Table 3.
Change From Baseline to Week 12 for Additional Biomarkers of Anemia
| Biomarker | Outcome | Placebo | Ziltivekimab 7.5 mg | Ziltivekimab 15 mg | Ziltivekimab 30 mg |
|---|---|---|---|---|---|
| Ferritin | Change from baseline to week 12 µg/L, estimated meana (95% CI) [n] | –16.56 (–45.10 to 11.97) [57] | –23.77 (–52.59 to 5.04) [58] | –7.13 (–35.44 to 21.18) [61] | –22.38 (–51.74 to 6.99) [57] |
| Treatment differencea (95% CI), µg/L | — | –7.21 (–43.61 to 29.18) | 9.43 (–26.70 to 45.56) | –5.81 (–42.65 to 31.02) | |
| Hepcidin | Change from baseline to week 12, µg/L, estimated meana (95% CI) [n] | –3.85 (–16.63 to 8.93) [56] | –13.49 (–26.48 to –0.49) [57] | –15.50 (–28.21 to –2.78) [60] | –18.79 (–31.98 to –5.61) [56] |
| Treatment differencea (95% CI), µg/L | — | –9.64 (–25.97 to 6.69) | –11.65 (–27.84 to 4.55) | –14.94 (–31.45 to 1.56) | |
| Iron | Change from baseline to week 12, µg/dl, estimated meana (95% CI) [n] | –1.91 (–10.94 to 7.13) [57] | 16.34 (7.24 to 25.43) [58] | 28.82 (19.84 to 37.81) [61] | 32.89 (23.61 to 42.17) [57] |
| Treatment differencea (95% CI), µg/dl | — | 18.24 (6.75 to 29.74)c | 30.73 (19.33 to 42.13)d | 34.79 (23.18 to 46.40)d | |
| TIBC | Change from baseline to week 12, µg/dl, estimated meana (95% CI) [n] | –0.04 (–8.04 to 7.96) [56] | 14.23 (6.21 to 22.25) [58] | 17.72 (9.86 to 25.59) [61] | 24.36 (16.20 to 32.51) [57] |
| Treatment differencea (95% CI), µg/dl | — | 14.27 (4.09 to 24.44)c | 17.76 (7.68 to 27.84)d | 24.39 (14.12 to 34.66)d | |
| Transferrin saturation | Change from baseline to week 12, %, estimated meana (95% CI) [n] | –0.26 (–2.80 to 2.27) [57] | 3.77 (1.21 to 6.32) [58] | 7.05 (4.53 to 9.57) [61] | 7.69 (5.08 to 10.30) [57] |
| Treatment differencea (95% CI), % | — | 4.03 (0.80 to 7.27)b | 7.31 (4.12 to 10.51)d | 7.95 (4.70 to 11.21)d | |
| Reticulocyte hemoglobin | Change from baseline to week 12, pg, estimated meana (95% CI) [n] | 0.19 (–0.17 to 0.54) [55] | 0.60 (0.23 to 0.97) [52] | 0.75 (0.38 to 1.11) [58] | 0.87 (0.51 to 1.24) [55] |
| Treatment differencea (95% CI), pg | — | 0.41 (–0.05 to 0.87) | 0.56 (0.10 to 1.01)b | 0.69 (0.23 to 1.14)c |
CI, confidence interval; Hb, hemoglobin; n, number of participants with baseline and week 12 values; TIBC, total iron-binding capacity.
a
Estimated from an analysis of covariance 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
P < 0.05 versus placebo.
c
P < 0.01 versus placebo.
d
P < 0.001 versus placebo.