Table 2. Patient characteristics in Feasibility (Stage 2) studies.
Study I | Study II | Study III | Study IV | PoC Study | |
Number of patients/samples | 128/128 | 320/320 | 85/255* | 119/119** | 24/107* |
Female, % | 82 | 80 | 91 | 77 | 75 |
CCP+, % | 63 | 62 | 62 | 61 | n/a |
RF+, % | 83 | 83 | 64 | 97 | n/a |
Smoker, % | n/a | 13 | 4 | 22 | n/a |
Methotrexate, % | 53 | 61 | 48 | 64 | 100 |
Non-biologic DMARDs, % | 69 | 76 | 64 | 81 | 100 |
Biologics, % | 65 | 53 | 43 | 50 | 50 |
Corticosteroids, % | 24 | 27 | 27 | 33 | n/a |
Age, mean±SD (min,max) | 60±13 | 59±14 | 59±13 | 60±14 | 56±13 |
DAS28-CRP, median (IQR) | 5.8 (4.7–6.5) | 4.0 (2.9–5.3) | 3.8 (2.7–5.0) | 5.2 (4.1–6.2) | 3.3 (2.2–4.4) |
TJC28, median (IQR) | 12 (4.8–20) | 2.0 (0–8.3) | 7.0 (2.0–14) | 8.0 (3.0–15) | 3.0 (0.0–8.0) |
SJC28, median (IQR) | 16 (12–21) | 6.5 (2–13) | 2.0 (0.0–10) | 14 (8.0–20) | 4.0 (1.0–7.0) |
CRP mg/L, median (IQR) | 14 (4.0–32) | 14 (5.1–45) | 14 (4.0–47) | 18 (6.9–47) | 25 (7.6–70) |
PG, median (IQR) | 5.0 (2.9–7.0) | 2.5 (1.0–5.0) | 3.0 (1.0–5.0) | 5.0 (2.0–6.5) | n/a |
DMARD, disease-modifying anti-rheumatic drug; IQR, inter-quartile range.
For studies with multiple samples per patient, sex, age, and serological status (when available) statistics are based on unique patients. Other statistics are based on all samples.
All studies used independent patients and samples, except Study IV, which used a subset of Study II samples.