Biologic DMARDs | Traditional DMARDs | Placebo therapies | |
Main analysis based on discrimination of drug groups (6-month data): | |||
Number of trial arms | 25 | 44 | 18 |
Total number of patients | 3388 | 5216 | 2051 |
Number of patients per arm, mean (range) | 136 (32–530) | 119 (12–969) | 114 (29–318) |
Year of trial, range | 1998–2005 | 1986–2004 | 1986–2004 |
Average duration of RA in years, mean (range) | 9.0 (0.9–13.1) | 4.2 (0.2–11.2) | 7.3 (0.5–12.7) |
Average baseline HAQ, mean (SD) | 1.54 (0.20) | 1.32 (0.38) | 1.38 (0.26) |
Average HAQ change at 6 months, mean (SD) | −0.44 (0.15) | −0.48 (0.31) | −0.15 (0.12) |
Main analysis based on discrimination by original randomisation (6-month data): | |||
Number of trial arms | 23 | 12 | – |
Total number of patients | 2600 | 1206 | – |
Number of patients per arm, mean (range) | 113 (32–318) | 101 (29–182) | – |
Year of trial, range | 1998–2004 | 1986–2002 | – |
Average duration of RA in years, mean (range) | 9.2 (3.9–13.1) | 5.2 (0.3–11.2) | – |
Average baseline HAQ, mean (SD) | 1.53 (0.20) | 1.28 (0.25) | – |
Average HAQ change at 6 months, mean (SD) | −0.27 (0.10) | −0.18 (0.32) | – |
Sensitivity analysis of 12-month data (drug group analysis): | |||
Number of trial arms | 12 | 26 | 4 |
Total number of patients | 2345 | 3557 | 473 |
Number of patients per arm, mean (range) | 195 (81–363) | 137 (29–501) | 118 (67–200) |
Year of trial, range | 2000–2006 | 1993–2006 | 1995–2004 |
Average duration of RA in years, mean (range) | 6.5 (0.7–12.0) | 3.3 (0.2–11.3) | 7.5 (1.3–11.0) |
Average baseline HAQ, mean (SD) | 1.52 (0.21) | 1.30 (0.28) | 1.46 (0.18) |
Average HAQ change at 6 months, mean (SD) | −0.65 (0.21) | −0.53 (0.20) | −0.16 (0.16) |
Sensitivity analysis of trials used for regulatory purposes (drug group analysis; 6-month data): | |||
Number of trial arms | 19 | 8 | 10 |
Total number of patients | 2779 | 1970 | 1276 |
Number of patients per arm, mean (range) | 146 (67–530) | 246 (130–501) | 128 (62–251) |
Year of trial, range | 1998–2005 | 1999–2004 | 1998–2004 |
Average duration of RA in years, mean (range) | 9.5 (0.9–13.1) | 5.9 (0.9–10.5) | 9.1 (3.7–12.7) |
Average baseline HAQ, mean (SD) | 1.59 (0.21) | 1.49 (0.13) | 1.49 (0.24) |
Average HAQ change at 6 months, mean (SD) | −0.46 (0.16) | −0.47 (0.14) | −0.12 (0.11) |
DMARD, disease modifying antirheumatic drugs; HAQ, Health Assessment Questionnaire Disability Index.