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Table 1 Patient demographics and clinical characteristics at study baseline for patients entering the open-label period

From: Long-term safety of brazikumab in the open-label period of a randomized phase 2a study of patients with Crohn’s disease

 

Brazikumab/ Brazikumab (n = 52)

Placebo/ Brazikumab (n = 52)

Total (N = 104)

Age, mean ± SD, y

35.3 ± 11.1

37.8 ± 10.6

36.5 ± 10.9

Female, n (%)

32 (61.5)

31 (59.6)

63 (60.6)

Weight, mean ± SD, kg

70.1 ± 21.0

71.9 ± 15.3

71.0 ± 18.3

Race, n (%)

 White

50 (96.2)

49 (94.2)

99 (95.2)

 Non-White

2 (3.8)

3 (5.8)

5 (4.8)

Not Hispanic or Latino, n (%)

48 (92.3)

47 (90.4)

95 (91.3)

Disease duration, mean ± SD, y

13.0 ± 9.7

12.1 ± 8.7

12.6 ± 9.2

CDAI, mean ± SD, pointsa

321.9 ± 62.2

308.3 ± 55.8

315.1 ± 59.2

Prior use of anti-TNFα agents, n (%)

 1

18 (34.6)

16 (30.8)

34 (32.7)

 2

32 (61.5)

31 (59.6)

63 (60.6)

 ≥ 3

2 (3.8)

5 (9.6)

7 (6.7)

Corticosteroid use at baseline, n (%)

28 (53.8)

26 (50.0)

54 (51.9)

Immunomodulator use at baseline, n (%)

15 (28.8)

13 (25.0)

28 (26.9)

  1. aCDAI score ranges from 0 to 600, with higher scores indicating worse disease
  2. CDAI, Crohn’s Disease Activity Index; SD, standard deviation; TNFα, tumor necrosis factor alpha