Respiratory Infections and Anti-Infective Medication Use From Phase 3 Dupilumab Respiratory Studies.
Academic Article
Overview
abstract
BACKGROUND: Patients with asthma and/or chronic rhinosinusitis with nasal polyps (CRSwNP) experience recurrent respiratory tract infections. Dupilumab targets type 2 inflammation, a common underlying pathophysiology of both conditions, with proven efficacy. OBJECTIVE: To examine investigator-reported respiratory infection adverse events and anti-infective medication use with dupilumab vs placebo in patients with moderate-to-severe asthma or severe CRSwNP. METHODS: We performed a post hoc analysis of the pivotal phase 3 trials LIBERTY ASTHMA QUEST (NCT02414854) and LIBERTY NP SINUS-52 (NCT02898454) in moderate-to-severe asthma and severe CRSwNP, respectively. RESULTS: Investigator-reported respiratory infection events occurred at a significantly lower incidence in patients treated with dupilumab vs placebo, in both asthma (22% lower; P<.0001; 95% confidence interval [CI] 0.71-0.85) and CRSwNP (38% lower; P<.0001; [95% CI 0.51-0.75]). Reported upper and lower respiratory tract infection events were numerically or significantly lower in dupilumab-treated patients in both conditions, as were the number of patients experiencing investigator-reported infections. Significantly less systemic anti-infective medication use occurred in dupilumab vs placebo in asthma (24% lower; P<.0001; [95% CI 0.70-0.83]) and CRSwNP patients (49% lower; P<.0001; [95% CI 0.43-0.61]), and significantly fewer dupilumab-treated patients used anti-infective medications. When examined by season and month, the data indicated that investigator-reported respiratory infections and anti-infective medication use were less frequent in dupilumab- vs placebo-treated patients throughout the calendar year. CONCLUSION: Dupilumab treatment was associated with a reduced incidence of investigator-reported respiratory infections in patients with moderate-to-severe asthma or severe CRSwNP. Further studies are required to determine the mechanism behind this reduction.
