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.