A systematic review of the effectiveness of adalimumab

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66 Effectiveness Review: Infliximab for rheumatoid arthritis 2006 Comparison: 03 Infliximab i.v. licensed dose only (3 mg kg –1 every 8 weeks) + MTX vs Placebo + MTX, end of trial Outcome: 03 ACR70 responder Study or subcategory Infliximab n/N Placebo n/N 01 With concurrent, ongoing MTX START, 111 [22 weeks] (+) ATTRACT, 132,133 [54 weeks] (+) Subtotal (95% CI) Total events: 57 (infliximab), 18 (placebo) Test for heterogeneity: 2 = 0.07, df = 1 (p = 0.79), I2 48/343 16/341 9/86 2/88 429 429 = 0% Test for overall effect: z = 4.77 (p < 0.00001) 02 With concurrent, newly initiated MTX (infliximab + MTX vs MTX) Quinn, 2005, 141 [54 weeks] (+) ASPIRE, 135 [54 weeks] (+) Subtotal (95% CI) Total events: 121 (infliximab), 61 (placebo) Test for heterogeneity: 2 = 1.90, df = 1 (p = 0.17), I2 7/10 3/10 114/351 58/274 361 284 = 47.5% Test for overall effect: z = 3.53 (p = 0.0004) Total (95% CI) Total events: 178 (infliximab), 79 (placebo) Test for heterogeneity: 2 = 2.77, df = 3 (p = 0.43), I2 790 713 = 0% Test for overall effect: z = 5.68 (p < 0.00001) FIGURE 40 ACR70 RD: infliximab licensed dose versus placebo (with concurrent MTX) RD (fixed) 95% CI –1 –0.5 0 0.5 1 Favours placebo Favours infliximab Review: Infliximab for rheumatoid arthritis 2006 Comparison: 03 Infliximab i.v. licensed dose only (3 mg kg –1 every 8 weeks) + MTX vs Placebo + MTX, end of trial Outcome: 12 HAQ, mean change from baseline Study or subcategory 01 With concurrent, ongoing MTX START, 111 [22 weeks] (+) ATTRACT, 132,133 [54 weeks] (+) Subtotal (95% CI) N Inflaximab mean (SD) N Test for heterogeneity: 2 = 0.46, df = 1 (p = 0.50), I 2 = 0% Test for overall effect: z = 6.74 (p < 0.00001) 02 With concurrent, newly initiated MTX (infliximab + MTX vs MTX) Quinn, 2005, 141 [54 weeks] (+) ASPIRE, 135 [54 weeks] (+) Subtotal (95% CI) Placebo mean (SD) 337 –0.39 (0.60) 336 –0.11 (0.51) 77 –0.50 (0.66 68 –0.30 (0.66) 414 404 10 –1.09 (0.65) 10 –0.22 (0.72) 311 –0.83 (0.71) 232 –0.72 (0.72) 321 242 Test for heterogeneity: 2 = 5.90, df = 1 (p = 0.02), I 2 = 83.0% Test for overall effect: z = 2.30 (p = 0.02) Total (95% CI) Test for heterogeneity: 2 = 9.52, df = 3 (p = 0.02), I2 735 646 = 68.5% Test for overall effect: z = 6.89 (p < 0.00001) WMD (fixed) 95% CI –1 –0.5 0 0.5 1 Favours infliximab Favours placebo FIGURE 41 HAQ change: infliximab licensed dose only versus placebo (with concurrent MTX) Weight % 45.80 11.65 57.45 1.34 41.21 42.55 100.00 Weight % 60.60 9.26 69.85 1.19 28.96 30.15 100.00 RD (fixed) 95% CI 0.09 (0.05 to 0.14) 0.08 (0.01 to 0.15) 0.09 (0.05 to 0.13) 0.40 (0.00 to 0.80) 0.11 (0.04 to 0.18) 0.12 (0.05 to 0.19) 0.10 (0.07 to 0.14) WMD (fixed) 95% CI –0.20 (–0.36 to –0.20) –0.20 (–0.42 to 0.02) –0.27 (–0.35 to –0.19) –0.87 (–1.47 to –0.27) –0.11 (–0.23 to 0.01) –0.14 (–0.26 to –0.02) –0.23 (–0.30 to –0.16)
Review: Infliximab for rheumatoid arthritis 2006 Comparison: 03 Infliximab i.v. licensed dose only (3 mg kg –1 every 8 weeks) + MTX vs Placebo + MTX, end of trial Outcome: 07 SAEs Study or subcategory Infliximab n/N Placebo n/N 01 With concurrent, ongoing MTX START, 111 [22 weeks] (+) ATTRACT, 132,133 [54 weeks] (+) Subtotal (95% CI) Total events: 38 (infliximab), 45 (placebo) Test for heterogeneity: 2 = 2.11, df = 1 (p = 0.15), I2 28/360 27/361 10/88 18/86 448 447 = 52.7% Test for overall effect: z = 0.84 (p = 0.40) 02 With concurrent, newly initiated MTX (infliximab + MTX vs MTX) ASPIRE, 135 [54 weeks] (+) Subtotal (95% CI) Total events: 52 (infliximab), 32 (placebo) Test for heterogeneity: NA Test for overall effect: z = 1.14 (p = 0.25) 52/372 32/291 372 291 Total (95% CI) Total events: 90 (infliximab), 77 (placebo) Test for heterogeneity: 2 = 4.09, df = 2 (p = 0.13), I2 820 738 = 51.1% Test for overall effect: z = 0.21 (p = 0.84) FIGURE 42 SAE RR: infliximab licensed dose versus placebo (with concurrent MTX) © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Health Technology Assessment 2006; Vol. 10: No. 42 RR (fixed) 95% CI 0.1 0.2 0.5 1 2 5 10 Favours infliximab Favours placebo Review: Infliximab for rheumatoid arthritis 2006 Comparison: 03 Infliximab i.v. licensed dose only (3 mg kg –1 every 8 weeks) + MTX vs Placebo + MTX, end of trial Outcome: 07 SAEs Study or subcategory Infliximab n/N Placebo n/N 01 With concurrent, ongoing MTX START, 111 [22 weeks] (+) ATTRACT, 132,133 [54 weeks] (+) Subtotal (95% CI) Total events: 38 (infliximab), 45 (placebo) Test for heterogeneity: 2 = 3.00, df = 1 (p = 0.08), I2 28/360 27/361 10/88 18/86 448 447 = 66.7% Test for overall effect: z = 0.84 (p = 0.40) 02 With concurrent, newly initiated MTX (infliximab + MTX vs MTX) ASPIRE, 135 [54 weeks] (+) Subtotal (95% CI) Total events: 52 (infliximab), 32 (placebo) Test for heterogeneity: NA Test for overall effect: z = 1.16 (p = 0.25) 52/372 32/291 372 291 Total (95% CI) Total events: 90 (infliximab), 77 (placebo) Test for heterogeneity: 2 = 4.26, df = 2 (p = 0.12), I2 820 738 = 53.0% Test for overall effect: z = 0.21 (p = 0.84) FIGURE 43 SAE RD: infliximab licensed dose versus placebo (with concurrent MTX) RD (fixed) 95% CI –1 –0.5 0 0.5 1 Favours infliximab Favours placebo Weight % 33.25 22.46 55.71 44.29 44.29 100.00 Weight % 46.57 11.24 57.81 42.19 42.19 100.00 RR (fixed) 95% CI 1.04 (0.63 to 1.73) 0.54 (0.27 to 1.11) 0.84 (0.56 to 1.26) 1.27 (0.84 to 1.92) 1.27 (0.84 to 1.92) 1.03 (0.77 to 1.38) RD (fixed) 95% CI 0.00 (–0.04 to 0.04) –0.10 (–0.20 to 0.01) –0.02 (–0.05 to 0.02) 0.03 (–0.02 to 0.08) 0.03 (–0.02 to 0.08) 0.00 (–0.03 to 0.03) 67
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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
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 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
Page 78 and 79: 62 Effectiveness significant advant
Page 80 and 81: 64 Effectiveness Review: Infliximab
Page 84 and 85: 68 Effectiveness FIGURE 44 Malignan
Page 86 and 87: 70 TABLE 17 Effectiveness Summary o
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
Page 95 and 96: TABLE 23 Published economic analyse
Page 97 and 98: TABLE 25 Treatment sequences: adali
Page 99 and 100: management of RA, i.e. 1st and 2nd
Page 101 and 102: To estimate the long-term consequen
Page 103 and 104: TABLE 32 TNF inhibitors as last act
Page 105 and 106: TABLE 34 Basic structure of the mod
Page 107 and 108: een quit on grounds of toxicity, ad
Page 109 and 110: TABLE 39 Strategy set: adalimumab a
Page 111 and 112: TABLE 43 Beta distributions for HAQ
Page 113 and 114: TABLE 44 Early cessation of DMARDs:
Page 115 and 116: TABLE 46 Unit costs for tests and v
Page 117 and 118: following properties, according to
Page 119 and 120: TABLE 52 Base case: TNF inhibitors
Page 121 and 122: TABLE 54 Base case: TNF inhibitors
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
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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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Volume 1, 1997 No. 1 Home parentera
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No. 3 Screening for sickle cell dis
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No. 25 A rapid and systematic revie
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No. 11 First and second trimester a
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No. 23 Clinical effectiveness and c
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No. 28 Outcomes of electrically sti
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No. 28 Adefovir dipivoxil and pegyl
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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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