Research Article| Volume 22, ISSUE 1, P128-139, January 2000

Health-related quality of life and functional status of patients with rheumatoid arthritis randomly assigned to receive etanercept or placebo

      This paper is only available as a PDF. To read, Please Download here.


      To compare the functional status and well-being of patients with rheumatoid arthritis (RA) who were randomly assigned to receive placebo, etanercept 10 mg, or etanercept 25 mg during a 26-week, phase III, double-blind clinical trial.


      No single indicator of disease activity, severity, or therapeutic efficacy has been established for RA. During the past decade, health-related quality of life, a multidimensional way to assess physical, emotional, and social aspects of a disease or its treatment, has become an important outcome in RA studies and in assessments of RA drug therapies.


      A total of 234 patients completed the Health Assessment Questionnaire (HAQ), the Short-Form 36 (SF-36) (n = 48 patients), items assessing energy and mental health from the Medical Outcomes Study (MOS), and a single-item rating scale assessing current health (feeling thermometer) at baseline and several times during 6 months.


      Significant improvements from baseline to last assessment were reported with etanercept versus placebo and in the HAQ Disability Index score (ie, the total HAQ score) and all 8 HAQ categories (P < 0.05), with the exception of grip. Significant improvements with etanercept in the MOS energy and mental health subscales, current health (from the feeling thermometer), and mental and physical function components of the SF-36 were reported (P < 0.05).


      Patients receiving 10- or 25-mg doses of etanercept reported significantly better functional status and well-being than did patients receiving placebo.

      Key words

      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'


      Subscribe to Clinical Therapeutics
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect


        • Grossman JM
        • Brahn E
        Rheumatoid arthritis: Current clinical and research directions.
        J Women's Health. 1997; 6: 627-638
        • Abdel-Nasser AM
        • Rasker JJ
        • Valkenburg HA
        Epidemiological and clinical aspects relating to the variability of rheumatoid arthritis.
        in: Semin Arthritis Rheum.27. 1997: 123-140
        • Drosos AA
        • Alamanos I
        • Voulgari PV
        • et al.
        Epidemiology of adult rheumatoid arthritis in northwest Greece 1987–1995.
        J Rheumatol. 1997; 24: 2129-2133
        • Lipsky PE
        Rheumatoid arthritis.
        in: Fauci AS Braunwald E Isselbacher KJ Harrison's Principles of Internal Medicine. 14th ed. McGraw-Hill, New York1998: 1880-1888
        • Bendtsen P
        • Hörnquist JO
        Change and status in quality of life in patients with rheumatoid arthritis.
        Qual Life Res. 1992; 1: 296-305
        • Mason JH
        • Weener JL
        • Gertman PM
        • Meenan RF
        Health status in chronic disease: A comparative study of rheumatoid arthritis.
        J Rheumatol. 1983; 10: 763-768
        • Sullivan S
        • Swims M
        Rheumatoid arthritis: Focus on appropriate drug therapy.
        Am J Managed Care. 1998; 4: 900-910
        • Liang MH
        • Cullen KE
        • Larson MG
        Measuring function and health status in rheumatic disease clinical trials.
        Clin Rheum Dis. 1983; 9: 531-539
        • Bombardier C
        • Ware J
        • Russell IJ
        Auranofin therapy and quality of life in patients with rheumatoid arthritis: Results of a multicenter trial.
        Am J Med. 1986; 81: 565-578
        • Cheah SY
        • Clark C
        • Goldberg A
        • et al.
        Outcome measures, pooled index and quality of life instruments in rheumatoid arthritis.
        J Clin Pharm Ther. 1996; 21: 297-316
        • Fries JF
        • Ramey DR
        “Arthritis specific” global health analog scales assess “generic” health related quality-of-life in patients with rheumatoid arthritis.
        J Rheumatol. 1997; 24: 1697-1702
        • Bendtsen P
        • Akerlind I
        • Hörnquist JO
        Assessment of quality of life in rheumatoid arthritis: Methods and implications.
        Pharmacoeconomics. 1994; 5: 286-298
        • Tugwell P
        • Bombardier C
        • Buchanan WW
        • et al.
        Methotrexate in rheumatoid arthritis. Impact on quality of life assessed by traditional standard-item and individualized patient preference health status questionnaires.
        Arch Intern Med. 1994; 150: 59-62
        • Bell MJ
        • Bombardier C
        • Tugwell P
        Measurement of functional status, quality of life, and utility in rheumatoid arthritis.
        Arthritis Rheum. 1990; 33: 591-601
        • Fries JF
        • Spitz PW
        • Craines RG
        • Holman HR
        Measurement of patient outcome in arthritis.
        Arthritis Rheum. 1980; 23: 137-145
        • Jette AM
        Functional status index: Reliability of a chronic disease evaluation instrument.
        Arch Phys Med Rehabil. 1980; 61: 395-401
        • Staff of the Benjamin Rose Hospital
        Multidisciplinary studies of illness in aged persons: III. Prognostic indices in fracture of hip.
        J Chronic Dis. 1960; 11: 445-455
        • Cella DF
        • Tulsky DS
        Measuring quality of life today: Methodological aspects.
        Oncology. 1990; 4: 29-38
        • Ware JE
        • Sherboume CD
        The MOS 36-Item Short-Form Health Status Survey (SF-36): I. Conceptual framework and item selection.
        Med Care. 1992; 30: 473-483
        • Tuttleman M
        • Pillemer SR
        • Tilley BC
        • et al.
        A cross sectional assessment of health status instruments in patients with rheumatoid arthritis participating in a clinical trial.
        J Rheumatol. 1997; 24: 1910-1915
        • Jensen MP
        • Karoly P
        Self-report scales and procedures for assessing pain in adults.
        in: Turk DC Melzack M Handbook of Pain Assessments. Guilford Press, New York1992: 35-151
        • Moreland LW
        • Schiff MH
        • Baumgartner SW
        • et al.
        Etanercept therapy in rheumatoid arthritis. A randomized, controlled trial.
        Ann Intern Med. 1999; 130: 478-486
        • Arnett FC
        • Edworthy SM
        • Bloch DA
        • et al.
        The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis.
        Arthritis Rheum. 1988; 31: 315-324
        • Hochberg MC
        • Chang RW
        • Dwosh I
        • et al.
        The American College of Rheumatology 1991 revised criteria for the classification of global functional status in rheumatoid arthritis.
        Arthritis Rheum. 1992; 35: 498-502
        • Hawley DJ
        • Wolfe F
        Sensitivity to change of the health assessment questionnaire (HAQ) and other clinical and health status measures in rheumatoid arthritis: Results of short-term clinical trials and observational studies versus long-term observational studies.
        Arthritis Care Res. 1992; 5: 130-136
        • Gardiner PV
        • Sykes HR
        • Hassey GA
        • Walker DJ
        An evaluation of the Health Assessment Questionnaire in long-term longitudinal follow-up of disability in rheumatoid arthritis.
        Br J Rheumatol. 1993; 32: 724-728
        • Kramer CY
        Extension of multiple range tests to group means with unequal numbers of replications.
        Biometrics. 1956; 12: 309-310
        • Strand V
        • Tugwell P
        • Claire B
        • et al.
        Function and health-related quality of life: Results from a randomized, controlled trial of leflunomide versus methotrexate or placebo in patients with active rheumatoid arthritis.
        Arthritis Rheum. 1999; 42: 1870-1878