A systematic review of the effectiveness of adalimumab

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viii Glossary and list of abbreviations List of abbreviations ACR American College for Rheumatology Adal adalimumab ADORE Add Enbrel or Replace Methotrexate (study) ARAMIS Arthritis, Rheumatism and Aging Medical Information System ARMADA Anti-Tumor Necrosis Factor Research Study Program of the Monoclonal Antibody Adalimumab (D2E7) in Rheumatoid Arthritis ASPIRE Active-controlled Study of Patients Receiving Infliximab for the Treatment of Rheumatoid Arthritis of Early Onset ATTRACT Anti-TNF Trial in Rheumatoid Arthritis with Concomitant Therapy AUC area under the curve AZA azathioprine BCP biochemical profile BeSt Behandel–Strategieën study BRAM Birmingham Rheumatoid Arthritis Model BSR British Society for Rheumatology BSRBR British Society for Rheumatology Biologics Register CHEC Consensus on Health Economic Criteria CI Confidence interval CRP C-reactive protein CXR chest X-ray CyA ciclosporin DAS Disease Activity Score DMARD disease-modifying antirheumatic drug DPen penicillamine EMEA European Medicines Agency EQ-5D EuroQol 5 Dimensions ERA Early Rheumatoid Arthritis study ESR erythrocyte sedimentation rate Etan etanercept EULAR European League Against Rheumatism FBC full blood count FDA Food and Drug Administration GPRD General Practice Research Database GST injectable gold HAQ Health Assessment Questionnaire HCQ hydroxychloroquine HLA human leucocyte antigen i.m. intramuscular i.v. intravenous ICER incremental cost-effectiveness ratio IgG immunoglobulin G IL-1 interleukin-1 IL-2 interleukin-2 IL-6 interleukin-6 Infl infliximab IQR interquartile range ITT intention-to-treat LEF leflunomide continued
List of abbreviations continued MCP metacarpophalangeal joint MHAQ Modified Health Assessment Questionnaire MRI magnetic resonance imaging MTX methotrexate NA not applicable NICE National Institute for Health and Clinical Excellence NNH number needed to harm NNT number needed to treat NR not reported NSAID non-steroidal anti-inflammatory drug Pall palliation PCT primary care trust PREMIER A prospective, randomised trial (DE013) comparing adalimumab, methotrexate, and the combination of both over 2 years in patients with early rheumatoid arthritis PSS Personal and Social Services QoL quality of life QALY quality-adjusted life-year QSE quasi-standard error TNF-R tumour necrosis factor receptor RA rheumatoid arthritis RCT randomised controlled trial RD risk difference RR relative risk s.c. subcutaneous Health Technology Assessment 2006; Vol. 10: No. 42 SAE serious adverse event SD standard deviation SDD smallest detectable difference SEER Surveillance Epidemiology and End Results SEM standard error of the mean SF-36 Short Form 36 SJC swollen joint count SLE systemic lupus erythematosus SMD standardised mean difference SSZ sulfasalazine STAR Safety Trial of Adalimumab in Rheumatoid Arthritis START Safety Trial for Rheumatoid Arthritis with Remicade Therapy sTNFR soluble tumour necrosis factor receptor TACE tumour necrosis factor- converting enzyme TEMPO Trial of Etanercept and Methotrexate with Radiographic Patient Outcomes TJC tender joint count TNF tumour necrosis factor TNF- tumour necrosis factor- VAS visual analogue scale WMD weighted mean difference WR weighted response All abbreviations that have been used in this report are listed here unless the abbreviation is well known (e.g. NHS), or it has been used only once, or it is a non-standard abbreviation used only in figures/tables/appendices in which case the abbreviation is defined in the figure legend or at the end of the table. © Queen’s Printer and Controller of HMSO 2006. All rights reserved. ix
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 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
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44 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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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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No. 11 First and second trimester a
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No. 28 Outcomes of electrically sti
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No. 28 Adefovir dipivoxil and pegyl
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