A phase 2 randomized, double-blind study of AMG 108, a fully human monoclonal antibody to IL-1R, in patients with rheumatoid arthritis

Table 2 ACR responses, DAS28 C-reactive protein, and EULAR28 responses at week 24

		AMG 108
	Placebo (n= 203)	50 mg (n= 204)	125 mg (n= 203)	250 mg (n= 203)
ACR response, n (%)^a
ACR20	59 (29.1)	63 (30.9) (P = 0.746)	73 (36.0) (P = 0.168)	82 (40.4) (P = 0.022)
ACR50	17 (8.4)	24 (11.8) (P = 0.323)	28 (13.8) (P = 0.113)	41 (20.2) (P < 0.001)
ACR70	8 (3.9)	4 (2.0) (P = 0.259)	5 (2.5) (P = 0.575)	12 (5.9) (P = 0.492)
DAS28 CRP, mean change from baseline^b	-0.60	-0.69 (P = 0.213)	-0.92 (P < 0.001)	-1.18 (P < 0.001)
EULAR28 response, n (%)^c
Good	16 (8%)	20 (10%)	28 (13.9%)	39 (19.5%)
Moderate	61 (30.7%)	59 (29.3%)	76 (37.8%)	76 (38%)
No response	122 (61.3%)	122 (60.7%)	97 (48.3%)	85 (42.5%)

ACR, American College of Rheumatology; CRP, C-reactive protein; DAS28, Disease Activity Score (28-joint count); EULAR28, European League Against Rheumatism (28-joint count). ^aNonresponder imputation: missing ACR responses were imputed as nonresponder. P values are nominal without multiplicity adjustment, using Fisher's exact test. ^bObserved cases. P values are comparisons with placebo, using two-sided Wilcoxon rank-sum test. ^cEULAR28 response is classified as good, moderate, and no response based on the DAS28 ESR at week 24 and the DAS28 ESR improvement from baseline at week 24 [31].

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