A systematic review of the effectiveness of adalimumab

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58 TABLE 13 Quality of included RCTs: infliximab 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) Placebo: 24 Yes Unclear Yes Yes Yes No No (only one patient Yes Infliximab: 49 withdrew and was replaced) Elliott, 1994 136 Placebo: 14 Unclear Yes Yes Unclear Yes Yes (HAQ) Yes Infliximab: 87 Placebo: 43% Unclear (yes Infliximab: 83% for Paulus response) Maini, 1998 137 Kavanaugh, Placebo: 7 Yes Yes Yes Unclear Unclear NA No No (except 2000 138 Infliximab: 21 (sample size Placebo: 100% ACR too small) Infliximab:100% responses) ATTRACT Up to week 54: Placebo: 88 Yes Yes Yes Yes Yes No Yes Yes (except Maini, 1999; 132 Infliximab: 340 Placebo: 50% radiographic Lipsky, 2000 133 Infliximab: 79% and safety outcomes) Week 102: Placebo: 28 Partiallya NA Partiallya Partiallya Partiallya (61% Yes Yes (except Maini, 2004; 134 Infliximab: 231 randomised Placebo: 16% SF-36, clinical study patients entering Infliximab: 59% radiographic report extension) and safety outcomes) START: Placebo: 363 Yes Yes Yes Yes Yes No No Yes Westhovens, Infliximab: 721 Placebo: 94% 2006; 111 Infliximab: 92% clinical study report ASPIRE: St Clair, Placebo: 291 Yes Yes Yes Yes Yes No No No b 2004; 135 Infliximab: 749 Placebo: 82% clinical study Infliximab: 86% report continued
TABLE 13 Quality of included RCTs: infliximab (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) Taylor, 2004140 Placebo: 12 Unclear Yes Yes Yes Yes No No (one patient No Infliximab: 12 withdrew, but did not state which arm) Durez, 2004 139 Methylprednisolone: 15 Unclear Unclear No Unclear Yes No Unclear Unclear Infliximab: 12 Quinn, 2005141 Placebo: 10 Yes Unclear Yes Yes Yes No No Yes Infliximab: 10 Placebo: 10/10 Infliximab: 9/10 a Only 28 (32%) of the those allocated MTX in year 1 continued compared with 231 (68%) of those on infliximab plus MTX. For ethical reasons the study was unblinded at week 54. Unblinding occurred in 12% of patients before completion of all HAQ evaluations. Ninety-four of the 259 patients had a gap of more than 8 weeks between treatments because of the timing of the protocol amendment. The mean length of time for which infliximab was suspended was 19.4 weeks. b –1 Before unblinding, 45 patients at two study sites were excluded from the efficacy analysis (16 in the MTX–placebo group, 14 in the MTX–3 mg kg infliximab group and 15 in the © Queen’s Printer and Controller of HMSO 2006. All rights reserved. MTX–6 mg kg –1 infliximab group) because their study data could not be verified with source documents. Health Technology Assessment 2006; Vol. 10: No. 42 59
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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
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 38 and 39: 22 TABLE 2 Quality of included RCTs
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 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
Page 89 and 90: Summary of review of existing econo
Page 91 and 92: TABLE 20 Summary of published ICERs
Page 93 and 94: TABLE 21 Published etanercept econo
Page 95 and 96: TABLE 23 Published economic analyse
Page 97 and 98: TABLE 25 Treatment sequences: adali
Page 99 and 100: management of RA, i.e. 1st and 2nd
Page 101 and 102: To estimate the long-term consequen
Page 103 and 104: TABLE 32 TNF inhibitors as last act
Page 105 and 106: TABLE 34 Basic structure of the mod
Page 107 and 108: een quit on grounds of toxicity, ad
Page 109 and 110: 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
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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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Volume 1, 1997 No. 1 Home parentera
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No. 3 Screening for sickle cell dis
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No. 25 A rapid and systematic revie
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No. 11 First and second trimester a
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246 Health Technology Assessment Pr
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