ATS 2021 will feature presentations of original research from accepted abstracts. Mini Symposia and Thematic Poster Sessions are abstract based sessions.
Please use the form below to browse scientific abstracts and case reports accepted for ATS 2021. Abstracts presented at the ATS 2021 will be published in the Online Abstract Issue of the American Journal of Respiratory and Critical Care Medicine, Volume 203, May 3, 2021.
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Assessment of Long-Term Maintenance of OCS Reduction and Efficacy in the Dupilumab LIBERTY ASTHMA TRAVERSE Extension Study
Session Title
TP10 - TP010 CLINICAL AND POPULATION-LEVEL STUDIES OF ASTHMA
Abstract
A1441 - Assessment of Long-Term Maintenance of OCS Reduction and Efficacy in the Dupilumab LIBERTY ASTHMA TRAVERSE Extension Study
Author Block: L. Sher1, M. Wechsler2, K. F. Rabe3, J. F. Maspero4, N. Daizadeh5, X. Mao6, B. Ortiz7, L. P. Mannent8, E. Laws6, M. K. Ruddy7, N. Pandit-Abid6, D. J. Lederer7, M. E. Hardin5; 1Peninsula Research Associates, Rolling Hills Estates, CA, United States, 2National Jewish Health, Denver, CO, United States, 3LungenClinic Grosshansdorf, Airway Research Center North (ARCN), Grosshansdorf, Germany and Christian Albrechts University, Airway Research Center North (ARCN), Kiel, Germany, 4Fundación CIDEA, Buenos Aires, Argentina, 5Sanofi, Cambridge, MA, United States, 6Sanofi, Bridgewater, NJ, United States, 7Regeneron Pharmaceuticals, Inc., Tarrytown, NY, United States, 8Sanofi, Chilly Mazarin, France.
Rationale: 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, 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 (NCT02528214), add-on dupilumab 300mg every 2 weeks (q2w) vs placebo significantly reduced OCS use from baseline over 24 weeks by 70.1% vs 41.9% in adults with OCS-dependent severe asthma; despite the decreased use of OCS in this population, dupilumab 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 (NCT02134028), evaluated the long-term safety, tolerability, and efficacy of add-on dupilumab in adults/adolescents rolled over from a previous dupilumab study. This post hoc analysis assessed whether the OCS dose reduction and efficacy of dupilumab observed in VENTURE were maintained when patients continued with dupilumab in TRAVERSE. Methods: 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 OCS use from VENTURE baseline at Weeks 48 and 96 and the percentage of patients who completely discontinued OCS 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. Results: Of 210 patients completing VENTURE, 187 enrolled in TRAVERSE (Table). At Weeks 48 and 96 of TRAVERSE, sustained reductions (89% by Week 96) from VENTURE baseline in OCS 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 OCS 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. Conclusions: Long-term dupilumab treatment of OCS-dependent asthma facilitated weaning OCS use, while concomitantly decreasing and maintaining low annualized rates of exacerbations and improving lung function.
Author Block: L. Sher1, M. Wechsler2, K. F. Rabe3, J. F. Maspero4, N. Daizadeh5, X. Mao6, B. Ortiz7, L. P. Mannent8, E. Laws6, M. K. Ruddy7, N. Pandit-Abid6, D. J. Lederer7, M. E. Hardin5; 1Peninsula Research Associates, Rolling Hills Estates, CA, United States, 2National Jewish Health, Denver, CO, United States, 3LungenClinic Grosshansdorf, Airway Research Center North (ARCN), Grosshansdorf, Germany and Christian Albrechts University, Airway Research Center North (ARCN), Kiel, Germany, 4Fundación CIDEA, Buenos Aires, Argentina, 5Sanofi, Cambridge, MA, United States, 6Sanofi, Bridgewater, NJ, United States, 7Regeneron Pharmaceuticals, Inc., Tarrytown, NY, United States, 8Sanofi, Chilly Mazarin, France.
Rationale: 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, 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 (NCT02528214), add-on dupilumab 300mg every 2 weeks (q2w) vs placebo significantly reduced OCS use from baseline over 24 weeks by 70.1% vs 41.9% in adults with OCS-dependent severe asthma; despite the decreased use of OCS in this population, dupilumab 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 (NCT02134028), evaluated the long-term safety, tolerability, and efficacy of add-on dupilumab in adults/adolescents rolled over from a previous dupilumab study. This post hoc analysis assessed whether the OCS dose reduction and efficacy of dupilumab observed in VENTURE were maintained when patients continued with dupilumab in TRAVERSE. Methods: 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 OCS use from VENTURE baseline at Weeks 48 and 96 and the percentage of patients who completely discontinued OCS 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. Results: Of 210 patients completing VENTURE, 187 enrolled in TRAVERSE (Table). At Weeks 48 and 96 of TRAVERSE, sustained reductions (89% by Week 96) from VENTURE baseline in OCS 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 OCS 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. Conclusions: Long-term dupilumab treatment of OCS-dependent asthma facilitated weaning OCS use, while concomitantly decreasing and maintaining low annualized rates of exacerbations and improving lung function.
