Dupilumab improves long-term outcomes in patients with uncontrolled, moderate-to-severe GINA-based type 2 asthma, irrespective of allergic status

被引:5
作者
Rabe, Klaus F. [1 ,2 ,3 ,11 ]
Pavord, Ian D. [4 ]
Busse, William W. [5 ]
Chupp, Geoffrey L. [6 ]
Izuhara, Kenji [7 ]
Altincatal, Arman [8 ]
Gall, Rebecca [9 ]
Pandit-Abid, Nami [10 ]
Deniz, Yamo [9 ]
Rowe, Paul J. [10 ]
Jacob-Nara, Juby A. [10 ]
Radwan, Amr [9 ]
机构
[1] LungenClin Grosshansdorf, Airway Res Ctr North ARCN, Grosshansdorf, Germany
[2] German Ctr Lung Res DZL, Grosshansdorf, Germany
[3] Univ Kiel, Airway Res Ctr North ARCN, Kiel, Germany
[4] Univ Oxford, NIHR Oxford Biomed Res Ctr, Oxford, England
[5] Univ Wisconsin, Sch Med & Publ Hlth, Madison, WI USA
[6] Yale Sch Med, New Haven, CT USA
[7] Saga Med Sch, Saga, Japan
[8] Sanofi, Cambridge, MA USA
[9] Regeneron Pharmaceut Inc, Tarrytown, NY USA
[10] Sanofi, Bridgewater, NJ USA
[11] LungenClin Grosshansdorf GmbH, Wohrendamm 80, D-22927 Grosshansdorf, Germany
关键词
HUMANIZATION; MEPOLIZUMAB; EFFICACY; THERAPY; SAFETY;
D O I
10.1111/all.15747
中图分类号
R392 [医学免疫学];
学科分类号
100102 ;
摘要
BackgroundPrevious research has shown greater efficacy of dupilumab in patients with uncontrolled asthma and type 2 inflammation. We analyzed dupilumab's efficacy in patients from the TRAVERSE study with or without evidence of allergic asthma and type 2 inflammation per current GINA guidelines (>= 150 eosinophils/mu L or FeNO >= 20 ppb). MethodsAll patients aged >= 12 years who rolled over from the placebo-controlled QUEST study (NCT02414854) to TRAVERSE (NCT02134028) received add-on dupilumab 300 mg every 2 weeks for up to 96 weeks. We assessed annualized severe asthma exacerbation rates (AERs) and changes from parent-study baseline (PSBL) in pre-bronchodilator FEV1 and 5-item asthma control questionnaire (ACQ-5) score in patients with moderate-to-severe type 2 asthma with and without evidence of allergic asthma at PSBL. ResultsIn TRAVERSE, dupilumab consistently reduced AER across all subgroups. By Week 96, dupilumab increased pre-bronchodilator FEV1 from PSBL by 0.35-0.41 L in patients receiving placebo during QUEST (placebo/dupilumab) and 0.34-0.44 L in those receiving dupilumab during QUEST (dupilumab/dupilumab) with an allergic phenotype at baseline. In patients without evidence of allergic asthma, pre-bronchodilator FEV1 improved by 0.38-0.41 L and 0.33-0.37 L, respectively. By Week 48, ACQ-5 scores decreased from PSBL by 1.63-1.69 (placebo/dupilumab) and 1.74-1.81 (dupilumab/dupilumab) points across subgroups with allergic asthma, and 1.75-1.83 (placebo/dupilumab) and 1.78-1.86 (dupilumab/dupilumab) in those without. ConclusionsLong-term treatment with dupilumab reduced exacerbation rates and improved lung function and asthma control in patients with asthma with type 2 inflammation as per current GINA guidance and irrespective of evidence of allergic asthma.
引用
收藏
页码:2148 / 2156
页数:9
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