Toward a better understanding of severe asthma phenotypes in Latin America: results from the PREPARE study

Abstract

Objective

Data on severe asthma phenotypes in Latin America are lacking. The PREPARE study describes the prevalence of certain determinants of severe asthma among patients in 5 Latin American countries with blood eosinophil counts (BEC) ≥300 cells/mm³ and serum immunoglobulin E (IgE) concentrations >100 IU/mL.

Methods

In this cross-sectional study, information on demographics, disease characteristics, and asthma treatments were extracted from the existing medical records of patients aged ≥12 years attending centers specialized in severe asthma management. Medical record data were transcribed onto electronic case report forms. Blood eosinophil counts and IgE concentrations were assayed from specimens obtained at study visit. Data were analyzed with descriptive statistics.

Results

Data from 461 patients with severe asthma (mean age, 50.5 years) were analyzed. Most patients were female (73%), had a body mass index of ≥25 kg/m² (77%), and received full healthcare reimbursement (63%). In the previous 12 months, 52% of patients experienced ≥1 severe exacerbation and 44% received oral corticosteroid burst therapy. Blood eosinophil counts ≥300 cells/mm³ and ≥150 cells/mm³ were reported in 44% and 76% of patients, respectively. In 58% of patients, serum IgE concentrations exceeded 100 IU/mL. Uncontrolled asthma was documented in 50% (n = 230) of patients.

Conclusions

The PREPARE study provides useful insights about the prevalence of eosinophilic and atopic phenotypes in patients with severe asthma in Latin America, thereby paving the way for a more personalized approach to managing severe asthma. Notwithstanding the treatment at specialized medical centers, disease burden remained high in this study population.

Keywords:

• Severe asthma
• eosinophils
• immunoglobulin E
• treatment
• asthma control
• exacerbations

Trial registration:

• Clinicaltrials.gov Identifier NCT03931954

Transparency

Declaration of funding

AstraZeneca funded the PREPARE study and was involved in designing the study, developing the study protocol, conducting the study, and performing the analyses. AstraZeneca was given the opportunity to review the manuscript before submission and funded medical writing support.

Declaration of financial/other relationships

Jorge Maspero is a consultant and has received fees as a speaker from AstraZeneca, Sanofi, Novartis, MSD, GlaxoSmithKline, Menarini, Novartis, Uriach, Menarini, Inmunotek, and TEVA. Juana Pavie has participated in clinical studies, conferences, and advisory boards sponsored by AstraZeneca. Carlos A Torres-Duque has received fees as advisory board participant and/or speaker from AstraZeneca, Boehringer-Ingelheim, GlaxoSmithKline, Novartis, and Sanofi-Aventis; has taken part in clinical trials from AstraZeneca, Novartis, and Sanofi-Aventis; has received unrestricted grants for investigator-initiated studies at Fundacion Neumologica Colombiana from AstraZeneca, Boehringer-Ingelheim, GlaxoSmithKline, Grifols, and Novartis. Felicia Montero-Arias has participated in clinical studies sponsored by AstraZeneca, Novartis, Moderna and National Institutes of Health. She has also participated in conferences and advisory boards sponsored by AstraZeneca, Novartis, and Roche. Ruth Cerino-Javier has participated in clinical studies sponsored by AstraZeneca, Novartis, and GlaxoSmithKline. Francisco Rovira is an employee of AstraZeneca. Maarten J.H.I Beekman was an employee of AstraZeneca at the time this study was conducted. Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

All authors contributed to the study design, data collection, data analysis, data interpretation, and manuscript composition. All authors have approved the manuscript contents and agree to be accountable for all aspects of the work

Acknowledgements

Authors acknowledge Libardo Jiménez-Maldonado and Mauricio Durán-Silva, ASMAIRE Program, Fundación Neumológica Colombiana, Bogotá, Colombia for their involvement in patient enrollment and registration. Writing and editorial support was provided by Cactus Life Sciences (part of Cactus Communications, Mumbai, India) in accordance with Good Publication Practice (GPP3) guidelines (http://www.ismpp.org/gpp3) and fully funded by AstraZeneca.

Data availability statement

Data underlying the findings described in this manuscript may be obtained in accordance with AstraZeneca’s data sharing policy described at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.