A systematic review of the effectiveness of adalimumab
A systematic review of the effectiveness of adalimumab A systematic review of the effectiveness of adalimumab
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
viii<br />
Glossary and list <strong>of</strong> abbreviations<br />
List <strong>of</strong> abbreviations<br />
ACR American College for<br />
Rheumatology<br />
Adal <strong>adalimumab</strong><br />
ADORE Add Enbrel or Replace<br />
Methotrexate (study)<br />
ARAMIS Arthritis, Rheumatism and Aging<br />
Medical Information System<br />
ARMADA Anti-Tumor Necrosis Factor<br />
Research Study Program <strong>of</strong> <strong>the</strong><br />
Monoclonal Antibody<br />
Adalimumab (D2E7) in<br />
Rheumatoid Arthritis<br />
ASPIRE Active-controlled Study <strong>of</strong><br />
Patients Receiving Infliximab for<br />
<strong>the</strong> Treatment <strong>of</strong> Rheumatoid<br />
Arthritis <strong>of</strong> Early Onset<br />
ATTRACT Anti-TNF Trial in Rheumatoid<br />
Arthritis with Concomitant<br />
Therapy<br />
AUC area under <strong>the</strong> curve<br />
AZA azathioprine<br />
BCP biochemical pr<strong>of</strong>ile<br />
BeSt Behandel–Strategieën study<br />
BRAM Birmingham Rheumatoid<br />
Arthritis Model<br />
BSR British Society for Rheumatology<br />
BSRBR British Society for Rheumatology<br />
Biologics Register<br />
CHEC Consensus on Health Economic<br />
Criteria<br />
CI Confidence interval<br />
CRP C-reactive protein<br />
CXR chest X-ray<br />
CyA ciclosporin<br />
DAS Disease Activity Score<br />
DMARD disease-modifying antirheumatic<br />
drug<br />
DPen penicillamine<br />
EMEA European Medicines Agency<br />
EQ-5D EuroQol 5 Dimensions<br />
ERA Early Rheumatoid Arthritis study<br />
ESR erythrocyte sedimentation rate<br />
Etan etanercept<br />
EULAR European League Against<br />
Rheumatism<br />
FBC full blood count<br />
FDA Food and Drug Administration<br />
GPRD General Practice Research<br />
Database<br />
GST injectable gold<br />
HAQ Health Assessment Questionnaire<br />
HCQ hydroxychloroquine<br />
HLA human leucocyte antigen<br />
i.m. intramuscular<br />
i.v. intravenous<br />
ICER incremental cost-<strong>effectiveness</strong><br />
ratio<br />
IgG immunoglobulin G<br />
IL-1 interleukin-1<br />
IL-2 interleukin-2<br />
IL-6 interleukin-6<br />
Infl infliximab<br />
IQR interquartile range<br />
ITT intention-to-treat<br />
LEF leflunomide<br />
continued
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