The long-term effect of dupilumab on dyspnea, sleep, and activity in oral corticosteroid-dependent severe asthma

被引:2
作者
Sher, Lawrence D. [1 ,9 ]
Passalacqua, Giovanni [2 ]
Taille, Camille [3 ]
Cohn, Lauren [4 ,5 ]
Daizadeh, Nadia [6 ]
Pandit-Abid, Nami [7 ]
Soler, Xavier [8 ]
Khodzhayev, Angela [8 ]
Jacob-Nara, Juby A. [7 ]
Deniz, Yamo [8 ]
Rowe, Paul J. [7 ]
Nag, Arpita [6 ]
Zhang, Yi [8 ]
机构
[1] Peninsula Res Associates, Los Angeles, CA USA
[2] Univ Genoa, Ist Ricovero & Cura Carattere Scienti IRCCS San Ma, Allergy & Resp Dis, Genoa, Italy
[3] Univ Paris, Serv Pneumol & Ctr Reference Malad Plum Rares, Assistance Publ Ho pitaux Paris, Paris, France
[4] Yale Ctr Asthma & Airway Dis, Yale Sch Med, New Haven, CT USA
[5] Vet Affairs Connecticut Hlth Care Syst, West Haven, CT USA
[6] Sanofi, Immunology, Cambridge, MA USA
[7] Sanofi, Immunology, Bridgewater, NJ USA
[8] Med Affairs, Regeneron Pharmaceut, Inc, Tarrytown, NY USA
[9] Peninsula Res Associates, 550 Deep Valley Dr, Suite 317, Rolling Hills Estates, CA 90274 USA
关键词
HUMANIZATION; TRAVERSE; OUTCOMES;
D O I
10.1016/j.anai.2022.12.002
中图分类号
R392 [医学免疫学];
学科分类号
100102 ;
摘要
Background: Severe asthma impacts quality of life (QoL), including dyspnea, sleep, and activity limitation. Dupi-lumab, a fully human monoclonal antibody, blocks the shared receptor component for interleukins-4 and-13, which are key and central drivers of type 2 inflammation. Phase 3 LIBERTY ASTHMA VENTURE (NCT02528214) and LIBERTY ASTHMA TRAVERSE open-label extension (NCT02134028) evaluated dupilumab 300 mg vs placebo every 2 weeks for 24 weeks (VENTURE) and dupilumab only for an additional 48 to 96 weeks (TRAVERSE) in patients with oral corticosteroid (OCS)-dependent severe asthma.Objective: To assess dupilumab's impact on Asthma QoL Questionnaire (AQLQ) items related to breathing symp-toms, sleep, and activity limitation, and on OCS reduction.Methods: The proportion of patients with AQLQ scores of 6 or 7 for breathing symptoms-, sleeping-, and activity -related items in VENTURE and TRAVERSE, together with OCS dose reductions in VENTURE.Results: In VENTURE, significantly greater proportions of dupilumab-vs placebo-treated patients achieved scores of 6 or 7 by week 24 in breathing symptoms-related (42.7%-60.2% vs 22.4%-39.3%), sleeping-related (45.6%-65.0% vs 27.1%-47.7%), and activity-related (44.7%-51.5% vs 22.4%-34.6%) AQLQ items. Improvements were maintained through TRAVERSE in the dupilumab/dupilumab group and increased to dupilumab treatment levels in the placebo/dupilumab group. Significant OCS dose reductions were observed in VENTURE; up to 90% and 60% of dupilumab-treated vs 65% and 41% of placebo-treated patients with AQLQ scores of 6 or 7 in breathing symptoms-, sleeping-, and activity-related items achieved greater than or equal to 50% dose reduction and elimi-nated OCS at week 24, respectively.Conclusion: In patients with severe OCS-dependent asthma, dupilumab improved QoL related to breathing symptoms, sleep, and activity limitation, and reduced OCS use.Trial Registration: ClinicalTrials.gov Identifiers: NCT02528214 and NCT02134028.(c) 2023 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. %S1081-1206(22)X0004-5%202303%130%3%298%304%TYP\gdef\pts@issuepubyear{2023}This is an open access article under the CC BY -NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/)
引用
收藏
页码:298 / 304
页数:7
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