Clinical response and remission in patients treated with dupilumab for severe asthma: Results from the nationwide Danish Severe Asthma Register

Susanne Hansen; Kjell Erik Julius Håkansson; Marianne Baastrup Soendergaard; Anne-Sofie Bjerrum; Johannes Martin Schmid; Sofie Lock Johansson; Linda Makowska Rasmussen; Claus Rikard Johnsen; Anna von Bülow; Barbara Bonnesen; Niels Steen Krogh; Ole Hilberg; Lycely Dongo; Roxana Vijdea; Charlotte Suppli Ulrik; Celeste Porsbjerg

doi:10.1016/j.rmed.2025.108203

Clinical response and remission in patients treated with dupilumab for severe asthma: Results from the nationwide Danish Severe Asthma Register

Susanne Hansen^*
, Kjell Erik Julius Håkansson
, Marianne Baastrup Soendergaard
, Anne-Sofie Bjerrum
, Johannes Martin Schmid
, Sofie Lock Johansson
, Linda Makowska Rasmussen
, Claus Rikard Johnsen
, Anna von Bülow
, Barbara Bonnesen
, Niels Steen Krogh
, Ole Hilberg
, Lycely Dongo
, Roxana Vijdea
, Charlotte Suppli Ulrik
, Celeste Porsbjerg

^*Corresponding author for this work

Medicine (Roskilde)

Research output: Contribution to journal › Article › Research › peer-review

Abstract

BACKGROUND: Randomized clinical trials have demonstrated that dupilumab reduces exacerbations and maintenance oral corticosteroids (mOCS) use in patients with uncontrolled and severe asthma. However, evidence in real-life settings is limited.

OBJECTIVE: This study aimed to evaluate the proportion of patients achieving a clinical response and remission after treatment with dupilumab and identify predictors of response.

METHODS: We conducted a prospective observational study involving 203 severe asthma patients from the nationwide Danish Severe Asthma Register treated with dupilumab for 12 months. Clinical response to treatment was defined as a 50% reduction in exacerbations and/or a 50% reduction in mOCS dose. Clinical remission required meeting all the following criteria: complete cessation of exacerbations, no mOCS use, an Asthma Control Questionnaire (ACQ-6) score <1.50 and forced expiratory volume in one second (FEV1) > 80% of the predicted value. Predictors of treatment response were identified in a multivariate logistic regression model.

RESULTS: After 12 months of dupilumab treatment, 91% of patients demonstrated a clinical response, and 30% achieved clinical remission. All patients experienced fewer exacerbations, while patients with a clinical response and those achieving remission also exhibited significant improvements in mOCS dose reduction, FEV1%, and ACQ-6 score. Predictors of remission included higher baseline fractional exhaled nitric oxide [OR=3.82 (95% CI: 0.90, 16.17)], lower body mass index [OR=0.82 (95% CI: 0.71, 0.93) for one unit increase], and the absence of allergic rhinitis [OR=0.30 (95% CI: 0.08, 1.11)].

CONCLUSION: In this real-life setting, involving over 200 patients treated with dupilumab for 12 months, 91% had a clinical response, and 30% of patients achieved clinical remission. These findings highlight dupilumab's potential in improving outcomes for severe asthma patients.

Original language	English
Article number	108203
Number of pages	9
Journal	Respiratory Medicine
Volume	245
Early online date	11 Jun 2025
DOIs	https://doi.org/10.1016/j.rmed.2025.108203
Publication status	Published - 2025

Keywords

Severity of Illness Index
Prospective Studies
Humans
Middle Aged
Anti-Asthmatic Agents/therapeutic use
Antibodies, Monoclonal, Humanized/therapeutic use
Forced Expiratory Volume/drug effects
Male
Treatment Outcome
Asthma/drug therapy
Remission Induction
Denmark/epidemiology
Adult
Female
Registries
Aged
Biologic therapies
Epidemiology
Remission
Severe asthma
Real-world evidence

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Hansen, S., Håkansson, K. E. J., Soendergaard, M. B., Bjerrum, A.-S., Schmid, J. M., Johansson, S. L., Rasmussen, L. M., Johnsen, C. R., von Bülow, A., Bonnesen, B., Krogh, N. S., Hilberg, O., Dongo, L., Vijdea, R., Ulrik, C. S., & Porsbjerg, C. (2025). Clinical response and remission in patients treated with dupilumab for severe asthma: Results from the nationwide Danish Severe Asthma Register. Respiratory Medicine, 245, Article 108203. https://doi.org/10.1016/j.rmed.2025.108203

@article{cd7ef2b7b2334d44910e70d27bcb8fe5,

title = "Clinical response and remission in patients treated with dupilumab for severe asthma: Results from the nationwide Danish Severe Asthma Register",

abstract = "BACKGROUND: Randomized clinical trials have demonstrated that dupilumab reduces exacerbations and maintenance oral corticosteroids (mOCS) use in patients with uncontrolled and severe asthma. However, evidence in real-life settings is limited.OBJECTIVE: This study aimed to evaluate the proportion of patients achieving a clinical response and remission after treatment with dupilumab and identify predictors of response.METHODS: We conducted a prospective observational study involving 203 severe asthma patients from the nationwide Danish Severe Asthma Register treated with dupilumab for 12 months. Clinical response to treatment was defined as a 50\% reduction in exacerbations and/or a 50\% reduction in mOCS dose. Clinical remission required meeting all the following criteria: complete cessation of exacerbations, no mOCS use, an Asthma Control Questionnaire (ACQ-6) score <1.50 and forced expiratory volume in one second (FEV1) > 80\% of the predicted value. Predictors of treatment response were identified in a multivariate logistic regression model.RESULTS: After 12 months of dupilumab treatment, 91\% of patients demonstrated a clinical response, and 30\% achieved clinical remission. All patients experienced fewer exacerbations, while patients with a clinical response and those achieving remission also exhibited significant improvements in mOCS dose reduction, FEV1\%, and ACQ-6 score. Predictors of remission included higher baseline fractional exhaled nitric oxide [OR=3.82 (95\% CI: 0.90, 16.17)], lower body mass index [OR=0.82 (95\% CI: 0.71, 0.93) for one unit increase], and the absence of allergic rhinitis [OR=0.30 (95\% CI: 0.08, 1.11)].CONCLUSION: In this real-life setting, involving over 200 patients treated with dupilumab for 12 months, 91\% had a clinical response, and 30\% of patients achieved clinical remission. These findings highlight dupilumab's potential in improving outcomes for severe asthma patients.",

keywords = "Severity of Illness Index, Prospective Studies, Humans, Middle Aged, Anti-Asthmatic Agents/therapeutic use, Antibodies, Monoclonal, Humanized/therapeutic use, Forced Expiratory Volume/drug effects, Male, Treatment Outcome, Asthma/drug therapy, Remission Induction, Denmark/epidemiology, Adult, Female, Registries, Aged, Biologic therapies, Epidemiology, Remission, Severe asthma, Real-world evidence",

author = "Susanne Hansen and H{\aa}kansson, \{Kjell Erik Julius\} and Soendergaard, \{Marianne Baastrup\} and Anne-Sofie Bjerrum and Schmid, \{Johannes Martin\} and Johansson, \{Sofie Lock\} and Rasmussen, \{Linda Makowska\} and Johnsen, \{Claus Rikard\} and \{von B{\"u}low\}, Anna and Barbara Bonnesen and Krogh, \{Niels Steen\} and Ole Hilberg and Lycely Dongo and Roxana Vijdea and Ulrik, \{Charlotte Suppli\} and Celeste Porsbjerg",

year = "2025",

doi = "10.1016/j.rmed.2025.108203",

language = "English",

volume = "245",

journal = "Respiratory Medicine",

issn = "0954-6111",

publisher = "W.B. Saunders Ltd",

}

Hansen, S, Håkansson, KEJ, Soendergaard, MB, Bjerrum, A-S, Schmid, JM, Johansson, SL, Rasmussen, LM, Johnsen, CR, von Bülow, A, Bonnesen, B, Krogh, NS, Hilberg, O, Dongo, L, Vijdea, R, Ulrik, CS & Porsbjerg, C 2025, 'Clinical response and remission in patients treated with dupilumab for severe asthma: Results from the nationwide Danish Severe Asthma Register', Respiratory Medicine, vol. 245, 108203. https://doi.org/10.1016/j.rmed.2025.108203

TY - JOUR

T1 - Clinical response and remission in patients treated with dupilumab for severe asthma

T2 - Results from the nationwide Danish Severe Asthma Register

AU - Hansen, Susanne

AU - Håkansson, Kjell Erik Julius

AU - Soendergaard, Marianne Baastrup

AU - Bjerrum, Anne-Sofie

AU - Schmid, Johannes Martin

AU - Johansson, Sofie Lock

AU - Rasmussen, Linda Makowska

AU - Johnsen, Claus Rikard

AU - von Bülow, Anna

AU - Bonnesen, Barbara

AU - Krogh, Niels Steen

AU - Hilberg, Ole

AU - Dongo, Lycely

AU - Vijdea, Roxana

AU - Ulrik, Charlotte Suppli

AU - Porsbjerg, Celeste

PY - 2025

Y1 - 2025

N2 - BACKGROUND: Randomized clinical trials have demonstrated that dupilumab reduces exacerbations and maintenance oral corticosteroids (mOCS) use in patients with uncontrolled and severe asthma. However, evidence in real-life settings is limited.OBJECTIVE: This study aimed to evaluate the proportion of patients achieving a clinical response and remission after treatment with dupilumab and identify predictors of response.METHODS: We conducted a prospective observational study involving 203 severe asthma patients from the nationwide Danish Severe Asthma Register treated with dupilumab for 12 months. Clinical response to treatment was defined as a 50% reduction in exacerbations and/or a 50% reduction in mOCS dose. Clinical remission required meeting all the following criteria: complete cessation of exacerbations, no mOCS use, an Asthma Control Questionnaire (ACQ-6) score <1.50 and forced expiratory volume in one second (FEV1) > 80% of the predicted value. Predictors of treatment response were identified in a multivariate logistic regression model.RESULTS: After 12 months of dupilumab treatment, 91% of patients demonstrated a clinical response, and 30% achieved clinical remission. All patients experienced fewer exacerbations, while patients with a clinical response and those achieving remission also exhibited significant improvements in mOCS dose reduction, FEV1%, and ACQ-6 score. Predictors of remission included higher baseline fractional exhaled nitric oxide [OR=3.82 (95% CI: 0.90, 16.17)], lower body mass index [OR=0.82 (95% CI: 0.71, 0.93) for one unit increase], and the absence of allergic rhinitis [OR=0.30 (95% CI: 0.08, 1.11)].CONCLUSION: In this real-life setting, involving over 200 patients treated with dupilumab for 12 months, 91% had a clinical response, and 30% of patients achieved clinical remission. These findings highlight dupilumab's potential in improving outcomes for severe asthma patients.

AB - BACKGROUND: Randomized clinical trials have demonstrated that dupilumab reduces exacerbations and maintenance oral corticosteroids (mOCS) use in patients with uncontrolled and severe asthma. However, evidence in real-life settings is limited.OBJECTIVE: This study aimed to evaluate the proportion of patients achieving a clinical response and remission after treatment with dupilumab and identify predictors of response.METHODS: We conducted a prospective observational study involving 203 severe asthma patients from the nationwide Danish Severe Asthma Register treated with dupilumab for 12 months. Clinical response to treatment was defined as a 50% reduction in exacerbations and/or a 50% reduction in mOCS dose. Clinical remission required meeting all the following criteria: complete cessation of exacerbations, no mOCS use, an Asthma Control Questionnaire (ACQ-6) score <1.50 and forced expiratory volume in one second (FEV1) > 80% of the predicted value. Predictors of treatment response were identified in a multivariate logistic regression model.RESULTS: After 12 months of dupilumab treatment, 91% of patients demonstrated a clinical response, and 30% achieved clinical remission. All patients experienced fewer exacerbations, while patients with a clinical response and those achieving remission also exhibited significant improvements in mOCS dose reduction, FEV1%, and ACQ-6 score. Predictors of remission included higher baseline fractional exhaled nitric oxide [OR=3.82 (95% CI: 0.90, 16.17)], lower body mass index [OR=0.82 (95% CI: 0.71, 0.93) for one unit increase], and the absence of allergic rhinitis [OR=0.30 (95% CI: 0.08, 1.11)].CONCLUSION: In this real-life setting, involving over 200 patients treated with dupilumab for 12 months, 91% had a clinical response, and 30% of patients achieved clinical remission. These findings highlight dupilumab's potential in improving outcomes for severe asthma patients.

KW - Severity of Illness Index

KW - Prospective Studies

KW - Humans

KW - Middle Aged

KW - Anti-Asthmatic Agents/therapeutic use

KW - Antibodies, Monoclonal, Humanized/therapeutic use

KW - Forced Expiratory Volume/drug effects

KW - Male

KW - Treatment Outcome

KW - Asthma/drug therapy

KW - Remission Induction

KW - Denmark/epidemiology

KW - Adult

KW - Female

KW - Registries

KW - Aged

KW - Biologic therapies

KW - Epidemiology

KW - Remission

KW - Severe asthma

KW - Real-world evidence

U2 - 10.1016/j.rmed.2025.108203

DO - 10.1016/j.rmed.2025.108203

M3 - Article

C2 - 40513967

SN - 0954-6111

VL - 245

JO - Respiratory Medicine

JF - Respiratory Medicine

M1 - 108203

ER -

Clinical response and remission in patients treated with dupilumab for severe asthma: Results from the nationwide Danish Severe Asthma Register

Abstract

Keywords

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