Clinical and imaging parameters before and during anakinra and methotrexate combination therapy
| Variables | Baseline | Week 12 | Week 36 | Change from baseline to week 36 | ||
|---|---|---|---|---|---|---|
| (No of patients) | ||||||
| Increase | No change | Decrease | ||||
| Except when otherwise stated, values are medians (ranges). The p values denote changes compared with baseline values (Wilcoxon-Pratt test). | ||||||
| DAS, Disease Activity Score; ESR, erythrocyte sedimentation rate; VAS, visual analogue scale; NS, not significant. | ||||||
| Clinical/biochemical parameters | ||||||
| Erythrocyte sedimentation rate (mm/1st h) | 28 (14–54) | 20 (5–46) p<0.01 | 17 (4–84) p = 0.06 (NS) | 3 | 2 | 12 |
| Swollen joint count (0–28) | 7 (0–22) | 5 (0–10) p<0.05 | 3 (0–8) p<0.01 | 4 | 0 | 13 |
| Tender joint count (0–28) | 10 (3–24) | 3 (0–15) p<0.01 | 2 (0–12) p<0.001 | 2 | 0 | 15 |
| Patients global assessment of pain (VAS 0–100) | 69 (30–85) | 44 (4–84) p<0.01 | 44 (6–80) p<0.01 | 1 | 0 | 16 |
| Patients global assessment of disease activity (VAS 0–100) | 70 (45–93) | 37 (3–87) p<0.05 | 41 (9–84) p<0.001 | 2 | 0 | 15 |
| Health Assessment Questionnaire (HAQ) (0–3) | 1.75 (0.63–2.75) | 1.62 (0–2.38) p<0.01 | 1.50 (0.25–2.50) p<0.05 | 1 | 1 | 15 |
| DAS28 (ESR based) | 5.6 (3.9–7.2) | 4.3 (2.4–6.4) p<0.01 | 3.8 (2.6–6.6) p<0.01 | 2 | 0 | 15 |
| MRI parameters (non-dominant wrist and 2nd-5th MCP joints) | ||||||
| Synovitis score (0–21) | 11 (3–21) | 13 (2–21) p = 0.90 (NS) | 14 (3–21) p = 0.22 (NS) | 4 | 4 | 9 |
| Bone oedema score (0–69) | 5 (0–45) | 5 (0–28) p = 0.08 (NS) | 4 (0–27) p = 0.06 (NS) | 1 | 7 | 9 |
| Erosion score (0–230) | 17 (0–116) | 19 (0–124) p<0.01 | 21 (1–122) p<0.01 | 12 | 3 | 2 |
| No of bones with erosion (0–23) | 10 (0–18) | 10 (0–17) p = 0.09 (NS) | 11 (1–18) p<0.05 | 10 | 4 | 3 |
| x Ray parameters (bilateral wrist, MCP and PIP joints) | ||||||
| Modified Sharp score— total (0–314) | 50 (1–233) | Not done | 59 (2–243) p<0.05 | 13 | 0 | 4 |
| Modified Sharp score—erosions (0–170) | 26 (0–125) | Not done | 29 (0–140) p<0.01 | 11 | 4 | 2 |
| Modified Sharp score—joint space narrowing (0–144) | 34 (0–108) | Not done | 36 (2–103) p = 0.86 (NS) | 9 | 2 | 6 |