A systematic review of the effectiveness of adalimumab

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154 Appendix 4 Infliximab plus MTX versus MTX TABLE 77 Meta-analyses: combination of infliximab (i.v. all doses) plus MTX versus MTX alone in MTX-naïve patients, end of trial Comparison or outcome Studies Participants Statistical method Effect size (95% CI) ACR20 responder 2135,141 1000 RR (fixed) 1.20 (1.07 to 1.36)* ACR50 responder 2135,141 1000 RR (fixed) 1.51 (1.26 to 1.82)* ACR70 responder 2135,141 1000 RR (fixed) 1.67 (1.31 to 2.13)* RD ACR20 responder 2135,141 1000 RD (fixed) 0.11 (0.04 to 0.18)* RD ACR50 responder 2135,141 1000 RD (fixed) 0.16 (0.10 to 0.23)* RD ACR70 responder 2135,141 1000 RD (fixed) 0.14 (0.08 to 0.20)* SJC, mean change from baseline 1135 846 WMD (fixed) –3.00 (–4.76 to –1.24)* Patient’s global assessment, mean change 1135 from baseline 842 WMD (fixed) –0.70(–1.18 to –0.22)* HAQ, mean change from baseline 2 135,141 1016 WMD (fixed) –0.17 (–0.28 to –0.07)* DAS28, end of study result 2135,141 838 WMD (fixed) –0.82 (–1.08 to –0.55)* Modified van de Heijde–Sharp score, 1135 mean change from baseline 1004 WMD (fixed) –3.23 (–4.43 to –2.03)* Withdrawal for any reasons 1 135 1040 RR (fixed) 0.93 (0.71 to 1.21) Withdrawal due to lack of efficacy 1135 1040 RR (fixed) 0.28 (0.16 to 0.49)* Withdrawal due to adverse events 2135,141 1060 RR (fixed) 3.02 (1.55 to 5.88)* Death 1135 1040 RR (fixed) 0.39 (0.05 to 2.75) SAEs 1135 1040 RR (fixed) 1.25 (0.86 to 1.82) Malignancy: all 1135 1040 RR (fixed) [Commercial-inconfidence information removed] Malignancy: skin cancer excluding melanoma 1 135 1040 RR (fixed) [Commercial-inconfidence information removed] Malignancy: all cancer excluding 1 135 non-melanoma skin cancer 1040 RR (fixed) 3.50 (0.19 to 64.88) Serious infection 1 135 1040 RR (fixed) 2.59 (1.11 to 6.04)* Any infection 1135 1040 RR (fixed) [Commercial-inconfidence information removed]* * Statistically significant result (p < 0.05).
Ovid MEDLINE(R) 1966 to February week 3 2005 1 arthritis rheumatoid/ 2 tum?r necrosis factor.mp. 3 exp receptors tumor necrosis factor/ 4 anti tnf.mp. 5 infliximab.mp. 6 remicade.mp. 7 enbrel.mp. 8 etanercept.mp. 9 or/2-8 10 1 and 9 11 economics/ 12 exp "costs and cost analysis"/ 13 cost of illness/ 14 exp health care costs/ 15 economic value of life/ 16 exp economics medical/ 17 exp economics hospital/ 18 economics pharmaceutical/ 19 exp "fees and charges"/ 20 (econom$ or cost or costs or costly or costing or price or pricing or pharmacoeconomic$).tw. 21 (expenditure$ not energy).tw. 22 (value adj1 money).tw. 23 budget$.tw. 24 or/11-23 25 10 and 24 26 limit 25 to yr=2001-2005 27 adalimumab.mp. 28 humira.mp. 29 or/27-28 30 29 and 24 31 26 or 30 32 quality of life/ 33 life style/ 34 health status/ 35 health status indicators/ 36 value of life/ 37 quality of wellbeing.tw. 38 or/32-37 39 1 and 38 40 limit 39 to yr=2001-2005 41 31 or 40 EMBASE (Ovid) 1980 to week 9 2005 1 arthritis rheumatoid/ Appendix 5 2 tum?r necrosis factor.mp. 3 exp receptors tumor necrosis factor/ 4 anti tnf.mp. 5 infliximab.mp. 6 remicade.mp. 7 enbrel.mp. 8 etanercept.mp. 9 or/2-8 10 1 and 9 11 cost benefit analysis/ 12 cost effectiveness analysis/ 13 cost minimization analysis/ 14 cost utility analysis/ 15 economic evaluation/ 16 (cost or costs or costed or costly or costing).tw. 17 (economic$ or pharmacoeconomic$ or price$ or pricing).tw. 18 (technology adj assessment$).tw. 19 or/11-18 20 10 and 19 21 limit 20 to yr=2001-2005 22 adalimumab.mp. 23 humira.mp. 24 or/22-23 25 24 and 19 26 21 or 25 27 exp quality of life/ 28 health status/ 29 27 or 28 30 1 and 29 31 limit 30 to yr=2001 - 2005 Cochrane Library (NHSEED) 2005 Issue 1 See search strategy for Cochrane Library under Clinical Effectiveness, page 141. HEED Health Technology Assessment 2006; Vol. 10: No. 42 Searches: economic evaluations © Queen’s Printer and Controller of HMSO 2006. All rights reserved. February 2005 A series of searches were done using the following terms: anti tnf; infliximab; remicade, enbrel, etanercept, adalimumab, humira and references which included rheumatoid arthritis were selected. 155
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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
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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
Page 119 and 120: TABLE 52 Base case: TNF inhibitors
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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
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Page 164 and 165: 148 Appendix 4 TABLE 71 Meta-analys
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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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246 Health Technology Assessment Pr
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A systematic review of the effectiveness of adalimumab

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