^**Patients with blood eosinophils >= 150 cells/μL.
1. Tim W Harrison et al. Lancet Respir Med. 2021 Mar;9(3):260-274.

PONENTE-studie: open fase 3b-studie naar de doeltreffendheid en de veiligheid van een progressieve vermindering van de orale corticosteroïden bij behandeling met FASENRA^® bij volwassenen met een ernstig astma dat niet onder controle was¹

^1,2
• % patiënten waarbij de orale corticosteroïden volledig konden worden stopgezet gedurende ≥ 4 weken zonder verslechtering van de controle van het astma
• % patiënten waarbij de orale corticosteroïden volledig konden worden stopgezet of waarbij de dosering van orale corticosteroïden kon worden verlaagd tot ≤ 5 mg (als een verdere verlaging onmogelijk was wegens bijnierinsufficiëntie) gedurende ≥ 4 weken zonder verslechtering van de controle van het astma

ICS = inhaled corticosteroid(s); LABA = long-acting beta-agonist; OCS = oral corticosteroid; Q2W = every 2 weeks; Q4W = every 4 weeks; Q8W = every 8 weeks; EOT=end of treatment; AI=adrenal insufficiency. Menzies-Gow A, et al. ERJ Open Res 2019;5:00009‒2019

• De meeste patiënten met een ernstig astma die orale corticosteroïden nodig hadden, hebben tijdens behandeling met Fasenra® de orale corticosteroïden kunnen stopzetten of de dosering ervan kunnen verlagen¹

Note: Data are provided with 95% confidence interval calculated using the Clopper-Pearson exact method. Analyses were descriptive only; no formal hypotheses were tested. aSustained over at least 4 weeks without worsening of asthma.*Included patients who have stopped OCS down-titration from >0 to <5mg for reasons other than AI, regardless of the cause for stopping the reduction. AI = adrenal insufficiency; OCS = oral corticosteriod.Menzies-Gow A et al. Oral corticosteroid elimination via a personalized reduction algorithm in adults with severe, eosinophilic asthma treated with benralizumab (PONENTE): a multicentre, open-label, single-arm study. Lancet Respir Med 2021 Oct 4-S2213-2600(21)00352-0. doi: 10.1016. Epub ahead of print. PMID: 34619104

• PONENTE-studie: Ondanks de stopzetting of verlaging van de dosering van orale corticosteroïden heeft de meerderheid van de patiënten geen astma-aanval meer gehad¹

OCS = oral corticosteriod; CSO = corticosteroïde oral
1. Menzies-Gow A et al. Oral corticosteroid elimination via a personalized reduction algorithm in adults with se-vere, eosinophilic asthma treated with benralizumab (PONENTE): a multicentre, open-label, single-arm study. Lancet Respir Med 2021 Oct 4-S2213-2600(21)00352-0. doi: 10.1016. Epub ahead of print. PMID: 34619104. 2. Menzies-Gow A, Gurnell M, Heaney LG, et al. Adrenal function recovery after durable OCS sparing with benralizumab in the PONENTE study. Eur Respir J 2022; in press (https://doi.org/10.1183/13993003.03226-2021).

MELTEMI- studie: phase III open-label extensie studie die de doeltreffendheid en veiligheid van Fasenra® na 5 jaar heeft aangetoond

1. Korn S, et al. J Allergy Clin Immunol Pract. 2021;S2213-2198(21)00968-5

Primaire eindpunten ^1-4,6

• Veiligheid en tolerantie
  Alle patiënten die deelnamen aan de MELTEMI-studie en die ten minste 1 dosis FASENRA® kregen

• Bijna 9 op de 10 patiënten hebben tijdens het 5e jaar geen enkele astma-aanval meer vertoond.^1,2,*

*MELTEMI was an open-label, Phase 3 extension study that enrolled patients who were previously enrolled in a predecessor clinical trial—SIROCCO, CALIMA, or ZONDA—and enrolled in BORA for ≥16 weeks and <40 weeks and then transitioned to MELTEMI. In predecessor studies, patients received placebo or FASENRA 30 mg subcutaneously, either Q4W or Q8W (first 3 doses Q4W); in BORA, patients receiving placebo were randomized to FASENRA Q4W or Q8W and continued on the same treatment in MELTEMI until FASENRA was commercially available in their local market. Results above are specific to the group of patients who received FASENRA Q8W from predecessor studies through MELTEMI with baseline blood eosinophils ≥300 cells/μL receiving high-dose inhaled corticosteroids (HD-ICS) at baseline.‡ ‡Per GINA guidelines, HD-ICS was defined as >500 μg fluticasone propionate equivalents daily. 1. Bourdin A, et al. Oral poster presented at the Virtual American Thoracic Society Annual Meeting: May 14-19, 2021. 2. Korn S, et al. J Allergy Clin Immunol Pract. 2021;S2213-2198(21)00968-5

• Fasenra’s gunstige tolerantie profiel bevestigd in de 5 jaar follow up MELTEMI studie

EMA = European Medicines Agency; FDA = Food and Drug Administration; IL-5 = interleukin 5; IL-5Rα = interleukin 5 receptor alpha; OLE = open-label extension; Ph2a = phase IIa; Ph2b = phase IIb; Ph3 = phase 3; RWE = real-world evidence; UK = United Kingdom. 1. Fasenra [summary of product characteristics]. Luton, UK: AstraZeneca UK Limited; 2021. 2. Korn S, et al. J Allergy Clin Immunol Pract. 2021;S2213-2198(21)00968-5 3. Busse WW, et al. Lancet Respir Med. 2019;7(1):46-59. 4. Laviolette M, et al. J Allergy Clin Immunol. 2013;132(5):1086-1096. 5. Jackson DJ, et al. Drug Safety. 2020;43(5):409-425; 6. Bleecker ER, et al. Lancet. 2016;388(10056):2115-2127. 7. FitzGerald JM, et al. Lancet. 2016;388(10056):2128-2141; 8. Padilla-Gallo A, et al. BMC Pulm Med. 2020;20:184. 9. Renner A, et al. Allergy. 2020;75(12):3272-3275.

Na 2 jaar Fasenra^® werd er nog steeds een aanhoudende verbetering van de longfunctie aangetoond^1-3

Patients from predecessor trials (SIROCCO and CALIMA) who continued on Q8W dosing integrated with data from the BORA extension trial and do not include patients who received placebo in the predecessor studies. FEV1 = forced expiratory volume in 1 second; Q8W = every 8 weeks.
1. Fitzgerald JM, et al. J Asthma Allergy. 2019;12:401–413.; 2. . 2. Bleecker ER, et al. Lancet. 2016;388(10056):2115-2127.; 3. Busse WW, et al. Lancet Respir Med. 2019;7(1):46-59.