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- W2117977218 abstract "A subset of severe asthma patients are inadequately controlled despite treatment with inhaled corticosteroids (ICS) and a second controller. Lebrikizumab is a humanized antibody to IL-13, a key effector cytokine in asthma pathogenesis. In a previous Phase 2 trial, lebrikizumab treatment increased forced expiratory volume in 1 sec (FEV1), particularly in patients with higher blood periostin levels. LUTE and VERSE were replicate, multicenter, double-blind studies that randomized (1:1:1:1) patients with uncontrolled asthma despite treatment with ICS and a second controller to receive lebrikizumab 37.5mg, 125mg, 250mg, or placebo subcutaneously every 4 weeks. The primary endpoint was the rate of exacerbations. Secondary endpoints included change in FEV1. The trials, initially Phase 3, were converted to Phase 2b upon identification of a process-related impurity requiring changes to the lebrikizumab manufacturing process. 463 patients were pooled for analysis. The median number of doses received was 6 (range 1–12). Compared with placebo (n=116), the exacerbation rate (95% CI) was reduced by 62% (23%–83%; n=117), 35% (−17%–65%; n=112), and 11% (−54%–49%; n=118) in all patients and by 81% (35%–97%), 77% (26%–95%), and 22% (−62%–63%) in periostin-high (≥50ng/mL) patients in the lebrikizumab 37.5mg, 125mg, and 250mg groups, respectively. At Week 12, increases in FEV1 were greater for lebrikizumab versus placebo, particularly in periostin-high patients. No important safety signals were observed. Lebrikizumab treatment reduced the exacerbation rate and increased FEV1 in patients with uncontrolled asthma on ICS and a second controller, particularly those who were periostin-high, confirming the findings from the previous Phase 2 trial." @default.
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- W2117977218 date "2014-02-01" @default.
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- W2117977218 title "Efficacy and Safety of Lebrikizumab in Severe Uncontrolled Asthma: Results from the Lute and Verse Phase II Randomized, Double-Blind, Placebo-Controlled Trials" @default.
- W2117977218 doi "https://doi.org/10.1016/j.jaci.2013.12.1064" @default.
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