Effects of tocilizumab on CDAI and haemoglobin levels in patients with RA who completed the 24-week treatment course (n=371)
| Patients with renal insufficiency (n=92) | Patients without renal insufficiency (n=279) | p Values between patient groups* | |||
|---|---|---|---|---|---|
| TCZ (n=64) | TCZ+MTX (n=28) | TCZ (n=106) | TCZ+MTX (n=173) | ||
| CDAI, mean (95%CI) | |||||
| Week 0 | 22.9 (19.9 to 25.9) | 23.5 (20.1 to 26.9) | 23.2 (20.7 to 25.7) | 21.5 (19.6 to 23.3) | 0.60 |
| Week 24† | 9.8 (7.9 to 11.6) | 9.9 (7.3 to 12.4) | 8.4 (6.9 to 9.8) | 9.3 (8.1 to 10.6) | 0.62 |
| Low CDAI or remission, number (%) | |||||
| Week 0 | 7 (10.9) | 1 (3.6) | 16 (15.1) | 27 (15.6) | 0.32 |
| Week 24 | 37 (57.8) | 16 (57.1) | 73 (68.9) | 109 (63) | 0.44 |
| CDAI reduction ≥6.5, number (%) | |||||
| Week 24 | 48 (75) | 22 (78.6) | 78 (73.6) | 120 (69.4) | 0.66 |
| Δ CDAI, mean (95%CI) | 13.1 (10.4 to 15.8) | 13.6 (9.5 to 17.7) | 14.9 (12.7 to 17.1) | 12.1 (10.5 to 13.8) | 0.25 |
| Haemoglobin, g/dL, mean (95% CI) | |||||
| Week 0 | 11.5 (11.1 to 11.9) | 11.5 (10.9 to 12.0) | 12.3 (12 to 12.6) | 12.1 (11.9 to 12.4) | 0.008‡, 0.04§ |
| Week 24† | 12.5 (12.1 to 12.9) | 12.0 (11.5 to 12.4) | 13.2 (12.9 to 13.5) | 12.9 (12.7 to 13.2) | 0.01‡, 0.001¶, 0.007** |
| Anaemia, number (%) | |||||
| Week 0 | 36 (56.3) | 12 (42.9) | 36 (34) | 65 (37.6) | 0.004‡, 0.01§ |
| Week 24 | 24 (37.5) | 9 (32.1) | 21 (19.8) | 25 (14.5) | 0.01‡, 0.0001§, 0.02** |
| Δ haemoglobin, mean (95% CI) | 0.96 (0.67 to 1.26) | 0.48 (0.16 to 0.81) | 0.89 (0.61 to 1.16) | 0.81 (0.65 to 0.98) | 0.33 |
Renal insufficiency, anaemia and abbreviations are defined in table 1. Δ CDAI, change from baseline in CDAI; Δ haemoglobin, change from baseline in haemoglobin.
*p Values for comparisons of measures between the patient groups were determined using ANOVA (analysis of variance) with a Tukey's HSD (honesty significant difference) post hoc test or the χ2 test. For all tests, p values <0.05 were considered to indicate statistical significance.
†Mean CDAI and haemoglobin levels were significantly improved at week 24 in all four groups, when compared with those at baseline (p<0.0001 with the matched-pair t test).
‡Based on comparisons between TCZ in the renal insufficiency group and that in the group without renal insufficiency.
§Based on comparisons between TCZ in the renal insufficiency group and TCZ+MTX in the group without renal insufficiency.
¶Based on comparisons between TCZ+MTX in the renal insufficiency group and TCZ in the group without renal insufficiency.
**Based on comparisons between TCZ+MTX in the renal insufficiency group and that in the group without renal insufficiency.