Table 3.

Summary of changes from baseline in iron parameters by baseline anemia status

PlaceboSiltuximab
ParameternBaseline Mean (SD)Posttreatment Mean (SD)Mean change (SD)Median changenBaseline Mean (SD)Posttreatment Mean (SD)Mean change (SD)Median changePa
Hepcidin, ng/mL
 No baseline anemia1492.6 (64.3)89.9 (61.4)−2.73 (33.8)2.2518126.2 (83.9)78.0 (50.7)−48.3 (64.2)−61.50.0227
 Baseline anemia11134.4 (63.3)154.6 (79.5)20.2 (49.5)16.630200.6 (191.0)98.8 (111.1)−102 (111)−90.60.0012
Hemoglobin, g/L
 No baseline anemia15146.73 (16.65)144.47 (17.23)−2.27 (8.36)−4.0022137.32 (13.05)139.68 (15.29)2.36 (7.40)2.500.0849
 Baseline anemia11107.06 (16.16)106.50 (16.10)−0.564 (5.33)−1.0030100.33 (19.21)110.43 (16.23)10.1 (11.4)9.500.0051
Iron, mol/L
 No baseline anemia1411.28 (4.63)12.01 (4.58)0.721 (4.06)−0.1792212.23 (4.45)16.44 (8.58)4.21 (6.97)2.250.0998
 Baseline anemia116.29 (3.10)5.65 (2.75)−0.645 (1.85)−0.890296.48 (3.36)9.64 (4.89)3.16 (3.50)3.000.0015
Transferrin saturation (fraction)
 No baseline anemia140.21 (0.077)0.22 (0.084)0.0170 (0.0747)0.0250180.26 (0.105)0.31 (0.159)0.0493 (0.0907)0.02850.2900
 Baseline anemia100.15 (0.065)0.14 (0.066)−0.00832 (0.0519)−0.0102280.16 (0.073)0.19 (0.091)0.0326 (0.0689)0.01840.0965
TIBC, mol/L
 No baseline anemia1355.00 (15.44)55.04 (13.40)0.0468 (11.7)1.002252.21 (13.77)53.39 (11.69)1.17 (7.59)3.400.7310
 Baseline anemia1044.93 (17.55)44.53 (18.42)−0.402 (6.9)1.802847.25 (24.87)53.98 (17.22)6.73 (14.5)7.850.1450
Ferritin, pmol/L
 No baseline anemia14526.78 (526)369.19 (276)−158 (524)−19.222410.24 (499)354.71 (475)−55.5 (136)−51.90.3880
 Baseline anemia11418.73 (322)487.97 (363)69.2 (148)25.828961.08 (1429)600.36 (1020)−361 (492)−1260.0075

NOTE: Baseline anemia was defined as patients with a hemoglobin reference range indicator of low at the baseline measurement. The hepcidin and iron parameter changes from baseline were measured using the time point at which the maximum median change from baseline was observed for each parameter (i.e., cycle 1 day 8 for hepcidin and cycle 2 day 1 for hemoglobin and iron parameters).

Abbreviation: TIBC, total iron-binding capacity.

  • aP value siltuximab versus placebo.