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

Étude PONENTE: Étude ouverte de phase 3b pour évaluer l’éfficacité et la sécurité de la réduction progressive des corticostéroïdes oraux lors d’un traitement avec FASENRA® chez des adultes souffrant​ d’asthme sévère non contrôlé¹

• Pourcentage de patients obtenant une réduction de 100 % de la dose quotidienne d’OCS maintenue pendant ≥ 4 semaines sans aggravation du contrôle de l’asthme
• Pourcentage de patients atteignant une réduction de 100 % de la dose quotidienne d’OCS ou une dose quotidienne ≤ 5 mg (si l’IA a empêché une réduction supplémentaire) maintenue pendant ≥ 4 semaines sans aggravation du contrôle de l’asthme

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

• La majorité des patients souffrant d’asthme sévère dépendant de CSOs ont pû éliminer ou réduire les doses.¹

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

• Étude PONENTE : Malgré la réduction/élimination des CSOs, la majorité des patients n’ont pas présenté d’exacerbations¹

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).

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 ans^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

• 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.

Après 2 ans, Fasenra^® a montré une amélioration durable de la fonction pulmonaire.^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.