Fasenra® est indiqué chez l’adulte en traitement de fond additionnel de l’asthme sévère
à éosinophiles non contrôlé malgré une corticothérapie inhalée à forte dose associée
à des ß-agonistes de longue durée d’action

Résultats à long-terme: Efficacité​ et sécurité à 5 ans

Étude MELTEMI: étude d’extension ouverte, phase III, qui évalue l’efficacité​ et la sécurité du Fasenra sur 5 ans

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

 

CRITÈRES PRIMAIRES D’ÉVALUATION 1-4,6

  • Sécurité et tolérabilité
    Tous les patients ayant participé à l’étude MELTEMI et ayant reçu au moins 1 dose de FASENRA
  • Près de 9 patients sur 10 ne présentent aucune exacerbation à 5 ans1,2,*

*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

Profil de sécurité à long terme:

  • bonne tolérabilité du Fasenra® confirmé sur 5 ans dans l’étude MELTEMI

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.

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