Table 3.

Mean change from baseline to study end in SF-36 PCS, SF-36 MCS, FAS, pain VAS and HAQ-DI scores in RAPID 1, 2 and FAST4WARD (ITT population) [4–6, 18, 21, 22]

RAPID 1,a,b,c adjusted mean change (s.e.m.)	Placebo + MTX Q2 W (n = 199)	CZP 200 mg + MTX Q2 W (n = 393)	CZP 400 mg + MTX Q2 W (n = 390)
Week 52
SF-36 PCS	1.7 (0.6)	7.8 (0.4), P < 0.001	8.6 (0.4), P < 0.001
SF-36 MCS	2.1 (0.8)	6.4 (0.6), P < 0.001	6.4 (0.6), P < 0.001
Fatigue (FAS)	−0.8 (0.2)	−2.6 (0.1), P < 0.001	−2.5 (0.1), P < 0.001
Arthritis pain (VAS)	−8.8 (1.6)	−31.0 (1.2), P < 0.001	−33.5 (1.2), P < 0.001
Physical function (HAQ-DI)	−0.18 (0.04)	−0.60 (0.03), P < 0.001	−0.63 (0.03), P < 0.001

RAPID 2,a,b,c adjusted mean change (s.e.m.)	Placebo + MTX Q2 W (n = 127)	CZP 200 mg + MTX Q2 W (n = 246)	CZP 400 mg + MTX Q2 W (n = 246)
Week 24
SF-36 PCS	0.9 (0.7)	5.2 (0.5), P < 0.001	5.5 (0.5), P < 0.001
SF-36 MCS	1.6 (0.9)	6.1 (0.7), P < 0.001	6.3 (0.7), P < 0.001
Fatigue (FAS)	−0.5 (0.2)	−2.0 (0.1), P < 0.001	−2.2 (0.1), P < 0.001
Arthritis pain (VAS)	−4.7 (1.9)	−23.7 (1.4), P < 0.001	−26.1 (1.4), P < 0.001
Physical function (HAQ-DI)	−0.14 (0.04)	−0.50 (0.03), P < 0.001	−0.50 (0.03), P < 0.001

FAST4WARD,d,e,f least square mean change	Placebo Q4 W (n = 109)		CZP 400 mg Q4 W (n = 111)
Week 24
SF-36 PCS	NA	NA	NA
SF-36 MCS	NA	NA	NA
Fatigue (FAS)e	−0.3	NA	−1.7, P < 0.001
Arthritis pain (VAS)b	1.7	NA	−20.6, P < 0.001
Physical function (HAQ-DI)b	0.13	NA	−0.36, P < 0.001

^aITT population. ^bAnalyses performed using last observation carried forward approach. ^cDosing every 2 weeks. ^dModified ITT population. ^eAnalyses based on observed data. ^fDosing every 4 weeks. P-values vs placebo plus MTX or placebo alone. Analyses were performed using analysis of covariance, with treatment and geographical region as factors and baseline value as covariate. ITT: intention-to-treat; NA: not available.