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Table 7 (Abstract O29). Efficacy results and summary of safety

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

 

PBO N = 35

CAN 150 mg q4w N = 37

p-value

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

2 (5.7)

13 (35.1)

<0.002*

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

PBO N = 7

CAN 150 mg q8w N = 6

p-value

1 (14.3)

3 (50.0)

0.2168

Safety

 

PBO N = 35

Any CAN*, E2 N = 68

Any CAN*, E2 + E3 N = 71

Exposure to CAN, pyr

3.2

19.1

51.0

Number of AEs (AE rate/100 pyr)

59 (1818.5)

251 (1313.6)

613 (1201.2)

Number of SAEs (SAE rate/100 pyr)

4 (123.3)

11 (57.6)

20 (39.2)

  1. *Indicates statistical significance (one-sided) at the 0.025 level. #Any patient who received a dose of CAN during E2 or E3
  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 AE ; Wk, week