Table 2.
Primary and secondary endpoints at weeks 52 and 104
| Week 52 | Week 104* | |||||||
| Obinutuzumab (n=63) | Placebo (n=62) |
Difference (95% CI) | P value | Obinutuzumab (n=63) | Placebo (n=62) |
Difference (95% CI) | P value | |
| Primary endpoint | ||||||||
| CRR, n (%) | 22 (35) | 14 (23) | 12 (−3.4 to 28) | 0.115 | 26 (41) | 14 (23) | 19 (2.7 to 35) | 0.026 |
| Secondary endpoints | ||||||||
| mCRR, n (%) | 29 (46) | 24 (39) | 7 (−10 to 25) | 0.373 | 35 (56) | 21 (34) | 22 (5 to 39) | 0.015 |
| ORR (CRR or PRR), n (%) | 35 (56) | 22 (36) | 20 (3.0 to 37) | 0.025 | 34 (54) | 18 (29) | 25 (8.2 to 42) | 0.005 |
| Change in C3 from baseline, mean† (SE) | 30 (3.4) | 12 (3.5) | 18 (8.0 to 27) | <0.001 | 29 (3.4) | 11 (3.4) | 19 (8.9 to 28) | <0.001 |
| Change in C4 from baseline, mean† (SE) | 9.7 (1.3) | 0.8 (1.3) | 8.8 (5.2 to 12) | <0.001 | 9.6 (1.3) | 0.4 (1.3) | 9.3 (5.7 to 13) | <0.001 |
| Change in log anti-dsDNA titre from baseline, mean† (SE) | −0.91 (0.12) | −0.10 (0.12) | −0.81 (−1.1 to 0.48) | <0.001 | −1.1 (0.13) | −0.05 (0.13) | −1.0 (−1.4 to 0.67) | <0.001 |
| Renal response components | ||||||||
| UPCR <0.5, n (%) | 33 (52) | 24 (39) | 14 (−3.6 to 31) | 0.102 | 39 (62) | 23 (37) | 25 (7.8 to 42) | 0.005 |
| SCr ≤15% increase from baseline and ≤ULN | 48 (76) | 38 (61) | 15 (−1.2 to 31) | 0.080 | 45 (71) | 32 (52) | 20 (3.1 to 37) | 0.019 |
| Urinary RBCs <10/HPF without RBC casts | 52 (83) | 51 (82) | 0.3 (−13 to 13) | 0.987 | 49 (78) | 41 (66) | 12 (−4.0 to 27) | 0.154 |
| No rescue immunosuppression or early discontinuation | 57 (91) | 53 (86) | 5 (−6.4 to 16) | 0.414 | 51 (81) | 38 (61) | 20 (4.1 to 35) | 0.012 |
| CRR in prespecified subgroups | ||||||||
| Baseline proteinuria, n (%) | ||||||||
| UPCR <3 (n=73) | 13 (38) | 12 (31) | 7.5 (−14 to 29) | 0.468 | 16 (47) | 12 (31) | 16 (−5.9 to 39) | 0.147 |
| UPCR ≥3 (n=47) | 8 (31) | 2 (10) | 21 (−0.5 to 43) | 0.163 | 8 (31) | 2 (10) | 21 (−0.5 to 43) | 0.098 |
| Baseline biopsy class, n (%) | ||||||||
| Class III (n=31) | 5 (36) | 6 (35) | 0.4 (−33 to 34) | 0.952 | 3 (21) | 7 (41) | −19 (−52 to 12) | 0.338 |
| Class IV (n=94) | 17 (35) | 8 (18) | 17 (−0.5 to 34) | 0.068 | 23 (47) | 7 (16) | 31 (14 to 49) | 0.001 |
| Baseline biopsy class, n (%) | ||||||||
| No class V (n=88) | 17 (40) | 9 (20) | 20 (0.8 to 38) | 0.054 | 17 (40) | 10 (22) | 17 (−1.7 to 36) | 0.117 |
| Class V (n=37) | 5 (25) | 5 (29) | −4.4 (−33 to 24) | 0.825 | 9 (45) | 4 (24) | 22 (−8.2 to 51) | 0.187 |
| Post hoc endpoints | ||||||||
| UPCR <0.8, n (%) | 41 (65) | 31 (50) | 15 (-2.1 to 32) | 0.085 | 45 (71) | 28 (45) | 26 (9.6 to 43) | 0.003 |
For all response analyses, non-response imputation was used after rescue immunosuppression or early discontinuation.
*Week 104 analyses were exploratory and not adjusted for multiplicity.
†Adjusted mean from analysis of covariance model adjusting baseline measurement and stratification factors race and region.
CRR, complete renal response (which required UPCR <0; CRR, complete renal response; HPF, high-power field; mCRR, modified CRR; ORR, overall renal response; PRR, partial renal response; RBC, red blood cell; SCr, serum creatinine; UPCR, urine protein-to-creatinine ratio.