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Clinical Features and Efficacy of Benralizumab in Patients with Blood Eosinophil Count Between 300 and 450 Cells/mm3: A Post Hoc Analysis from the ANANKE Study.
Senna, Gianenrico; Aliani, Maria; Altieri, Elena; Bracciale, Pietro; Brussino, Luisa; Caiaffa, Maria Filomena; Cameli, Paolo; Canonica, Giorgio Walter; Caruso, Cristiano; D'Amato, Maria; De Michele, Fausto; Del Giacco, Stefano; Di Marco, Fabiano; Menzella, Francesco; Pelaia, Girolamo; Rogliani, Paola; Romagnoli, Micaela; Schino, Pietro; Schroeder, Jan Walter; Vultaggio, Alessandra; Rizzoli, Sara; Zullo, Alessandro; Boarino, Silvia; Palmisano, Marilena; Rossi, Alessandra; Vitiello, Gianfranco; Centanni, Stefano.
Afiliación
  • Senna G; Department of Medicine, University of Verona, Verona, Italy.
  • Aliani M; Allergy Unit and Asthma Center, Verona University Hospital, Verona, Italy.
  • Altieri E; UO Pneumologia e Pneumologia Riabilitativa, ICS Maugeri, IRCCS Bari, Bari, Italy.
  • Bracciale P; Reparto di Pneumologia, P.O., Garbagnate Milanese, Italy.
  • Brussino L; Reparto di Pneumologia, Ospedale Ostuni, Ostuni, BR, Italy.
  • Caiaffa MF; Dipartimento di Scienze Mediche, SSDDU Allergologia e Immunologia Clinica, Università degli Studi di Torino, AO Ordine Mauriziano Umberto I, Torino, Italy.
  • Cameli P; Cattedra e Scuola di Allergologia e Immunologia Clinica, Dipartimento di Scienze Mediche, Università di Foggia, Foggia, Italy.
  • Canonica GW; Respiratory Diseases and Lung Transplantation, Department of Medical and Surgical Sciences & Neurosciences, Siena University Hospital, Siena, Italy.
  • Caruso C; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, MI, Italy.
  • D'Amato M; Personalized Medicine Center: Asthma and Allergology, Humanitas Research Hospital, Rozzano, MI, Italy.
  • De Michele F; Dipartimento di Scienze Mediche e Chirurgiche, Fondazione Policlinico A. Gemelli, IRCCS, Università Cattolica del Sacro Cuore, Roma, Italy.
  • Del Giacco S; UOSD Malattie Respiratorie "Federico II", Ospedale Monaldi, AO Dei Colli, Napoli, Italy.
  • Di Marco F; UOC Pneumologia e Fisiopatologia Respiratoria, AORN A. Cardarelli, Napoli, Italy.
  • Menzella F; Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.
  • Pelaia G; Department of Health Sciences, Università Degli Studi Di Milano, Pneumologia, ASST Papa Giovanni XXIII, Bergamo, Italy.
  • Rogliani P; UOC Pneumologia, Ospedale "S. Valentino", AULSS 2 Marca Trevigiana, Montebelluna, TV, Italy.
  • Romagnoli M; Dipartimento di Scienze della Salute, Università Magna Graecia, Catanzaro, Italy.
  • Schino P; Division of Respiratory Medicine, University Hospital "Tor Vergata", Roma, Italy.
  • Schroeder JW; Unit of Respiratory Medicine, Department of Experimental Medicine, University of Rome "Tor Vergata", Roma, Italy.
  • Vultaggio A; UOC Pneumologia, ULSS 2 Marca Trevigiana, Treviso, Italy.
  • Rizzoli S; Fisiopatologia Respiratoria, Ospedale Generale Regionale, Ente Ecclesiastico "F. Miulli", Acquaviva delle Fonti, BA, Italy.
  • Zullo A; Allergy and Clinical Immunology, ASST Grande Ospedale Metropolitano Niguarda, Milano, Italy.
  • Boarino S; Dipartimento di Medicina Sperimentale e Clinica, Università degli Studi di Firenze, Firenze, Italy.
  • Palmisano M; Medineos Observational Research - An IQVIA Company, Modena, Italy.
  • Rossi A; Medineos Observational Research - An IQVIA Company, Modena, Italy.
  • Vitiello G; Medical Evidence R&I, AstraZeneca, Milano, Italy.
  • Centanni S; Medical Affairs R&I, AstraZeneca, Milano, Italy.
J Asthma Allergy ; 15: 1593-1604, 2022.
Article en En | MEDLINE | ID: mdl-36387835
ABSTRACT

Purpose:

Benralizumab effectively reduces severe eosinophilic asthma (SEA) exacerbations in patients with a wide range of baseline blood eosinophil count (BEC). Patients included in real-world studies are often characterized by high mean/median BEC, while patients with BEC close to 300 cells/mm3 are poorly represented. This post hoc analysis from the Italian study ANANKE aims to define the clinical features and corroborate the efficacy of benralizumab in real world in the BEC 300-450 cells/mm3 subset of patients. Patients and

Methods:

Post hoc analysis of the Italian, multicenter, observational, retrospective real-life study ANANKE (NCT04272463). Baseline clinical and laboratory characteristics were collected in the 12 months prior to benralizumab treatment and presented for a BEC 300-450 cells/mm3 subgroup of patients. Change over time of BEC, annualized exacerbation rate (AER), asthma control (ACT), lung function and oral corticosteroid (OCS) use at 16, 24 and 48 weeks after benralizumab introduction were collected.

Results:

A total of 164 patients were analyzed, 34 of whom with a BEC of 300-450 cells/mm3. This subgroup was more likely to be female (64.7%), with lower rates of severe exacerbations at baseline when compared to the total population (0.69 vs 1.01). After 48 weeks of benralizumab treatment, the BEC 300-450 subset showed similar reductions in AER (-94.8% vs -92.2%) and OCS use (median dose reduction of 100% in both groups), as well as improvement in ACT score (median scores 22.5 vs 22) and lung function (pre-BD FEV1 +200 mL vs +300 mL) when compared to the total population. No discontinuations for safety reasons were registered.

Conclusion:

At baseline, apart from lower severe exacerbation rate, the BEC 300-450 cells/mm3 subset of patients is comparable to the total population prescribed with benralizumab. In this real-life study, benralizumab is as effective in BEC 300-450 patients as in the total population.
Palabras clave

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Tipo de estudio: Clinical_trials Idioma: En Revista: J Asthma Allergy Año: 2022 Tipo del documento: Article País de afiliación: Italia

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Tipo de estudio: Clinical_trials Idioma: En Revista: J Asthma Allergy Año: 2022 Tipo del documento: Article País de afiliación: Italia