Long-Term Safety of Dupilumab in Patients With Moderate-to-Severe Asthma: TRAVERSE Continuation Study.
J Allergy Clin Immunol Pract
; 12(4): 991-997.e6, 2024 Apr.
Article
in En
| MEDLINE
| ID: mdl-38163585
ABSTRACT
BACKGROUND:
Previous clinical trials have demonstrated dupilumab efficacy and safety in adults and adolescents with moderate to severe asthma for up to 3 years.OBJECTIVE:
The TRAVERSE continuation study (NCT03620747), a single-arm, open-label study, assessed safety and tolerability of dupilumab 300 mg every 2 weeks up to an additional 144 weeks (â¼3 years) in patients with moderate to severe asthma who previously completed TRAVERSE (NCT02134028).METHODS:
Primary end points were incidence and event rates per 100 patient-years of treatment-emergent adverse events (TEAEs). Secondary end points included adverse events (AEs) of special interest, serious AEs, and AEs leading to study discontinuation.RESULTS:
A total of 393 patients participated in the TRAVERSE continuation study (cumulative dupilumab exposure, 431.7 patient-years; median treatment duration, 309 days). A total of 29 patients (7.4%) received more than 958 days of treatment. A total of 214 (54.5%) patients reported at least 1 TEAE (event rate 171.4); 37 (9.4%) experienced at least 1 treatment-related TEAE, none of which were considered severe; 2 patients reported 6 TEAEs of moderate intensity. A total of 22 (5.6%) patients reported serious AEs (event rate 6.9). AEs of special interest were reported in 24 patients (6.1%; event rate 6.0). Five (1.3%) deaths occurred (event rate 1.2) following serious AEs of coronavirus disease 2019 (COVID-19)-related pneumonia (3 patients), pancreatitis (1 patient), and pulmonary embolism (1 patient). None of the TEAEs leading to death were considered treatment-related.CONCLUSIONS:
Dupilumab treatment was well tolerated for up to an additional 3 years. Safety findings were consistent with the known safety profile of dupilumab. These findings further support the long-term use of dupilumab in patients with moderate to severe asthma.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Asthma
/
Antibodies, Monoclonal, Humanized
Limits:
Adolescent
/
Adult
/
Humans
Language:
En
Journal:
J Allergy Clin Immunol Pract
Year:
2024
Document type:
Article
Country of publication:
United States