Table 1.
Demographic indicators and baseline disease characteristics of rheumatoid arthritis (RA) patients in the intent‐to‐treat population enrolled in the trial by treatment group
| Itolizumab dose levels | |||||
|---|---|---|---|---|---|
| Characteristic | 0·1 mg/kg (n = 5) | 0·2 mg/kg (n = 5) | 0·4 mg/kg (n = 5) | 0·8 mg/kg (n = 5) | Total (n = 20) |
| Sex, no. (%) female | 5 (100) | 5 (100) | 4 (80) | 4 (80) | 18 (90) |
| Skin, no. (%) | |||||
| White | 2 (40) | 3 (60) | 2 (40) | 2 (40) | 9 (45) |
| Black | 2 (40) | 1 (20) | 2 (40) | 0 | 5 (25) |
| Other | 1 (20) | 1 (20) | 1 (20) | 3 (60) | 6 (30) |
| Age, years, median (range) | 59 (34–65) | 48 (35–64) | 41 (20–61) | 59 (32–64) | 56 (20–65) |
| RA duration, years, median (range) | 12 (3–41) | 8 (2–10) | 6 (1–23) | 5 (1–11) | 6 (1–41) |
| RA activity, moderate, no. (%) | 3 (60) | 4 (80) | 5 (100) | 4 (80) | 16 (80) |
| SJC, 66 joints * , median (range) | 32 (10–34) | 25 (12–29) | 9 (8–29) | 9 (8–21) | 14·5 (8–34) |
| TJC, 68 joints * , median (range) | 33 (10–44) | 31 (22–38) | 10 (8–30) | 12 (10–24) | 23 (8–44) |
| PAP * , median (range) | 9 (6–10) | 10 (8–10) | 8 (7–9) | 8 (8–10) | 9 (6–10) |
| GDAP * , median (range) | 9 (6–10) | 10 (6–10) | 8 (7–9) | 8 (7–10) | 9 (6–10) |
| GDAO * , median (range) | 10 (5–10) | 10 (7–10) | 8 (7–9) | 8 (7–10) | 9 (5–10) |
| HAQ * , median (range) | 2·1 (1·2–3) | 2 (0·8–2·6) | 1·3 (0·8–1·6) | 1·1 (0·3–2) | 1·6 (0·3–3) |
| ESR * , median (range) | 61 (13–117) | 55 (11–128) | 80 (20–105) | 50 (38–91) | 60 (11–128) |
| RF positive * , no. (%) | 4 (60) | 4 (80) | 4 (80·0) | 5 (100) | 17 (85) |
| CRP positive, no. (%) | 5 (100) | 4 (80) | 5 (100·0) | 5 (100) | 5 (100) |
| DAS28, median (range) | 8·1 (4·3–9·0) | 7·8 (6·4–8·0) | 6·2 (5·7–7·5) | 6·1 (5·6–6·9) | 6·9 (4·3–9·0) |
| DMARD failures, no. (%) | |||||
| ≥ 2 DMARDs | 5 (100) | 5 (100) | 4 (80) | 5 (100) | 19 (95) |
| Oral corticosteroid | 3(60) | 5 (100) | 5 (100) | 5 (100) | 18 (90) |
*Clinical indicators after the washout period were considered as baseline. CRP = C‐reactive protein; DAS 28 = disease activity score in 28 joints; DMARDs = disease‐modifying anti‐rheumatic drugs; ESR = erythrocyte sedimentation rate; GDAO = global disease assessment by observer; GDAP = global disease assessment by patient; HAQ = health assessment questionnaire; hb = haemoglobin; PAP = patient assessment of pain; RF = rheumatoid factor; SJC = swollen joint count; TJC = tender joint count.