A systematic review of the effectiveness of adalimumab

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148 Appendix 4 TABLE 71 Meta-analyses: adalimumab (s.c. or i.v. all doses) versus placebo (with or without ongoing conventional DMARDs), end of trial Comparison or outcome Studies N included Statistical method Effect size (95% CI) in analysis ACR20 responder 8112–119 ACR50 responder 8112–119 ACR70 responder 5112–115,119 RD ACR20 responder 8112–119 RD ACR50 responder 8112–119 RD ACR70 responder 5112–115,119 SJC, mean change from baseline 8112–119 Patient’s global assessment, mean change 8112–119 from baseline HAQ, mean change from baseline 8 112–119 DAS28, mean change from baseline 2113,119 Modified van de Heijde–Sharp score, 1114 mean change from baseline Withdrawal for any reasons 8 112–119 Withdrawal due to lack of efficacy 8112–119 Withdrawal due to adverse events 8112–119 Death 8112–119 SAEs 8112–119 Malignancy: all 6112–115,118,119 Malignancy: skin cancer excluding 6112–115,118,119 melanoma Malignancy: all cancer excluding 6 112–115,118,119 non-melanoma skin cancer Serious infection 7 112–115,117–119 Any infection 4 112–115 * Statistically significant result (p < 0.05). 2581 RR (fixed) 2.27 (1.99 to 2.60)* 2581 RR (fixed) 3.78 (2.96 to 4.83)* 2347 RR (fixed) 5.09 (3.36 to 7.71)* 2581 RD (fixed) 0.30 (0.27 to 0.34)* 2581 RD (random) 0.23 (0.18 to 0.28)* 2347 RD (fixed) 0.13 (0.11 to 0.15)* 2578 WMD (fixed) –5.37 (–6.11 to –4.64)* 2577 WMD (fixed) –1.74 (–1.97 to –1.51)* 2577 WMD (fixed) –0.31 (–0.35 to –0.27)* 827 WMD (fixed) –1.23 (–1.44 to –1.02)* 551 WMD (fixed) –2.20 (–3.33 to –1.07)* 2588 RR (random) 0.62 (0.46 to 0.84)* 2588 RR (fixed) 0.39 (0.32 to 0.47)* 2588 RR (fixed) 1.44 (0.93 to 2.24) 2588 RR (fixed) 1.53 (0.44 to 5.26) 2588 RR (fixed) 1.06 (0.80 to 1.40) 2414 RR (fixed) 2.84 (0.90 to 8.97) 2414 RR (fixed) 2.00 (0.55 to 7.24) 2414 RR (fixed) 2.23 (0.50 to 9.91) 2468 RR (fixed) 2.27 (1.00 to 5.18) 2070 RR (fixed) 1.19 (1.08 to 1.31)*
Etanercept © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Health Technology Assessment 2006; Vol. 10: No. 42 Etanercept versus sulfasalazine in sulfasalazine partial responders/non-responders TABLE 72 Summary of 24-week results from Codreanu: 103 etanercept (25 mg s.c. twice weekly) versus sulfasalazine in sulfasalazine partial responders/non-responders Comparison or outcome N included Statistical method Effect size (95% CI) in analysis ACR20 responder 153 RR (fixed) 2.64 (1.67 to 4.17)* ACR50 responder 153 RR (fixed) 3.33 (1.62 to 6.82)* ACR70 responder 153 RR (fixed) 10.68 (1.48 to 76.99)* RD ACR20 responder 153 RD (fixed) 0.46 (0.31 to 0.61)* RD ACR50 responder 153 RD (fixed) 0.33 (0.19 to 0.46)* RD ACR70 responder 153 RD (fixed) 0.19 (0.11 to 0.28)* SJC, end of study result 153 WMD (fixed) –5.90 (–9.54 to –2.26)* Patient’s global assessment, end of study result 153 WMD (fixed) –2.40 (–2.94 to –1.86)* HAQ, end of study result 153 WMD (fixed) –0.40 (–0.58 to –0.22)* DAS, end of study result 153 WMD (fixed) –1.50 (–1.87 to –1.13)* Modified van de Heijde–Sharp score, mean change from baseline 0 Not estimable Not assessed Withdrawal for any reasons 153 RR (fixed) 0.26 (0.12 to 0.54)* Withdrawal due to lack of efficacy 153 RR (fixed) 0.04 (0.01 to 0.30)* Withdrawal due to adverse events 153 RR (fixed) 0.97 (0.25 to 3.72) Death 153 RR (fixed) 1.47 (0.06 to 35.48) SAEs 153 RR (fixed) 2.43 (0.29 to 20.23) Malignancy: all 153 RR (fixed) 2.45 (0.12 to 50.13) Malignancy: skin cancer excluding melanoma 153 RR (fixed) 1.47 (0.06 to 35.48) Malignancy: all cancer excluding non-melanoma skin cancer 153 RR (fixed) 1.47 (0.06 to 35.48) Serious infection 153 RR (fixed) 2.45 (0.12 to 50.13) Any infection 153 RR (fixed) 1.76 (1.05 to 2.93)* * Statistically significant result (p < 0.05). 149
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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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Page 115 and 116: TABLE 46 Unit costs for tests and v
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Page 119 and 120: TABLE 52 Base case: TNF inhibitors
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Page 135 and 136: inhibitors, although the incrementa
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Page 139: Adalimumab, etanercept and inflixim
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Page 145 and 146: 46. Young A, Dixey J, Cox N, Davies
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Volume 1, 1997 No. 1 Home parentera
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A systematic review of the effectiveness of adalimumab

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