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Table 8 (Abstract O30). Efficacy and summary of safety

From: Proceedings of the 24th Paediatric Rheumatology European Society Congress: Part one

 

CAN 150 mg q4w N = 22

PBO N = 24

p-value

Proportion of responders at Wk 16 (E2), n(%)

10 (45.5)

2 (8.3)

0.005*

Proportion of patients with no new flare at Wk 40 (E3), n(%)

CAN 150 mg q8w N = 4

PBO N = 5

p-value

3 (75.0)

2 (40.0)

0.3571

Safety

 

PBO (N = 24)

Any CAN*, E2 (N = 43)

Any CAN*, E2 + E3 (N = 61)

Exposure to CAN, pyr

2.0

12.1

39.2

Number of AEs (AE rate/100 pyr)

34 (1698.8)

112 (925.7)

265 (676.2)

Number of SAEs (SAE rate/100 pyr)

1 (50.0)

3 (24.8)

5 (12.8)

  1. *Indicates statistical significance (one-sided) at the 0.025 level. #Any patient who received a dose of CAN during E2 or 3.
  2. n = number of patients who responded; N = number of patients evaluated for response. AE, adverse event; CAN, canakinumab; E, epoch; PBO, placebo; q4w, every 4 weeks pyr, patient-years; SAE, serious adverse event; W, week