A systematic review of the effectiveness of adalimumab

34 TABLE 6
Effectiveness
Description of included studies and baseline patient characteristics: etanercept (cont’d)
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 16.0036 (Prior use)
Keystone et al., 2004 129
Placebo (55% with ongoing MTX, 53 54 10.8 89% NR NR 1.4
USA and Canada, 48 centres, mean 14 mg per week)
double-blind Etanercept 25 mg s.c. twice weekly (52% with 153 52 8.2 90% 1.4
Duration of treatment and follow-up: ongoing MTX, mean 15 mg per week)
8 weeks e
Etanercept 50 mg s.c. once weekly (53% with 214 53 9.0 88% 1.4
ongoing MTX, mean 14 mg per week)
Protocol 0881A-100093
Lan et al., 2004 130
Placebo + MTX (12.5–20 mg per week) 29 51 NR NR NR NR 1.2
Taiwan, single centre, double-blind Etanercept 25 mg s.c. twice weekly + MTX 29 48 1.0
Duration of treatment and follow-up: (same as above)
12 weeks
NR NR NR NR
60 10
Protocol 16.0029
Baumgartner et al., 2004 104 Placebo twice s.c. weekly 269
USA, multicentre, double-blind Etanercept 25 mg s.c. twice weekly 266
Duration of treatment: 16 weeks
Duration of follow-up: 20 weeks
a
Some of the groups receiving active treatment also received matching placebo (where necessary) to maintain blinding. These placebo injections are not listed.
b
All patients had received at least one previous DMARD, but details are not reported. The values shown are percentages using methotrexate in the year before the study.
c
On this scale, 45 is best and 245 worst.
d
Double-blind extension up to 60–100 weeks is not included in current review: data not provided.
e
The placebo group switched to etanercept 25 mg twice weekly from week 8 and all treatment groups were followed up to week 16. The results from week 8 onwards are not
included in the current review.
SSZ, sulfasalazine.