A systematic review of the effectiveness of adalimumab
A systematic review of the effectiveness of adalimumab A systematic review of the effectiveness of adalimumab
152 Appendix 4 Infliximab versus placebo (with concomitant, ongoing methotrexate) TABLE 75 Meta-analyses: infliximab i.v. licensed dose and above versus placebo with ongoing MTX in MTX partial responders/ non-responders, end of trial Comparison or outcome Studies N included Statistical method Effect size (95% CI) in analysis ACR20 responder 4111,133,137,140 1513 RR (fixed) 2.50 (2.10 to 2.99)* ACR50 responder 4111,133,137,140 1513 RR (fixed) 3.73 (2.75 to 5.07)* ACR70 responder 2111,133 1448 RR (fixed) 3.79 (2.34 to 6.15)* RD ACR20 responder 4111,133,137,140 1513 RD (fixed) 0.34 (0.30 to 0.39)* RD ACR50 responder 4111,133,137,140 1513 RD (fixed) 0.25 (0.21 to 0.29)* RD ACR70 responder 2111,133 1448 RD (fixed) 0.12 (0.09 to 0.14)* SJC, mean change from baseline 2111,133 1401 WMD (fixed) –5.28 (–6.27 to –4.29)* Patient’s global assessment, mean change 2111,133 from baseline 1400 WMD (fixed) –1.60 (–1.91 to –1.29)* HAQ, mean change from baseline 2 111,133 1381 WMD (fixed) –0.29 (–0.36 to –0.23)* DAS28, end of study result 1140 24 WMD (fixed) –1.80 (–2.68 to –0.92)* Modified van de Heijde–Sharp score, 2133,140 mean change from baseline 373 WMD (fixed) –6.79 (–9.19 to –4.39)* Withdrawal for any reasons 3 111,133,137 1553 RR (random) 0.48 (0.17 to 1.33) Withdrawal due to lack of efficacy 2133,137 471 RR (fixed) 0.28 (0.19 to 0.41)* Withdrawal due to adverse events 4111,133,137,140 1577 RR (fixed) 1.65 (0.97 to 2.81) Death 2111,133 1510 RR (fixed) 0.55 (0.16 to 1.81) SAEs 2111,133 1510 RR (fixed) 0.92 (0.67 to 1.27) Malignancy: all 3111,133,137 1553 RR (fixed) 2.64 (0.62 to 11.26) Malignancy: skin cancer excluding 3111,133,137 melanoma 1553 RR (fixed) 1.68 (0.31 to 9.04) Malignancy: all cancer excluding 3 111,133,137 non-melanoma skin cancer 1553 RR (fixed) 2.30 (0.40 to 13.17) Serious infection 3 111,133,137 1553 RR (fixed) 1.32 (0.74 to 2.35) Any infection 2111,132 1510 RR (fixed) [Commercial-inconfidence information removed]* * Statistically significant result (p < 0.05).
© Queen’s Printer and Controller of HMSO 2006. All rights reserved. Health Technology Assessment 2006; Vol. 10: No. 42 TABLE 76 Meta-analyses: infliximab i.v. all doses versus placebo with ongoing MTX in MTX partial responders/non-responders, end of trial Comparison or outcome Studies N included Statistical method Effect size (95% CI) in analysis ACR20 responder 5111,133,137,138,140 ACR50 responder 5111,133,137,138,140 ACR70 responder 2111,133 RD ACR20 responder 5111,133,137,138,140 RD ACR50 responder 5111,133,137,138,140 RD ACR70 responder 2111,133 SJC, end of study result 2111,133 Patient’s global assessment, end of 2111,133 study result HAQ, mean change from baseline 2 111,133 DAS28, end of study result 1140 Modified van de Heijde–Sharp score, 2133,140 mean change from baseline Withdrawal for any reasons 4 111,133,137,138 Withdrawal due to lack of efficacy 3133,137,138 Withdrawal due to adverse events 5111,133,137,138,140 Death 2111,133 SAEs 2111,133 Malignancy: all 3111,133,137 Malignancy: skin cancer excluding 3111,133,137 melanoma Malignancy: all cancer excluding 3 111,133,137 non-melanoma skin cancer Serious infection 4 111,133,137,138 Any infection 2111,133 * Statistically significant result (p < 0.05). 1555 RR (fixed) 2.50 (2.10 to 2.99)* 1555 RR (fixed) 3.68 (2.72 to 4.98)* 1448 RR (fixed) 3.79 (2.34 to 6.15)* 1555 RD (fixed) 0.34 (0.29 to 0.39)* 1555 RD (fixed) 0.24 (0.21 to 0.28)* 1448 RD (fixed) 0.12 (0.09 to 0.14)* 1401 WMD (fixed) –5.28 (–6.27 to –4.29)* 1400 WMD (fixed) –1.60 (–1.91 to –1.29)* 1381 WMD (fixed) –0.29 (–0.36 to –0.23)* 24 WMD (fixed) –1.80 (–2.68 to –0.92)* 373 WMD (fixed) –6.79 (–9.19 to –4.39)* 1595 RR (random) 0.45 (0.16 to 1.28) 513 RR (fixed) 0.27 (0.18 to 0.40)* 1619 RR (fixed) 1.66 (0.97 to 2.82) 1510 RR (fixed) 0.55 (0.16 to 1.81) 1510 RR (fixed) 0.92 (0.67 to 1.27) 1567 RR (fixed) 2.64 (0.62 to 11.26) 1567 RR (fixed) 1.68 (0.31 to 9.04) 1567 RR (fixed) 2.30 (0.40 to 13.17) 1595 RR (fixed) 1.29 (0.72 to 2.31) 1510 RR (random) [Commercial-inconfidence information removed] 153
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152<br />
Appendix 4<br />
Infliximab versus placebo (with concomitant, ongoing methotrexate)<br />
TABLE 75 Meta-analyses: infliximab i.v. licensed dose and above versus placebo with ongoing MTX in MTX partial responders/<br />
non-responders, end <strong>of</strong> trial<br />
Comparison or outcome Studies N included Statistical method Effect size (95% CI)<br />
in analysis<br />
ACR20 responder 4111,133,137,140 1513 RR (fixed) 2.50 (2.10 to 2.99)*<br />
ACR50 responder 4111,133,137,140 1513 RR (fixed) 3.73 (2.75 to 5.07)*<br />
ACR70 responder 2111,133 1448 RR (fixed) 3.79 (2.34 to 6.15)*<br />
RD ACR20 responder 4111,133,137,140 1513 RD (fixed) 0.34 (0.30 to 0.39)*<br />
RD ACR50 responder 4111,133,137,140 1513 RD (fixed) 0.25 (0.21 to 0.29)*<br />
RD ACR70 responder 2111,133 1448 RD (fixed) 0.12 (0.09 to 0.14)*<br />
SJC, mean change from baseline 2111,133 1401 WMD (fixed) –5.28 (–6.27 to –4.29)*<br />
Patient’s global assessment, mean change 2111,133 from baseline<br />
1400 WMD (fixed) –1.60 (–1.91 to –1.29)*<br />
HAQ, mean change from baseline 2 111,133 1381 WMD (fixed) –0.29 (–0.36 to –0.23)*<br />
DAS28, end <strong>of</strong> study result 1140 24 WMD (fixed) –1.80 (–2.68 to –0.92)*<br />
Modified van de Heijde–Sharp score, 2133,140 mean change from baseline<br />
373 WMD (fixed) –6.79 (–9.19 to –4.39)*<br />
Withdrawal for any reasons 3 111,133,137 1553 RR (random) 0.48 (0.17 to 1.33)<br />
Withdrawal due to lack <strong>of</strong> efficacy 2133,137 471 RR (fixed) 0.28 (0.19 to 0.41)*<br />
Withdrawal due to adverse events 4111,133,137,140 1577 RR (fixed) 1.65 (0.97 to 2.81)<br />
Death 2111,133 1510 RR (fixed) 0.55 (0.16 to 1.81)<br />
SAEs 2111,133 1510 RR (fixed) 0.92 (0.67 to 1.27)<br />
Malignancy: all 3111,133,137 1553 RR (fixed) 2.64 (0.62 to 11.26)<br />
Malignancy: skin cancer excluding 3111,133,137 melanoma<br />
1553 RR (fixed) 1.68 (0.31 to 9.04)<br />
Malignancy: all cancer excluding 3 111,133,137 non-melanoma skin cancer<br />
1553 RR (fixed) 2.30 (0.40 to 13.17)<br />
Serious infection 3 111,133,137 1553 RR (fixed) 1.32 (0.74 to 2.35)<br />
Any infection 2111,132 1510 RR (fixed) [Commercial-inconfidence<br />
information<br />
removed]*<br />
* Statistically significant result (p < 0.05).
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