A systematic review of the effectiveness of adalimumab

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36 TABLE 7 Effectiveness Quality of included studies: etanercept (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) Week 52–100110 MTX: 152 Yes NA Yes Yes Yes Unclear Yes Yes Etanercept: 163 MTX: 52% Etanercept + Etanercept: 61% MTX: 188 Etanercept + MTX: 71% Keystone, 2004 129 Placebo: 53 Yes Yes Yes Yes Yes No No Yes Etanercept: 367 Placebo: 94% Etanercept: 95% Placebo: 29 Unclear Unclear Yes Unclear Unclear Unclear Unclear Yes Etanercept: 29 Lan 2004, 130 Baumgartner, Placebo: 269 Yes Yes Yes Yes Yes No Yes Yes 2004 104 Etanercept: 266 Placebo: 72% Etanercept: 86% NA, not applicable.
European Etanercept Investigators Study: Wajdula and colleagues, 2000 126 This double-blind, multicentre RCT compared four etanercept treatment regimens (10 mg s.c. once weekly, 10 mg twice weekly, 25 mg once weekly, 25 mg twice weekly) with placebo. This study was planned to run for 6 months, but the protocol was modified to a 3-month double-blind study after inception for reasons that were unclear. Patients with at least six swollen joints and 12 tender joints, and who had failed to respond to at least one DMARD, were recruited. The primary efficacy endpoints were change from baseline in the number of swollen and painful joints at 3 months. ERA: Bathon and colleagues, 2000; 123 Genovese and colleagues, 2002 124 This multicentre RCT compared etanercept 10 mg s.c. twice weekly or 25 mg s.c. twice weekly with methotrexate. There was a 12-month double-blind phase and a further 12-month open-label phase. Results at 2 years were provided by the manufacturer and are referred to as the end of study results in this review unless otherwise specified. Recruited patients had RA for less than 3 years, at least ten swollen joints and 12 tender joints, and were positive for rheumatoid factor or had at least three bony erosions on radiographs of hands, feet and wrists. Patients who had previously been treated with methotrexate were not eligible. Patients on other DMARDs at recruitment had a 4-week washout before entry. Fifty-nine per cent of patients had never received a DMARD. The primary clinical end-point was ACR-N area under the curve (AUC) during the first 6 months, and the primary radiological end-point was the change in modified Sharp scores over 12 months. This trial was originally designed to show the superiority of etanercept over methotrexate in preventing joint damage. However, this goal was changed to that of showing equivalence of etanercept and methotrexate. TEMPO: Klareskog and colleagues, 2004; 127 van der Heijde and colleagues, 2005 128 2006 110 This multicentre trial consisted of two periods. Period one was a 52-week double-blind RCT, followed by a double-blind extension of variable duration during which patients remained on randomised treatment. Two-year results were provided by the manufacturer and are referred to as the end of study results unless otherwise specified. TEMPO compared methotrexate alone (7.5 mg per week escalated to 20 mg per week if any tender or swollen joints remained), etanercept © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Health Technology Assessment 2006; Vol. 10: No. 42 alone (25 mg s.c. twice weekly), and a combination of the two. RA patients who had previously received methotrexate were allowed to enter (at the discretion of the investigator) provided that methotrexate had not been used within 6 months of study entry, had not been discontinued for lack of efficacy and had not caused toxicity. Patients with disease durations between 6 months and 20 years who had failed at least one DMARD other than methotrexate were recruited. At least ten swollen joints and 12 tender joints were required. The primary clinical end-point was the 24-week AUC of the ACR-N. The 52-week change from baseline in van der Heijde modified total Sharp score was a conditional primary end-point. TEMPO appears to be the only trial in established RA (not early RA) that genuinely compares a conventional DMARD with a TNF inhibitor. However, around 42% of patients in each arm of this trial had previously tried methotrexate. It is not at all clear why these individuals discontinued methotrexate in the face of active disease if, as stated in the entry criteria, the drug was not ineffective or toxic. Codreanu and colleagues, 2003 103 The study was only published as an abstract at the time of review, but a clinical study report was made available to the authors. This multicentre trial consisted of two periods. Period one was a 24week double-blind RCT, which was followed by a double-blind extension with patients participating between 60 to 100 weeks. The 24-week results were provided by the manufacturer and are referred to as the end of study results. The trial compared sulfasalazine alone (2–3 g per day), etanercept alone (25 mg s.c. twice weekly) and the combination of both in RA patients who were not adequately controlled while having received sulfasalazine for at least 4 months. The addition of other DMARDs was not permitted during the study. Patients with disease duration less than 20 years, with at least six swollen joints and ten tender joints were recruited. The primary endpoint was ACR20 response at 24 weeks. Lan and colleagues, 2004 130 This single-centre, 12-week RCT compared etanercept (25 mg s.c. twice weekly) and placebo in patients who had been receiving stable doses (12.5–20 mg per week) of methotrexate for at least 4 weeks. Patients with duration of RA longer than 1 year, with at least six swollen joints and six tender joints despite methotrexate treatment were recruited. The baseline HAQ score of the patients in this trial (average 1.1) was better than in other 37
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 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 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
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Page 82 and 83: 66 Effectiveness Review: Infliximab
Page 84 and 85: 68 Effectiveness FIGURE 44 Malignan
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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
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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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A systematic review of the effectiveness of adalimumab

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