Table 1 Characteristics of trials
Biologic DMARDsTraditional DMARDsPlacebo therapies
Main analysis based on discrimination of drug groups (6-month data):
    Number of trial arms254418
    Total number of patients338852162051
    Number of patients per arm, mean (range)136 (32–530)119 (12–969)114 (29–318)
    Year of trial, range1998–20051986–20041986–2004
    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 arms2312
    Total number of patients26001206
    Number of patients per arm, mean (range)113 (32–318)101 (29–182)
    Year of trial, range1998–20041986–2002
    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 arms12264
    Total number of patients23453557473
    Number of patients per arm, mean (range)195 (81–363)137 (29–501)118 (67–200)
    Year of trial, range2000–20061993–20061995–2004
    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 arms19810
    Total number of patients277919701276
    Number of patients per arm, mean (range)146 (67–530)246 (130–501)128 (62–251)
    Year of trial, range1998–20051999–20041998–2004
    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.