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New data suggest that dupilumab is safe for long-term use among patients with moderate-to-severe asthma or oral corticosteroid (OCS)-dependent severe asthma.

Previous studies have demonstrated the efficacy and safety of dupilumab in adults and adolescents with moderate-to-severe asthma for up to 3 years. Findings from the new study showed that dupilumab was well tolerated for up to an additional 3 years.

These results come from the phase 3b TRAVERSE continuation study, which was a single-arm, multicenter, open-label study “that evaluated long-term safety in patients with moderate-to-severe asthma who had previously completed TRAVERSE for a further 3 years,” wrote first author Jorge F. Maspero, MD, medical director of Fundación CIDEA in Buenos Aires, Argentina, and colleagues.

The study included 393 participants (mean age, 52.1 years; 58.8% women) with moderate-to-severe asthma or OCS-dependent severe asthma who completed the TRAVERSE trial after their participation in a prior phase 2b trial or the phase 3 LIBERTY ASTHMA QUEST or LIBERTY ASTHMA VENTURE studies of dupilumab.

To determine long-term safety of dupilumab, all participants received 300 mg doses every 2 weeks for up to 144 weeks, or approximately 3 years, according to the study.

Primary endpoints were incidence and event rates per 100 patient-years (PY) of treatment-emergent adverse events (TEAEs). Secondary endpoints included adverse events of special interest (AESIs), serious adverse events (SAEs), and adverse events (AEs) leading to study discontinuation, noted investigators.

FINDINGS

A total 374 participants took part in the TRAVERSE continuation study and 19 discontinued treatment, resulting in a cumulative exposure to dupilumab of 431.7 PY and a median study treatment duration of 309 days (range, 25-1047).

Approximately half of the participants received treatment for 286 or more days, and 29 patients (7.4%) had treatment exposure of more than 958 days, according to the results.

Researchers noted that 214 participants (54.5%) experienced at least 1 TEAE—the most common of which were asthma (13.7%), nasopharyngitis (8.4%), COVID-19 infection (6.4%), upper respiratory tract infections (3.8%), and bronchitis (3.6%)—for an event rate of 171.4 per 100 PY.

Thirty-seven (9.4%) participants experienced at least 1 treatment-related TEAE, none of which were considered severe, for an event rate of 29 per 100 PY. Treatment-related TEAEs included decreased platelet counts, injection-site erythema, decreased neutrophil count, and decreased white blood cell count. Investigators noted that none of these events led to treatment discontinuation.

In addition, 22 participants (5.6%) reported at least 1 SAE (event rate: 6.9 per 100 PY). The most frequently reported SAEs were asthma exacerbation in 1% of participants and COVID-19 and COVID-19 pneumonia in 0.8% of participants, each, according to researchers.

Twenty-four participants (6.1%) experienced AESIs (event rate: 6.0 per 100 PY). The AESIs that occurred most frequently were influenza (n=7 [1.8%]), COVID-19 pneumonia (n=3 [0.8%]), herpes zoster (n=3 [0.8%]), and oral herpes (n=3 [0.8%]).

“Here, it is of note that the safety profile and tolerability observed during long-term treatment for an additional 3 years in the TRAVERSE continuation study was consistent with that initially observed for up to 3 years throughout the phase 2b, QUEST, VENTURE, and TRAVERSE studies, thus affirming the overall long-term safety and tolerability of dupilumab,” wrote Maspero et al.

Source: Maspero JF, Peters AT, Chapman KR, et al. Long-term safety of dupilumab in patients with moderate-to-severe asthma: TRAVERSE continuation study. J Allergy Clin Immunol Pract. Published online December 30, 2023. doi:10.1016/j.jaip.2023.12.043