A systematic review of the effectiveness of adalimumab

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22 TABLE 2 Quality of included RCTs: adalimumab Effectiveness Study Sample size Truly random Adequate Blinding Important Important Use of ITT allocation/ allocation differences in differences in analysis remain on concealment Participants Investigators Assessors baseline completion rates randomised characteristics between groups treatment between (% randomised groups (item) patients completed) DE001 den Broeder, Placebo: 31 Unclear Unclear Yes Yes Unclear No No Yes 2002 116 Adalimumab: 89 Placebo: 100% Adalimumab: 99% DE005 Weisman, Placebo: 15 Yes Yes Yes Yes Unclear NA No Yes 2003 118 Adalimumab: 45 (sample size Placebo: 100% too small) Adalimumab: 100% DE007 van de Putte, Placebo: 70 Unclear Unclear Unclear Unclear Unclear No No Yes 2003 119 Adalimumab: 214 Placebo: 97% Adalimumab: 95% DE009 ARMADA: Placebo: 62 Yes Yes Yes Yes Yes No [Commercial-in- Yes Weinblatt, Adalimumab: 209 confidence 2003 112 information removed] Placebo: 18 Unclear Unclear Yes Yes Unclear No No Yes Adalimumab: 36 Placebo: 100% Adalimumab: 97% DE010 Rau, 2004 117 DE011 van de Putte, Placebo: 110 Yes Yes Yes Yes Yes No Yes Yes 2004 113 Adalimumab: 434 Placebo: 44% Adalimumab: 73% continued
TABLE 2 Quality of included RCTs: adalimumab (cont’d) Study Sample size Truly random Adequate Blinding Important Important Use of ITT allocation/ allocation differences in differences in analysis remain on concealment Participants Investigators Assessors baseline completion rates randomised characteristics between groups treatment between (% randomised groups (item) patients completed) DE013 PREMIER: MTX: 257 Yes Yes Yes Yes Yes No Yes Yes Breedveld, Adalimumab: 274 MTX: 66% 2006 102,109 Combination: 268 Adalimumab: 61% Combination: 76% DE019 Keystone, Placebo: 200 Unclear Yes Yes Yes Yes No Yes Yes (except 2004 114 Adalimumab: 419 Placebo: 70% radiographic Adalimumab: 78% outcomes) DE031 STAR: Placebo: 318 Yes Yes Yes Yes Yes No No Yes Furst, 2003 115 Adalimumab: 318 Placebo: 91% Adalimumab: 91% © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Health Technology Assessment 2006; Vol. 10: No. 42 NA, not applicable. 23
Page 1 and 2: A systematic review of the effectiv
Page 3 and 4: A systematic review of the effectiv
Page 5 and 6: Objectives: This report reviews the
Page 7: Glossary and list of abbreviations
Page 10 and 11: viii Glossary and list of abbreviat
Page 13 and 14: Background Rheumatoid arthritis (RA
Page 15: increased risk of serious infection
Page 19 and 20: Summary RA is a common, chronic, in
Page 21 and 22: (IL-2) and interleukin-6 (IL-6), pr
Page 23 and 24: Assessment of response to DMARDs Re
Page 25 and 26: combination with methotrexate or al
Page 27: disease between clinic appointments
Page 30 and 31: 14 Effectiveness in juvenile arthri
Page 32 and 33: 16 Effectiveness adalimumab plus me
Page 34 and 35: 18 Effectiveness Monoclonal Antibod
Page 36 and 37: 20 TABLE 1 Description of included
Page 40 and 41: 24 Effectiveness change in modified
Page 42 and 43: 26 Effectiveness TABLE 4 Meta-analy
Page 44 and 45: 28 Effectiveness Review: Adalimumab
Page 46 and 47: 30 Effectiveness Review: Adalimumab
Page 48 and 49: 32 TABLE 6 Effectiveness Descriptio
Page 50 and 51: 34 TABLE 6 Effectiveness Descriptio
Page 52 and 53: 36 TABLE 7 Effectiveness Quality of
Page 54 and 55: 38 Effectiveness etanercept trials.
Page 56 and 57: 40 Effectiveness TABLE 9 Summary of
Page 58 and 59: 42 Effectiveness Review: Etanercept
Page 70 and 71: 54 Effectiveness TABLE 11 Summary o
Page 72 and 73: 56 TABLE 12 Description of included
Page 74 and 75: 58 TABLE 13 Quality of included RCT
Page 76 and 77: 60 Effectiveness per week and escal
Page 78 and 79: 62 Effectiveness significant advant
Page 80 and 81: 64 Effectiveness Review: Infliximab
Page 82 and 83: 66 Effectiveness Review: Infliximab
Page 84 and 85: 68 Effectiveness FIGURE 44 Malignan
Page 86 and 87: 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:
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TABLE 46 Unit costs for tests and v
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following properties, according to
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TABLE 52 Base case: TNF inhibitors
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TABLE 54 Base case: TNF inhibitors
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TABLE 59 Third TNF inhibitor follow
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TABLE 65 Sensitivity analyses: TNF
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TABLE 67 Sensitivity analyses: TNF
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The substantial economic impact of
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Summary Effectiveness: principal fi
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inhibitors, although the incrementa
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introduce bias which generally exag
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Adalimumab, etanercept and inflixim
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1. Jobanputra P, Barton P, Bryan S,
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46. Young A, Dixey J, Cox N, Davies
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tumor necrosis factor therapy in th
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arthritis: a 12-week, double-blind,
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171. Geborek P, Crnkic M, Petersson
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216. Schotte H, Willeke P, Mickholz
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The Health Assessment Questionnaire
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Cochrane Library (CENTRAL) 2005 Iss
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Appendix 3 © Queen’s Printer and
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TABLE 69 Studies excluded from clin
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148 Appendix 4 TABLE 71 Meta-analys
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150 Appendix 4 TABLE 73 Meta-analys
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152 Appendix 4 Infliximab versus pl
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154 Appendix 4 Infliximab plus MTX
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Ovid MEDLINE(R) 1966 to February we
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Appendix 8 © Queen’s Printer and
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TABLE 79 Wong et al., 2002 161 © Q
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TABLE 80 Kobelt et al., 2003 162 (c
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TABLE 82 Brennan et al., 2004 160
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TABLE 85 Bansback et al., 2005 166
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176 Appendix 9 TABLE 89 Strategy se
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Extensive sensitivity analysis was
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TABLE 96 Variation 1: TNF inhibitor
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TABLE 99 Variation 2: TNF inhibitor
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TABLE 102 Variation 3: TNF inhibito
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TABLE 132 Variation 10: TNF inhibit
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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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