未上市  

其中生物指標-嗜酸性細胞數量 <150/ul, 招募人數比約30%.

主要指標為年化急診比率,

52週治療後, 實驗組和對照組的風險比>1, 療效無差異Dupilumab治療無效.

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C. <150/ul -------人數比約30%,

風險比=(實驗組年化急診比率0.47/0.74)/(對照組年化急診比率0.51/0.64)=1.04

<200mg/300mg *2週一針>

結果: 和對照組無差異. Dupilumab 52週治療無效

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生物指標-嗜酸性細胞數量(高中低三組) VS 療效(主要指標) /年化急診比率

A. >=300 /ul-------招募人數比約43%,

風險比(實驗組年化急診比率0.37/0.4)/(對照組年化急診比率1.08/1.24)=0.33

B.>=150~<300/ul-------人數比約27%

風險比=(實驗組年化急診比率0.56/0.56)/(對照組年化急診比率0.87/0.84)=0.6

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www.tsim.org.tw/journal/jour29-6/02.PDF?fbclid=IwAR2B85aLqBUAt5agx6K7u0NkCGTGpr7w6HDCagHhLuu54ZH7FEqHMAdXG3M

www.nejm.org/doi/full/10.1056/nejmoa1804092

Dupilumab Efficacy and Safety in Moderate-to-Severe Uncontrolled Asthma

dupilumab 3期哮喘, N=1902人

We randomly assigned 1902 patients 12 years of age or older with uncontrolled asthma in a 2:2:1:1 ratio to receive add-on subcutaneous dupilumab at a dose of 200 or 300 mg every 2 weeks or matched-volume placebos for 52 weeks.

The primary end points were the annualized rate of severe asthma exacerbations

and the absolute change from baseline to week 12 in the forced expiratory volume in 1 second (FEV1)

before bronchodilator use in the overall trial population.

Secondary end points included the exacerbation rate and FEV1 in patients with a blood eosinophil count of 300 or more per cubic millimeter. Asthma control and dupilumab safety were also assessed.

clinicaltrials.gov/ct2/show/NCT01854047

Detailed Description:

Total duration per participant of approximately 43 weeks including a screening period (14-21 days), a randomized treatment period (24 weeks), and a post-treatment period (16 weeks).

Study Design

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Study Type :

Interventional (Clinical Trial)

Actual Enrollment :

776 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate Dupilumab in Patients With Moderate to Severe Uncontrolled Asthma

Study Start Date :

June 2013

Actual Primary Completion Date :

November 2014

Actual Study Co