Table 2

Responses at month 1

	Group 1	Group 2
	Anakinra (n = 12)	Placebo (n = 12)
Response	Number of responders (%)		p Value^*
Primary objective (modified ACRpedi 30)^†	8 (67)	1 (8)	0.003
Systemic symptoms responders^†	8 (67)	1 (8)	0.003
Primary objectives used in other trials
ACRpedi 30 responders	11 (92)	7 (58)	0.059
ACRpedi 30 and no fever^‡	11 (92)	6 (50)	0.025
ACRpedi 30, no fever and CRP <15 mg/l^§	10 (83)	3 (25)	0.004
Modified ACRpedi 50, 70 and 100 response^†
Modified ACRpedi 50 responders	7 (58)	0	0.005
Modified ACRpedi 70 responders	5 (42)	0	0.038
Modified ACRpedi 100 responders	0	0	1

Response to individual variables	Mean variation from D1 to M1 (%)		p Value^¶
CRP	−71	−16	0.001
ESR	−64	−18	0.002
SAA	−70	−2	<0.001
Number of active joints	−46	−18	0.040
Number of joints with LOM	−36	−20	0.148
CHAQ	−37	−9	0.236
Physician's disease activity assessment^**	−63	−20	0.002
Parent/patient's global assessment^**	−36	−23	0.544
Parent/patient's assessment of pain^**	−29	−21	0.219

↵* χ² Test.
↵† Body temperature <38°C for more than 7 days, CRP and ESR normalised or decreased by at least 50% (=systemic symptoms responders) and also, in responders to the trial primary objective, ACRpedi 30, 50, 70 or 100 (whichever level is indicated) response compared with D1.
↵‡ Body temperature <38°C for more than 7 days and ACRpedi 30 response compared with D1.
↵§ Body temperature <38°C for more than 7 days, CRP <15 mg/l and ACRpedi 30 response compared with D1 as in a recent trial with the anti-interleukin 6 receptor antibody tocilizumab.
↵¶ Mann–Whitney test.
↵** Using a visual analogue scale (0–100 mm).
ACRpedi 30, American College of Rheumatology Pediatric 30 response; CHAQ, Childhood Health Assessment Questionnaire; CRP, C-reactive protein; ESR, erythrocyte sedimentation rate; LOM, joints with limitation of passive motion; SAA, serum amyloid A.