Long-term Treatment Sustains Corticosteroid Dose Reductions in Severe Asthma

Patients with corticosteroid-dependent severe asthma treated with dupilumab long term sustained oral corticosteroid (OSC) dose reduction while also maintaining low exacerbation rates and improved lung function. Researchers published the findings in Chest.

“An estimated 30% of patients with severe asthma remain dependent on systemic corticosteroids to maintain symptom control,” researchers wrote. “While several OCS-sparing studies have demonstrated the ability of add-on biologic therapy to support a reduction in OCS dose in patients with severe asthma, there are limited data to support long-term maintenance of OCS reduction, or sustained improvements in exacerbation rate or lung function in this population.”

The TRAVERSE open-label extension study involved 187 patients with OCS-dependent severe asthma from a previous 24-week placebo-controlled trial of dupilumab called VENTURE. In the extension, patients were treated with dupilumab 300 mg every 2 weeks for up to 96 weeks. The analysis included 90 patients treated with dupilumab in both the original study and the extension (dupilumab/dupilumab group) and 97 patients initially treated with placebo who switched to dupilumab for the extension (placebo-dupilumab group).

At week 0 of TRAVERSE, the mean daily OCS dose was 3.1 mg/day for the dupilumab/dupilumab group and 6.4 mg/day for placebo/dupilumab group, according to the study. At week 48, the mean daily OSC dose decreased to 2.2 mg/day for the dupilumab/dupilumab group and 4.9 mg/day for the placebo/dupilumab group and, by week 96, to 1.2 mg/day for the dupilumab/dupilumab group and 3 mg/day for the placebo/dupilumab group.

“The majority of patients that achieved a ≥ 50% reduction in OCS at the end of VENTURE were able to maintain this reduction through weeks 48 and 96 of TRAVERSE, and similarly, the majority of patients that discontinued OCS at the end of VENTURE were able to maintain this reduction through weeks 48 and 96,” researchers reported.

Exacerbation rates over the course of the extension were low, the study found. Further improvements occurred in forced expiratory volume in 1 second and 5-item Asthma Control Questionnaire scores.

“In conclusion,” researchers wrote, “we demonstrate that in a population with severe asthma and chronic OCS dependence at parent study baseline, long-term exposure to dupilumab supports sustained reduction in OCS dose and improvement in clinical endpoints for up to 96 weeks. The dupilumab safety profile during TRAVERSE was consistent with that seen during VENTURE.”

Reference:
Sher LD, Wechsler ME, Rabe KF, et al. Dupilumab reduces oral corticosteroid use in patients with corticosteroid-dependent severe asthma: an analysis of the phase 3, open-label extension TRAVERSE trial. Chest. 2022;S0012-3692(22)00388-9. doi:10.1016/j.chest.2022.01.071