Efectivity of dupilumab in patients with severa astma in real clinical practice using EXACTO score

<bold>Introduction:</bold> Dupilumab has shown efficacy in asthma in randomized clinical trials1-4. As real-world evidence data with dupilumab is limited to date 5-10, there is a need to extend this knowledge to allow a deeper analysis of the response to this drug in real life. <bold>Methods:</bold> Effectivity was assessed by measuring annualized exacerbation rate (AER), asthma control test (ACT), use of oral corticosteroids (OCS), and pre-bronchodilator forced expiratory volume in the first second (pre-BD FEV1) scores at baseline visit, and at follow up weeks 16 (V1) and 52 (V2). We have performed an effectivity assessment with the EXACTO Score tool11. <bold>Results:</bold> We present a series of 137 severe asthma patients from 18 Spanish reference hospitals treated with dupilumab, between April 2022 and September 2023. At V1, AER reduced from 2.18 at baseline to 0.29 (86.7%), ACT improved from 12.4 to 18.2, FEV1 raised from 69.8% to 88.1%, and OCS cycles diminished from 2.12 to 0.27. At V1, EXACTO scores were calculated (n=119), and 17.6%/37.8%/40.3%/4.2% showed complete/good/partial/no response, respectively. At V2, AER was 0.37, ACT scored 16.8, FEV1 counted 75.1% and OCS cycles were 0.37. At this endpoint (week 52) EXACTO scored 26,3%/29,8%/38,6%/5,3% complete/good/partial/no response, respectively. OCS were prescribed to XX patients at baseline, being necessary in XX cases at week 52. Safety profile was favorable. <bold>Discussion:</bold> We found dupilumab safe and effective in severe asthma patients, as 55.4% of the patients obtained perfect or good early response (16 week visit) as assessed by EXACTO, and 56,1% achieved complete or good response at 12-months follow-up visit.

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Published
2024-09-14
DOI
https://doi.org/10.1183/13993003.congress-2024.pa3572
Primary Topic
Asthma and respiratory diseases
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article
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article

Efectivity of dupilumab in patients with severa astma in real clinical practice using EXACTO score

Gerardo Pérez Chica, Alicia Padilla‐Galo, José Gregorio Soto Campos, Francisco Casas Maldonado et al.
Asthma and respiratory diseases
article

Efectivity of dupilumab in patients with severa astma in real clinical practice using EXACTO score

Gerardo Pérez Chica, Alicia Padilla‐Galo, José Gregorio Soto Campos, Francisco Casas Maldonado, A. Gómez-Bastero Fernández, Juan M. Díez Piña, Lorena Piñel Jiménez, Francisco Javier Álvarez Gutiérrez
article en

Abstract

<bold>Introduction:</bold> Dupilumab has shown efficacy in asthma in randomized clinical trials1-4. As real-world evidence data with dupilumab is limited to date 5-10, there is a need to extend this knowledge to allow a deeper analysis of the response to this drug in real life. <bold>Methods:</bold> Effectivity was assessed by measuring annualized exacerbation rate (AER), asthma control test (ACT), use of oral corticosteroids (OCS), and pre-bronchodilator forced expiratory volume in the first second (pre-BD FEV1) scores at baseline visit, and at follow up weeks 16 (V1) and 52 (V2). We have performed an effectivity assessment with the EXACTO Score tool11. <bold>Results:</bold> We present a series of 137 severe asthma patients from 18 Spanish reference hospitals treated with dupilumab, between April 2022 and September 2023. At V1, AER reduced from 2.18 at baseline to 0.29 (86.7%), ACT improved from 12.4 to 18.2, FEV1 raised from 69.8% to 88.1%, and OCS cycles diminished from 2.12 to 0.27. At V1, EXACTO scores were calculated (n=119), and 17.6%/37.8%/40.3%/4.2% showed complete/good/partial/no response, respectively. At V2, AER was 0.37, ACT scored 16.8, FEV1 counted 75.1% and OCS cycles were 0.37. At this endpoint (week 52) EXACTO scored 26,3%/29,8%/38,6%/5,3% complete/good/partial/no response, respectively. OCS were prescribed to XX patients at baseline, being necessary in XX cases at week 52. Safety profile was favorable. <bold>Discussion:</bold> We found dupilumab safe and effective in severe asthma patients, as 55.4% of the patients obtained perfect or good early response (16 week visit) as assessed by EXACTO, and 56,1% achieved complete or good response at 12-months follow-up visit.

Hospital Costa del Sol (ES), Hospital Universitario Virgen Macarena (ES), Instituto de Investigación Biosanitaria de Granada (ES), Complejo Hospitalario de Jaén (ES), Hospital Universitario de Valme (ES), Hospital Universitario Virgen del Rocío (ES), Hospital Jerez Puerta del Sur (ES), Hospital Clínico Universitario Virgen de la Victoria (ES)
Openalex Percentile: Top 72%
Asthma and respiratory diseases
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