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Donahue KE, Gartlehner G, Jonas DE, et al. Comparative Effectiveness of Drug Therapy for Rheumatoid Arthritis and Psoriatic Arthritis in Adults [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2007 Nov. (Comparative Effectiveness Reviews, No. 11.)

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Comparative Effectiveness of Drug Therapy for Rheumatoid Arthritis and Psoriatic Arthritis in Adults [Internet].

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Appendix HCharacteristics of Studies With Poor Internal Validity

StudyDesignSample SizeInterventionReason for Exclusion
Bathon et al., 20061Pooled data analysis2,402EtanerceptSelection bias
de Nijs et al., 20012Cross-sectional410CorticosteroidsSelection bias
Faarvang et al., 19933RCT91Hydroxychloroquine SulfasalazineNo ITT analysis; high LTF
†Fleischmann et al., 20034Pooled data analysis1128EtanerceptSelection bias
Flendrie et al, 20035Retrospective cohort study230Adalimumab Etanercept InfliximabHigh differential LTF; no ITT analysis
Flendrie et al., 20056Observational162Leflunomide infliximabHigh LTF; selection bias
Hansen et al., 19997RCT102DMARDs PrednisoloneHigh attrition; no ITT analysis
Langer et al., 20038Post-marketing surveillance454AnakinraNo comparison group; no ITT analysis
Moreland et al., 20069Pooled retrospective analysis714EtanerceptHigh LTF; completers analysis only
O’Dell et al., 200610Prospective open-label study119Etanercept Hydroxychloroquine SulfasalazineBias due to poor ITT design
Svensson et al, 200311Open-label RCT245Methotrexate Prednisolone SulfasalazineHigh post-randomization exclusions; high differential LTF

ITT, intention to treat; LTF, loss to followup; RCT, randomized controlled trial.

Included for subgroups

Rated fair for adverse events


Bathon JM, Fleischmann RM, Van der Heijde D, Tesser JR, Peloso PM, Chon Y, et al. Safety and efficacy of etanercept treatment in elderly subjects with rheumatoid arthritis. J Rheumatol. 2006 Feb;33(2):234–43. [PubMed: 16465653]
de Nijs RN, Jacobs JW, Bijlsma JW, Lems WF, Laan RF, Houben HH, et al. Prevalence of vertebral deformities and symptomatic vertebral fractures in corticosteroid treated patients with rheumatoid arthritis. Rheumatology (Oxford) 2001 Dec;40(12):1375–83. [PubMed: 11752508]
Faarvang K, Egsmose C, Kryger P, Podenphant J, Ingeman Nielsen M, Hansen TM. Hydroxychloroquine and Sulphasalazine Alone and in Combination in Rheumatoid Arthritis: a Randomised Double Blind Trial. Annals of the rheumatic diseases. 1993;52(10):711–5. [PMC free article: PMC1005166] [PubMed: 7903034]
Fleischmann RM, Baumgartner SW, Tindall EA, Weaver AL, Moreland LW, Schiff MH, et al. Response to etanercept (Enbrel) in elderly patients with rheumatoid arthritis: a retrospective analysis of clinical trial results. J Rheumatol. 2003 Apr;30(4):691–6. [PubMed: 12672185]
Flendrie M, Creemers MC, Welsing PM, den Broeder AA, van Riel PL. Survival during treatment with tumour necrosis factor blocking agents in rheumatoid arthritis. Ann Rheum Dis . 2003 Nov;62(Suppl 2):ii, 30–3. [PMC free article: PMC1766750] [PubMed: 14532145]
Flendrie M, Creemers MC, Welsing PM, van Riel PL. The influence of previous and concomitant leflunomide on the efficacy and safety of infliximab therapy in patients with rheumatoid arthritis; a longitudinal observational study. Rheumatology (Oxford) 2005 Apr;44(4):472–8. [PubMed: 15598707]
Hansen M, Podenphant J, Florescu A, Stoltenberg M, Borch A, Kluger E, et al. A Randomised Trial of Differentiated Prednisolone Treatment in Active Rheumatoid Arthritis. Clinical Benefits and Skeletal Side Effects. Annals of the rheumatic diseases. 1999;58(11):713–8. [PMC free article: PMC1752793] [PubMed: 10531077]
Langer HE, Missler-Karger B. Kineret: efficacy and safety in daily clinical practice: an interim analysis of the Kineret response assessment initiative (kreative) protocol. Int J Clin Pharmacol Res. 2003;23(4):119–28. [PubMed: 15224501]
Moreland LW, Weinblatt ME, Keystone EC, Kremer JM, Martin RW, Schiff MH, et al. Etanercept treatment in adults with established rheumatoid arthritis: 7 years of clinical experience. J Rheumatol. 2006 May;33(5):854–61. [PubMed: 16541481]
O’Dell JR, Petersen K, Leff R, Palmer W, Schned E, Blakely K, et al. Etanercept in combination with sulfasalazine, hydroxychloroquine, or gold in the treatment of rheumatoid arthritis. J Rheumatol. 2006 Feb;33(2):213–8. [PubMed: 16358366]
Svensson B, Ahlmen M, Forslind K. Treatment of early RA in clinical practice: a comparative study of two different DMARD/corticosteroid options. Clin Exp Rheumatol . 2003 May–Jun;21(3):327–32. [PubMed: 12846051]


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