A systematic review of the effectiveness of adalimumab
A systematic review of the effectiveness of adalimumab A systematic review of the effectiveness of adalimumab
154 Appendix 4 Infliximab plus MTX versus MTX TABLE 77 Meta-analyses: combination of infliximab (i.v. all doses) plus MTX versus MTX alone in MTX-naïve patients, end of trial Comparison or outcome Studies Participants Statistical method Effect size (95% CI) ACR20 responder 2135,141 1000 RR (fixed) 1.20 (1.07 to 1.36)* ACR50 responder 2135,141 1000 RR (fixed) 1.51 (1.26 to 1.82)* ACR70 responder 2135,141 1000 RR (fixed) 1.67 (1.31 to 2.13)* RD ACR20 responder 2135,141 1000 RD (fixed) 0.11 (0.04 to 0.18)* RD ACR50 responder 2135,141 1000 RD (fixed) 0.16 (0.10 to 0.23)* RD ACR70 responder 2135,141 1000 RD (fixed) 0.14 (0.08 to 0.20)* SJC, mean change from baseline 1135 846 WMD (fixed) –3.00 (–4.76 to –1.24)* Patient’s global assessment, mean change 1135 from baseline 842 WMD (fixed) –0.70(–1.18 to –0.22)* HAQ, mean change from baseline 2 135,141 1016 WMD (fixed) –0.17 (–0.28 to –0.07)* DAS28, end of study result 2135,141 838 WMD (fixed) –0.82 (–1.08 to –0.55)* Modified van de Heijde–Sharp score, 1135 mean change from baseline 1004 WMD (fixed) –3.23 (–4.43 to –2.03)* Withdrawal for any reasons 1 135 1040 RR (fixed) 0.93 (0.71 to 1.21) Withdrawal due to lack of efficacy 1135 1040 RR (fixed) 0.28 (0.16 to 0.49)* Withdrawal due to adverse events 2135,141 1060 RR (fixed) 3.02 (1.55 to 5.88)* Death 1135 1040 RR (fixed) 0.39 (0.05 to 2.75) SAEs 1135 1040 RR (fixed) 1.25 (0.86 to 1.82) Malignancy: all 1135 1040 RR (fixed) [Commercial-inconfidence information removed] Malignancy: skin cancer excluding melanoma 1 135 1040 RR (fixed) [Commercial-inconfidence information removed] Malignancy: all cancer excluding 1 135 non-melanoma skin cancer 1040 RR (fixed) 3.50 (0.19 to 64.88) Serious infection 1 135 1040 RR (fixed) 2.59 (1.11 to 6.04)* Any infection 1135 1040 RR (fixed) [Commercial-inconfidence information removed]* * Statistically significant result (p < 0.05).
Ovid MEDLINE(R) 1966 to February week 3 2005 1 arthritis rheumatoid/ 2 tum?r necrosis factor.mp. 3 exp receptors tumor necrosis factor/ 4 anti tnf.mp. 5 infliximab.mp. 6 remicade.mp. 7 enbrel.mp. 8 etanercept.mp. 9 or/2-8 10 1 and 9 11 economics/ 12 exp "costs and cost analysis"/ 13 cost of illness/ 14 exp health care costs/ 15 economic value of life/ 16 exp economics medical/ 17 exp economics hospital/ 18 economics pharmaceutical/ 19 exp "fees and charges"/ 20 (econom$ or cost or costs or costly or costing or price or pricing or pharmacoeconomic$).tw. 21 (expenditure$ not energy).tw. 22 (value adj1 money).tw. 23 budget$.tw. 24 or/11-23 25 10 and 24 26 limit 25 to yr=2001-2005 27 adalimumab.mp. 28 humira.mp. 29 or/27-28 30 29 and 24 31 26 or 30 32 quality of life/ 33 life style/ 34 health status/ 35 health status indicators/ 36 value of life/ 37 quality of wellbeing.tw. 38 or/32-37 39 1 and 38 40 limit 39 to yr=2001-2005 41 31 or 40 EMBASE (Ovid) 1980 to week 9 2005 1 arthritis rheumatoid/ Appendix 5 2 tum?r necrosis factor.mp. 3 exp receptors tumor necrosis factor/ 4 anti tnf.mp. 5 infliximab.mp. 6 remicade.mp. 7 enbrel.mp. 8 etanercept.mp. 9 or/2-8 10 1 and 9 11 cost benefit analysis/ 12 cost effectiveness analysis/ 13 cost minimization analysis/ 14 cost utility analysis/ 15 economic evaluation/ 16 (cost or costs or costed or costly or costing).tw. 17 (economic$ or pharmacoeconomic$ or price$ or pricing).tw. 18 (technology adj assessment$).tw. 19 or/11-18 20 10 and 19 21 limit 20 to yr=2001-2005 22 adalimumab.mp. 23 humira.mp. 24 or/22-23 25 24 and 19 26 21 or 25 27 exp quality of life/ 28 health status/ 29 27 or 28 30 1 and 29 31 limit 30 to yr=2001 - 2005 Cochrane Library (NHSEED) 2005 Issue 1 See search strategy for Cochrane Library under Clinical Effectiveness, page 141. HEED Health Technology Assessment 2006; Vol. 10: No. 42 Searches: economic evaluations © Queen’s Printer and Controller of HMSO 2006. All rights reserved. February 2005 A series of searches were done using the following terms: anti tnf; infliximab; remicade, enbrel, etanercept, adalimumab, humira and references which included rheumatoid arthritis were selected. 155
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154<br />
Appendix 4<br />
Infliximab plus MTX versus MTX<br />
TABLE 77 Meta-analyses: combination <strong>of</strong> infliximab (i.v. all doses) plus MTX versus MTX alone in MTX-naïve patients, end <strong>of</strong> trial<br />
Comparison or outcome Studies Participants Statistical method Effect size (95% CI)<br />
ACR20 responder 2135,141 1000 RR (fixed) 1.20 (1.07 to 1.36)*<br />
ACR50 responder 2135,141 1000 RR (fixed) 1.51 (1.26 to 1.82)*<br />
ACR70 responder 2135,141 1000 RR (fixed) 1.67 (1.31 to 2.13)*<br />
RD ACR20 responder 2135,141 1000 RD (fixed) 0.11 (0.04 to 0.18)*<br />
RD ACR50 responder 2135,141 1000 RD (fixed) 0.16 (0.10 to 0.23)*<br />
RD ACR70 responder 2135,141 1000 RD (fixed) 0.14 (0.08 to 0.20)*<br />
SJC, mean change from baseline 1135 846 WMD (fixed) –3.00 (–4.76 to –1.24)*<br />
Patient’s global assessment, mean change 1135 from baseline<br />
842 WMD (fixed) –0.70(–1.18 to –0.22)*<br />
HAQ, mean change from baseline 2 135,141 1016 WMD (fixed) –0.17 (–0.28 to –0.07)*<br />
DAS28, end <strong>of</strong> study result 2135,141 838 WMD (fixed) –0.82 (–1.08 to –0.55)*<br />
Modified van de Heijde–Sharp score, 1135 mean change from baseline<br />
1004 WMD (fixed) –3.23 (–4.43 to –2.03)*<br />
Withdrawal for any reasons 1 135 1040 RR (fixed) 0.93 (0.71 to 1.21)<br />
Withdrawal due to lack <strong>of</strong> efficacy 1135 1040 RR (fixed) 0.28 (0.16 to 0.49)*<br />
Withdrawal due to adverse events 2135,141 1060 RR (fixed) 3.02 (1.55 to 5.88)*<br />
Death 1135 1040 RR (fixed) 0.39 (0.05 to 2.75)<br />
SAEs 1135 1040 RR (fixed) 1.25 (0.86 to 1.82)<br />
Malignancy: all 1135 1040 RR (fixed) [Commercial-inconfidence<br />
information<br />
removed]<br />
Malignancy: skin cancer excluding melanoma 1 135 1040 RR (fixed) [Commercial-inconfidence<br />
information<br />
removed]<br />
Malignancy: all cancer excluding 1 135 non-melanoma skin cancer<br />
1040 RR (fixed) 3.50 (0.19 to 64.88)<br />
Serious infection 1 135 1040 RR (fixed) 2.59 (1.11 to 6.04)*<br />
Any infection 1135 1040 RR (fixed) [Commercial-inconfidence<br />
information<br />
removed]*<br />
* Statistically significant result (p < 0.05).