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Vol. 60. Issue 1.
Pages 23-32 (January 2024)
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Vol. 60. Issue 1.
Pages 23-32 (January 2024)
Original Article
Comparison of Long-term Response and Remission to Omalizumab and Anti-IL-5/IL-5R Using Different Criteria in a Real-life Cohort of Severe Asthma Patients
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Marcela Valverde-Mongea,b,
Corresponding author
marcela.valverde@quironsalud.es

Corresponding author.
, Patricia Sánchez-Carrascoc, Diana Betancora,b, Blanca Barrosoa,b, José Manuel Rodrigo-Muñozb,d, Ignacio Mahillo-Fernándeze, Ebymar Arismendib,f,g,h, Irina Boboleab,f,g,h, Blanca Cárdabab,d, María Jesús Cruzb,i,j, Victoria Del Pozob,c,d, Javier Domínguez-Ortegab,j, Francisco Javier González-Barcalab,k, José María Olaguibelb,l, Juan Alberto Luna-Portab,q, Carlos Martínez-Riverab,m,n, Joaquim Mullolb,h,o,p, Xavier Muñozb,j, Lorena Peleteiro-Pedrazak, Cesar Picado Vallesb,f,g,h..., Vicente Plazab,r,s, Santiago Quirceb,q, Manuel Jorge Rialb,t, Lorena Soto-Retesb,r,s, Antonio Valerob,f,g,h, Joaquín Sastrea,b,cVer más
a Allergy Department, Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain
b CIBER de Enfermedades Respiratorias (CIBERES), Madrid, Spain
c Faculty of Medicine, Universidad Autónoma de Madrid, Spain
d Immunology Department, Instituto de Investigación Sanitaria Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain
e Epidemiology and Biostatistics Department, Instituto de Investigación Sanitaria Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain
f Allergy Unit & Severe Asthma Unit, Pneumonology and Allergy Department, Hospital Clínic, Barcelona, Spain
g IDIBAPS, Barcelona, Spain
h Universitat de Barcelona, Barcelona, Spain
i Cellular Biology, Physiology and Immunology Department, Universitat Autónoma de Barcelona, Barcelona, Spain
j Pneumology Department, Hospital Vall d’Hebron, Barcelona, Spain
k Pneumology Department, Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, La Coruña, Spain
l Allergy Department, Hospital Universitario de Navarra, Pamplona, Navarra, Spain
m Pneumology Department, Hospital Germans Trias i Pujol, Institut d’Investigació Germans Trias i Pujol, Badalona, Barcelona, Spain
n Universitat Autónoma de Barcelona, Spain
o Rhinology Unit & Smell Clinic, ENT Department, Hospital Clinic, Barcelona, Spain
p Clinical and Experimental Respiratory Immunoallergy (IDIBAPS), Barcelona, Spain
q Allergy Department, Hospital Universitario La Paz, IdiPAZ, Madrid, Spain
r Pneumology and Allergy Department, Hospital de la Santa Creu i Sant Pau, Instituto de Investigación Biomédica Sant Pau (IIB Sant Pau), Universidad Autónoma de Barcelona, Barcelona, Spain
s Departamento de Medicina, Universidad de Autónoma, Barcelona, Spain
t Allergy Department, Complexo Hospitalario Universitario A Coruña, A Coruña, Spain
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Tables (4)
Table 1. Summary of Criteria Published for Definition of Response in Severe Eosinophilic Asthma Treated With Biologics.
Table 2. Baseline Characteristics of Total Sample and Biologic Subgroups.
Table 3. Changes Between Before and After the Long-term With Biologics in the Total Population and among Biologics Subgroups.
Table 4. Comparison of the Response to Long-term (>6 Months) Treatment With Biologics in Our Sample According to Different Criteria.
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Abstract
Background

Evaluation of biologic therapy response is vital to monitor its effectiveness. Authors have proposed various response criteria including good responder, super-responder, non-responder, and clinical remission.

Objectives

To ascertain the prevalence of response and clinical remission after long-term treatment (>6 months) of anti-IgE and anti-IL-5/IL-5Rα biologics, compare these results with existing criteria, and identify predictors for non-responders and clinical remission.

Methods

A multicenter, real-life study involving severe asthma patients in Spain. Various outcomes were assessed to gauge response and clinical remission against established criteria.

Results

The study included 429 patients, 209 (48.7%) omalizumab, 112 (26.1%) mepolizumab, 19 (4.4%) reslizumab and 89 (20.7%) benralizumab, with a mean treatment duration of 55.3±38.8 months. In the final year of treatment, 218 (50.8%) were super-responders, 173 (40.3%) responders, 38 (8.9%) non-responders, and clinical remission in 116 (27%), without differences among biologics. The short-term non-responders (<6 months) were 25/545 (4.6%). Substantial variations in response and clinical remission were observed when applying different published criteria. Predictors of non-response included higher BMI (OR:1.14; 95% CI:1.06–1.23; p<0.001), admissions at ICU (2.69; 1.30–5.56; p=0.01), high count of SAE (1.21; 1.03–1.42; p=0.02) before biologic treatment. High FEV1% (0.96; 0.95–0.98; p<0.001), a high ACT score (0.93; 0.88–0.99; p=0.01) before biologic treatment or NSAID-ERD (0.52; 0.29–0.91; p=0.02) showed strong associations with achieving clinical remission.

Conclusion

A substantial proportion of severe asthma patients treated long-term with omalizumab or anti-IL5/IL-5Rα achieved a good response. Differences in response criteria highlight the need for harmonization in defining response and clinical remission in biologic therapy to enable meaningful cross-study comparisons.

Keywords:
Severe uncontrolled asthma
Biologic treatment
Responders
Non-responders
Super-responders
Clinical remission
Non‒responders
Severe asthma
Predictors
Abbreviations:
ACT
AD
Anti-IgE
Anti-IL-5
Anti-IL-5Rα
AUC
BMI
BQ
CI
CRSwNP
FeNO
FEV1
FEV1/FVC
GERD
ICU
ICS
IQR
MCID
N-ERD
OR
ROC
SAE
SCS
SD

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