Placebo (n=11) | 0.5 mg/kg (n=8) | 1–10 mg/kg (n=31) | p Value | |
Age, mean (SD) (years) | 60 (8) | 53 (18) | 57 (14) | |
Female (%) | 73 | 75 | 55 | |
RF1-150 positivity (%) | 100 | 100 | 97 | |
Disease duration, median (p25–p75) (years) | 13 (4–23) | 8 (4–15) | 10 (5–19) | |
Previous DMARDs1-150, mean (SD) (n) | 4.5 (1.6) | 4.5 (2.6) | 5 (1.7) | |
Prednisone (%) | 72 | 38 | 52 | |
DAS1-150, mean (SD) | 4.8 (1.1) | 5.2 (1.3) | 5.2 (1) | |
Ritchie articular index, mean (SD) | 22 (13) | 25 (11) | 26 (11) | |
Swollen joint count, mean (SD) | 18 (5) | 18 (5) | 18 (6) | |
ESR1-150, median (p25–p75) (mm/1st h) | 24 (7–39) | 15 (9–38) | 36 (23–55) | 0.05 |
CRP1-150, median (p25–p75) (mg/l) | 23 (6–90) | 22 (12–42) | 63 (33–115) | 0.05 |
Haemoglobin, mean (SD) (mmol/l) | 7.6 (0.9) | 7.4 (1.2) | 7.2 (1.0) | |
Leucocytes, median (p25–p75) (×109/l) | 8.1 (6.3–10.5) | 7.5 (6.5–8.9) | 7.2 (5.9–10.4) | |
Polymorphonuclear cells | 5.77 (4.76–8.12) | 5.07 (4.55–6.51) | 4.78 (4.05–8.16) | |
Lymphocytes | 1.16 (0.85–1.60) | 1.37 (1.08–2.26) | 1.14 (0.85–1.31) | |
Monocytes | 0.52 (0.40–0.58 | 0.42 (0.38–0.49) | 0.46 (0.38–0.63) | |
Platelets, mean (SD) (×109/l) | 329 (48) | 306 (65) | 377 (130) | |
Responders1-151 at (%) | ||||
2 Weeks | 9 | 37.5 | 651-152 | |
12 Weeks | — | 50 | 76.6 | |
24 Weeks | — | 87.5 | 70 |
↵1-150 RF = rheumatoid factor; DMARDs = disease modifying antirheumatic drugs; DAS = disease activity score; ESR = erythrocyte sedimentation rate; CRP = C reactive protein.
↵1-151 Response according to the EULAR criteria for moderate and good response.
↵1-152 16% of the patients showed clinical response already at 24 hours after 1–10 mg/kg D2E7 administration.