TRAVERSE Study: Long-Term Dupilumab for Asthma
The TRAVERSE Study was an open-label extension trial assessing dupilumab's long-term safety and efficacy for moderate to severe asthma. It confirmed a favorable safety profile and sustained improvements in lung function and asthma control over 148 weeks. This suggests dupilumab is a promising long-term treatment, particularly for patients with a type 2 inflammatory phenotype.
Key Takeaways
Dupilumab maintained a consistent safety profile over 148 weeks.
Patients experienced sustained improvements in lung function and asthma control.
Benefits were particularly notable for type 2 inflammatory asthma.
The study supports dupilumab as a viable long-term asthma treatment.
What was the background and objectives of the TRAVERSE Study?
The TRAVERSE Study served as a crucial open-label extension, meticulously building upon the foundational data from previous dupilumab trials. Its core purpose was to comprehensively assess the long-term safety and sustained efficacy of dupilumab in adults and adolescents grappling with moderate to severe asthma. Specifically, the study aimed to track patient outcomes over an extended period, reaching up to 148 weeks. This prolonged observation was vital because earlier studies typically concluded after approximately one year of treatment, leaving a significant gap in understanding the very long-term effects and durability of this important therapy.
- Open-label extension of previous dupilumab studies.
- Evaluate long-term efficacy and safety (up to 148 weeks).
- Previous studies covered up to 1 year of treatment.
How was the TRAVERSE Study conducted?
The TRAVERSE Study was meticulously structured as a multicenter, multinational, single-arm, open-label extension to provide robust long-term data on dupilumab. It enrolled a specific population: adults and adolescents aged 12 to 84 years who had previously participated in key dupilumab trials such as EXPEDITION, P2b, QUEST, and VENTURE. These participants continued their regimen of dupilumab 300 mg every two weeks for an additional period, extending up to 96 weeks. The study's primary endpoint focused on the incidence of treatment-emergent adverse events, ensuring a thorough evaluation of safety. Numerous secondary endpoints were also tracked, including annual exacerbation rates, lung function changes, and patient-reported outcomes.
- Multicenter, multinational, single-arm, open-label extension study.
- Population: Adults and adolescents (12-84 years) with moderate to severe asthma from previous dupilumab studies.
- Continued dupilumab 300 mg every 2 weeks for up to 96 weeks.
- Primary Endpoint: Treatment-emergent adverse events.
- Secondary Endpoints: Annual exacerbation rate (AER), changes in pre-bronchodilator FEV1, Asthma Control Questionnaire (ACQ-5), Asthma Quality of Life Questionnaire (AQLQ), Type 2 biomarkers (blood eosinophils and serum total IgE), Anti-drug antibodies (ADA).
What were the key safety and efficacy results of the TRAVERSE Study?
The TRAVERSE Study's safety findings consistently aligned with the known profile of dupilumab, even across the extended treatment duration. The most frequently reported adverse events were generally mild, including nasopharyngitis, injection site erythema, and bronchitis. While the proportion of serious adverse events remained low, severe asthma exacerbations and pneumonia were the most commonly reported serious issues, and four deaths were related to treatment-emergent adverse events. On the efficacy front, the annual exacerbation rate remained remarkably low, ranging from 0.277 to 0.327 across all parent studies and groups. Patients experienced sustained and significant improvements in pre-bronchodilator FEV1, asthma control (ACQ-5), and quality of life (AQLQ) for up to 96 weeks.
- Safety: Adverse events consistent with known dupilumab profile; most common were nasopharyngitis, injection site erythema, and bronchitis.
- Low proportion of serious adverse events, with severe asthma exacerbations and pneumonia most frequently reported.
- Four deaths related to treatment-emergent adverse events were observed.
- Efficacy: Annual exacerbation rate (AER) remained low (0.277–0.327).
- Sustained improvements in pre-bronchodilator FEV1 up to week 96.
- Improvements in asthma control (ACQ-5) and quality of life (AQLQ) maintained up to week 48.
- Progressive decrease in blood eosinophils and serum total IgE.
- Anti-drug antibodies (ADA) status did not impact safety or efficacy.
What conclusions can be drawn from the TRAVERSE Study?
The TRAVERSE Study definitively concluded that dupilumab maintains a highly favorable safety profile for the long-term management of moderate to severe asthma, reinforcing its established safety record. Crucially, the study provided compelling evidence of sustained improvements in both lung function and the effective control of asthma exacerbations over the extensive 148-week observation period. These robust findings strongly position dupilumab as a promising and highly viable long-term treatment option for patients grappling with chronic moderate to severe asthma. Its therapeutic benefits are particularly pronounced and significant for individuals identified with a distinct type 2 inflammatory phenotype, offering a targeted and effective approach to disease management.
- Dupilumab demonstrated a favorable safety profile in long-term treatment of moderate to severe asthma.
- Sustained improvements in lung function and control of asthma exacerbations observed over 148 weeks.
- Dupilumab may be a promising long-term treatment option for patients with moderate to severe asthma, particularly those with type 2 inflammatory phenotype.
Frequently Asked Questions
What was the primary goal of the TRAVERSE Study?
The TRAVERSE Study aimed to evaluate the long-term safety and efficacy of dupilumab for moderate to severe asthma over an extended period of up to 148 weeks. It built upon previous shorter trials to provide comprehensive long-term data.
What were the main safety findings for dupilumab in the TRAVERSE Study?
Dupilumab showed a consistent and favorable safety profile. Common adverse events were mild, like nasopharyngitis. Serious adverse events were low, though some deaths related to treatment-emergent events occurred, consistent with known risks.
Did dupilumab show sustained benefits for asthma patients in the long term?
Yes, the study observed sustained improvements in lung function, asthma control, and quality of life over 148 weeks. The annual exacerbation rate remained low, particularly benefiting patients with a type 2 inflammatory phenotype.
