Table 1

	Trial 1			Trial 2

	120 Q2W	120 Q4W	Pbo	120 Q2W	120 Q4W	Pbo
	(n=387)	(n=389)	(n=388)	(n=372)	(n=376)	(n=376)

SRI-5, ^{^a,^b}	31.8	35.2	29.3	38.4	34.8	27.7
	p=0.409	p=0.052^f		p=0.002	p=0.051^{^f}
Corticosteroid sparing, %^{^c}	23.4	17.5	18.9	22.5	17.5	13.9
	p=0.280	p=0.747		p=0.051^f	p=0.342
Time to severe flare, HR^d	0.94	0.79		0.88	0.98
	p=0.724	p=0.204		p=0.480	p=0.911
Worst fatigue in last 24 hrs, LSM^e	−1.31	−1.38	−1.01	−0.73	−0.66	−0.57
	p=0.163	p=0.081		p=0.957	p=0.779

Abbreviations: HR = hazard ratio; LSM = least squares mean.
↵a SRI-5: reduction ≥5 points from baseline in SELENA-SLEDAI score, no new BILAG A or no more than 1 new BILAG B, and no worsening (increase of ≥0.3 points from baseline) in Physician's Global Assessment.
↵b Concomitant medication rules defining nonresponse: Trial 1, unable to taper to baseline corticosteroid dose by Wk 24, increased corticosteroid dose after Wk 24, or had new, increased, or decreased concomitant AM or immunosuppressants (IS) at any time. Trial 2, same rules as Trial 1 except decreases in AM or IS were allowed.
↵c For pts receiving >7.5 mg/day of prednisone (or equivalent) at baseline, a reduction in corticosteroid dose by ≥25% to ≤7.5 mg/day for ≥3 consecutive months during Wks 24–52 without increasing AM or IS at any time.
↵d Using modified SELENA-SLEDAI Flare Index.
↵e Using Brief Fatigue Inventory.
↵f Not significant at p<0.050.