ChAracterization of ItaliaN severe uncontrolled Asthmatic patieNts Key features when receiving Benralizumab in a real-life setting: the observational rEtrospective ANANKE study.


Journal

Respiratory research
ISSN: 1465-993X
Titre abrégé: Respir Res
Pays: England
ID NLM: 101090633

Informations de publication

Date de publication:
19 Feb 2022
Historique:
received: 06 08 2021
accepted: 01 02 2022
entrez: 20 2 2022
pubmed: 21 2 2022
medline: 22 3 2022
Statut: epublish

Résumé

Data from phase 3 trials have demonstrated the efficacy and safety of benralizumab in patients with severe eosinophilic asthma (SEA). We conducted a real-world study examining the baseline characteristics of a large SEA population treated with benralizumab in clinical practice and assessed therapy effectiveness. ANANKE is an Italian multi-center, retrospective cohort study including consecutive SEA patients who had started benralizumab therapy ≥ 3 months before enrolment (between December 2019 and July 2020), in a real-world setting. Data collection covered (1) key patient features at baseline, including blood eosinophil count (BEC), number and severity of exacerbations and oral corticosteroid (OCS) use; (2) clinical outcomes during benralizumab therapy. We also conducted two post-hoc analyses in patients grouped by body mass index and allergic status. Analyses were descriptive only. Of 218 patients with SEA enrolled in 21 Centers, 205 were evaluable (mean age, 55.8 ± 13.3 years, 61.5% females). At treatment start, the median BEC was 580 cells/mm We described the set of characteristics of a large cohort of patients with uncontrolled SEA receiving benralizumab in clinical practice, with a dramatic reduction in exacerbations and significant sparing of OCS. These findings support benralizumab as a key phenotype-specific therapeutic strategy that could help physicians in decision-making when prescribing biologics in patients with SEA. Trial registration ClinicalTrials.gov Identifier: NCT04272463.

Sections du résumé

BACKGROUND BACKGROUND
Data from phase 3 trials have demonstrated the efficacy and safety of benralizumab in patients with severe eosinophilic asthma (SEA). We conducted a real-world study examining the baseline characteristics of a large SEA population treated with benralizumab in clinical practice and assessed therapy effectiveness.
METHODS METHODS
ANANKE is an Italian multi-center, retrospective cohort study including consecutive SEA patients who had started benralizumab therapy ≥ 3 months before enrolment (between December 2019 and July 2020), in a real-world setting. Data collection covered (1) key patient features at baseline, including blood eosinophil count (BEC), number and severity of exacerbations and oral corticosteroid (OCS) use; (2) clinical outcomes during benralizumab therapy. We also conducted two post-hoc analyses in patients grouped by body mass index and allergic status. Analyses were descriptive only.
RESULTS RESULTS
Of 218 patients with SEA enrolled in 21 Centers, 205 were evaluable (mean age, 55.8 ± 13.3 years, 61.5% females). At treatment start, the median BEC was 580 cells/mm
CONCLUSIONS CONCLUSIONS
We described the set of characteristics of a large cohort of patients with uncontrolled SEA receiving benralizumab in clinical practice, with a dramatic reduction in exacerbations and significant sparing of OCS. These findings support benralizumab as a key phenotype-specific therapeutic strategy that could help physicians in decision-making when prescribing biologics in patients with SEA. Trial registration ClinicalTrials.gov Identifier: NCT04272463.

Identifiants

pubmed: 35183167
doi: 10.1186/s12931-022-01952-8
pii: 10.1186/s12931-022-01952-8
pmc: PMC8858449
doi:

Substances chimiques

Anti-Asthmatic Agents 0
Antibodies, Monoclonal, Humanized 0
benralizumab 71492GE1FX

Banques de données

ClinicalTrials.gov
['NCT04272463']

Types de publication

Journal Article Multicenter Study Observational Study

Langues

eng

Sous-ensembles de citation

IM

Pagination

36

Informations de copyright

© 2022. The Author(s).

Références

J Asthma Allergy. 2019 Dec 09;12:401-413
pubmed: 31849500
Respir Med. 2019 Nov - Dec;160:105819
pubmed: 31734469
Biomed Pharmacother. 2020 Sep;129:110444
pubmed: 32593131
Eur Respir J. 2018 Oct 18;52(4):
pubmed: 30139780
Respir Med. 2020 Sep;171:106080
pubmed: 32917354
Eur Respir J. 2020 Jan 9;55(1):
pubmed: 31601713
Lancet. 2016 Oct 29;388(10056):2115-2127
pubmed: 27609408
Pulm Pharmacol Ther. 2020 Oct;64:101974
pubmed: 33137516
J Allergy Clin Immunol. 2018 Jan;141(1):110-116.e7
pubmed: 28456623
Allergy. 2020 Dec;75(12):3272-3275
pubmed: 32526056
N Engl J Med. 2017 Jun 22;376(25):2448-2458
pubmed: 28530840
J Allergy Clin Immunol. 2004 Jan;113(1):59-65
pubmed: 14713908
Eur Respir J. 2017 Nov 30;50(5):
pubmed: 29191955
J Asthma Allergy. 2021 Feb 22;14:149-161
pubmed: 33654412
Chest. 2021 Feb;159(2):496-506
pubmed: 32882249
Biomed Res Int. 2018 May 10;2018:4839230
pubmed: 29862274
Thorax. 2016 Apr;71(4):339-46
pubmed: 26819354
J Asthma Allergy. 2018 Aug 29;11:193-204
pubmed: 30214247
Chest. 1999 May;115(5):1265-70
pubmed: 10334138
BMC Pulm Med. 2020 Jun 29;20(1):184
pubmed: 32600318
Eur Respir J. 2019 Nov 28;54(5):
pubmed: 31515404
Eur Respir J. 2018 Dec 13;52(6):
pubmed: 30361247
Allergy. 2018 Mar;73(3):683-695
pubmed: 29072882
J Asthma Allergy. 2021 Feb 22;14:163-173
pubmed: 33654413
J Asthma. 2021 Apr;58(4):514-522
pubmed: 31859541
Respir Med. 2020 May;166:105946
pubmed: 32250874
J Allergy Clin Immunol. 2006 Mar;117(3):549-56
pubmed: 16522452
Pulm Pharmacol Ther. 2019 Oct;58:101830
pubmed: 31344472
Adv Ther. 2020 Feb;37(2):718-729
pubmed: 31836949
Lancet Respir Med. 2019 Jan;7(1):46-59
pubmed: 30416083
World Allergy Organ J. 2019 Jan 26;12(1):100007
pubmed: 30937132
SAGE Open Med Case Rep. 2020 Feb 16;8:2050313X20906963
pubmed: 32110408
J Allergy Clin Immunol. 2015 Apr;135(4):896-902
pubmed: 25441637
Ann Allergy Asthma Immunol. 2018 May;120(5):504-511.e4
pubmed: 29409951
ERJ Open Res. 2015 Sep 23;1(1):
pubmed: 27730141
Eur Respir J. 2014 Feb;43(2):343-73
pubmed: 24337046
J Clin Med. 2019 Sep 02;8(9):
pubmed: 31480806
J Allergy Clin Immunol. 2018 Apr;141(4):1169-1179
pubmed: 29627041
Pulm Pharmacol Ther. 2020 Oct;64:101966
pubmed: 33039666
Eur Ann Allergy Clin Immunol. 2021 May;53(3):103-114
pubmed: 33728838
Lancet Respir Med. 2021 Mar;9(3):260-274
pubmed: 33357499
J Allergy Clin Immunol Pract. 2019 May - Jun;7(5):1462-1468
pubmed: 30368004
Lancet. 2016 Oct 29;388(10056):2128-2141
pubmed: 27609406
Biologics. 2019 May 22;13:89-95
pubmed: 31190733
Allergy. 2021 Jan;76(1):14-44
pubmed: 32484954
J Allergy Clin Immunol. 2015 Dec;136(6):1488-1495
pubmed: 26414880
Lancet Respir Med. 2018 Jan;6(1):51-64
pubmed: 28919200

Auteurs

Francesco Menzella (F)

Department of Medical Specialties, Pneumology Unit, Arcispedale Santa Maria Nuova, Azienda USL di Reggio Emilia-IRCCS, Reggio Emilia, Italy. Francesco.Menzella@ausl.re.it.

Elena Bargagli (E)

Respiratory Diseases and Lung Transplantation, Department of Medical and Surgical Sciences and Neurosciences, Siena University Hospital, Siena, Italy.

Maria Aliani (M)

Respiratory Rehabilitation Unit of the Institute of Cassano Delle Murge, Istituti Clinici Scientifici Maugeri IRCCS, Bari, Italy.

Pietro Bracciale (P)

Reparto di Pneumologia, Ospedale Ostuni, Ostuni, BR, Italy.

Luisa Brussino (L)

Dipartimento di Scienze Mediche, SSDDU Allergologia e Immunologia Clinica, Università Degli Studi di Torino, AO Ordine Mauriziano Umberto I, Torino, Italy.

Maria Filomena Caiaffa (MF)

Cattedra e Scuola di Allergologia e Immunologia Clinica, Dipartimento di Scienze Mediche, Università di Foggia, Foggia, Italy.

Cristiano Caruso (C)

Allergy Unit, Columbus Hospital, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.

Stefano Centanni (S)

Respiratory Unit, Department of Health Sciences, ASST Santi Paolo e Carlo, Università Degli Studi di Milano, Milan, Italy.

Maria D'Amato (M)

UOSD Malattie Respiratorie "Federico II", Ospedale Monaldi, AO Dei Colli, Napoli, Italy.

Stefano Del Giacco (S)

Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.

Fausto De Michele (F)

UOC Pneumologia e Fisiopatologia Respiratoria, AORN A. Cardarelli, Napoli, Italy.

Fabiano Di Marco (F)

Department of Health Sciences, University of Milan, Pneumology, ASST Papa Giovanni XXIII, Bergamo, Italy.

Elide Anna Pastorello (EA)

Allergy and Immunology, Niguarda Hospital, Milano, Italy.

Girolamo Pelaia (G)

Dipartimento di Scienze Della Salute, Università Magna Graecia, Catanzaro, Italy.

Paola Rogliani (P)

Division of Respiratory Medicine, University Hospital "Tor Vergata", Rome, Italy.
Unit of Respiratory Medicine, Department of Experimental Medicine, University of Rome "Tor Vergata", Rome, Italy.

Micaela Romagnoli (M)

UOC Pneumologia, ULSS 2 Marca Trevigiana, Treviso, Italy.

Pietro Schino (P)

Miulli Hospital, Acquaviva Delle Fonti, Bari, Italy.

Gianenrico Senna (G)

Department of Medicine, University of Verona, Verona, Italy.
Allergy Unit and Asthma Center, Verona University Hospital, Verona, Italy.

Alessandra Vultaggio (A)

Immunoallergology Unit, Careggi University Hospital, Florence, Italy.

Lucia Simoni (L)

Medineos Observational Research, Viale Virgilio 54/U, 41123, Modena, Italy.

Alessandra Ori (A)

Medineos Observational Research, Viale Virgilio 54/U, 41123, Modena, Italy.

Silvia Boarino (S)

AstraZeneca Italia, Basiglio, MI, Italy.

Gianfranco Vitiello (G)

AstraZeneca Italia, Basiglio, MI, Italy.

Elena Altieri (E)

Reparto di Pneumologia, P.O. Garbagnate Milanese, Garbagnate Milanese, MI, Italy.

Giorgio Walter Canonica (GW)

Centro di Medicina Personalizzata: Asma e Allergia, Humanitas Clinical and Research Center, IRCCS, Rozzano, MI, Italy.

Articles similaires

[Redispensing of expensive oral anticancer medicines: a practical application].

Lisanne N van Merendonk, Kübra Akgöl, Bastiaan Nuijen
1.00
Humans Antineoplastic Agents Administration, Oral Drug Costs Counterfeit Drugs

Smoking Cessation and Incident Cardiovascular Disease.

Jun Hwan Cho, Seung Yong Shin, Hoseob Kim et al.
1.00
Humans Male Smoking Cessation Cardiovascular Diseases Female
Humans United States Aged Cross-Sectional Studies Medicare Part C
1.00
Humans Yoga Low Back Pain Female Male

Classifications MeSH