Table 2.

Baseline and on-treatment levels and responses of inflammatory, cardiac, and cardiovascular biomarkers among patients on hemodialysis treated with placebo or 2-, 6-, or 20-mg ziltivekimab

ParameterPlacebo, Mean (SD) or Median (IQL) (n=12)Ziltivekimab, Mean (SD) or Median (IQL)aP-DRb
2 mg (n=16)6 mg (n=13)20 mg (n=12)
hsCRP (mg/L)
 BL4.0 (1.5–8.1)6.1 (3.8–25.0)9.8 (3.8–19.6)13.2 (4.7–21.5)
 Wk 44.5 (1.3–13.5)2.7 (0.8–4.5)0.5 (0.3–3.3)0.6 (0.2–1.0)
from BL, wk 4−0.2 (−0.9 to 1.3)−3.5 (−18.5 to −2.4)c−12.1 (−18.8 to 3.5)c−13.0 (−20.6 to −4.3)c<0.001
 Wk 10–123.0 (1.8–6.3)3.5 (0.8–6.9)0.8 (0.5–2.2)0.3 (0.2–0.4)
 ∆ from BL, wk 10–12−0.6 (−2.0 to 1.0)−3.9 (−16.7 to −1.8)c−10.6 (−15.8 to −4.7)c−10.5 (−20.8 to −4.3)c<0.001
SAA (mg/L)
 BL6.5 (2.8–21.1)8.2 (5.0–39.3)10.4 (6.9–15.2)19.1 (9.3–42.6)
 Wk 46.0 (2.3–13.8)3.3 (1.8–9.3)2.8 (1.5–5.4)2.7 (2.1–6.9)
from BL, wk 4−1.5 (−2.6 to 0.3)−6.2 (−23.9 to −2.1)c−9.0 (−13.3 to −4.2)c−17.0 (−41.6 to −6.1)c0.004
 Wk 10–125.1 (3.2–12.4)6.5 (1.8–11.9)2.5 (1.4–3.7)1.9 (1.7–4.2)
from BL, wk 10–120.0 (−10.1 to 0.7)−6.1 (−25.3 to −1.6)c−7.2 (−11.6 to −4.3)c−17.0 (−32.8 to −7.4)c0.002
Fibrinogen (mg/dl)
 BL447 (101)498 (100)484 (85.1)486 (96.5)
 Wk 12453 (133)410 (92.4)323 (68.8)266 (64.4)
from BL, wk 124.6 (53.3)−87.3 (67.1)c−161 (90.1)c−216 (83.7)c<0.001
LDL cholesterol (mg/dl)
 BL72.8 (41.1)69.6 (36.4)64.4 (34.2)67.1 (38.6)
 Wk 1267.2 (29.6)61.4 (31.4)63.8 (32.7)68.1 (39.6)
from BL, wk 12−5.6 (22.8)−6.5 (15.0)−1.2 (12.5)4.7 (14.8)0.24
HDL cholesterol (mg/dl)
 BL51.3 (18.1)46.9 (17.1)46.4 (14.5)45.9 (13.5)
 Wk 1251.6 (16.5)50.1 (18.1)54.2 (17.2)52.5 (15.1)
from BL, wk 120.3 (4.0)3.2 (7.2)7.8 (6.1)c6.1 (6.9)c0.002
Lipoprotein(a) (nmol/L)
 BL21.5 (13.5–41.0)63.5 (36.5–148)60.0 (40.0–118)57.0 (27.0–109)
 Wk 1222.0 (13.5–46.0)52.0 (37.5–138)57.0 (30.0–121)29.0 (21.0–97.0)
from BL, wk 12−0.5 (−5.5 to 3.5)−3.0 (−13.0 to 1.0)−16.0 (−26.0 to −3.0)−13.0 (−35.0 to 3.0)0.02
  • SI conversions: fibrinogen, multiply by 0.0294 for µmol/L; LDL and HDL cholesterol, multiply by 0.0259 for mmol/L; lipoprotein (a), multiply by 0.0357 for µmol/L. IQL, interquartile limit; BL, baseline; , change.

  • a hsCRP, SAA, and lipoprotein(a) were non-normally distributed (Shapiro–Wilk P value was <0.01), so analyses were performed on the ranked values and median (IQL) values are shown. Fibrinogen and LDL and HDL cholesterol were normally distributed and results are reported as mean (SD).

  • b No adjustments were made for multiple comparison groups or time points. For the key pharmacodynamic end point (hsCRP at wk 4), a nominal P value <0.017 should be considered statistically significant.

  • c P<0.05 versus placebo.