- In patients with moderate-severe asthma, long-term treatment with dupilumab was well tolerated, with a long-term safety profile consistent with that observed in short-term parent trials.
- Among nonoral corticosteroid (OCS)-dependent patients, dupilumab maintained the clinical efficacy observed in parent studies, including a persistently low exacerbation rate and sustained improvement in lung function.
Why this matters
- Efficacy and safety of dupilumab up to 1 year have already been demonstrated.
- LIBERTY ASTHMA TRAVERSE, open-label extension (OLE) study evaluated 2282 patients with moderate-to-severe asthma or OCS-dependent severe asthma, who completed a previous dupilumab asthma study (P2b DRI, EXPEDITION, QUEST, or VENTURE).
- Patients received add-on subcutaneous dupilumab (300 mg) every 2 weeks up to 96 weeks.
- Treatment-emergent adverse events (TEAEs), annualized exacerbations rate (AER) of severe asthma during the treatment period, and change from parent study baseline in forced expiratory volume in 1 second (FEV1) up to week 96 were evaluated.
- Funding: GSK, Sanofi.
- Rate of TEAEs in overall population of the parent study was as follows:
- P2b: 75%-83%;
- QUEST: 81%-83%; and
- VENTURE: 62%-64%.
- Rates of TEAEs in OLE were similar to those observed in the parent study with no new safety signal identified in patients from:
- P2b: placebo/dupilumab, 79.3%; dupilimab/dupilumab, 87.6%;
- QUEST: placebo/dupilumab, 80.1%; dupilimab/dupilumab, 77.9%; and
- VENTURE: placebo/dupilumab, 76.3%; dupilimab/dupilumab, 77.8%.
- Serious adverse events were experienced by 9%-13% of patients.
- TEAEs leading to treatment discontinuation were low.
- The low unadjusted AER observed in the parent study among non-OCS-dependent patients was maintained in OLE:
- P2b: placebo/dupilumab, 0.314; dupilimab/dupilumab, 0.330; and
- QUEST: placebo/dupilumab, 0.351; dupilimab/dupilumab, 0.331.
- Improvements in FEV1 observed in the parent study among the non-OCS population were sustained during the OLE (mean FEV1 at week 96, 2.02-2.12 L; mean percent change from parent study baseline, 13%-22%).
- Open-label design.