Long-term dupilumab treatment of OCS-dependent asthma reduced OCS use

Long-term treatment with dupilumab helped patients with oral corticosteroid-dependent asthma wean their oral corticosteroid use and also reduced exacerbations and improved lung function.

At the American Thoracic Society International Conference, researchers presented a post hoc analysis that evaluated whether the oral corticosteroid (OCS) dose reductions and efficacy of dupilumab (Dupixent, Sanofi/Regeneron) that occurred in the LIBERTY ASTHMA VENTURE study of patients with severe OCS-dependent asthma were maintained when patients continued treatment with dupilumab in the LIBERTY ASTHMA TRAVERSE open-label extension study.

Patients in the VENTURE study received add-on dupilumab 300 mg every 2 weeks or placebo over 24 weeks; those assigned dupilumab experienced significant reductions in OCS use from baseline and reductions in severe exacerbations and improved pre-bronchodilator FEV₁ compared with placebo. Of the 210 patients who completed the VENTURE study, 187 were enrolled in TRAVERSE and received dupilumab 300 mg every 2 weeks for up to 96 weeks.

“Dupilumab reduced oral corticosteroid use over time compared with the parent study baseline in patients who were rolled over into TRAVERSE. Patients who were unable to taper their oral corticosteroids because they were on placebo in the VENTURE study were now able to taper their oral corticosteroids and large proportions of these [patients] became oral corticosteroid-free by the end of the treatment period,” Michael E. Wechsler, MD, MMSc, professor of medicine at National Jewish Health in Denver, told Healio.

At 96 weeks, patients assigned dupilumab in both VENTURE and TRAVERSE achieved 89% OCS reduction from VENTURE baseline. Those assigned placebo in VENTURE then treated with dupilumab in TRAVERSE achieved 74% reduction in OCS use by week 96, according to the results.

At 24 weeks’ follow-up in the VENTURE study, 53.3% of patients who received dupilumab and 29.9% of those assigned placebo had discontinued their OCS. Of the 29 patients who received placebo and then dupilumab during TRAVERSE and the 48 who received dupilumab in both studies and were OCS free at the end of VENTURE, 21 and 33, respectively, provided OCS dose data during TRAVERSE; nearly all remained OCS free during TRAVERSE (21 placebo/dupilumab, 31 dupilumab/dupilumab).

In addition, patients who rolled over from the dupilumab group showed sustained improvements in exacerbation rates and FEV₁, according to the results. Moreover, patients who rolled over from the placebo group had an initial rapid improvement in exacerbation rates and lung function following initiated dupilumab that was sustained during TRAVERSE, according to the presentation.

“This study is important because it demonstrates the long-term safety of dupilumab out to 96 weeks. Furthermore, it shows that the effects of dupilumab don’t wear off over time and, even in patients who are on oral corticosteroids, they will continue to have a reduction in exacerbations [and] improvement in lung function even as oral corticosteroid doses are tapering,” Wechsler told Healio. “This therapy is safe over the long term, it’s effective over the long term, and patients who were in placebo arms gained additional improvements despite the fact that they were on oral corticosteroids when dupilumab was added. These data are very reassuring.”

Reference:

Wechsler ME, et al. Am J Respir Crit Care Med. 2021;doi:10.1164/ajrccm-conference.2021.203.1.

Editor’s note: This article was updated on June 23, 2021, to clarify the number of patients who remained free from oral corticosteroids during the TRAVERSE study.