A systematic review of the effectiveness of adalimumab

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20 TABLE 1 Description of included RCTs and baseline patient characteristics: adalimumab (cont’d) Effectiveness No. of Mean Mean Mean On On Mean patients age disease no. of steroids NSAIDs baseline (years) duration previous (%) (%) HAQ (years) DMARDs score Study and description Interventions a DE010 Rau et al., 2004 117 Placebo s.c. and i.v. (one dose) + MTX 18 54 12 3.5 72 94 1.38 Netherlands and Germany, four centres, (7.5–25 mg per week, mean 14 mg per week) double-blind Adalimumab 1 mg kg –1 i.v. (one dose) + MTX 18 52 11 3.4 72 100 1.32 Duration of treatment and follow-up: (7.5–25 mg per week, mean 18 mg per week) 4 weeks e Adalimumab 1 mg kg –1 s.c. (one dose) + MTX 18 53 11 3.3 83 89 1.33 (7.5–25 mg per week, mean 16 mg per week) DE011 van de Putte et al., 2004 113 Placebo s.c. weekly 110 54 12 3.6 67 84 1.88 Europe, Canada and Australia, 52 centres, Adalimumab 20 mg s.c. every other week 106 53 9 3.7 70 81 1.88 double-blind Adalimumab 20 mg s.c. weekly 112 54 11 3.6 68 75 1.88 Duration of treatment and follow-up: Adalimumab 40 mg s.c. every other week 113 53 11 3.8 68 82 1.83 26 weeks f Adalimumab 40 mg s.c. weekly 103 52 12 3.8 82 77 1.84 DE013, PREMIER Breedveld et al., 2006102,109 MTX (7.5–20 mg per week) weekly g 257 52 0.8 0.4 35 NR 1.48 North America, Europe and Australia, Adalimumab 40 mg s.c. every other week g 274 52 0.7 0.4 37 1.63 multicentre, double-blind Duration of treatment and follow-up: 2 years Adalimumab 40 mg s.c. every other week + MTX 268 52 0.7 0.4 36 1.47 (7.5–20 mg per week) weekly g DE019 Keystone et al., 2004 114 USA and Canada, 89 centres, double-blind Placebo s.c. + MTX (12.5–25 mg per week, 200 56 11 2.4 [Commercial- NR 1.48 Duration of treatment and follow-up: mean 17 mg per week) in-confidence 52 weeks Adalimumab 20 mg s.c. weekly + MTX 212 57 11 2.4 information 1.44 (12.5–25 mg per week, mean 16 mg per week) removed] Adalimumab 40 mg s.c. every other week + 207 56 11 2.4 1.45 placebo s.c. on alternate weeks + MTX (12.5–25 mg per week, mean 17 mg per week) continued
TABLE 1 Description of included RCTs and baseline patient characteristics: adalimumab (cont’d) No. of Mean Mean Mean On On Mean patients age disease no. of steroids NSAIDs baseline (years) duration previous (%) (%) HAQ (years) DMARDs score Study and description Interventions a DE 031, STAR Furst et al., 2003 115 Placebo s.c. + baseline standard antirheumatic 318 56 12 ≥ 2.0 54 64 1.43 USA and Canada, 69 centres, double-blind therapy Duration of treatment and follow-up: Adalimumab 40 mg s.c. every other week + 318 55 9 ≥ 2.1 51 62 1.37 24 weeks baseline standard antirheumatic therapy a Some of the groups receiving active treatment also received matching placebo (where necessary) to maintain blinding. These placebo injections are not listed. b Open-label, continuation study (DE003) in which patients in the placebo group were switched to receive adalimumab is not included in current review. c Patients in the placebo group were switched to adalimumab 40 mg at week 12. Subsequent blinded and open-label continuation studies without placebo control are not included in the current review. d Patients received the first dose at baseline and the second dose after 4 weeks or on loss of response. Once the second dose was administered, the patient was considered to have completed the study and had the option to participate in a continuation study. This open-label continuation study (DE005X) in which the placebo group was switched to receive adalimumab is not included in the current review. e A second double-blinded injection of randomised drug was given between 4 weeks and 3 months after the first injection according to the patient’s response. Follow-up beyond 4 weeks and further 2.5-year open-label continuation study are not included in the current review. f Further open-label extension is not included in the current review. g Oral medication (MTX) started at 7.5 mg per week for 4 weeks. If any swollen joints remained, it could be escalated to a maximum of 20 mg per week by week 26. The dosing frequency of the parenteral medication (adalimumab) could be increased to every week on or after week 16, in patients who failed to respond or lost their response (ACR20) after escalating the oral medication. MTX, methotrexate; NR, not reported. © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Health Technology Assessment 2006; Vol. 10: No. 42 21
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 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 74 and 75: 58 TABLE 13 Quality of included RCT
Page 76 and 77: 60 Effectiveness per week and escal
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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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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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A systematic review of the effectiveness of adalimumab

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