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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60<br />
Effectiveness<br />
per week and escalated to up to 25 mg per week<br />
depending on disease activity) and methotrexate<br />
combined with infliximab 3 mg kg –1 i.v. every<br />
8 weeks. Patients with early RA, judged to have a<br />
poor prognosis, were treated for 12 months, with a<br />
fur<strong>the</strong>r open-label phase up to 24 months. The<br />
latter data are not included in this <strong>review</strong> as o<strong>the</strong>r<br />
DMARDs could be introduced during <strong>the</strong><br />
extension. RA patients with symptoms for less<br />
than 12 months and no previous treatment with<br />
DMARDs or oral corticosteroids were recruited.<br />
Metacarpophalangeal joint disease and poor<br />
prognosis according to a scoring system based on<br />
rheumatoid factor positivity, genetic markers, CRP,<br />
gender and HAQ score were required. The<br />
primary end-point was MRI-measured synovitis at<br />
week 14. Allocation concealment was not clearly<br />
stated.<br />
BeSt: Goekoop-Ruiterman and<br />
colleagues 108,143,144<br />
This important trial compared four strategies for<br />
using DMARDs, ra<strong>the</strong>r than individual drugs.<br />
Patients with RA diagnosed within 2 years were<br />
recruited. Because patients received infliximab in<br />
all arms, this trial does not meet <strong>the</strong> inclusion<br />
criteria defined in <strong>the</strong> current protocol, which<br />
sought comparative studies <strong>of</strong> TNF inhibitors<br />
against alternative treatments. Nor can its results<br />
be incorporated meaningfully in <strong>the</strong> metaanalyses.<br />
Never<strong>the</strong>less, it is reported in detail<br />
here, as it is important evidence to inform<br />
guidance on appropriate use <strong>of</strong> infliximab. The<br />
primary end-points <strong>of</strong> BeSt were HAQ and<br />
radiographic joint damage according to <strong>the</strong> van<br />
der Heijde modified Sharp score after 1 year <strong>of</strong><br />
follow-up. A sequence <strong>of</strong> drug treatments was<br />
strictly defined and patients moved along <strong>the</strong><br />
sequence <strong>of</strong> <strong>the</strong>rapies based on <strong>the</strong>ir response.<br />
Those who did not achieve a DAS <strong>of</strong> 2.4 or less,<br />
based on evaluation <strong>of</strong> 44 joints (Appendix 1),<br />
moved to <strong>the</strong> next step in <strong>the</strong> defined sequence. A<br />
sustained response to <strong>the</strong>rapy, defined as DAS <strong>of</strong><br />