Table 4. Efficacy outcomes at 3 and 6 months by treatment arm.
| ALMS | AURA-LV/AURORA 1 | ||
| IVC (n=91) | MMF (n=88) | VCS (N=179) | |
| At3 months | |||
| UPCR reduction of ≥25%, n (%) | 56 (61.5) | 68 (77.3) | 164 (91.6) |
| OR (95% CI), p value VCS vs IVC or MMF | 6.88 (3.48,>9.99), p<0.001 | 3.06 (1.47, 6.37), p=0.003 | |
| At6 months | |||
| UPCR ≤0.5 g/g, n (%) | 27 (29.7) | 15 (17.0) | 68 (38.0) |
| OR (95% CI), p value VCS vs IVC or MMF | 1.54 (0.87, 2.73), p=0.141 | 3.24 (1.68, 6.25), p<0.001 | |
| UPCR reduction of ≥50%, n (%) | 52 (57.1) | 50 (56.8) | 127 (70.9) |
| OR (95% CI), p value VCS vs IVC or MMF | 1.83 (1.06, 3.14), p=0.029 | 2.00 (1.16, 3.45), p=0.013 | |
Propensity score methodology was used to generate two groups of matched participants (N=179) from the ALMS (IVC and MMF) and AURA-LV/AURORA 1 (voclosporin) studies based on the following parameters: age, duration of lupus nephritis, duration of SLE, albumin, C3, C4, creatinine, anti-dsDNA, eGFR, UPCR, biopsy class, sex, and geographical region. The proportion of participants achieving UPCR outcomes at 3 and 6 months months wereas calculated using a logistic regression model with terms for treatment arm, baseline UPCR, biopsy class, and region. ORs >unity indicate a benefit of voclosporin treatment over IVC or MMF.
ALMSAspreva Lupus Management StudyC, complement; dsDNA, double-stranded DNA; eGFR, estimated glomerular filtration rate; IVC, intravenous cyclophosphamide; MMF, mycophenolate mofetil; SLE, systemic lupus erythematosus; UPCR, urine protein creatinine ratio; VCS, voclosporin