A systematic review of the effectiveness of adalimumab

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44 Effectiveness Review: Etanercept for rheumatoid arthritis 2006 Comparison: 03 Etanercept s.c. licensed dose only (25 mg twice weekly) vs other active treatment Outcome: 12 HAQ, end of study result Study or subcategory N Etanercept mean (SD) N Control mean (SD) 01 Partial responders to comparator DMARD (SSZ) Codreanu, 2003103 [24 weeks] 103 1.10 (0.60) 50 1.50 (0.50) Subtotal (95% CI) Test for heterogeneity: NA 103 50 Test for overall effect: z = 4.34 (p < 0.0001) 02 Responders or naive to comparator DMARD (MTX) TEMPO 110 [100 weeks] ERA 124 [104 weeks] Subtotal (95% CI) 223 1.00 (0.70) 228 1.10 (0.70) 207 0.70 (0.70) 217 0.80 (0.70) 430 445 Test for heterogeneity: 2 = 8.59E-32, df = 1 (p = 1.00), I 2 = 0% Test for overall effect: z = 2.11 (p = 0.03) Total (95% CI) Test for heterogeneity: 2 = 8.38, df = 2 (p = 0.02), I2 533 495 = 76.1% Test for overall effect: z = 3.86 (p = 0.0001) FIGURE 19 HAQ change: etanercept licensed dose versus other active treatment Review: Etanercept for rheumatoid arthritis 2006 Comparison: 03 Etanercept s.c. licensed dose only (25 mg twice weekly) vs other active treatment Outcome: 07 SAEs Study or subcategory 01 Partial responders to comparator DMARD (SSZ) Codreanu, 2003 103 [24 weeks] Subtotal (95% CI) Total events: 5 (etanercept), 1 (control) Test for heterogeneity: NA Test for overall effect: z = 0.82 (p = 0.41) 02 Responders or naive to comparator DMARD (MTX) TEMPO 110 [104 weeks] Subtotal (95% CI) Total events: 44 (etanercept), 41 (control) Test for heterogeneity: NA Test for overall effect: z = 0.47 (p = 0.64) Etanercept n/N Control n/N 5/103 1/50 103 50 44/223 41/228 223 228 Total (95% CI) Total events: 49 (etanercept), 42 (control) Test for heterogeneity: 2 = 0.53, df = 1 (p = 0.47), I2 326 278 = 0% Test for overall effect: z = 0.68 (p = 0.50) FIGURE 20 SAE RR: etanercept licensed dose versus other active treatment WMD (fixed) 95% CI –1 –0.5 0 0.5 1 Favours etanercept Favours control RR (fixed) 95% CI 0.01 0.1 1 10 100 Favours etanercept Favours control Weight % 20.87 20.87 40.79 38.33 79.13 100.00 Weight % 3.21 3.21 96.79 96.79 100.00 WMD (fixed) 95% CI –0.40 (–0.58 to –0.22) –0.40 (–0.58 to –0.22) –0.10 (–0.23 to 0.03) –0.10 (–0.23 to 0.03) –0.10 (–0.19 to –0.01) RR (fixed) 95% CI 2.43 (0.29 to 20.23) 2.43 (0.29 to 20.23) 1.10 (0.75 to 1.61) 1.10 (0.75 to 1.61) 1.14 (0.78 to 1.66)
Review: Etanercept for rheumatoid arthritis 2006 Comparison: 03 Etanercept s.c. licensed dose only (25 mg twice weekly) vs other active treatment Outcome: 07 SAEs Study or subcategory 01 Partial responders to comparator DMARD (SSZ) Codreanu, 2003 103 [24 weeks] Subtotal (95% CI) Total events: 5 (etanercept), 1 (control) Test for heterogeneity: NA Test for overall effect: z = 0.98 (p = 0.32) 02 Responders or naive to comparator DMARD (MTX) TEMPO 110 [104 weeks] Subtotal (95% CI) Total events: 44 (etanercept), 41 (control) Test for heterogeneity: NA Test for overall effect: z = 0.47 (p = 0.64) Etanercept n/N © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Control n/N 5/103 1/50 103 50 44/223 41/228 223 228 Total (95% CI) Total events: 49 (etanercept), 42 (control) Test for heterogeneity: 2 = 0.09, df = 1 (p = 0.76), I2 326 278 = 0% Test for overall effect: z = 0.69 (p = 0.49) FIGURE 21 SAE RD: etanercept licensed dose versus other active treatment Review: Etanercept for rheumatoid arthritis 2006 Comparison: 03 Etanercept s.c. licensed dose only (25 mg twice weekly) vs other active treatment Outcome: 09 Malignancy Study or subcategory 01 Partial responders to comparator DMARD (SSZ) Codreanu, 2003 103 [24 weeks] Subtotal (95% CI) Total events: 2 (etanercept), 0 (control) Test for heterogeneity: NA Test for overall effect: z = 0.58 (p = 0.56) Etanercept n/N Control n/N 2/103 0/50 103 50 02 Responders or naive to comparator DMARD (MTX) TEMPO110 [104 weeks] ERA124 [104 weeks] Subtotal (95% CI) Total events: 10 (etanercept), 7 (control) Test for heterogeneity: 2 = 0.74, df = 1 (p = 0.39), I2 5/223 2/228 5/207 5/217 430 445 = 0% Test for overall effect: z = 0.8 (p = 0.42) Total (95% CI) Total events: 12 (etanercept), 7 (control) Test for heterogeneity: 2 = 0.85, df = 2 (p = 0.66), I2 533 495 = 0% Test for overall effect: z = 0.97 (p = 0.33) FIGURE 22 Malignancy RR: etanercept licensed dose versus other active treatment Health Technology Assessment 2006; Vol. 10: No. 42 RD (fixed) 95% CI –0.5 –0.25 0 0.25 0.5 Favours etanercept Favours control RR (fixed) 95% CI 0.01 0.1 1 10 100 Favours etanercept Favours control Weight % 22.99 22.99 77.01 77.01 100.00 Weight % 8.91 8.91 26.26 64.83 91.09 100.00 RD (fixed) 95% CI 0.03 (–0.03 to 0.09) 0.03 (–0.03 to 0.09) 0.02 (–0.05 to 0.09) 0.02 (–0.05 to 0.09) 0.02 (–0.04 to 0.08) RR (fixed) 95% CI 2.45 [0.12 to 50.13] 2.45 [0.12 to 50.13] 2.56 [0.50 to 13.04] 1.05 [0.31 to 3.57] 1.48 [0.57 to 3.87] 1.57 [0.63 to 3.91] 45
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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
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 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 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
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
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Page 109 and 110: 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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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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246 Health Technology Assessment Pr
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A systematic review of the effectiveness of adalimumab

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