Table 2.
Results of physician global assessment and serological markers at various time points throughout treatment
| Baseline (n = 22) | 3 months (n = 20) | 6 months (n = 18) | Last visit on anakinra [median 19 months (range 1–100 months)] (n = 22) | Last visit off anakinra [median 35 months (range 11–153 months)] (n = 15) | |
|---|---|---|---|---|---|
| Primary outcome measures | |||||
| Physician global assessment | 2 (1–2) | 1 (0–2) | 0 (0–2) | 0 (0–2) | 0 (0–2) |
| CRP (mg/l) | 41 (5–344) | 5 (1–26) | 5 (1–53) | 6 (1–350) | 5 (1–20) |
| P = 0.001 | P = 0.007 | P = 0.08 | P = 0.018 | ||
| Serum amyloid A (mg/l) | 146 (3–637) | 4 (3–216) | 3 (1–32) | 5 (3–58) | 3.3 (3–4) |
| P = 0.012 | P = 0.075 | P = 0.028 | P = 0.109 | ||
| Secondary laboratory outcome measures | |||||
| ESR (mm/h) | 50 (3–100) | 10 (1–52) | 17 (4––50) | 14 (2–110) | 7 (2–110) |
| P = 0.023 | P = 0.025 | P = 0.086 | P = 0.017 | ||
| Hb (g/l) | 110 | 120 | 121 | 122 | 130 |
| (76–126) | (90–145) | (107–129) | (70–155) | (96–135) | |
| P = 0.002 | P = 0.021 | P = 0.02 | P = 0.021 | ||
| WBC count (×109/l) | 11 (3–7) | 8 (3–14) | 7 (3–13) | 9 (2–24) | 6 (3–24) |
| P = 0.088 | P = 0.173 | P = 0.233 | P = 0.401 | ||
| Platelets | 393 (107–615) | 321 | 385 | 298 | 312 |
| (196–653) | (130–530) | (204–493) | (202–430) | ||
| P = 1 | P = 0.176 | P = 0.363 | P = 0.674 | ||
| Baseline (n = 11) | 3 months (n = 11) | 6 months (n = 8) | Last visit on anakinra [median 19 months (range 1–100)] (n = 8) | Last visit off anakinra [median 35 months (range 11–153)] | |
| Daily prednisolone dose analysis | |||||
| Prednisolone (mg/kg) | 0.33 | 0.32 | 0.30 | 0.08 | N/A |
| (0–1.43) | (0.06–2) | (0–0.71) | (0–1.25) | ||
| P = 0.241 | P = 0.161 | P = 0.398 | |||
All results are displayed as the median (range). The P-values represent comparison at 3 and 6 months and last clinical follow-up (on and off anakinra) compared with the baseline for each variable using the two-tailed Wilcoxon signed-rank pair test; P-values < 0.05 were considered significant and are highlighted in bold. The daily prednisolone dose (in milligrams per kilogram body weight) was analysed at baseline, 3 and 6 months after commencing anakinra and the last visit on anakinra. Physician global assessment ranges from zero to two, where two represents maximal disease activity and zero represents minimal disease activity. ESR, normal range 0–10 mm/h; N/A: not applicable (the daily prednisolone dose was not analysed after patients stopped anakinra, because the primary aim of analysing the daily doses was to looking for a steroid-sparing effect of anakinra); serum amyloid A, normal range 0–10 mg/l; WBC count: white blood cell count, normal range 4 × 109 to 11 × 109/l.