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Table 2 MEDI3902 phase II EVADE: efficacy through study day 22 (mITT)

From: Safety, efficacy, and pharmacokinetics of gremubamab (MEDI3902), an anti-Pseudomonas aeruginosa bispecific human monoclonal antibody, in P. aeruginosa-colonised, mechanically ventilated intensive care unit patients: a randomised controlled trial

 

MEDI3902 500 mg (N = 16)

MEDI3902 1500 mg (N = 85)

Placebo (N = 83)

RRRa

80% CIa

P valuea

Primary endpoint

 P. aeruginosa Pneumonia

2 (12.5%)

19 (22.4%)

15 (18.1%)

− 23.7%

− 83.8 to 16.8%

0.491

Exploratory endpoints of interest (FDA)

 All-cause pneumoniab

3 (18.8%)

25 (29.4%)

17 (20.5%)

− 43.6%

− 104 to -1.1%

0.186

 All-cause pneumonia or deathc

4 (25.0%)

30 (35.3%)

22 (26.5%)

− 33.2%

− 79.8 to 1.4%

0.222

  1. RRR: relative risk reduction (a negative RRR denotes more PA pneumonia in the MEDI3902 1500 mg group compared to placebo); mITT = modified intent-to-treat population
  2. All pneumonias were determined by an adjudication committee
  3. aRelative risk reduction (MEDI3902 1500 mg vs. placebo), 80% confidence interval (CI), and p value based on Poisson regression with robust variance
  4. bAll-cause pneumonia: P. aeruginosa pneumonia or non-P. aeruginosa pneumonia occurring through study day 22
  5. cAll-cause pneumonia or death: P. aeruginosa pneumonia, non-P. aeruginosa pneumonia, or death occurring through study day 22