Respiratory Infections and Anti-Infective Medication Use From Phase 3 Dupilumab Respiratory Studies.
J Allergy Clin Immunol Pract
; 10(3): 732-741, 2022 03.
Article
in En
| MEDLINE
| ID: mdl-34954123
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 versus 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 versus placebo, in both asthma (22% lower; P < .0001; 95% 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 versus 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- versus placebo-treated patients throughout the calendar year.CONCLUSIONS:
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.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Asthma
/
Sinusitis
/
Rhinitis
/
Nasal Polyps
Type of study:
Clinical_trials
Limits:
Humans
Language:
En
Journal:
J Allergy Clin Immunol Pract
Year:
2022
Document type:
Article