Table 3.
Secondary outcomes | SLE (n=38) | P value* | LN (n=17) | P value* | Non-LN (n=21) | P value* |
Change in SLEDAI score at last visit | −0.37±1.67 | 0.24 | −0.56±1.81 | 0.22 | 0±1.30 | 1.0 |
SFI† | 7 (18.42%) | 4 (23.53%) | 3 (14.29%) | |||
Major flare | 3 (7.89%) | 1 (5.88%) | 2 (9.52%) | |||
Mild-to-moderate flare | 4 (10.53%) | 3 (17.65%) | 1 (4.76%) | |||
Change in daily prednisone at last visit, mg | −3.54±5.46 | <0.001 | −3.60±4.53 | 0.001 | −2.83±6.19 | <0.001 |
Change in 24-hour UPRO at last visit, g | 0.14 (−0.34, 0.55) | 0.36 | ||||
Exploratory outcomes | Nominal p value | Nominal p value | Nominal p value | |||
Change in BMI at last visit, kg/m2 | −0.50±0.97 | 0.004 | −0.50±0.70 | 0.01 | −0.50±1.16 | 0.54 |
Change in SBP at last visit, mm Hg | −3.94±10.57 | <0.001 | −5.08±9.65 | 0.04 | −2.47±8.87 | 0.21 |
Mean SBP over 6 months (within-person SD), mm Hg | 119.3 (6.14) | – | 117.4 (5.85) | – | 121.73 (6.09) | – |
Change in DBP at last visit, mm Hg | −0.81±7.44 | 0.48 | −1.63±7.12 | 0.26 | −0.06±6.63 | 0.89 |
Change in haemoglobin at last visit, g/L | 8.26±15.52 | 0.003 | 10.47±20.79 | 0.06 | 6.48±11.07 | 0.11 |
Change in eGFR at last visit, mL/min/1.73 m2 | −0.24±12.87 | 0.90 | 0.87±16.31 | 0.73 | −1.15±9.58 | 0.44 |
6-month eGFR slope, mL/min/1.73 m2 per 6 months | 0.92±15.54 | 1.12±17.90 | 0.75±13.81 |
*Calculation based on comparing values at last visit with those at baseline.
†Three patients had major flare including one case of relapse of LN in LN group and two cases of thrombocytopaenia in non-LN group, and four had mild-to-moderate flare including one case of rash in non-LN group and three cases of increased proteinuria in LN group.
BMI, body mass index; DBP, diastolic blood pressure; eGFR, estimated glomerular filtration rate; LN, lupus nephritis; SBP, systolic blood pressure; SFI, Safety of Estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Flare Index; SLE, systemic lupus erythematosus; SLEDAI, SLE Disease Activity Index; UPRO, urine protein.