A systematic review of the effectiveness of adalimumab

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Appendix 4 © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Health Technology Assessment 2006; Vol. 10: No. 42 Additional tables for clinical effectiveness review Adalimumab Adalimumab versus placebo: sensitivity analyses TABLE 70 Meta-analyses: adalimumab licensed dose (40 mg every other week or equivalent) and above versus placebo (with or without ongoing conventional DMARDs), end of trial Comparison or outcome Studies N included Statistical method Effect size (95% CI) in analysis ACR20 responder 5112–115,119 2172 RR (fixed) 2.23 (1.94 to 2.56)* ACR50 responder 5112–115,119 2172 RR (fixed) 3.73 (2.91 to 4.77)* ACR70 responder 5112–115,119 2172 RR (fixed) 5.28 (3.49 to 8.00)* RD ACR20 responder 5112–115,119 2172 RD (fixed) 0.30 (0.26 to 0.34)* RD ACR50 responder 5112–115,119 2172 RD (fixed) 0.24 (0.21 to 0.27)* RD ACR70 responder 5112–115,119 2172 RD (fixed) 0.14 (0.11 to 0.16)* SJC, mean change from baseline 5112–115,119 2169 WMD (fixed) –5.52 (–6.39 to –4.64)* Patient’s global assessment, mean change 5112–115,119 from baseline 2168 WMD (fixed) –1.76 (–2.01 to –1.50)* HAQ, mean change from baseline 5 112–115,119 2168 WMD (fixed) –0.33 (–0.38 to –0.28)* DAS28, mean change from baseline 2113,119 721 WMD (random) –1.30 (–1.69 to –0.92)* Modified van de Heijde–Sharp score, 1114 mean change from baseline 551 WMD (fixed) –2.20 (–3.33 to –1.07)* Withdrawal for any reasons 5 112–115,119 2179 RR (random) 0.60 (0.40 to 0.88)* Withdrawal due to lack of efficacy 5112–115,119 2179 RR (fixed) 0.35 (0.28 to 0.43)* Withdrawal due to adverse events 5112–115,119 2179 RR (fixed) 1.41 (0.90 to 2.21) Death 5112–115,119 2179 RR (fixed) 1.76 (0.45 to 6.86) SAEs 5112–115,119 2179 RR (fixed) 1.08 (0.81 to 1.44) Malignancy: all 5112–115,119 2179 RR (fixed) 2.99 (0.93 to 9.66) Malignancy: skin cancer excluding 5112–115,119 melanoma 2179 RR (fixed) 1.97 (0.53 to 7.27) Malignancy: all cancer excluding 5 112–115,119 non-melanoma skin cancer 2179 RR (fixed) 2.52 (0.56 to 11.47) Serious infection 5112–115,119 2179 RR (fixed) 2.35 (1.03 to 5.34)* Any infection 4112–115 1895 RR (fixed) 1.19 (1.08 to 1.31)* * Statistically significant result (p < 0.05). 147
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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
Page 111 and 112: TABLE 43 Beta distributions for HAQ
Page 113 and 114: 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
Page 121 and 122: TABLE 54 Base case: TNF inhibitors
Page 123 and 124: TABLE 59 Third TNF inhibitor follow
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
Page 147 and 148: tumor necrosis factor therapy in th
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
Page 155 and 156: The Health Assessment Questionnaire
Page 157 and 158: Cochrane Library (CENTRAL) 2005 Iss
Page 159 and 160: Appendix 3 © Queen’s Printer and
Page 161: TABLE 69 Studies excluded from clin
Page 165 and 166: Etanercept © Queen’s Printer and
Page 167 and 168: Infliximab Infliximab alone versus
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Page 171: Ovid MEDLINE(R) 1966 to February we
Page 175: Ovid MEDLINE(R) 1999 to March week
Page 178 and 179: 162 Appendix 8 TABLE 78 Choi et al.
Page 180 and 181: 164 Appendix 8 TABLE 80 Kobelt et a
Page 182 and 183: 166 Appendix 8 TABLE 81 Welsing et
Page 184 and 185: 168 Appendix 8 TABLE 82 Brennan et
Page 186 and 187: 170 Appendix 8 TABLE 84 Chiou et al
Page 188 and 189: 172 Appendix 8 TABLE 86 Kobelt et a
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Page 193: TABLE 92 Strategy set: infliximab a
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Page 198 and 199: 182 Appendix 10 Variation 2 For thi
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196 Appendix 10 TABLE 119 Variation
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198 Appendix 10 Variation 8 For thi
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206 Appendix 10 Variation 11 In thi
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Additional ongoing/unpublished tria
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232 Health Technology Assessment re
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Members Chair, Professor Tom Walley
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Members Chair, Professor Bruce Camp
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Feedback The HTA Programme and the
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A systematic review of the effectiveness of adalimumab

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