Table 1.

Patient-reported outcomes at baseline (ITT populations)

	Methotrexate add-on study							Monotherapy study
	Placebo (N = 86)	50 mg q.d. (N = 82)	100 mg q.d. (N = 85)	200 mg q.d. (N = 86)	25 mg b.i.d. (N = 86)	50 mg b.i.d. (N = 85)	100 mg b.i.d. (N = 84)	Placebo (N = 72)	50 mg q.d. (N = 72)	100 mg q.d. (N = 70)	200 mg q.d. (N = 69)	Score interpretation
HAQ-DI, mean (SE)	1.69 (0.06)	1.71 (0.07)	1.70 (0.07)	1.76 (0.06)	1.70 (0.05)	1.78 (0.06)	1.78 (0.07)	1.80 (0.06)	1.84 (0.07)	1.80 (0.07)	1.79 (0.06)	0–3; higher score indicates higher disability
Patient Global, mean (SE)	64.2 (1.96)	68.2 (2.23)	67.6 (2.09)	68.7 (2.09)	64.3 (1.95)	65.7 (1.92)	66.6 (2.20)	71.1 (2.02)	68.6 (2.41)	71.5 (2.23)	68.9 (2.07)	VAS score 0–100; higher score indicates lower health state
Patient Pain, mean (SE)	65.7 (2.16)	66.9 (2.20)	65.4 (2.41)	67.0 (2.16)	65.7 (2.23)	67.8 (2.12)	67.2 (2.19)	71.6 (2.37)	71.0 (2.38)	72.6 (1.85)	68.1 (2.35)	VAS score 0–100; higher score indicates more severe pain
FACIT-Fatigue, mean (SE)	26.2 (1.09)	26.2 (1.10)	26.6 (1.06)	25.2 (1.25)	28.1 (1.18)	26.2 (1.04)	25.6 (1.25)	25.1 (1.12)	25.1 (1.28)	24.8 (1.13)	24.8 (1.16)	0–52; higher score indicates better QoL
SF-36 PCS, mean (SE)	33.0 (0.71)	32.7 (0.75)	31.6 (0.79)	31.6 (0.64)	31.6 (0.69)	31.3 (0.73)	32.2 (0.78)	31.1 (0.70)	31.1 (0.82)	30.9 (0.76)	31.8 (0.90)	0–100; higher score indicates better QoL
SF-36 MCS, mean (SE)	42.8 (1.09)	42.2 (1.26)	44.0 (1.11)	41.4 (1.14)	45.5 (1.29)	44.7 (1.23)	42.1 (1.29)	40.5 (1.31)	42.8 (1.32)	41.2 (1.23)	42.6 (1.17)	0–100; higher score indicates better QoL

b.i.d. twice daily; HAQ-DI Health Assessment Questionnaire-Disability Index, FACIT Functional Assessment of Chronic Illness Therapy, ITT intent-to-treat, MCS mental component summary score, PCS physical component summary score, Patient Global Patient Global Assessment of Disease Activity, q.d. once daily, QoL quality of life, SE standard error, SF-36, 36-Item Short Form Health Survey, VAS visual analog scale