Table 3.

Summary of results of secondary efficacy end pointsa

ParameterMMF (n = 185)IVC (n = 185)Odds Ratio (95% CI)
Responders with renal biopsy class III or IV88 (56.4)b83 (53.9)c1.1 (0.7 to 1.8)
Patients with renal biopsy class V16 (55.2)d15 (48.4)e
Renal remission criterion metTreatment difference (% [95% CI])
    serum creatinine130 (70.3)125 (67.6)2.7 (−6.7 to 12.1)
    urine protein44 (23.8)50 (27.0)−3.2 (−12.1 to 5.6)
    urine sediment58 (31.4)44 (23.8)7.6 (−1.5 to 16.6)
    all three criteria16 (8.6)15 (8.1)0.5 (−5.1 to 6.2)
Renal and extrarenal remission
    complete absence of BILAG As and Bs54 (29.7)f45 (24.9)g4.8 (4.3 to 14.0)
SELENA-SLEDAIDifference between means (95% CI)
    change in score from baseline to end point (mean ± SD)−6.2 ± 10.1h−6.6 ± 8.0i0.41 (−1.48 to 2.30)
Anti-dsDNA
    patients with dsDNA >60 IU/ml at baselinej117 (67.2)k124 (72.5)l
    patients with dsDNA >60 IU/ml at end point72 (41.4)k91 (53.2)l
C3
    patients with low C3 at baselinem125 (71.0)n139 (79.9)k
    patients with low C3 at end pointm70 (39.8)n90 (51.7)k
C4
    patients with low C4 at baselineo104 (59.1)n125 (72.3)p
    patients with low C4 at end pointo51 (29.0)n72 (41.6)p
  • a Data 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.

  • b n = 156.

  • c n = 154.

  • d n = 29.

  • e n = 31.

  • f n = 182.

  • g n = 181.

  • h n = 179.

  • i n = 178.

  • j The threshold >60 IU/ml was twice the upper limit of the range defined as normal.

  • k n = 174.

  • l n = 171.

  • m Low C3 was defined as <0.9 g/L.

  • n n = 176.

  • o Low 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.

  • p n = 173.