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 (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)].

Conclusions: 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.