LIBERTY ASTHMA TRAVERSE Trial: Long-Term Safety and Efficacy of Dupilumab in Moderate-to-Severe Asthma
Long-term Safety and Efficacy of Dupilumab in Patients With Moderate-to-severe
Asthma (TRAVERSE): An Open-label Extension Study
Wechsler ME, et al. Lancet Respir Med. 2022;10(1):11–25.
These materials are presented by Sanofi and Regeneron Medical for scientific exchange purposes only. Please refer to the package insert for full prescribing information. Sanofi will not foster the application of our medicinal products in a way outside of the approved indication. Please always refer to the SmPC approved in your country before prescribing Dupilumab
aPlease see manuscript for full details; bStudies included in safety analysis: phase 2A EXPEDITION, phase 2B DRI [P2b], phase 3 QUEST, and VENTURE and studies included in efficacy analysis: phase 2B DRI [P2b] and phase 3 QUEST; cThismeasure refers to ACQ-5 improvement from parent study baseline that exceeded the minimal clinically important difference ≥0·5
ACQ-5, 5-item Asthma Control Questionnaire; AER, annualised exacerbation rate; AQLQ, Asthma Quality of Life Questionnaire; DUP; dupilumab; EOS, eosinophil; HRQoL, health related quality of life; ICS, inhaled corticosteroids; IgE, immunoglobulin E; N, number of patients who participated and were exposed to dupilumab in TRAVERSE; N1, number of patients who completed TRAVERSE to week 48; N2, number of patients who completed TRAVERSE to week 96; OCS, oral corticosteroid; OLE, open labeled study; PBO, placebo; pre BD-FEV1, pre bronchodilator forced expiratory volume in 1 second; q2w, every 2 weeks; SAE, serious adverse event; TEAE, treatment-emergent adverse event.
Dupilumab Reduces Oral Corticosteroid Use in Patients With Corticosteroid-Dependent
Severe Asthma: An Analysis of the Phase 3, Open-Label Extension TRAVERSE Trial
Sher LD, et al. Chest. 2022;162(1):46–55.
These materials are presented by Sanofi and Regeneron Medical for scientific exchange purposes only. Please refer to the package insert for full prescribing information. Sanofi will not foster the application of our medicinal products in a way outside of the approved indication. Please always refer to the SmPC approved in your country before prescribing Dupilumab
aPlease see manuscript for full details; bOCS use was captured for VENTURE patients that rolled over to TRAVERSE as a concomitant medication. OCS dose was recorded for 187/187, 134/172, and 47/65 patients at Week 0, 48 and 96, respectively. Missing values occurred when providers did not record OCS as a concomitant medication; cFor all analyses, Week 0 corresponds to the start of the TRAVERSE study. OCS data were passively collected, and available only for patients who reported it.
ACQ-5, 5-item Asthma Control Questionnaire; AER, annualised exacerbation rate; DUP; dupilumab; OCS, oral corticosteroid; LS, least squares; n1, number of patients who completed TRAVERSE to week 48; n2, number of patients who completed TRAVERSE to week 96; OLE, open labeled study; PBO, placebo; pre BD-FEV1, pre bronchodilator forced expiratory volume in 1 second; PSBL, parent study baseline; q2w, every 2 weeks; SD, standard deviation.
