A systematic review of the effectiveness of adalimumab

Infliximab
Infliximab alone versus placebo or methotrexate
© Queen’s Printer and Controller of HMSO 2006. All rights reserved.
Health Technology Assessment 2006; Vol. 10: No. 42
TABLE 74 Meta-analyses: infliximab i.v. (all doses) without MTX versus control (placebo or MTX) in MTX partial responders/
non-responders, end of trial
Comparison or outcome Comparator Studies N included Statistical Effect size (95% CI)
in analysis method
Paulus 20 responder vs placebo 1136 73 RR (fixed) 7.35 (1.91 to 28.21)*
vs MTX 1 137 58 RR (fixed) 2.86 (0.40 to 20.67)
Paulus 50 responder vs placebo 1136 73 RR (fixed) 5.14 (1.31 to 20.15)*
vs MTX 1 137 58 RR (fixed) 4.33 (0.26 to 72.44)
ACR70 responder – 0 0 Not estimable Data not available
RD Paulus 20 responder vs placebo 1136 73 RD (fixed) 0.53 (0.35 to 0.70)*
vs MTX 1 137 58 RD (fixed) 0.13 (–0.05 to 0.31)
RD Paulus 50 responder vs placebo 1136 73 RD (fixed) 0.35 (0.17 to 0.52)*
vs MTX 1 137 58 RD (fixed) 0.14 (0.00 to 0.27)
RD ACR70 responder – 0 0 Not estimable Data not available
SJC, end of study result vs placebo 1136 73 WMD (fixed) –12.20 (–17.17 to –7.23)*
Patient’s global assessment, vs placebo 1136 end of study result
73 WMD (fixed) –1.00 (–1.39 to –0.61)*
HAQ, mean change from baseline – 0 0 Not estimable Data not available
DAS28, end of study result – 0 0 Not estimable Data not available
Modified van de Heijde–Sharp score,
mean change from baseline
– 0 0 Not estimable Data not available
Withdrawal for any reasons vs MTX 1137 58 RR (fixed) 0.48 (0.25 to 0.93)*
Withdrawal due to lack of efficacy vs MTX 1137 58 RR (fixed) 0.32 (0.15 to 0.69)*
Withdrawal due to adverse events vs MTX 1137 58 RR (fixed) 3.00 (0.17 to 52.53)
Death – 0 0 Not estimable Data not available
SAEs – 0 0 Not estimable Data not available
Malignancy vs MTX 1137 58 Not estimable No events
Serious infection vs MTX 1137 58 Not estimable No events
Any infection vs placebo 1136 73 RR (fixed) 2.94 (0.37 to 23.06)
* Statistically significant result (p < 0.05).
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