A systematic review of the effectiveness of adalimumab

32 TABLE 6
Effectiveness
Description of included studies and baseline patient characteristics: etanercept
No. of Mean Mean No. of On On Mean
patients age disease previous steroids NSAIDs baseline
(years) duration DMARDs (%) (%) HAQ
(years) score
Study and description Interventions a
Protocol 16.0002
Moreland et al., 1996 120
USA, single centre, double-blind Placebo single i.v. injection followed by s.c. 4 54 19.8 NR NR NR NR
Duration of treatment and follow-up: injection twice weekly
4 weeks Etanercept 4 mg m –2 single i.v. injection followed by 3 56 5.3
2 mg m –2 s.c. injection twice weekly
Etanercept 8 mg m –2 single i.v. injection followed by 3 38 4.3
4 mg m –2 s.c. injection twice weekly
Etanercept 16 mg m –2 single i.v. injection followed by 3 53 4.7
8 mg m –2 s.c. injection twice weekly
Etanercept 32 mg m –2 single i.v. injection followed by 3 62 6.3
16 mg m –2 s.c. injection twice weekly
Protocol 16.0004
Moreland et al., 1997 121
Placebo s.c. twice weekly 44 55 71% > 5 years 34% MTXb 66 73 146c USA, multicentre, double-blind Etanercept 0.25 mg m –2 s.c. twice weekly 46 54 76% > 5 years 41% MTX 59 70 153
Duration of treatment and follow-up: Etanercept 2 mg m –2 s.c. twice weekly 46 52 80% > 5 years 30% MTX 65 80 138
3 months Etanercept 16 mg m –2 s.c. twice weekly 44 52 80% > 5 years 27% MTX 77 75 135
Protocol 16.0009
Moreland et al., 1999122 Placebo s.c. twice weekly 80 51 12 3.0 58 84 1.7
North America, 13 centres, double-blind Etanercept 10 mg s.c. twice weekly 76 53 13 3.4 66 67 1.7
Duration of treatment and follow-up: Etanercept 25 mg s.c. twice weekly 78 53 11 3.3 81 67 1.6
6 months
Protocol 16.0012
ERA: Bathon et al., 2000; 123 MTX (starting 7.5 and escalating to 20 mg per week 217 49 1.0 0.6 41 80 1.4
Genovese et al., 2002 124 by week 8; mean 19 mg per week) + placebo
USA and Canada, 69 centres, Etanercept 10 mg s.c. twice weekly + placebo 208 50 0.9 0.5 42 76 1.4
double-blind Etanercept 25 mg s.c. twice weekly + placebo 207 51 1.0 0.5 39 86 1.5
Duration of treatment and follow-up:
24 months (double-blind for the first
12 months, and open-label for a
further 12 months)
continued