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Long-term maintenance of oral corticosteroid reduction and efficacy of Dupilumab in severe asthma patients


Many patients whose severe asthma is driven by type 2 inflammation require long-term treatment with systemic corticosteroids to control disease and prevent exacerbations.
Dupilumab ( Dupixent ), a fully human monoclonal antibody, is approved in the USA for the treatment of moderate-to-severe eosinophilic and oral corticosteroid ( OCS )-dependent asthma.

In the phase 3 LIBERTY ASTHMA VENTURE study, add-on Dupilumab 300mg every 2 weeks ( q2w ) versus placebo has significantly reduced oral corticosteroid use from baseline over 24 weeks by 70.1% vs 41.9% in adults with OCS-dependent severe asthma; despite the decreased use of oral corticosteroid in this population, Dupilumab has still reduced the severe exacerbation rate by 59% and improved pre-bronchodilator forced expiratory volume in 1 second ( FEV1 ) by 0.22L compared with placebo.

LIBERTY ASTHMA TRAVERSE, a single-arm, open-label extension study, has evaluated the long-term safety, tolerability, and efficacy of add-on Dupilumab in adults / adolescents rolled over from a previous Dupilumab study.

A post hoc analysis has assessed whether the oral corticosteroid dose reduction and efficacy of Dupilumab observed in VENTURE were maintained when patients continued with Dupilumab in TRAVERSE.

VENTURE patients treated with Dupilumab q2w or matched placebo who enrolled in TRAVERSE received Dupilumab 300mg q2w for up to 96 weeks.

Endpoints that were assessed in Dupilumab / Dupilumab-treated and placebo / Dupilumab-treated patients included change in oral corticosteroid use from VENTURE baseline at weeks 48 and 96 and the percentage of patients who completely discontinued oral corticosteroids during VENTURE and remained OCS-free at Weeks 48 and 96 of TRAVERSE.
Treating physicians were not specifically instructed to reduce patient OCS dose.

Efficacy endpoints were severe exacerbation rates and change in pre-bronchodilator FEV1 from VENTURE baseline.

Of 210 patients completing VENTURE, 187 enrolled in TRAVERSE.

At Weeks 48 and 96 of TRAVERSE, sustained reductions ( 89% by week 96 ) from VENTURE baseline in oral corticosteroids were observed in Dupilumab / Dupilumab-treated patients; substantial improvements were achieved in placebo / Dupilumab patients ( 74% reduction by week 96 ).

Of the patients who had discontinued oral corticosteroids by week 24 of VENTURE ( Dupilumab / Dupilumab: 53.3%, placebo / Dupilumab: 29.9% ), most remained OCS-free during TRAVERSE ( Dupilumab / Dupilumab: 31/33 [ 93.3% ] and 14/14 [ 100% ], placebo / Dupilumab: 21/21 [ 100% ] and 9/9 [ 100% ] at weeks 48 and 96, respectively ).
Despite reductions in OCS requirement, exacerbation rates during TRAVERSE were low and FEV1 change greatly improved.

In conclusion, long-term Dupilumab treatment of oral corticosteroids-dependent asthma facilitated weaning oral corticosteroids use, while concomitantly decreasing and maintaining low annualized rates of exacerbations and improving lung function. ( Xagena )

Source: American Thoracic Society - ATS Meeting, 2021

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