-on treatment for patients with severe, uncontrolled, eosinophilic asthma (CALIMA): a randomised, double-blind, placebo-controlled phase 3 trial. 2018;121:S18-S21. If you meet the program eligibility criteria, a Patient Savings Program … Let's get you started with AstraZeneca provider portal. FitzGerald JM, Bleecker ER, Nair P, et al. FitzGerald JM, Bleecker ER, Menzies-Gow A, et al. Patients previously receiving placebo were re-randomized 1:1 to FASENRA 30 mg SC Q4W for the first 3 doses, then Q8W thereafter or benralizumab 30 mg SC Q4W except for adolescent patients in the EU who were randomized to FASENRA 30 mg SC Q8W. 8. 2. Ihre Ärztin wird entscheiden, ob Sie sich Fasenra selbst injizieren oder ob Sie sich Fasenra von einer Sie betreuenden Person verabreichen lassen können. 15. Fasenra (benralizumab) is a brand-name drug used for severe eosinophilic asthma. The AZ&Me Prescription Savings program is designed to help qualifying patients, including those who receive their medications through participating healthcare facilities. Presented at: the American Academy of Allergy, Asthma and Immunology (AAAAI) Congress; February 22-25, 2019; San Francisco, CA. 7. 2016;388:2115-2127. Check ticket status. Presented at: the American Thoracic Society (ATS) International Conference; May 17-22, 2019; Dallas, TX. Rescue medication use reduction with benralizumab for patients with severe, uncontrolled eosinophilic asthma. 2016;388:2115-2127. 888-686-8560 x1. E-MAIL ADRESSE. When you start treatment with Fasenra, the first 3 injections are given every 4 weeks. Long-term safety and efficacy of benralizumab in patients with severe, uncontrolled asthma: 1-year results from the BORA phase 3 extension trial. 2017;376:2448-2458. About Access 360 ... CALQUENCE, FASENRA, FASLODEX, FLUMIST, IMFINZI, IRESSA, … Although not defined by clinical guidelines, for this analysis, eosinophilic asthma was defined as treatment with anti-IL5/IL5R therapy (estimated 28% of eligible patients) or blood eosinophil counts >150 cells/μL in patients not receiving anti-IL5/IL5R therapy (estimated 41% of eligible patients). You can also enroll yourself by contacting AstraZeneca Access 360 TM at 1-844-ASK-A360 (1-844-275-2360). FASENRA (n=239), Placebo (n=248) (P=0.019).1,3 The primary endpoint for SIROCCO and CALIMA was the rate of asthma exacerbations in patients with baseline blood eosinophil count of ≥300 cells/µL who were taking high-dose ICS and LABA.1. References: 10. 14. If you’re not using Access 360, make sure the patient asks their Specialty Pharmacy about the FASENRA … Eur Respir J. To learn more about patient support, please, FASENRA is not indicated for treatment of other eosinophilic conditions, FASENRA is not indicated for the relief of acute bronchospasm or status asthmaticus, US-29837; US-34026; US-38902 Last Updated 3/20. Estimates for patients not receiving anti-IL5/IL5R therapy were derived from enrolled patients with available blood eosinophil counts (n=213) and projected to the full eligible population.6. FitzGerald JM, Bleecker ER, Nair P, et al. Wilmington, DE: AstraZeneca Pharmaceuticals LP; October 2019. 1. 10. Research Triangle Park, NC: GlaxoSmithKline LLC; September 2019. The data on pregnancy exposure from the clinical trials are insufficient to inform on drug-associated risk. 5. Results are descriptive only. 2018;6(1):56-64. 2016;111:21-29. Predictors of enhanced response with benralizumab for patients with severe asthma: pooled analysis of the SIROCCO and CALIMA studies. 2019;7:46-59. Data on File, REF-19697, AZPLP. Passwort vergessen? I consent to receive marketing and non-marketing calls and texts from and on behalf of AstraZeneca and AstraZeneca’s Access 360… 5. 6. Data on File, REF-59636, AZPLP. SAVE ON FASENRA. 2016;388:2128-2141. Data on File, REF-52421, AZPLP. 2017;376:2448-2458. 2015;3:849-858. Results are at Weeks 68 (adult follow-up) and 56 (adolescents), unless otherwise noted.5. 1. 1. Carr TF, Berdnikovs S, Simon H-U, et al. Management of the patient with eosinophilic asthma: a new era begins. Busse WW, Bleecker ER, FitzGerald JM, et al. 2016;388:2115-2127. 2019;35:1309-1318. Busse WW, Bleecker ER, FitzGerald JM, et al. Securing the places where people live and thrive. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting ß2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting ß2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Ann Allergy Asthma Immunol. This guide provides you with information to help navigate the Access 360 HCP Portal. 2016;388:2128-2141. Lancet Respir Med. Fasenra… Presented at: the American Thoracic Society (ATS) International Conference; May 17-22, 2019; Dallas, TX. 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. Data on File, REF-19698, AZPLP. Bleecker ER, FitzGerald JM, Chanez P, et al. Xolair [package insert]. 2019;7:46-59. 4. After this, you will be given an injection every 8-weeks. Patients enrolled in the previous studies were aged 12-75 years and had physician-diagnosed asthma requiring treatment with medium-dosage or high-dosage ICS plus LABA for at least 12 months with or without additional controllers prior to enrollment. Create an … Lancet. Medicines such as FASENRA … Lancet Respir Med. 2016;388:2128-2141. Lancet Respir Med. Nair P, Wenzel S, Rabe KF, et al. Data on File, REF-19697, AZPLP. You may report side effects related to AstraZeneca products by clicking here. Sie sind bereits bei Connect 360 registriert? Respir Med. FASENRA is indicated for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype... Hypersensitivity reactions (eg, anaphylaxis, angioedema, urticaria, rash) have occurred after administration of FASENRA. If you meet the program eligibility criteria, a Patient Savings Program account will be created for you. ‡ Information … End of treatment was at Week 56 for adults and Week 108 for adolescents. Vendor Drug Program (VDP) Pharmacy Enrollment and Revalidation Resources and Instruction. This site is intended for residents of the United Kingdom aged 18 years or over who have been prescribed Fasenra to help treat their asthma.. References: 2. 2016;388:2128-2141. 4. 11. Bleecker ER, FitzGerald JM, Chanez P, et al. Ortega H, Llanos J-P, Lafeuille M-H, et al. 1. Price DB, Rigazio A, Campbell JD, et al. Pham TH, Damera G, Newbold P, Ranade K. Reductions in eosinophil biomarkers by benralizumab in patients with asthma. 4. DOWNLOAD. It provides you with financial support, helpful tips about your treatment, and supplies if you self-administer FASENRA. SIROCCO (48-week) and CALIMA (56-week) were 2 randomized, double-blind, parallel-group, placebo-controlled, multicenter studies comparing FASENRA 30 mg SC Q4W for the first 3 doses, then Q8W thereafter; benralizumab 30 mg SC Q4W, and placebo SC. FASENRA (n=267), Placebo (n=267) (P<0.0001).1,2 FASENRA (0.73) reduced AER by 28% vs placebo + SOC (1.01) in CALIMA (Trial 2, 56 weeks). Lancet. Please read full Prescribing Information, including Patient Information. 2018;52:1800936. O’Quinn S, Xu X, Hirsch I. Wilmington, DE: AstraZeneca Pharmaceuticals LP; October 2019. If you are concerned about your patients coming into the office to receive their FASENRA® (benralizumab) injection during the COVID-19 pandemic and have made the determination that it is appropriate to switch your patient(s) to the FASENRA Pen, please click the button below for important steps you need to know. Baseline patient factors impact on the clinical efficacy of benralizumab for severe asthma. Effects of systemic corticosteroids on blood eosinophil counts in asthma: real-world data. References: 3. 1,2 FASENRA (0.73) reduced AER by 28% vs placebo + SOC (1.01) in CALIMA (Trial 2, 56 weeks). 1. Wilmington, DE: AstraZeneca Pharmaceuticals LP; November 2017. Find out about financial assistance options and helpful resources for FASENRA. If patients become infected while receiving FASENRA and do not respond to anti-helminth treatment, discontinue FASENRA until infection resolves. 2016;2(2):00100-2015. FASENRA demonstrated reductions in exacerbation rate in two phase 3 clinical trials.1 51% reduction in AER‡ (0.74) vs placebo + SOC (1.52) in SIROCCO (Trial 1, 48 weeks). AstraZeneca Pty Ltd. ABN 54 009 682 311, 66 … References: 1. Modified on: Fri, 29 Jan, 2021 at 3:59 PM. Global Initiative for Asthma. The primary objective was assessment of safety and tolerability. ERJ Open Res. 1. 2015;1:00024-2015. FitzGerald JM, Bleecker ER, Bourdin A, et al. World Allergy Organ J. Recent News. Busse WW, Bleecker ER, FitzGerald JM, et al. N Engl J Med. FitzGerald JM, Bleecker ER, Nair P, et al. 5. Known hypersensitivity to benralizumab or excipients. N Engl J Med. Certified … Lancet. (1-844-275-2360). Supplementary Appendix to: Oral glucocorticoid–sparing effect of benralizumab in severe asthma. 2. The relationship between the pharmacologic properties and clinical efficacy has not been established. Lancet. O’Quinn S, Xu X, Hirsch I. Skolnik NS, Carnahan SP. The primary endpoint was annual exacerbation rate ratio vs placebo in patients with blood eosinophil counts of ≥300 cells/μL on high-dose ICS and LABA. Discontinue in the event of a hypersensitivity reaction. Two-year integrated efficacy and safety analysis of benralizumab SIROCCO, CALIMA, ZONDA, and BORA trials in severe asthma. References: Appendix to: Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting ß2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting β2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. 10. zip . Solution home General eForms General eForms. Dupixent [package insert]. FASENRA demonstrated an adverse event profile similar to placebo in Year 1, maintained in Year 2.1,5, In SIROCCO and CALIMA, FASENRA and placebo were administered plus standard of care (SOC), which is defined as high-dose ICS/LABA (inhaled corticosteroids/long-acting ß2-agonist) with or without other controllers, including systemic steroids.1 In BORA (Phase 3 Safety Extension Trial of SIROCCO and CALIMA), patients from SIROCCO and CALIMA were to be maintained on their same dose of ICS/LABA.5, †The pharmacodynamic response (blood eosinophil depletion) following repeat subcutaneous (SC) dosing was evaluated in asthma patients in a 12-week phase 2 trial. 4. 13. AstraZeneca is committed to providing resources for our patients, their loved ones and the healthcare professionals caring for them during these uncertain times. visit the resources section, {{#let {zoneName:'Banner'}}}{{#foreach:$root.partsByZone(zoneName, ID)}}{{#template:{name: $root.getPartTemplate}}}{{//template}}{{//foreach}}{{//let}}, {{#foreach Tree.Children |where:'Type':'GeneralPage'}}, {{#let {zoneName:'Body'}}}{{#foreach:$root.partsByZone(zoneName, ID)}}{{#template:{name: $root.getPartTemplate}}}{{//template}}{{//foreach}}{{//let}}, I am not a UK patient that has been prescribed Fasenra, or their caregiver, I am a UK patient that has been prescribed Fasenra, or their caregiver. Clinical profile of patients with adult-onset eosinophilic asthma. FASENRA should not be used to treat acute asthma symptoms, acute exacerbations, or acute bronchospasm. 8. Busse WW, Bleecker ER, FitzGerald JM, et al. The FASENRA 360 program is designed to help you get the most out of your treatment. Two-year integrated efficacy and safety analysis of benralizumab SIROCCO, CALIMA, ZONDA, and BORA trials in severe asthma.
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