A systematic review of the effectiveness of adalimumab
A systematic review of the effectiveness of adalimumab A systematic review of the effectiveness of adalimumab
150 Appendix 4 TABLE 73 Meta-analyses: etanercept s.c. all doses (including sublicence doses) versus placebo (with or without ongoing conventional DMARDs), end of trial Comparison or outcome Studies N included Statistical Effect size (95% CI) in analysis method ACR20 responder 7103,121,122,125,126,129,130 1672 RR (fixed) 3.48 (2.78 to 4.35)* ACR50 responder 7103,121,122,125,126,129,130 1672 RR (fixed) 4.97 (3.40 to 7.27)* ACR70 responder 6103,122,125,126,129,130 1492 RR (fixed) 8.55 (3.59 to 20.37)* RD ACR20 responder 7103,121,122,125,126,129,130 1672 RD (fixed) 0.43 (0.38 to 0.47)* RD ACR50 responder 7103,121,122,125,126,129,130 1672 RD (fixed) 0.26 (0.22 to 0.30)* RD ACR70 responder 6103,122,125,126,129,130 1492 RD (fixed) 0.11 (0.08 to 0.14)* SJC, end of study result 7103,121,122,125,126,129,130 1689 WMD (random) –5.78 (–8.12 to –3.43)* Patient’s global assessment, end of study 7 103,121,122,125,126,129,130 1689 WMD –2.33 (–2.56 to –2.10)* result (fixed) HAQ, end of study result 6 103,122,125,126,129,130 1440 WMD (fixed) –0.49 (–0.57 to –0.40)* DAS, end of study result 1 103 150 WMD (fixed) –1.50 (–1.89 to –1.11)* Modified van de Heijde–Sharp score, 0 0 Not No data available mean change from baseline estimable Withdrawal for any reasons 7 103,104,121,122,125,126,129 2168 RR (fixed) 0.43 (0.36 to 0.51)* Withdrawal due to lack of efficacy 6103,104,121,122,125,126 1748 RR (fixed) 0.28 (0.21 to 0.36)* Withdrawal due to adverse events 7103,104,121,122,125,126,129 2168 RR (fixed) 0.87 (0.54 to 1.38) Death 7103,104,121,122,125,126,129 2168 RR (fixed) 1.44 (0.44 to 4.69) SAEs 5103,104,122,125,129 1429 RR (fixed) 1.25 (0.76 to 2.06) Malignancy: all 6103,104,122,125,126,129 1988 RR (fixed) 0.47 (0.13 to 1.67) Malignancy: skin cancer excluding 6103,104,122,125,126,129 melanoma 1988 RR (fixed) 0.64 (0.15 to 2.77) Malignancy: all cancer excluding 6103,104,122,125,126,129 non-melanoma skin cancer 1988 RR (fixed) 0.34 (0.07 to 1.74) Serious infection 7103,104,122,125,126,129,130 2046 RR (fixed) 0.75 (0.37 to 1.48) Any infection 6103,104,122,125,126,129 1988 RR (random) 1.01 (0.83 to 1.24) * Statistically significant result (p < 0.05).
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). 151
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Infliximab<br />
Infliximab alone versus placebo or methotrexate<br />
© Queen’s Printer and Controller <strong>of</strong> HMSO 2006. All rights reserved.<br />
Health Technology Assessment 2006; Vol. 10: No. 42<br />
TABLE 74 Meta-analyses: infliximab i.v. (all doses) without MTX versus control (placebo or MTX) in MTX partial responders/<br />
non-responders, end <strong>of</strong> trial<br />
Comparison or outcome Comparator Studies N included Statistical Effect size (95% CI)<br />
in analysis method<br />
Paulus 20 responder vs placebo 1136 73 RR (fixed) 7.35 (1.91 to 28.21)*<br />
vs MTX 1 137 58 RR (fixed) 2.86 (0.40 to 20.67)<br />
Paulus 50 responder vs placebo 1136 73 RR (fixed) 5.14 (1.31 to 20.15)*<br />
vs MTX 1 137 58 RR (fixed) 4.33 (0.26 to 72.44)<br />
ACR70 responder – 0 0 Not estimable Data not available<br />
RD Paulus 20 responder vs placebo 1136 73 RD (fixed) 0.53 (0.35 to 0.70)*<br />
vs MTX 1 137 58 RD (fixed) 0.13 (–0.05 to 0.31)<br />
RD Paulus 50 responder vs placebo 1136 73 RD (fixed) 0.35 (0.17 to 0.52)*<br />
vs MTX 1 137 58 RD (fixed) 0.14 (0.00 to 0.27)<br />
RD ACR70 responder – 0 0 Not estimable Data not available<br />
SJC, end <strong>of</strong> study result vs placebo 1136 73 WMD (fixed) –12.20 (–17.17 to –7.23)*<br />
Patient’s global assessment, vs placebo 1136 end <strong>of</strong> study result<br />
73 WMD (fixed) –1.00 (–1.39 to –0.61)*<br />
HAQ, mean change from baseline – 0 0 Not estimable Data not available<br />
DAS28, end <strong>of</strong> study result – 0 0 Not estimable Data not available<br />
Modified van de Heijde–Sharp score,<br />
mean change from baseline<br />
– 0 0 Not estimable Data not available<br />
Withdrawal for any reasons vs MTX 1137 58 RR (fixed) 0.48 (0.25 to 0.93)*<br />
Withdrawal due to lack <strong>of</strong> efficacy vs MTX 1137 58 RR (fixed) 0.32 (0.15 to 0.69)*<br />
Withdrawal due to adverse events vs MTX 1137 58 RR (fixed) 3.00 (0.17 to 52.53)<br />
Death – 0 0 Not estimable Data not available<br />
SAEs – 0 0 Not estimable Data not available<br />
Malignancy vs MTX 1137 58 Not estimable No events<br />
Serious infection vs MTX 1137 58 Not estimable No events<br />
Any infection vs placebo 1136 73 RR (fixed) 2.94 (0.37 to 23.06)<br />
* Statistically significant result (p < 0.05).<br />
151
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