Table 3.

Summary of results of secondary efficacy end points^a

Parameter	MMF (n = 185)	IVC (n = 185)	Odds Ratio (95% CI)
Responders with renal biopsy class III or IV	88 (56.4)b	83 (53.9)c	1.1 (0.7 to 1.8)
Patients with renal biopsy class V	16 (55.2)d	15 (48.4)e
Renal remission criterion met			Treatment difference (% [95% CI])
serum creatinine	130 (70.3)	125 (67.6)	2.7 (−6.7 to 12.1)
urine protein	44 (23.8)	50 (27.0)	−3.2 (−12.1 to 5.6)
urine sediment	58 (31.4)	44 (23.8)	7.6 (−1.5 to 16.6)
all three criteria	16 (8.6)	15 (8.1)	0.5 (−5.1 to 6.2)
Renal and extrarenal remission
complete absence of BILAG As and Bs	54 (29.7)f	45 (24.9)g	4.8 (4.3 to 14.0)
SELENA-SLEDAI			Difference between means (95% CI)
change in score from baseline to end point (mean ± SD)	−6.2 ± 10.1h	−6.6 ± 8.0i	0.41 (−1.48 to 2.30)
Anti-dsDNA
patients with dsDNA >60 IU/ml at baselinej	117 (67.2)k	124 (72.5)l
patients with dsDNA >60 IU/ml at end point	72 (41.4)k	91 (53.2)l
C3
patients with low C3 at baselinem	125 (71.0)n	139 (79.9)k
patients with low C3 at end pointm	70 (39.8)n	90 (51.7)k
C4
patients with low C4 at baselineo	104 (59.1)n	125 (72.3)p
patients with low C4 at end pointo	51 (29.0)n	72 (41.6)p

^aData are n(%), unless specified otherwise. BILAG, British Isles Lupus Assessment Group Scale; SELENA-SLEDAI, Safety of Exogenous Estrogens in Lupus Erythematosus National Assessment / Systemic Lupus Erythematosus Disease Activity Index.

^bn = 156.

^cn = 154.

^dn = 29.

^en = 31.

^fn = 182.

^gn = 181.

^hn = 179.

ⁱn = 178.

^jThe threshold >60 IU/ml was twice the upper limit of the range defined as normal.

^kn = 174.

^ln = 171.

^mLow C3 was defined as <0.9 g/L.

ⁿn = 176.

^oLow C4 was defined as <0.16 g/L in one laboratory and <0.10 g/L in the other; each patient's baseline and end point samples were analyzed at the same laboratory.

^pn = 173.