Early Failure, Late Failure, and Sustained Response to Biologics in Severe Asthma: A Long-term, Real-world, Multicentre study

Dacal Rivas, D.; Martinez-Moragón, E.; Plaza, V.; Cisneros Serrano, C.; Benchimol, C.; Izaguirre Flores, H.; Sánchez-Cuéllar, S.; Martínez-Pitarch, M.D.; Fernández Aracil, C.; Trisán Alonso, A.; Serrano Rebollo, J.C.; Vásquez Gambasica, Z.; Díaz Campos, R.M.; Trujillo Mulato, P.; Escribano Gimeno, I.; Laorden, D.; Arismendi, E.; Marina Malanda, N.; De Diego Damia, A.; Ferrer Galvan, M.; Dávila, I.; Ortiz de Saracho Bobo, J.; Cosio, B.G.; Pérez de Llano, L.A.

doi:10.1016/j.arbres.2025.04.003

Archivos de Bronconeumología

ISSN: 0300-2896

Archivos de Bronconeumologia is an international journal that publishes original studies whose content is based upon results of research initiatives dealing with several aspects of respiratory medicine including epidemiology, respiratory physiology, pathophysiology of respiratory diseases, clinical management, thoracic surgery, pediatric lung diseases, respiratory critical care, respiratory allergy and translational research. Other types of articles such as editorials, reviews, and different types of letters are also published in the journal. Additionally, the journal expresses the voice of the following scientific societies: the Spanish Respiratory Society of Pneumology and Thoracic Surgery (SEPAR; https://www.separ.es/), the Latin American Thoracic Society (ALAT; https://alatorax.org/), and the Iberian American Association of Thoracic Surgery (AIACT; http://www.aiatorax.com/).

It is a monthly journal in which all manuscripts are sent to peer-review and handled by the editor or an associate editor from the team and the final decision is made on the basis of the comments from the expert reviewers and the editors. The journal is published solely in English. All the published data is composed of novel manuscripts not previously published in any other journal and not being in consideration for publication in any other journal..

The journal is indexed at Science Citation Index Expanded, Medline/Pubmed, Embase and SCOPUS. Access to any published article is possible through the journal's web page as well as from Pubmed, ScienceDirect, and other international databases. Furthermore, the journal is also present in X, Facebook and Linkedin. Manuscripts can be submitted electronically using the following web site: https://www.editorialmanager.com/ARBR/.

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D. Dacal Rivasa,b, E. Martinez-Moragónc, V. Plazad,e, C. Cisneros Serranof, C. Benchimold,e, H. Izaguirre Floresg, S. Sánchez-Cuéllarh, M.D. Martínez-Pitarchi, C. Fernández Aracilj, A. Trisán Alonsok, J.C. Serrano Rebollol, Z. Vásquez Gambasicam, R.M. Díaz Camposn, P. Trujillo Mulatoo, I. Escribano Gimenop, D. Laordenq, E. Arismendir,s, N. Marina Malandat, A. De Diego Damiau, M. Ferrer Galvanv..., I. Dávilaw,x, J. Ortiz de Saracho Boboy, B.G. Cosioz, L.A. Pérez de Llanoaa,b,

Corresponding author

eremos26@hotmail.com

Corresponding author.

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a Pneumology Service, Lucus Augusti University Hospital, EOXI Lugo, Monforte, Cervo, Lugo, Spain

b University of Santiago de Compostela, Spain

c Pneumology Service, Doctor Peset University Hospital, Valencia, Spain

d Servicio de Neumología y Alergia, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain

e Universidad Autónoma Barcelona, Facultad de Medicina, Barcelona, Spain

f Pneumology Service, La Princesa University Hospital, Instituto de investigación La Princesa, Madrid, Spain

g Servicio de Neumología, Complejo Hospitalario Universitario de Canarias, Las Palmas, Spain

h Servicio de Neumologia, Hospital Universitario Ramón y Cajal, Madrid, Spain

i Hospital Lluís Alcanys de Xátiva, Valencia, Spain

j Servicio de Neumología, Hospital General Universitario Dr. Balmis, Universidad Miguel Hernández, Instituto de Investigación Sanitaria y Biomédica de Alicante (ISABIAL), Alicante, Spain

k Pneumology Service, Hospital Universitario Puerta de Hierro Majadahonda (Madrid), Spain

l Hospital de Llerena-Zafra, Spain

m Hospital Universitario de Getafe, Madrid, Spain

n Servicio de Neumología, Hospital Universitario 12 de Octubre, Madrid, Spain

o Instituto Nacional del Tórax, Santiago de Chile, Spain

p Hospital Infanta Sofía, San Sebastián de los Reyes, Madrid, Spain

q Department of Pulmonology, La Paz University Hospital, Madrid, Spain

r Servei de Pneumologia del Hospital Clínic de Barcelona, IDIBAPS, Universitat de Barcelona, Barcelona, Spain

s CIBERES, Instituto de Salud Carlos III, Spain

t Departamento de Neumología, Unidad de Asma Grave, Hospital Universitario Cruces, Bilbao, Spain

u Area de Enfermedades Respiratorias, Hospital Universitario y Politécnico La Fe, Valencia, Spain

v Pneumology Service, Hospital Universitario Virgen del Rocío, Sevilla, Spain

w Servicio de Alergia, Hospital Universitario de Salamanca, Spain

x Departamento de Ciencias Biomédicas y del Diagnóstico, Facultad de Medicina, Universidad de Salamanca, Salamanca, Spain

y Pneumology Service, Hospital Universitario del Bierzo, Ponferrada, Spain

z Department of Respiratory Medicine, Hospital Universitario Son Espases-IdISBa-CIBERES, Palma de Mallorca, Spain

aa Pneumology Service, Lucus Augusti University Hospital, EOXI Lugo, Monforte, Cervo, Lugo, Spain

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Tables (2)

Table 1. Clinical and Demographic Characteristics of the Population. Comparison Between Patients who Experienced Response and Early Failure.

Table 2. Comparison Between Patients who Experienced Sustained Response and Early and Late Failure.

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Additional material (3)

Abstract

Objectives

Only one-third of patients with severe asthma (SA) achieve a complete response to biologics. This study aims to characterize two types of failure: early (EF), occurring ≤12 months after biologic initiation, and late (LF), occurring at any time during follow-up after response has been achieved at 12 months.

Methods

This is a multicentre retrospective study of adults treated with the same biologic for ≥24 months. Response was defined as no severe exacerbations in the preceding 12 months, asthma control test ≥20, and no need for maintenance oral corticosteroids. Failure (EF or LF) was defined as non-achievement of any of these objectives.

Results

Two hundred and seventy-two patients were analysed with a mean follow-up of 46.1±19.4 months. At 12 months, 97/272 were classified as PF, but 40% of them recovered response on subsequent visits (by changing inhaled therapy in 74%). Among the 175 responders at 12 months, 124 (70.8%) maintained response throughout the study period, while 51 (29.1%) experienced SF; those patients had lower FEV1 values after 12 months of biological therapy. SF reverted in 36% of cases, with inhaled therapy changes in 41.6%. FEV1 decreased by ≥100mL in 12 of 16 cases who did not recover response after SF.

Conclusion

Most patients who achieve response at 12 months maintain it over time, but 29% of them suffer LF. Optimization of inhaled therapy can aid response recovery from EF or LF. Maximizing pulmonary function helps to prevent loss of response.

Keywords:

Severe asthma

Biologics

Early failure

Late failure

Long-term study

Treatment response

Graphical abstract