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

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 (FEV 1 ) > 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, FEV 1 %, 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.