A systematic review of the effectiveness of adalimumab

56 TABLE 12 Description of included RCTs and baseline patient characteristics: infliximab (cont’d)
Effectiveness
Study and description Interventions No. of Mean Mean No. of On On Mean
patients age disease previous steroids NSAIDs baseline
(years) duration DMARDs (%) (%) HAQ
(years) score
C0168T29 DMARD naïve (Mean)
ASPIRE: St Clair et al., 2004 135
Placebo + MTX (starting 7.5 and increasing to 282 50 0.9 65% 38 82 1.5
North America, Europe and Israel, 20 mg per week by week 8)
multicentre, double-blind Infliximab 3 mg kg –1 i.v. every 8 weeks + MTX 359 51 0.8 71% 37 85 1.5
Infliximab treatment: repeated infusion (as above)
at 0, 2 and 6 weeks then every Infliximab 6 mg kg –1 i.v. every 8 weeks + 363 50 0.9 68% 39 82 1.5
8 weeks until week 46 MTX (as above)
Duration of follow-up: 54 weeks
Durez et al., 2004 139
(Median) (Median) (Median) (Median)
Belgium, two centres, open-label Methylprednisolone single IV infusion 1 g + 15 56 12 3 NR NR 1.5
Infliximab treatment: three infusions at MTX 10–15 mg per week
weeks 0, 2 and 6 Infliximab 3 mg kg –1 i.v. + MTX (as above) 12 48 10 3 1.3
Duration of follow-up: 14 weeks
Taylor et al., 2004140 UK, single centre, double-blind Placebo (normal saline) + MTX 12 51 1.6 NR NR NR NR
Infliximab treatment: repeated infusion (12.5–17.5 mg per week at baseline, increasing to
at 0, 2 and 6 weeks then every 25 mg per week if needed)
8 weeks until week 46 Infliximab 5 mg kg –1 i.v. every 8 weeks + MTX 12 55 1.3
Duration of follow-up: 54 weeks (as above)
C0168T41
START: Westhovens 2006 105,111 (Mean)
Multicentre, double-blind Placebo + MTX (mean 14 mg per week) 363 52 10.2 NR (25% 59 39 1.4
Infliximab treatment: four infusions at Infliximab 3 mg kg –1 i.v. + MTX 360 53 10.3 receiving 2 59 43 1.5
0, 2 and 6 weeks and 14 weeks (mean 14 mg per week) or more
Duration of follow-up: 22 weeks d Infliximab 10 mg kg –1 i.v. + MTX 361 51 9.1 DMARDs) 59 41 1.4
(mean 14 mg per week)
continued