Index of Studies by Key Question

Abbreviations used in the evidence tables

ACR

American College of Rheumatology

ADA

adalimumab

AEs

adverse events

AIDS

acquired immunodeficiency syndrome

AIMS

Arthritis Impact Measurement Scales

ANA

anakinra

ARA

American Rheumatism Association criteria (pre-1987)

AS

ankylosing spondylitis

ASHI

Arthritis-Specific Health Index (Medical Outcomes Study Short Form SF-36 Arthritis-specific Health Index)

AUC

area under the curve

BUD

budesonide

Ccs

corticosteroids

CFS

chronic fatigue syndrome

CHF

coronary heart failure

Cm

centimeters

Combo

combination therapy

CI

confidence interval

CHD

coronary heart disease

COPD

Chronic Obstructive Pulmonary Disease

CRP

C-reactive protein

CVD

cardiovascular disease

CXT

cyclophosamide

CYP

cyclosporine

Ds

days

DM

diabetes mellitus

DAS

Disease Activity Score

DMARD

disease modifying antirheumatic drug

D-HAQ

Dutch version of the Health Assessment Questionnaire (HAQ)

EQ-5D–

Quality of Life Questionnaire

ESR

erythrocyte sedimentation rate

ETA

etanercept

EULAR

European League against Rheumatism

EuroQol EQ-5D

European Quality of Life Questionnaire

EuroQOL VAS

European Quality of Life Visual Analogue Scale

GI

gastrointestinal

HAQ

Health Assessment Questionnaire

HAQ-DI

Disability Index of the Heath Assessment Questionnaire (HAQ)

HIV

Human immunodeficiency virus

HLA-DR4

Human immune-response, D-related antigen encoded by the D locus on chromosome 6

HR

hazard ratio

HRQOL

health related quality of life

ICD

International Classification of Diseases

INF

infliximab

ISRs

injection site reactions

ITT

intention to treat

JRA

juvenile rheumatoid arthritis

HCQ

hydroxychloroquine

JSN

joint space narrowing

LEF

leflunomide

MTX

methotrexate

Mg

milligrams

mSharp Scale

Modified Sharp Method for Scoring Radiographs

mos

months

MHAQ

Modified Health Assessment Questionnaire

NSAIDs

non-steroidal anti-inflammatory drugs

NSFHS

National Survey of Functional Health Status

NA

not applicable

NMSC

non-melanoma skin cancer

NR

not reported

NS

not significant

NYHA

New York Heart Association

OA

osteoarthritis

OR

odds ratio

OMERACT

Outcome Measures in Rheumatology Clinical Trials

PASI

Psoriasis Area and Severity Index

PNL

prednisolone

PRED

prednisone

PsA

psoriatic arthritis

PsARC

Psoriatic Arthritis Response Scale

Pt

patient

PY

person-year

QOL

quality of life

RCT

randomized controlled trial

RAI

Ritchie Articular Index

RA

rheumatoid arthritis

RDS

radiological damage score

RF

rheumatoid factor

RIT

rituximab

RR

risk ratio

SAEs

serious adverse events

SAARDs

slow-acting anti-rheumatic drugs

SCC

squamous cell carcinoma

SD

standard deviation

SF-36

Medical Outcomes Study Short Form 36 Health Survey

SJC

swollen joint count

SHS

Sharp/van der Heijde Method (SHS) for Scoring Radiographs

SIR

standardized incidence ratio

SLE

Systemic Lupus Erythematosus

SMR

standardized morbidity ratio

SSZ

sulfasalazine

SSTG

South Swedish Arthritis Treatment Group

TB

Tuberculosis

TIM

targeted immune modulator

TJC

tender joint count

TNF

tumor necrosis factor

Txt

treatment

URTI

upper respiratory tract infection

UTI

urinary tract infection

vs.

versus

yrs

years

w/

with

w/in

with in

w/o

with out

Evidence Tables

Evidence Table 1. Randomized controlled trials and observational studies (MS Word, 1.0M)

Evidence Table 2. Systematic reviews and meta-analyses (MS Word, 159K)

References

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2.

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3.

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15.

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16.

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17.

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18.

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19.

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20.

Brown SL, Greene MH, Gershon SK, et al. Tumor necrosis factor antagonist therapy and lymphoma development: twenty-six cases reported to the Food and Drug Administration. Arthritis Rheum. 2002 Dec;46(12):3151–8. [PubMed: 12483718]

21.

Burmester GR, Mariette X, Montecucco C, et al. Adalimumab alone and in combination with disease-modifying antirheumatic drugs for the treatment of rheumatoid arthritis in clinical practice: the Research in Active Rheumatoid Arthritis (ReAct) trial. Ann Rheum Dis. 2007;66(6):732–9. [PMC free article: PMC1954645] [PubMed: 17329305]

22.

Cannon GW, Holden WL, Juhaeri J, et al. Adverse events with disease modifying antirheumatic drugs (DMARD): a cohort study of leflunomide compared with other DMARD. J Rheumatol. 2004 Oct;31(10):1906–11. [PubMed: 15468352]

23.

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24.

Chakravarty EF, Michaud K, Wolfe F. Skin cancer, rheumatoid arthritis, and tumor necrosis factor inhibitors. J Rheumatol. 2005 Nov;32(11):2130–5. [PubMed: 16265690]

25.

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26.

Chung ES, Packer M, Lo KH, et al. Randomized, double-blind, placebo-controlled, pilot trial of infliximab, a chimeric monoclonal antibody to tumor necrosis factor-alpha, in patients with moderate-to-severe heart failure: results of the anti-TNF Therapy Against Congestive Heart Failure (ATTACH) trial. Circulation. 2003 Jul 1;107(25):3133–40. [PubMed: 12796126]

27.

Cohen SB, Emery P, Greenwald MW, et al. Rituximab for rheumatoid arthritis refractory to anti-tumor necrosis factor therapy: results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial evaluating primary efficacy and safety at twenty-four weeks. Arthritis Rheum. 2006;54(9):2793–806. [PubMed: 16947627]

28.

Keystone E, Burmester GR, Furie R, et al. Improvement in patient-reported outcomes in a rituximab trial in patients with severe rheumatoid arthritis refractory to anti-tumor necrosis factor therapy. Arthritis Rheum. 2008;59(6):785–93. [PubMed: 18512710]

29.

Keystone E, Emery P, Peterfy CG, et al. Rituximab inhibits structural joint damage in patients with rheumatoid arthritis with an inadequate response to tumour necrosis factor inhibitor therapies. Ann Rheum Dis. 2009;68(2):216–21. [PubMed: 18388156]

30.

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31.

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32.

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33.

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34.

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35.

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36.

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37.

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38.

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39.

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40.

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41.

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42.

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43.

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44.

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45.

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46.

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47.

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48.

Emery P, Breedveld FC, Hall S, et al. Comparison of methotrexate monotherapy with a combination of methotrexate and etanercept in active, early, moderate to severe rheumatoid arthritis (COMET): a randomised, double-blind, parallel treatment trial. Lancet. 2008;372(9636):375–82. [PubMed: 18635256]

49.

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50.

Emery P, Fleischmann RM, Moreland LW, et al. Golimumab, a human anti-tumor necrosis factor alpha monoclonal antibody, injected subcutaneously every four weeks in methotrexate-naive patients with active rheumatoid arthritis: twenty-four-week results of a phase III, multicenter, randomized, double-blind, placebo-controlled study of golimumab before methotrexate as first-line therapy for early-onset rheumatoid arthritis. Arthritis Rheum. 2009;60(8):2272–83. [PubMed: 19644849]

51.

Emery P, Breedveld F, van der Heijde D, et al. Two-year clinical and radiographic results with combination etanercept-methotrexate therapy versus monotherapy in early rheumatoid arthritis: a two-year, double-blind, randomized study. Arthritis Rheum. 2010;62(3):674–82. [PubMed: 20187135]

52.

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53.

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54.

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55.

Finckh A, Ciurea A, Brulhart L, et al. B cell depletion may be more effective than switching to an alternative anti-tumor necrosis factor agent in rheumatoid arthritis patients with inadequate response to anti-tumor necrosis factor agents. Arthritis Rheum. 2007;56(5):1417–23. [PubMed: 17469098]

56.

Finckh A, Dehler S, Gabay C. The effectiveness of leflunomide as a co-therapy of tumour necrosis factor inhibitors in rheumatoid arthritis: a population-based study. Ann Rheum Dis. 2009;68(1):33–9. [PubMed: 18230627]

57.

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58.

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59.

Schiff MH, DiVittorio G, Tesser J, et al. The safety of anakinra in high-risk patients with active rheumatoid arthritis: six-month observations of patients with comorbid conditions. Arthritis Rheum. 2004 Jun;50(6):1752–60. [PubMed: 15188350]

60.

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61.

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62.

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63.

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64.

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65.

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66.

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67.

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68.

Geborek P, Bladstrom A, Turesson C, et al. Tumour necrosis factor blockers do not increase overall tumour risk in patients with rheumatoid arthritis, but may be associated with an increased risk of lymphomas. Ann Rheum Dis. 2005 May;64(5):699–703. [PMC free article: PMC1755491] [PubMed: 15695534]

69.

Genovese MC, Cohen S, Moreland L, et al. Combination therapy with etanercept and anakinra in the treatment of patients with rheumatoid arthritis who have been treated unsuccessfully with methotrexate. Arthritis Rheum. 2004 May;50(5):1412–9. [PubMed: 15146410]

70.

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71.

Goekoop-Ruiterman YP, de Vries-Bouwstra JK, Allaart CF, et al. Clinical and radiographic outcomes of four different treatment strategies in patients with early rheumatoid arthritis (the BeSt study): a randomized, controlled trial. Arthritis Rheum. 2005 Nov;52(11):3381–90. [PubMed: 16258899]

72.

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73.

Goekoop-Ruiterman YPM, De Vries-Bouwstra JK, Allaart CF, et al. Comparison of treatment strategies in early rheumatoid arthritis: a randomized trial. Ann Intern Med. 2007;146(6):406–15. [PubMed: 17371885]

74.

van der Kooij SM, de Vries-Bouwstra JK, Goekoop-Ruiterman YP, et al. Patient-reported outcomes in a randomized trial comparing four different treatment strategies in recent-onset rheumatoid arthritis. Arthritis Rheum. 2009 Jan 15;61(1):4–12. [PubMed: 19116965]

75.

van der Kooij SM, Goekoop-Ruiterman YP, de Vries-Bouwstra JK, et al. Drug-free remission, functioning and radiographic damage after 4 years of response-driven treatment in patients with recent-onset rheumatoid arthritis. Ann Rheum Dis. 2009;68(6):914–21. [PubMed: 18662933]

76.

Gomez-Reino JJ, Carmona L, Valverde VR, et al. Treatment of rheumatoid arthritis with tumor necrosis factor inhibitors may predispose to significant increase in tuberculosis risk: a multicenter active-surveillance report. Arthritis Rheum. 2003 Aug;48(8):2122–7. [PubMed: 12905464]

77.

Greenberg JD, Reed G, Kremer JM, et al. Association of methotrexate and tumour necrosis factor antagonists with risk of infectious outcomes including opportunistic infections in the CORRONA registry. Ann Rheum Dis. 2010;69(2):380–6. [PMC free article: PMC2861900] [PubMed: 19359261]

78.

Grijalva CG, Chung CP, Arbogast PG, et al. Assessment of adherence to and persistence on disease-modifying antirheumatic drugs (DMARDs) in patients with rheumatoid arthritis. Med Care. 2007;45(10 Supl 2):S66–76. [PubMed: 17909386]

79.

Grijalva CG, Kaltenbach L, Arbogast PG, et al. Initiation of rheumatoid arthritis treatments and the risk of serious infections. Rheumatology (Oxford). 2010:4982–90. [PMC free article: PMC2909794] [PubMed: 19906833]

80.

Haagsma CJ, van Riel PL, de Jong AJ, et al. Combination of sulphasalazine and methotrexate versus the single components in early rheumatoid arthritis: a randomized, controlled, double-blind, 52 week clinical trial. Br J Rheumatol. 1997;36(10):1082–8. [PubMed: 9374925]

81.

Harley CR, Frytak JR, Tandon N. Treatment compliance and dosage administration among rheumatoid arthritis patients receiving infliximab, etanercept, or methotrexate. Am J Manag Care. 2003 Oct;9(6 Suppl):S136–43. [PubMed: 14577718]

82.

Harrison MJ, Dixon WG, Watson KD, et al. Rates of new-onset psoriasis in patients with rheumatoid arthritis receiving anti-tumour necrosis factor alpha therapy: results from the British Society for Rheumatology Biologics Register. Ann Rheum Dis. 2009;68(2):209–15. [PMC free article: PMC2605571] [PubMed: 18385277]

83.

Hetland ML, Christensen IJ, Tarp U, et al. Direct comparison of treatment responses, remission rates, and drug adherence in patients with rheumatoid arthritis treated with adalimumab, etanercept, or infliximab results from eight years of surveillance of clinical practice in the Nationwide Danish DANBIO Registry. Arthritis Rheum. 2010;62(1):22–32. [PubMed: 20039405]

84.

Hjardem E, Ostergaard M, Podenphant J, et al. Do rheumatoid arthritis patients in clinical practice benefit from switching from infliximab to a second tumor necrosis factor alpha inhibitor? Ann Rheum Dis. 2007;66(9):1184–9. [PMC free article: PMC1955158] [PubMed: 17389656]

85.

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