Table 2.
Changes from baseline to week 14/16 and 24 in haemoglobin in patients with anaemia, with or without elevated CRPa,b
| Change from baseline in haemoglobin levels, g/dl | Normal CRP at baseline (≤0.6 mg/dl) | Elevated CRP at baseline (>0.6 mg/dl) | P-value |
|---|---|---|---|
| Week 14c | |||
| Patients with anaemia | |||
| All studies | |||
| Placebo | |||
| n | 15 | 86 | |
| Median (IQR) | 0.0 (−0.30–0.50) | 0.30 (−0.30–0.90) | 0.266 |
| Golimumab | |||
| n | 55 | 241 | |
| Median (IQR) | 0.40 (−0.30–1.00) | 0.90 (0.30–1.70) | <0.001 |
| RA studies | |||
| Placebo | |||
| n | 13 | 70 | |
| Median (IQR) | 0.0 (−0.30–0.40) | 0.35 (−0.20–1.00) | 0.124 |
| Golimumab | |||
| n | 43 | 182 | |
| Median (IQR) | 0.30 (−0.30–1.00) | 0.90 (0.10–1.50) | 0.005 |
| Patients with anaemia of mixed aetiology | |||
| All studies | |||
| Placebo | |||
| n | 2 | 21 | |
| Median (IQR) | 0.25 (−0.20–0.70) | 0.40 (−0.20–1.20) | 0.817 |
| Golimumab | |||
| n | 11 | 60 | |
| Median (IQR) | 0.30 (−0.80–0.70) | 0.90 (−0.05–1.45) | 0.031 |
| RA studies | |||
| Placebo | |||
| n | 1 | 18 | |
| Median (IQR) | −0.20 (−0.20, −0.20) | 0.55 (−0.10–1.20) | 0.395 |
| Golimumab | |||
| n | 9 | 49 | |
| Median (IQR) | 0.03 (0.20–0.70) | 0.70 (−0.20–1.30) | 0.138 |
| Patients with anaemia of inflammationd | |||
| All studies | |||
| Placebo | |||
| n | 3 | 21 | |
| Median (IQR) | 0.00 (−0.50–0.50) | 0.20 (−0.40–0.80) | 0.613 |
| Golimumab | |||
| n | 7 | 74 | |
| Median (IQR) | 1.50 (−0.10–2.90) | 1.40 (0.70–2.10) | 0.823 |
| RA studies | |||
| Placebo | |||
| n | 2 | 17 | |
| Median (IQR) | 0.25 (0.00–0.50) | 0.30 (−0.30–1.00) | 0.874 |
| Golimumab | |||
| n | 5 | 48 | |
| Median (IQR) | 1.50 (1.00–1.60) | 1.20 (0.65–1.90) | 0.566 |
| Week 24 | |||
| Patients with anaemia | |||
| All studies | |||
| Placebo | |||
| n | 14 | 84 | |
| Median (IQR) | 0.15 (−0.20–0.50) | 0.50 (−0.05–1.20) | 0.193 |
| Golimumab | |||
| n | 55 | 231 | |
| Median (IQR) | 0.50 (−0.50–1.70) | 1.00 (0.40–1.80) | 0.006 |
| RA studies | |||
| Placebo | |||
| n | 12 | 69 | |
| Median (IQR) | 0.05 (−0.25–0.45) | 0.60 (0.00–1.20) | 0.158 |
| Golimumab | |||
| n | 43 | 174 | |
| Median (IQR) | 0.20 (−0.60–1.40) | 0.80 (0.20–1.60) | 0.017 |
| Patients with anaemia of mixed aetiology | |||
| All studies | |||
| Placebo | |||
| n | 2 | 21 | |
| Median (IQR) | 0.90 (0.50–1.30) | 0.50 (−0.20–1.20) | 0.517 |
| Golimumab | |||
| n | 11 | 61 | |
| Median (IQR) | 0.20 (−0.80–0.70) | 0.80 (0.00–1.60) | 0.040 |
| RA studies | |||
| Placebo | |||
| n | 1 | 18 | |
| Median (IQR) | 1.30 (1.30–1.30) | 0.70 (0.20–1.20) | 0.450 |
| Golimumab | |||
| n | 9 | 50 | |
| Median (IQR) | 0.20 (−0.80–0.40) | 0.70 (−0.10–1.20) | 0.062 |
| Patients with anaemia of inflammationd | |||
| All studies | |||
| Placebo | |||
| n | 3 | 21 | |
| Median (IQR) | 0.20 (0.00–0.20) | 0.60 (0.20–0.90) | 0.234 |
| Golimumab | |||
| n | 7 | 70 | |
| Median (IQR) | 1.80 (0.00–2.30) | 1.45 (0.70–2.30) | 0.492 |
| RA studies | |||
| Placebo | |||
| n | 2 | 17 | |
| Median (IQR) | 0.10 (0.00–0.20) | 0.60 (0.40–0.90) | 0.292 |
| Golimumab | |||
| n | 5 | 46 | |
| Median (IQR) | 0.60 (0.00–1.90) | 1.30 (0.60–2.10) | 0.391 |
aPatients were observed from baseline to weeks 14/16 and 24 and were considered to be anaemic if their haemoglobin levels were less than the age- and sex-specific normal range of the central laboratory. bPatients were considered to have anaemia of mixed aetiology if their haemoglobin levels were below the normal range for the central laboratory and their ferritin levels were ≥15 ng/ml and <60 ng/ml. cWeek 16 values were used for the GO-BEFORE RA study. dPatients were considered to have anaemia of inflammation if their haemoglobin levels were below the normal range for the central laboratory and their ferritin levels were ≥60 ng/ml. All P values are from analysis of variance on the van der Waerden scores comparing changes from baseline in haemoglobin levels in patients with normal CRP levels at baseline (≤0.6 mg/dl) vs those in patients with elevated CRP levels (>0.6 mg/dl).