ERS 2020 — Long-term dupilumab well tolerated in patients with asthma


  • Antara Ghosh
  • Conference Reports
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Takeaway

  • 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.

Study design

  • 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.

Key results

  • 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%).

Limitations

  • Open-label design.