New data support the long-term use of dupilumab in adult and adolescent patients with moderate-to-severe asthma.
TRAVERSE, an extension trial funded by Sanofi and Regeneron Pharmaceuticals, assessed the safety and efficacy of extended dupilumab use in 2,282 adults and adolescents across 27 countries who had taken part in prior studies with the drug.
Patients were given 300mg dupilumab every two weeks for up to 96 weeks, following their treatment in either the QUEST (52 weeks), VENTURE (24 weeks) or EXPEDITION (12 weeks) parent trials.
The data, published in The Lancet Respiratory Medicine, showed that the both safety and efficacy of dupilumab seen in the TRAVERSE study were consistent with the drug’s known profile.
The proportion of patients reporting treatment-emergent side effects during the study was 76.3% to 94.7%, the most frequently reported being nasopharyngitis (17.5-25·9%), injection-site erythema (2.2-23.4%), and bronchitis (9.3-19.0%).
Serious asthma exacerbations (0.5-3.6%) and pneumonia (0.7-2.7%) were the most frequently reported serious adverse events, and four side effects led to death, the researchers noted.
On the efficacy side, the rate of annualised exacerbations (AER) remained low (0.277-0.327) in patients who were non-oral-corticosteroid dependent.
Pre-bronchodilator FEV1 improvements were sustained to the end of treatment at week 96 (mean changes from parent study baseline ranged from 0.22L to 0.33L), while blood eosinophils levels and serum total IgE decreased progressively with exposure to dupilumab.
Improvements observed in quality of life and symptom control were also sustained until week 48 (when last assessed), as shown by ACQ-5 (symptom control) and AQLQ (asthma quality of life questionnaire) scores.
The researchers noted that “sustained improvements were seen in all outcome measures for patients given dupilumab who previously received placebo in parent studies [and] further improvements in AER, asthma control, and health-related quality of life were observed in patients who continued receiving dupilumab”.
They concluded that the study’s findings show that dupilumab’s safety and efficacy in adults and adolescents with moderate-to-severe asthma were sustained when treatment was extended up to 148 weeks, and therefore “support the long-term use of dupilumab in this patient population”.