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Table 3 Clinical asthma endpoints

From: In patients with severe asthma with eosinophilia in reslizumab clinical trials, high peripheral blood eosinophil levels are associated with low FEV1 reversibility

 PlaceboReslizumab  
Baseline52 weeksBaseline52 weeksTreatment effectp value
≥ 400 EOS < 14% reversibility group
     RR (reslizumab vs placebo) (95% CI) 
 ≥ 1 exacerbation, n (%)NA28 (53.8%)NA26 (40.6%)  
 Adjusted exacerbation rate (over 52 weeks)a (95% CI)NA1.52 (0.84, 2.72)NA0.91 (0.48, 1.72)0.600 (0.330, 1.090)0.0937
  Change from baseline at Week 52 Change from baseline at Week 5252-week treatment difference (reslizumab vs placebo) (95% CI) 
N52446452  
ACQ-7 scoreb2.511 (0.117)− 0.781 (0.158)2.464 (0.111)− 1.189 (0.159)− 0.408 (− 0.753, − 0.064)0.0206
AQLQ scoreb4.259 (0.153)0.872 (0.198)c4.518 (0.140)1.425 (0.200)0.554 (0.148, 0.959)0.0079
ASUI scoreb0.634 (0.028)0.118 (0.029)c0.690 (0.024)0.193 (0.029)c0.075 (0.013, 0.137)0.0174
Overall population excluding the ≥ 400 EOS < 14% reversibility group
     RR (reslizumab vs placebo) (95% CI) 
 ≥ 1 exacerbation, n (%)NA209 (49.3%)NA125 (30.3%)  
 Adjusted exacerbation rate over 52 weeksa (95% CI)NA1.80 (1.37, 2.36)NA0.80 (0.61, 1.05)0.446 (0.346, 0.575)< 0.0001
  Change from baseline at Week 52 Change from baseline at Week 5252-week treatment difference (reslizumab vs placebo) (95% CI) 
N424371413367  
ACQ-7 scoreb2.708 (0.041)− 0.805 (0.065)2.637 (0.043)− 1.141 (0.064)− 0.336 (− 0.470, − 0.201)< 0.0001
AQLQ scoreb4.182 (0.053)0.874 (0.077)d4.297 (0.053)1.171 (0.076)c0.297 (0.150, 0.445)< 0.0001
ASUI scoreb0.630 (0.010)0.145 (0.012)e0.641 (0.010)0.198 (0.012)f0.053 (0.028, 0.078)< 0.0001
  1. ACQ Asthma Control Questionnaire, AQLQ Asthma Quality of Life Questionnaire, ASUI Asthma Symptom Utility Index, CI confidence interval, EOS blood eosinophil level, LS least square, NA not applicable, SE standard error
  2. aAdjusted exacerbation rates and confidence intervals based on Negative Binomial regression model adjusted for baseline use of oral corticosteroids (yes or no) and geographical region (US or other)
  3. bBaseline data are mean (SE). All change from baseline data are LS mean (SE)
  4. cData unavailable for one patient
  5. dData unavailable for three patients
  6. eData unavailable for five patients
  7. fData unavailable for four patients