TRAVERSE Trial of Dupilumab for Severe Oral Corticosteroid-Dependent Asthma

Among patients with severe oral corticosteroid (OCS)-dependent asthma, dupilumab can reduce the patient’s OCS dosage level and improve asthma outcomes, according to study findings presented at the American Thoracic Society (ATS) 2022 International Conference, held in San Francisco, CA, May 13 to 18.

The long-term OCS therapy frequently used to manage severe asthma has potentially problematic side effects, noted the study authors, who sought to determine whether use of dupilumab could reduce OCS dosage. Building upon results of the phase 3 LIBERTY ASTHMA VENTURE trial (ClinicalTrials.gov Identifier: NCT02528214), which found that add-on dupilumab of 300 mg every 2 weeks significantly reduced OCS use, researchers for the LIBERTY ASTHMA TRAVERSE trial (ClinicalTrials.gov Identifier: NCT02134028), a single-arm, open-label extension study, examined the long-term safety, tolerability, and efficacy of dupilumab for patients with severe asthma who are OCS-dependent. 

In the TRAVERSE trial, 187 participants from VENTURE with OCS-dependent asthma who had received add-on dupilumab 300 mg or placebo every 2 weeks for 24 weeks were given add-on dupilumab 300 mg every 2 weeks for almost 2 years. For their analysis, researchers for TRAVERSE trial divided the VENTURE patients into 4 cohorts that were stratified according to patients’ baseline OCS dose (ie, ≤10 or >10 mg/day OCS) in the VENTURE trial and the therapies received (ie, dupilumab vs placebo) during the 2 trials.

The TRAVERSE investigators found that after 48 weeks, patients on dupilumab showed the greatest reductions in OCS use (patients with baseline OCS use ≤10 mg/day: −82.8%; patients with baseline OCS use >10 mg/day: −74.7%) — a finding that supported the findings of the VENTURE trial. Moreover, this OCS reduction occurred even though “Treating physicians were not specifically instructed to reduce patient OCS dose during TRAVERSE,” noted study authors. 

Among those patients on placebo in VENTURE who were switched to dupilumab in TRAVERSE, the investigators found that reduction in OCS use was almost as dramatic through week 48 in TRAVERSE (patients with baseline OCS use ≤10 mg/day: −49.6%; patients with baseline OCS use >10 mg/day: −66.5%). In TRAVERSE, severe asthma exacerbations declined (range: 0.284-0.599) and pre-bronchodilator FEV₁ improved (range at TRAVERSE week 48: 1.83-1.92 L).

The level of reductions in OCS use seen in VENTURE continued in TRAVERSE, stressed study authors. “Dupilumab reduced OCS dose and improved and maintained clinical efficacy outcomes of asthma, regardless of baseline OCS starting dose….without a tapering schema of reduction in TRAVERSE,” the investigators concluded. 

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for more information.

Reference

Gurnell M, Domingo Ribas C, Rabe KF, et al. Persistent reductions in OCS use in patients with severe, OCS-dependent asthma treated with dupilumab: LIBERTY ASTHMA TRAVERSE study. Presented at: the American Thoracic Society (ATS) 2022 International Conference; May 13-18, 2022; San Francisco, CA. Session B15.