The following is a summary of “Long-Term Safety of Dupilumab in Patients With Moderate-to-Severe Asthma: TRAVERSE Continuation Study,” published in the April 2024 issue of Allergy & Immunology by Maspero, et al.

Previous clinical trials have demonstrated the efficacy and safety of dupilumab in adults and adolescents with moderate to severe asthma for up to 3 years. For a TRAVERSE continuation study, a single-arm, open-label study, researchers sought to assess the safety and tolerability of dupilumab 300 mg every 2 weeks for an additional 144 weeks (∼3 years) in patients with moderate to severe asthma who previously completed TRAVERSE (NCT02134028).

Primary endpoints included the incidence and event rates per 100 patient-years of treatment-emergent adverse events (TEAEs). Secondary endpoints comprised adverse events (AEs) of special interest, serious AEs, and AEs leading to study discontinuation.

In the TRAVERSE continuation study, 393 patients participated, with a cumulative dupilumab exposure of 431.7 patient-years and a median treatment duration of 309 days. Notably, 29 patients (7.4%) received more than 958 days of treatment. Overall, 214 patients (54.5%) reported at least 1 TEAE (event rate: 171.4), with 37 (9.4%) experiencing at least 1 treatment-related TEAE, none of which were considered severe. Two patients reported 6 TEAEs of moderate intensity. Serious AEs were reported in 22 patients (5.6%; event rate: 6.9), while AEs of special interest were reported in 24 patients (6.1%; event rate: 6.0). Tragically, five deaths occurred (1.3%; event rate: 1.2), attributed to severe coronavirus AEs disease 2019 (COVID-19)-related pneumonia (3 patients), pancreatitis (1 patient), and pulmonary embolism (1 patient). Importantly, none of the TEAEs leading to death were considered treatment-related.

The TRAVERSE continuation study revealed that dupilumab treatment was well tolerated for up to an additional 3 years, with safety findings consistent with the drug’s known safety profile. The findings further support the long-term use of dupilumab in patients with moderate to severe asthma.

Reference: jaci-inpractice.org/article/S2213-2198(23)01406-X/fulltext