The following article is a part of conference coverage from the American College of Allergy, Asthma & Immunology 2020 Annual Scientific Meeting, being held virtually from November 13-15, 2020. The team at Pulmonology Advisor will be reporting on the latest news and research conducted by leading experts in the field. Check back for more from the ACAAI 2020 Annual Scientific Meeting.
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.
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.
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