Table 2

Responses of SLE patients to low-dose IL-2 treatment

CharacteristicsBaselineWeek 12Week 24P value (week 0 vs 12)P value (week 0 vs 24)
SLEDAI, median (range)
 IL-212 (8–27)6 (0–16)4 (0–18)<0.001<0.001
 Placebo11 (8–22)6 (0–25)8 (0–25)<0.0010.002
BILAG, median (range)
 IL-210 (8–13)6 (4–11)6 (4–11)0.014<0.001
 Placebo10.5 (8–13.75)10 (4–11)8 (4–10.75)0.0370.004
≥1 BLIAG A or 2B score (%)
 IL-221 (70.00)2 (6.67)1 (3.33)<0.001<0.001
 Placebo21 (70.00)4 (13.33)2 (6.67)<0.001<0.001
PGA, median (range)
 IL-22.3 (1.55–2.75)0 (0–2)0 (0–1)<0.001<0.001
 Placebo2.2 (1–2.3)1 (0–2)1 (0–2)<0.001<0.001
Rash, n (%)
 IL-213 (44.83)2 (6.90)2 (6.90)0.0020.002
 Placebo16 (53.33)6 (20.0)6 (20.0)0.0150.015
Oral ulceration, n (%)
 IL-24 (13.79)0 (0)0 (0)0.1120.112
 Placebo1 (3.33)0 (0)0 (0)1.0001.000
Arthritis, n (%)
 IL-214 (48.28)4 (13.79)3 (10.34)0.0100.003
 Placebo15 (50.0)9 (30.00)8 (26.67)0.1870.110
Vasculitis, n (%)
 IL-24 (13.79)0 (0)0 (0)0.1120.112
 Placebo2 (6.67)0 (0)0 (0)0.4920.492
Alopecia, n (%)
 IL-212 (41.38)6 (20.69)5 (17.24)0.1580.082
 Placebo7 (23.33)2 (6.67)2 (6.67)0.1440.144
Fever, n (%)
 IL-23 (10.34)0 (0)0 (0)0.2370.237
 Placebo4 (13.33)1 (3.33)0 (0)0.3520.167
Myositis, n (%)
 IL-21 (3.45)0 (0)0 (0)1.0001.000
 Placebo2 (6.67)0 (0)0 (0)0.4920.492
Prednisone dose, mg/day, median (range)
 IL-215 (0–50)10 (0–25)10 (0–20)0.001<0.001
 Placebo15 (7.5–60)15 (5–40)10 (2.5–35)0.004<0.001
ANA decreased, n (%)
 IL-2, n=290 (0)7 (24.14)8 (27.59)0.5000.320
 Placebo, n=300 (0)11 (36.67)12 (40.0)0.0360.036
Anti-ds-DNA, IU/mL, median (range)
 IL-2, n=2934.80 (1.0–1783.15)33.0 (7.0–876.21)29.0 (1.0–348.50)0.0370.063
 Placebo, n=3073.30 (1.0–2525.53)37.60 (1.40–3467.80)36.3 (1.0–3467.80)0.1960.235
AnuA, IU/mL, median (range)
 IL-2, n=2914.45 (0.87–449.06)20.84 (1.28–287.07)16.72 (1.17–287.07)0.4390.044
 Placebo, n=3041.725 (0.0–315.80)16.03 (0.0–296.32)12.08 (0.0–266.740)0.2820.149
Albumin, g/L, median (range)
 IL-2, n=2939.25 (27.60–44.70)43.90 (37.70–46.90)43.50 (39.80–47.20)0.0460.017
 Placebo, n=3039.80 (25.10–44.40)38.65 (31.90–43.60)40.40 (32.80–47.50)0.4420.848
LN complete remission, n (%)
 IL-2, n=130 (0)7 (53.85)7 (53.85)0.0050.005
 Placebo, n=120 (0)1 (8.33)2 (16.67)1.0000.478
LN partial remission, n (%)
 IL-2, n=130 (0)10 (76.92)10 (76.92)<0.001<0.001
 Placebo, n=120 (0)3 (25.0)6 (50.0)0.2170.014
  • Data are median (IQR), n (%) or difference (95% CI).

  • ANA, antinuclear antibodies; AnuA, antinucleosome antibodies; BILAG, British Isles Lupus Assessment Group; LN, lupus nephritis; PGA, physician’s global assessment of disease activity;SLEDAI, Safety of Estrogens in Lupus Erythematosus National Assessment version of the SLE Disease Activity Index; anti-dsDNA, anti–double-stranded DNA.