S86 Long-term assessment of exacerbations and lung function in the LIBERTY ASTHMA TRAVERSE study, stratified by lung function improvements at the end of the phase 3 LIBERTY ASTHMA QUEST parent study

A. Bourdin, N. Hanania, D. Dorscheid, X. Muñoz, Y. Tohda, N. Daizadeh, J. Jacob-Nara, B. Ortiz, M. Djandji, Y. Deniz, P. Rowe
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Abstract

S86 Table 1 Efficacy endpoints during QUEST and TRAVERSE in type 2 QUEST patients stratified by level of pre-bronchodilator FEV1 improvement at Week 52 of QUEST <100mL improvement $100mL improvement $200mL improvement Combined PBO Combined DPL Combined PBO Combined DPL Combined PBO Combined DPL Number of severe asthma exacerbations experienced in the year prior to QUEST (exacerbation history) N 32 70 199 462 158 398 Mean (SD) 2.19 (1.97) 1.96 (1.71) 2.27 (1.97) 2.09 (2.00) 2.20 (1.85) 2.12 (2.10) Adjusted annualized event rate of severe exacerbation during 52-week treatment period of QUEST Patients with $1 severe exacerbation events, n (%) 12(37.5) 18 (25.7) 72(36.2) 109 (23.6) 53 (33.5) 94(23.6) Estimate 0.690 0.481 0.679 0.331 0.704 0.331 Relative risk (95% CI) vs matching placebo 0.697 (0.291, 1.667) P = 0.4134 0.487 (0.355, 0.669) P < 0.0001 0.471 (0.330, 0.673) P < 0.0001 Unadjusted annualized event rate of severe exacerbation by year during treatment period of TRAVERSE PBO/DPL DPL/DPL PBO/DPL DPL/DPL PBO/DPL DPL/DPL Patients with $1 severe exacerbation events, Weeks 0–48, n/N (%) 8/32 (25.0)
S86 LIBERTY ASTHMA TRAVERSE研究中急性加重和肺功能的长期评估,根据3期LIBERTY ASTHMA QUEST亲本研究结束时肺功能改善进行分层
表12型QUEST患者在QUEST和TRAVERSE期间的疗效终点,按QUEST治疗第52周支气管扩张剂前FEV1改善水平分层<100mL改善$100mL改善$200mL改善联合PBO联合DPL联合PBO联合DPL联合PBO联合DPL联合PBO联合DPL联合PBO联合DPL在QUEST治疗前一年经历的严重哮喘发作次数(发作史)N 32 70 199 462 158 398平均(SD) 2.19 (1.97) 1.96 (1.97) 2.09 (2.00) 2.20 (1.85) 2.12(2.10) 1美元严重加重事件的QUEST患者52周治疗期间严重加重事件的调整年化事件率,n(%) 12(37.5) 18(25.7) 72(36.2) 109(23.6) 53(33.5) 94(23.6)估计相对风险(95% CI) vs匹配安慰剂0.697 (0.291,1.667)P = 0.4134 0.487 (0.355, 0.669) P < 0.0001 0.471 (0.330),1美元严重加重事件患者,0 ~ 48周,n/ n(%) 8/32(25.0)。在TRAVERSE PBO/DPL治疗期间,未调整年化严重加重事件发生率(按年计算)
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