A systematic review of the effectiveness of adalimumab
A systematic review of the effectiveness of adalimumab A systematic review of the effectiveness of adalimumab
22 TABLE 2 Quality of included RCTs: adalimumab 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) DE001 den Broeder, Placebo: 31 Unclear Unclear Yes Yes Unclear No No Yes 2002 116 Adalimumab: 89 Placebo: 100% Adalimumab: 99% DE005 Weisman, Placebo: 15 Yes Yes Yes Yes Unclear NA No Yes 2003 118 Adalimumab: 45 (sample size Placebo: 100% too small) Adalimumab: 100% DE007 van de Putte, Placebo: 70 Unclear Unclear Unclear Unclear Unclear No No Yes 2003 119 Adalimumab: 214 Placebo: 97% Adalimumab: 95% DE009 ARMADA: Placebo: 62 Yes Yes Yes Yes Yes No [Commercial-in- Yes Weinblatt, Adalimumab: 209 confidence 2003 112 information removed] Placebo: 18 Unclear Unclear Yes Yes Unclear No No Yes Adalimumab: 36 Placebo: 100% Adalimumab: 97% DE010 Rau, 2004 117 DE011 van de Putte, Placebo: 110 Yes Yes Yes Yes Yes No Yes Yes 2004 113 Adalimumab: 434 Placebo: 44% Adalimumab: 73% continued
TABLE 2 Quality of included RCTs: adalimumab (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) DE013 PREMIER: MTX: 257 Yes Yes Yes Yes Yes No Yes Yes Breedveld, Adalimumab: 274 MTX: 66% 2006 102,109 Combination: 268 Adalimumab: 61% Combination: 76% DE019 Keystone, Placebo: 200 Unclear Yes Yes Yes Yes No Yes Yes (except 2004 114 Adalimumab: 419 Placebo: 70% radiographic Adalimumab: 78% outcomes) DE031 STAR: Placebo: 318 Yes Yes Yes Yes Yes No No Yes Furst, 2003 115 Adalimumab: 318 Placebo: 91% Adalimumab: 91% © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Health Technology Assessment 2006; Vol. 10: No. 42 NA, not applicable. 23
- 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 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 60 and 61: 44 Effectiveness Review: Etanercept
- Page 62 and 63: 46 Effectiveness Review: Etanercept
- Page 64 and 65: 48 Effectiveness Review: Etanercept
- Page 66 and 67: 50 Effectiveness Review: Etanercept
- Page 68 and 69: 52 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
- 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
TABLE 2 Quality <strong>of</strong> included RCTs: <strong>adalimumab</strong> (cont’d)<br />
Study Sample size Truly random Adequate Blinding Important Important Use <strong>of</strong> ITT<br />
allocation/ allocation differences in differences in analysis<br />
remain on concealment Participants Investigators Assessors baseline completion rates<br />
randomised characteristics between groups<br />
treatment between (% randomised<br />
groups (item) patients completed)<br />
DE013<br />
PREMIER: MTX: 257 Yes Yes Yes Yes Yes No Yes Yes<br />
Breedveld, Adalimumab: 274 MTX: 66%<br />
2006 102,109<br />
Combination: 268 Adalimumab: 61%<br />
Combination: 76%<br />
DE019<br />
Keystone, Placebo: 200 Unclear Yes Yes Yes Yes No Yes Yes (except<br />
2004 114<br />
Adalimumab: 419 Placebo: 70% radiographic<br />
Adalimumab: 78% outcomes)<br />
DE031<br />
STAR: Placebo: 318 Yes Yes Yes Yes Yes No No Yes<br />
Furst, 2003 115<br />
Adalimumab: 318 Placebo: 91%<br />
Adalimumab: 91%<br />
© Queen’s Printer and Controller <strong>of</strong> HMSO 2006. All rights reserved.<br />
Health Technology Assessment 2006; Vol. 10: No. 42<br />
NA, not applicable.<br />
23
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