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Table 5 Exploratory Analyses in Studies 1 and 2 (Evaluable Population)

From: Safety profile and clinical activity of multiple subcutaneous doses of MEDI-528, a humanized anti-interleukin-9 monoclonal antibody, in two randomized phase 2a studies in subjects with asthma

 

Study 1

Study 2

  

MEDI-528

  

Parameter

Placebo

0.3 mg/kg

1 mg/kg

3 mg/kg

Placebo

MEDI-528 50 mg

Pulmonary function

      

   FEV1, L

      

Baseline

2.8 ± 0.58

(n = 9)

2.8 ± 0.93

(n = 9)

3.2 ± 0.73

(n = 9)

3.4 ± 0.43

(n = 9)

3.3 ± 1.25

(n = 2)

2.8 ± 0.56

(n = 7)

End of study

2.9 ± 0.48

(n = 8)

2.6 ± 1.02

(n = 9)

3.3 ± 0.67

(n = 8)

3.6 ± 0.56

(n = 8)

3.0 ± 1.30

(n = 2)

2.9 ± 0.42

(n = 5)

   FEV1, % predicted

      

Baseline

89.3 ± 10.49

(n = 9)

85.8 ± 7.95

(n = 9)

86.0 ± 12.07

(n = 9)

93.3 ± 12.40

(n = 9)

  

End of study

91.4 ± 8.87

(n = 8)

79.2 ± 11.04

(n = 9)

90.3 ± 9.64

(n = 8)

99.6 ± 13.14

(n = 8)

  

   Asthma symptom score, overall

      

Baseline

1.11 ± 0.83

(n = 6)

1.87 ± 1.70

(n = 7)

1.37 ± 1.59

(n = 6)

0.00 ± N/A

(n = 1)

1.92 ± 1.53

(n = 2)

0.93 ± 0.82

(n = 6)

Treatment

0.74 ± 0.55

(n = 7)

0.91 ± 0.63

(n = 6)

1.10 ± 1.49

(n = 6)

0.13 ± 0.18

(n = 2)

0.91 ± 0.07

(n = 2)

0.41 ± 0.66

(n = 6)

   Rescue short-acting β2-agonist use (no. of puffs/day), overall during study

0.63 ± 0.60

(n = 9)

0.65 ± 0.51

(n = 8)

0.66 ± 0.80

(n = 8)

0.02 ± 0.04

(n = 5)

0.22 ± 0.02

(n = 2)

0.28 ± 0.32

(n = 7)

   AQLQ score, overall

      

Baseline

5.56 ± 1.11

(n = 9)

5.20 ± 0.79

(n = 9)

5.73 ± 0.70

(n = 9)

5.97 ± 0.78

(n = 9)

5.73 ± 0.11

(n = 2)

5.75 ± 0.65

(n = 7)

Day 28

5.64 ± 0.82

(n = 9)

5.68 ± 0.66

(n = 9)

5.95 ± 0.87

(n = 9)

6.07 ± 0.60

(n = 9)

6.22 ± 0.09

(n = 2)

5.94 ± 0.57

(n = 7)

  1. Values are mean ± SD.
  2. AQLQ = Asthma Quality of Life Questionnaire; FEV1 = forced expiratory volume in 1 second.