A systematic review of the effectiveness of adalimumab

TABLE 1 Description of included RCTs and baseline patient characteristics: adalimumab
No. of Mean Mean Mean On On Mean
patients age disease no. of steroids NSAIDs baseline
(years) duration previous (%) (%) HAQ
(years) DMARDs score
Study and description Interventions a
DE001
den Broeder et al., 2002 116
Placebo i.v. (one dose) 31 55 11.9 3.7 77 68 1.57
Netherlands and Germany, three centres, Adalimumab 0.5 mg kg –1 i.v. (one dose) 17 54 11.0 3.6 53 94 1.57
double-blind Adalimumab 1 mg kg –1 i.v. (one dose) 18 58 11.2 3.9 78 72 1.85
Adalimumab treatment: single injection Adalimumab 3 mg kg –1 i.v. (one dose) 18 54 10.8 3.9 67 56 1.41
Duration of follow-up: 4 weeks to 3 months b Adalimumab 5 mg kg –1 i.v. (one dose) 18 59 14.5 4.4 78 89 1.61
Adalimumab 10 mg kg –1 i.v. (one dose) 18 53 8.9 3.9 67 72 1.93
DE005
Weisman et al., 2003 118
Placebo i.v. (one dose) + MTX 15 51 15 NR NR NR 1.1
USA and Canada, six centres, double-blind (12.5–25 mg per week, mean 17 mg per week)
Adalimumab treatment: single injection c
Adalimumab 0.25 mg kg –1 i.v. (one dose) + MTX 9 50 17 1.3
Duration of follow-up: 4 weeks d
(12.5–25 mg per week, mean 17 mg per week)
Adalimumab 0.5 mg kg –1 i.v. (one dose) + MTX 9 56 13 0.9
(12.5–25 mg per week, mean 13 mg per week)
Adalimumab 1 mg kg –1 i.v. (one dose) + MTX 9 51 16 1.5
(12.5–25 mg per week, mean 16 mg per week)
Adalimumab 3 mg kg –1 i.v. (one dose) + MTX 9 56 15 1.0
(12.5–25 mg per week, mean 15 mg per week)
Adalimumab 5 mg kg –1 i.v. (one dose) + MTX 9 54 18 1.4
(12.5–25 mg per week, mean 18 mg per week)
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Health Technology Assessment 2006; Vol. 10: No. 42
DE007
van de Putte et al., 2003 119
Placebo s.c. weekly 70 50 9 3.5 77 80 1.63
Europe, 25 centres, double-blind Adalimumab 20 mg s.c. weekly 72 54 10 4.1 76 76 1.79
Duration of treatment and follow-up: Adalimumab 40 mg s.c. weekly 70 53 10 3.7 70 81 1.74
12 weeks c
Adalimumab 80 mg s.c. weekly 72 53 10 3.7 75 78 1.66
DE009, ARMADA
Weinblatt et al., 2003 112
Placebo s.c. every other week + MTX 62 56 11 3.0 58 NR 1.64
USA and Canada, 35 centres, double-blind (12.5–25 mg per week, mean 17 mg per week)
Duration of treatment and follow-up: Adalimumab 20 mg s.c. every other week + MTX 69 54 13 3.0 1.52
24 weeks (12.5–25 mg per week, mean 17 mg per week)
Adalimumab 40 mg s.c. every other week + MTX 67 57 12 2.9 46 1.55
(12.5–25 mg per week, mean 16 mg per week)
Adalimumab 80 mg s.c. every other week + MTX 73 56 13 3.1 1.55
(12.5–25 mg per week, mean 17 mg per week) (n = 72)
continued
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