Dupilumab Demonstrates Long-Term Efficacy, Safety for Improving Asthma Control

Treatment with monoclonal antibody and dual interleukin-4 (IL-4)/interleukin-13 (IL-13) inhibitor dupilumab was well tolerated and associated with sustained improvement in asthma control for up to 96 weeks, according to study results presented at the American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting, held virtually from November 13 to 15.

In the open-label LIBERTY ASTHMA TRAVERSE extension study (ClinicalTrials.gov Identifier: NCT02134028), a multinational team of researchers examined the long-term safety and efficacy of add-on subcutaneous 300 mg dupilumab in 2282 patients with moderate to severe asthma.

Patients had received dupilumab every 2 weeks for up to 96 weeks in the phase 2B DRI study, phase 2 EXPEDITION study, phase 3 QUEST study, or phase 3 VENTURE study. The investigators examined treatment-emergent adverse events (TEAEs), annualized rate of severe asthma exacerbations (AER), and changes in forced expiratory volume in 1 second (FEV₁) and biomarkers from baseline to up to week 96. The change in the 5-item Asthma Control Questionnaire (ACQ-5) score at up to week 48 was also assessed.

The safety profile of dupilumab in the open-label extension was consistent with that observed in the parent studies. Additionally, there was a sustained low unadjusted rate of AERs and improvements in FEV₁ during the open-label extension trial.

In the patients from the DRI and QUEST trials, the ACQ-5 score continued to improve during the extension phase. The mean change in the ACQ-5 score in these patients was -1.63 from baseline in the parent study to week 48 in the extension study. Blood eosinophils decreased below baseline levels from the parent trials by 96 weeks in the open-label extension.

In patients from the VENTURE study, blood eosinophils by 96 weeks had decreased to near baseline levels from the parent trial. Total levels of immunoglobulin E also decreased by a median of 82% from baseline levels in the parent trials.

Disclosure: This clinical trial was supported by Sanofi. Please see the original reference for a full list of authors’ disclosures.

Reference

Wechsler M, Ford L, Maspero J, et al. Dupilumab is well tolerated and shows sustained efficacy in patients with asthma: Liberty Asthma Traverse. Presented at: the American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting (Virtual Experience); November 13-15, 2020. Abstract P219.