Table 3

Secondary and exploratory outcomes at last visit in patients with SLE

Secondary outcomesSLE (n=38)P value*LN (n=17)P value*Non-LN (n=21)P value*
Change in SLEDAI score at last visit−0.37±1.670.24−0.56±1.810.220±1.301.0
SFI†7 (18.42%)4 (23.53%)3 (14.29%)
 Major flare3 (7.89%)1 (5.88%)2 (9.52%)
 Mild-to-moderate flare4 (10.53%)3 (17.65%)1 (4.76%)
 Change in daily prednisone at last visit, mg−3.54±5.46<0.001−3.60±4.530.001−2.83±6.19<0.001
Change in 24-hour UPRO at last visit, g0.14 (−0.34, 0.55)0.36
Exploratory outcomesNominal p valueNominal p valueNominal p value
 Change in BMI at last visit, kg/m2−0.50±0.970.004−0.50±0.700.01−0.50±1.160.54
 Change in SBP at last visit, mm Hg−3.94±10.57<0.001−5.08±9.650.04−2.47±8.870.21
 Mean SBP over 6 months (within-person SD), mm Hg119.3 (6.14)117.4 (5.85)121.73 (6.09)
 Change in DBP at last visit, mm Hg−0.81±7.440.48−1.63±7.120.26−0.06±6.630.89
 Change in haemoglobin at last visit, g/L8.26±15.520.00310.47±20.790.066.48±11.070.11
 Change in eGFR at last visit, mL/min/1.73 m2−0.24±12.870.900.87±16.310.73−1.15±9.580.44
 6-month eGFR slope, mL/min/1.73 m2 per 6 months0.92±15.541.12±17.900.75±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.