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

Table 5 (Abstract P182). Efficacy results and summary of safety

Proportion of responders at Week 16 (E2), n (%)	PBO N = 32	CAN 150 mg q4w N = 31	p-value
Proportion of responders at Week 16 (E2), n (%)	2 (6.3)	19 (61.3)	<0.0001*
Proportion of patients with no new flare at Week 40 (E3), n (%)	PBO N = 10	CAN 150 mg q8w N = 9	p-value
	3 (30.0)	7 (77.8)	0.0513
Safety
	PBO N = 32	Any CAN^# E2 N = 58	Any CAN^# E2 + E3 N = 61
Exposure to CAN, pyr	3.1	16.4	45.6
Number of AEs (AE rate/100 pyr)	54 (1754.8)	134 (816.7)	332 (728.2)
Number of SAEs (SAE rate/100 pyr)	3 (97.5)	7 (42.7)	17 (37.3)

*Indicates statistical significance (one-sided) at the 0.025 level. ^#Any patient who received a dose of CAN during E2 or E3. 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; q8w, every 8 weeks; pyr, patient-years; SAE, serious adverse event

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