A systematic review of the effectiveness of adalimumab

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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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A systematic review of the effectiv
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A systematic review of the effectiv
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Objectives: This report reviews the
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Glossary and list of abbreviations
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viii Glossary and list of abbreviat
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Background Rheumatoid arthritis (RA
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increased risk of serious infection
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Summary RA is a common, chronic, in
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(IL-2) and interleukin-6 (IL-6), pr
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Assessment of response to DMARDs Re
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combination with methotrexate or al
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disease between clinic appointments
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14 Effectiveness in juvenile arthri
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16 Effectiveness adalimumab plus me
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18 Effectiveness Monoclonal Antibod
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20 TABLE 1 Description of included
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22 TABLE 2 Quality of included RCTs
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24 Effectiveness change in modified
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26 Effectiveness TABLE 4 Meta-analy
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28 Effectiveness Review: Adalimumab
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30 Effectiveness Review: Adalimumab
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32 TABLE 6 Effectiveness Descriptio
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34 TABLE 6 Effectiveness Descriptio
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36 TABLE 7 Effectiveness Quality of
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38 Effectiveness etanercept trials.
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40 Effectiveness TABLE 9 Summary of
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42 Effectiveness Review: Etanercept
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54 Effectiveness TABLE 11 Summary o
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56 TABLE 12 Description of included
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58 TABLE 13 Quality of included RCT
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60 Effectiveness per week and escal
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62 Effectiveness significant advant
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64 Effectiveness Review: Infliximab
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66 Effectiveness Review: Infliximab
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68 Effectiveness FIGURE 44 Malignan
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70 TABLE 17 Effectiveness Summary o
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Summary of review of existing econo
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TABLE 20 Summary of published ICERs
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TABLE 21 Published etanercept econo
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TABLE 23 Published economic analyse
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TABLE 25 Treatment sequences: adali
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management of RA, i.e. 1st and 2nd
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To estimate the long-term consequen
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TABLE 32 TNF inhibitors as last act
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TABLE 34 Basic structure of the mod
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een quit on grounds of toxicity, ad
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TABLE 39 Strategy set: adalimumab a
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TABLE 43 Beta distributions for HAQ
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TABLE 44 Early cessation of DMARDs:
Page 115 and 116: TABLE 46 Unit costs for tests and v
Page 117 and 118: following properties, according to
Page 119 and 120: TABLE 52 Base case: TNF inhibitors
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Page 125 and 126: TABLE 65 Sensitivity analyses: TNF
Page 127 and 128: TABLE 67 Sensitivity analyses: TNF
Page 129: The substantial economic impact of
Page 133 and 134: Summary Effectiveness: principal fi
Page 135 and 136: inhibitors, although the incrementa
Page 137 and 138: introduce bias which generally exag
Page 139: Adalimumab, etanercept and inflixim
Page 143 and 144: 1. Jobanputra P, Barton P, Bryan S,
Page 145 and 146: 46. Young A, Dixey J, Cox N, Davies
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Page 149 and 150: arthritis: a 12-week, double-blind,
Page 151 and 152: 171. Geborek P, Crnkic M, Petersson
Page 153 and 154: 216. Schotte H, Willeke P, Mickholz
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Page 157 and 158: Cochrane Library (CENTRAL) 2005 Iss
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Page 168 and 169: 152 Appendix 4 Infliximab versus pl
Page 170 and 171: 154 Appendix 4 Infliximab plus MTX
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TABLE 126 Variation 9: TNF inhibito
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246 Health Technology Assessment Pr
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A systematic review of the effectiveness of adalimumab

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