Table 2.
Hb Levels at Baseline and at Week 12 and Estimated Change From Baseline and Treatment Difference
| Hb Level | Placebo | Ziltivekimab 7.5 mg | Ziltivekimab 15 mg | Ziltivekimab 30 mg |
|---|---|---|---|---|
| Overall population | ||||
| Hb at baseline, mean (SD), g/dl | 12.35 (1.71) | 12.50 (1.63) | 12.52 (1.70) | 12.21 (1.55) |
| Hb at week 12, observed mean (SD), g/dl | 12.20 (1.87) | 12.67 (1.91) | 13.39 (1.69) | 13.05 (1.54) |
| Change from baseline to week 12, g/dl, estimated meana (95% CI) [n] | −0.22 (−0.44 to −0.01) [57] | 0.34 (0.12 to 0.56) [53] | 0.82 (0.61 to 1.03) [60] | 0.77 (0.55 to 0.99) [57] |
| Treatment differencea (95% CI), g/dl | — | 0.57 (0.27 to 0.86)c | 1.05 (0.76 to 1.33)c | 0.99 (0.70 to 1.28)c |
| Baseline Hb <11 g/dl | ||||
| Hb at baseline, mean (SD), g/dl | 9.92 (0.85) | 10.23 (0.58) | 10.54 (0.67) | 10.05 (0.96) |
| Hb at week 12, observed mean (SD), g/dl | 9.72 (1.32) | 10.38 (0.86) | 11.50 (1.01) | 11.25 (1.13) |
| Change from baseline to week 12, g/dl, estimated meanb (95% CI) [n] | −0.29 (−0.75 to 0.17) [12] | 0.07 (−0.38 to 0.51) [13] | 0.80 (0.33 to 1.27) [11] | 1.18 (0.71 to 1.66) [11] |
| Treatment differenceb (95% CI), g/dl | — | 0.36 (–0.26 to 0.98) | 1.09 (0.45 to 1.73)c | 1.48 (0.83 to 2.12)c |
| Baseline Hb ≥11 g/dl | ||||
| Hb at baseline, mean (SD), g/dl | 12.94 (1.29) | 13.05 (1.28) | 13.05 (1.48) | 12.79 (1.09) |
| Hb at week 12, observed mean (SD), g/dl | 12.86 (1.37) | 13.42 (1.52) | 13.82 (1.51) | 13.48 (1.29) |
| Change from baseline to week 12, g/dl, mean (95% CI)b [n] | −0.22 (−0.45 to 0.01) [45] | 0.41 (0.16 to 0.65) [40] | 0.81 (0.58 to 1.04) [49] | 0.65 (0.42 to 0.89) [46] |
| Treatment differenceb (95% CI), g/dl | — | 0.62 (0.29 to 0.96)c | 1.03 (0.71 to 1.35)c | 0.87 (0.55 to 1.20)c |
CI, confidence interval; Hb, hemoglobin; n, number of participants with baseline and week 12 Hb values.
a
Estimated from a mixed model for repeated measures, with baseline Hb (<11 and ≥11 g/dl), CKD stage (3a and 3b–5), concomitant iron medication, treatment group, visit, and treatment group-by-visit as fixed factors and baseline value as covariate.
b
Estimated from a mixed model for repeated measures, with CKD stage (3a and 3b–5), concomitant iron medication, treatment group, visit, and treatment group-by-visit-by-subgroup as fixed factors and baseline values as covariate.
c
P < 0.001 versus placebo.