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- W2775885523 abstract "<b>Background:</b> Patients with eosinophilic (EOS)-COPD & frequent exacerbations may benefit from mepolizumab (MEP). <b>Objective:</b> Assess efficacy & safety of MEP vs placebo (PBO) in EOS-COPD. <b>Methods:</b> Phase III, randomised, PBO-controlled, double-blind trial (METREX), stratified by screening (S)/historical (H: prior yr) eosinophil counts (mITT-EOS: S, ≥150 cells/µL or H, ≥300 cells/µL; mITT-Low EOS: S, <150 cells/µL & no historical ≥300 cells/µL). Patients with COPD & a history of ≥2 moderate/≥1 severe exacerbations & ICS+bronchodilator maintenance therapies (ICS+MT) received MEP 100mg SC or PBO, plus ICS+MT, every 4wks for 52wks. Primary endpoint: rate/yr of moderate (systemic corticosteroid/antibiotics)/severe (hospitalisation/death) exacerbations. Secondary endpoints included time to first moderate/severe exacerbation & rate/yr of exacerbations requiring ER/hospitalisation. Safety was assessed. Endpoints were assessed in the mITT-EOS & mITT-ALL. P-values are shown after multiplicity adjustment. <b>Results:</b> In mITT-EOS(n=462), MEP vs PBO reduced the rate/yr of moderate/severe exacerbations (rate ratio:0.82[95%CI:0.68,0.98];p=0.036) & increased time to first moderate/severe exacerbation (hazard ratio:0.75[95%CI: 0.60,0.94];p=0.036). Similar treatment effects were not seen in mITT-ALL(n=836). No treatment differences seen for exacerbations requiring ER/hospitalisation. MEP safety profile was similar to PBO. <b>Conclusions:</b> Clinically relevant & statistically significant reductions in moderate/severe exacerbation rate/yr & increased time to first exacerbation were seen with MEP vs PBO in patients with EOS-COPD. MEP was well tolerated. The data support blood EOS as a biomarker for COPD treatment response to MEP. Funding: GSK (NCT02105948)" @default.
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- W2775885523 date "2017-09-01" @default.
- W2775885523 modified "2023-09-23" @default.
- W2775885523 title "Late Breaking Abstract - Mepolizumab reduces exacerbations in eosinophilic COPD" @default.
- W2775885523 doi "https://doi.org/10.1183/1393003.congress-2017.oa3194" @default.
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