A systematic review of the effectiveness of adalimumab

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42 Effectiveness Review: Etanercept for rheumatoid arthritis 2006 Comparison: 03 Etanercept s.c. licensed dose only (25 mg twice weekly) vs other active treatment Outcome: 02 ACR50 responder Study or subcategory 01 Partial responders to comparator DMARD (SSZ) Codreanu, 2003 103 [24 weeks] Subtotal (95% CI) Total events: 48 (etanercept), 7 (control) Test for heterogeneity: NA Test for overall effect: z = 3.29 (p = 0.001) 02 Responders or naive to comparator DMARD (MTX) TEMPO 110 [100 weeks] ERA 124 [104 weeks] Subtotal (95% CI) Etanercept n/N Test for heterogeneity: 2 = 2.05, df = 1 (p = 0.15), I 2 = 51.1% Test for overall effect: z = 3.18 (p = 0.001) Control n/N 48/103 7/50 103 50 98/223 68/228 101/207 91/217 430 445 Total (95% CI) Total events: 247 (etanercept), 166 (control) Test for heterogeneity: 2 = 8.88, df = 2 (p = 0.001), I2 533 495 = 77.5% Test for overall effect: z = 4.28 (p < 0.0001) FIGURE 15 ACR50 RR: 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: 02 ACR50 responder Study or subcategory 01 Partial responders to comparator DMARD (SSZ) Codreanu, 2003 103 [24 weeks] Subtotal (95% CI) Total events: 48 (etanercept), 7 (control) Test for heterogeneity: NA Test for overall effect: z = 4.69 (p < 0.00001) Etanercept n/N Control n/N 48/103 7/50 103 50 02 Responders or naive to comparator DMARD (MTX) TEMPO110 [100 weeks] ERA124 [104 weeks] Subtotal (95% CI) Total events: 199 (etanercept), 159 (control) Test for heterogeneity: 2 = 1.21, df = 1 (p = 0.27), I2 98/223 101/207 68/228 91/217 430 445 = 17.7% Test for overall effect: z = 3.22 (p = 0.001) Total (95% CI) Total events: 247 (etanercept), 166 (control) Test for heterogeneity: 2 = 9.47, df = 2 (p = 0.009), I2 533 495 = 78.9% Test for overall effect: z = 4.51 (p < 0.00001) FIGURE 16 ACR50 RD: etanercept licensed dose versus other active treatment RR (fixed) 95% CI 0.01 0.1 1 10 100 Favours control Favours etanercept RD (fixed) 95% CI –1 –0.5 0 0.5 1 Favours control Favours etanercept Weight % 5.69 5.69 40.63 53.68 94.31 100.00 Weight % 13.34 13.34 44.68 41.98 86.66 100.00 RR (fixed) 95% CI 3.33 (1.62 to 6.82) 3.33 (1.62 to 6.82) 1.47 (1.15 to 1.89) 1.16 (0.94 to 1.44) 1.30 (1.10 to 1.52) RD (fixed) 95% CI 0.33 (0.19 to 0.46) 0.33 (0.19 to 0.46) 0.14 (0.05 to 0.23) 0.07 (–0.03 to 0.16) 0.11 (0.04 to 0.17)
Review: Etanercept for rheumatoid arthritis 2006 Comparison: 03 Etanercept s.c. licensed dose only (25 mg twice weekly) vs other active treatment Outcome: 03 ACR70 responder Study or subcategory 01 Partial responders to comparator DMARD (SSZ) Codreanu, 2003 103 [24 weeks] Subtotal (95% CI) Total events: 22 (etanercept), 1 (control) Test for heterogeneity: NA Test for overall effect: z = 2.35 (p = 0.02) Etanercept n/N © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Control n/N 22/103 1/50 103 50 02 Responders or naive to comparator DMARD (MTX) TEMPO110 [100 weeks] ERA124 [104 weeks] Subtotal (95% CI) Total events: 113 (etanercept), 88 (control) Test for heterogeneity: 2 = 0.46, df = 1 (p = 0.50), I2 53/223 60/207 37/228 51/217 430 445 = 0% Test for overall effect: z = 2.29 (p = 0.02) Total (95% CI) Total events: 135 (etanercept), 89 (control) Test for heterogeneity: 2 = 5.05, df = 2 (p = 0.08), I2 533 495 = 60.4% Test for overall effect: z = 3.13 (p = 0.002) FIGURE 17 ACR70 RR: 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: 03 ACR70 responder Study or subcategory 01 Partial responders to comparator DMARD (SSZ) Codreanu, 2003 103 [24 weeks] Subtotal (95% CI) Total events: 22 (etanercept), 1 (control) Test for heterogeneity: NA Test for overall effect: z = 4.30 (p < 0.0001) Etanercept n/N Control n/N 22/103 1/50 103 50 02 Responders or naive to comparator DMARD (MTX) TEMPO110 [100 weeks] ERA124 [104 weeks] Subtotal (95% CI) Total events: 113 (etanercept), 88 (control) Test for heterogeneity: 2 = 0.13, df = 1 (p = 0.72), I2 53/223 60/207 37/228 51/217 430 445 = 0% Test for overall effect: z = 2.31 (p = 0.02) Total (95% CI) Total events: 135 (etanercept), 189 (control) Test for heterogeneity: 2 = 6.56, df = 2 (p = 0.04), I2 533 495 = 69.5% Test for overall effect: z = 3.27 (p = 0.001) FIGURE 18 ACR70 RD: etanercept licensed dose versus other active treatment Health Technology Assessment 2006; Vol. 10: No. 42 RR (fixed) 95% CI 0.01 0.1 1 10 100 Favours control Favours etanercept RD (fixed) 95% CI –1 –0.5 0 0.5 1 Favours control Favours etanercept Weight % 1.53 1.53 41.71 56.76 98.47 100.00 Weight % 13.34 13.34 44.68 41.98 86.66 100.00 RR (fixed) 95% CI 10.68 (1.48 to 76.99) 10.68 (1.48 to 76.99) 1.46 (1.00 to 2.14) 1.23 (0.89 to 1.70) 1.33 (1.04 to 1.70) RD (fixed) 95% CI 0.19 (0.11 to 0.28) 0.19 (0.11 to 0.28) 0.08 (0.00 to 0.15) 0.05 (–0.03 to 0.14) 0.07 (0.01 to 0.12) 43
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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
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 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 60 and 61: 44 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
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Page 101 and 102: To estimate the long-term consequen
Page 103 and 104: TABLE 32 TNF inhibitors as last act
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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
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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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