S136 Long-term safety and efficacy of dupilumab in patients with asthma: LIBERTY ASTHMA TRAVERSE open-label extension study

Id Pavord,N Amin,X Mao,C Domingo,A Bourdin,M Hardin,A Papi,U Kapoor,H Watz,M Ruddy,Lp Mannent,Fa Khokhar,Me Wechsler,E Laws

doi:10.1136/thorax-2020-btsabstracts.141

Id Pavord, N Amin + Show 12 more

https://doi.org/10.1136/thorax-2020-btsabstracts.141

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<h3>Introduction and Objectives</h3> Dupilumab, a fully human monocolonal antibody, blocks the shared receptor component for interleukin (IL)–4 and IL–13, key and central drivers of type 2 inflammation in multiple diseases. The efficacy and safety up to 52 weeks of dupilumab in asthma have been demonstrated in phase 2 and phase 3 studies. We assess the long-term safety and efficacy of dupilumab in the open-label extension (OLE) LIBERTY ASTHMA TRAVERSE study (NCT02134028) in adult and adolescent patients who had completed a dupilumab asthma study (phase 2b DRI, phase 2 EXPEDITION, phase 3 QUEST, or phase 3 VENTURE). <h3>Methods</h3> Patients with moderate-to-severe or oral corticosteroid (OCS)-dependent severe asthma received add–on subcutaneous dupilumab 300 mg every 2 weeks (q2w), up to 96 weeks. Treatment-emergent adverse events (TEAEs), annualized rate of severe asthma exacerbations (AER) during the treatment period, and change from parent study baseline (PSBL) in forced expiratory volume in 1 second (FEV<sub>1</sub>) and biomarkers up to Week 96 were assessed. <h3>Results</h3> Of 2,930 patients randomized in the parent studies, 78% enrolled into the OLE; of 2,282 patients enrolled and exposed in the OLE, 96% had a study duration of 48 weeks and 54% had a study duration of 96 weeks. Long-term safety profile was consistent with the parent studies (<b>table 1</b>). The low unadjusted AER and improvement in FEV<sub>1</sub> observed in the parent studies were sustained during the OLE. Similar efficacy was seen in patients with elevated type 2 biomarkers from DRI/QUEST. By Week 96, blood eosinophils decreased to below PSBL levels in patients from DRI/QUEST and were near PSBL levels in patients from VENTURE; total IgE levels decreased by 82% (median percent change from PSBL). <h3>Conclusions</h3> Long-term use of dupilumab was well tolerated and showed sustained efficacy in asthma patients up to 96 weeks.

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