A systematic review of the effectiveness of adalimumab
A systematic review of the effectiveness of adalimumab
A systematic review of the effectiveness of adalimumab
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TABLE 1 Description <strong>of</strong> included RCTs and baseline patient characteristics: <strong>adalimumab</strong> (cont’d)<br />
No. <strong>of</strong> Mean Mean Mean On On Mean<br />
patients age disease no. <strong>of</strong> steroids NSAIDs baseline<br />
(years) duration previous (%) (%) HAQ<br />
(years) DMARDs score<br />
Study and description Interventions a<br />
DE 031, STAR<br />
Furst et al., 2003 115<br />
Placebo s.c. + baseline standard antirheumatic 318 56 12 ≥ 2.0 54 64 1.43<br />
USA and Canada, 69 centres, double-blind <strong>the</strong>rapy<br />
Duration <strong>of</strong> treatment and follow-up: Adalimumab 40 mg s.c. every o<strong>the</strong>r week + 318 55 9 ≥ 2.1 51 62 1.37<br />
24 weeks baseline standard antirheumatic <strong>the</strong>rapy<br />
a<br />
Some <strong>of</strong> <strong>the</strong> groups receiving active treatment also received matching placebo (where necessary) to maintain blinding. These placebo injections are not listed.<br />
b<br />
Open-label, continuation study (DE003) in which patients in <strong>the</strong> placebo group were switched to receive <strong>adalimumab</strong> is not included in current <strong>review</strong>.<br />
c<br />
Patients in <strong>the</strong> placebo group were switched to <strong>adalimumab</strong> 40 mg at week 12. Subsequent blinded and open-label continuation studies without placebo control are not included in<br />
<strong>the</strong> current <strong>review</strong>.<br />
d<br />
Patients received <strong>the</strong> first dose at baseline and <strong>the</strong> second dose after 4 weeks or on loss <strong>of</strong> response. Once <strong>the</strong> second dose was administered, <strong>the</strong> patient was considered to have<br />
completed <strong>the</strong> study and had <strong>the</strong> option to participate in a continuation study. This open-label continuation study (DE005X) in which <strong>the</strong> placebo group was switched to receive<br />
<strong>adalimumab</strong> is not included in <strong>the</strong> current <strong>review</strong>.<br />
e<br />
A second double-blinded injection <strong>of</strong> randomised drug was given between 4 weeks and 3 months after <strong>the</strong> first injection according to <strong>the</strong> patient’s response. Follow-up beyond 4<br />
weeks and fur<strong>the</strong>r 2.5-year open-label continuation study are not included in <strong>the</strong> current <strong>review</strong>.<br />
f<br />
Fur<strong>the</strong>r open-label extension is not included in <strong>the</strong> current <strong>review</strong>.<br />
g<br />
Oral medication (MTX) started at 7.5 mg per week for 4 weeks. If any swollen joints remained, it could be escalated to a maximum <strong>of</strong> 20 mg per week by week 26. The dosing<br />
frequency <strong>of</strong> <strong>the</strong> parenteral medication (<strong>adalimumab</strong>) could be increased to every week on or after week 16, in patients who failed to respond or lost <strong>the</strong>ir response (ACR20) after<br />
escalating <strong>the</strong> oral medication.<br />
MTX, methotrexate; NR, not reported.<br />
© Queen’s Printer and Controller <strong>of</strong> HMSO 2006. All rights reserved.<br />
Health Technology Assessment 2006; Vol. 10: No. 42<br />
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